text:
Moxibustion for treating knee osteoarthritis: study protocol of a multicentre randomised controlled trial
Seunghoon Lee1,2,
Kun Hyung Kim3,
Tae-Hun Kim4,
Jung-Eun Kim1,
Joo-Hee Kim1,2,
Jung Won Kang2,
Kyung-Won Kang1,
So-Young Jung1,
Ae-Ran Kim1,
Hyo-Ju Park1,
Mi-Suk Shin1,
Kwon-Eui Hong5,
Ho-Sueb Song6,
Jin-Bong Choi7,
Hyung-Jun Kim8 &
Sun-Mi Choi1
The treatment of knee osteoarthritis, which is a major cause of disability among the elderly, is typically selected from multidisciplinary options, including complementary and alternative medicine. Moxibustion has been used in the treatment of knee osteoarthritis in Korea to reduce pain and improve physical activity. However, there is no sufficient evidence of its effectiveness, and it cannot therefore be widely recommended for treating knee osteoarthritis. We designed a randomised controlled clinical trial to evaluate the effectiveness, safety, cost-effectiveness, and qualitative characteristics of moxibustion treatment of knee osteoarthritis compared to usual care.
Methods/designs
This is a protocol for a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. A total of 212 participants will be assigned to the moxibustion group (n = 106) and the usual care group (n = 106) at 4 clinical research centres. The participants assigned to the moxibustion group will receive moxibustion treatment of the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) 3 times per week for 4 weeks (a total of 12 sessions). Participants in the usual care group will not receive moxibustion treatment during the study period. Follow-up will be performed on the 5th and 13th weeks after random allocation. Both groups will be allowed to use any type of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. Educational material that explains knee osteoarthritis, the current management options, and self-exercise will be provided to each group. The global scale of the Korean Western Ontario and McMaster Osteoarthritis Index (K-WOMAC) will be the primary outcome measurement used in this study. Other subscales (pain, stiffness, and function) of the K-WOMAC, the Short-Form 36v2 Health Survey, the Beck Depression Inventory, the Physical Function test, Patient Global Assessment, and the Pain Numerical Rating Scale will be used as outcome variables to evaluate the effectiveness of moxibustion. Safety will be assessed at every visit. In addition, an economic evaluation and a qualitative study will be conducted as a mixed-methods approach.
This trial may contribute to developing evidence for the effectiveness and safety of moxibustion for treating knee osteoarthritis.
Trial registration number:KCT0000130
Osteoarthritis (OA) is the most common form of arthritis in the elderly, and it is characterised by pain and functional limitation, leading to a reduction in quality of life [1, 2]. It is an active disease process involving the focal loss of articular cartilage, subchondral bone thickening, and new bone formation [3].
Non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen are the most common pharmacological agents used to treat OA. However, according to recent studies, these products only help to slightly reduce short-term pain and do not inhibit disease progression [4, 5]. Furthermore, these drugs are associated with adverse events, such as gastrointestinal irritation and bleeding, perforating ulcers, and renal and hepatic toxicity. Therefore, patients who experience unsatisfactory results and a risk of adverse events using pharmacological agents are recommended to pursue non-pharmacological treatments, including complementary and alternative medicines, such as acupuncture and moxibustion [6].
Moxibustion is a traditional oriental therapy that treats diseases through thermal stimulation by burning herbs, primarily Artemisia vulgaris, at specific spots on the skin [7]. It has been used for various diseases, such as OA, stroke, and hot flushes, in addition to acupuncture in the traditional medical systems of Korea, China, Japan, Vietnam, and Mongolia [8].
Acupuncture has been studied sufficiently to demonstrate that it has benefits for peripheral knee osteoarthritis (KOA) [6, 9]. One systematic review evaluated acupuncture for peripheral joint OA and included 14 randomised controlled trials (RCTs) for KOA (a total of 18 RCTs); acupuncture was shown to be efficacious for pain control in KOA in sham-controlled RCTs [6]. In the Cochrane review, the authors concluded that acupuncture for peripheral joint OA had statistically significant and clinically relevant benefits in waiting list-controlled trials [9].
However, according to a recent systematic review [10] on the use of moxibustion for rheumatic conditions, only 4 RCTs [11–14] on KOA using moxibustion have been published, and it is difficult to provide conclusive evidence for the effectiveness of moxibustion in treating rheumatic conditions, including KOA because of a high risk of bias with low methodological quality. Therefore, high-quality studies following the CONSORT 2010 Statement and revised STRICTA are necessary to determine whether moxibustion is an effective treatment for KOA [15, 16]. In addition, even if a placebo moxibustion procedure was developed, a successfully validated placebo moxibustion method that could be used in a double-blind RCT does not yet exist [17, 18]. Thus, a pragmatic design using a usual care group is appropriate for evaluating overall effectiveness in a moxibustion trial [19].
More than half of Doctors of Korean Medicine (DKMs) use moxibustion to treat KOA [20], and moxibustion is one of the most common complementary and alternative medicines in Korea [21]. Because of the wide prevalence of moxibustion in Korea, it is necessary to evaluate the economic worth of moxibustion for treating KOA, and a qualitative study is needed in addition to the quantitative approach to understand why KOA patients seek moxibustion treatment and how they regard moxibustion treatment performed by a DKM.
Our study will therefore take a pragmatic approach and use a process of randomisation to assess the effectiveness and safety of moxibustion for treating KOA compared to usual care with a sample size calculated on the basis of a previous pilot study. Moreover, an economic analysis will be evaluated to assess the economic value of moxibustion in Korea, and a qualitative study will be conducted to understand the patient's experience and perspective on the use of moxibustion to treat KOA.
The aims of this study are as follows: (1) to assess the effectiveness of moxibustion treatment for treating KOA on the occurrence of pain, function, depression, quality of life, and adverse events compared to usual care and (2) to assess the cost-effectiveness and cost-utility of moxibustion in addition to usual care in the treatment of KOA patients and explore how KOA patients experience moxibustion in Korea.
Design and setting
This is a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. From May 2011 to November 2011, 4 clinical research centres in Korea will participate in this trial: the Korea Institute of Oriental Medicine (Daejeon University Hospital) in Daejeon, Gachon University Gil Oriental Medical Hospital in Incheon, Dongshin University Gwangju Oriental Hospital in Gwangju, and Semyung University Oriental Medicine Hospital in Jecheon. The population of each city is greater than 140,000, and the estimated prevalence rates of KOA are 14.9% over 40 years old [22] and 38.1% over 65 years old [23] in Korea. Recruitment will therefore be expected to be completed within the study period. To recruit the participants, we will advertise in the media (daily papers, local newspapers, and public newsletters), in each hospital, and on the internet homepages of hospitals and public institutions. Eligible participants will be randomly allocated into 2 groups (the moxibustion group or the usual care group) with a 1:1 allocation ratio and receive treatment for 4 weeks with 2 months of follow-up (Figure 1). The evaluation of participants and the analysis of the results will be performed by professionals blinded to the group allocation. Written consent will be obtained from each participant before the start of this trial. We will obtain oral and written consent from each participant before collecting information at the first visit.
A flowchart of the study process.
Types of participants
A total of 212 participants with KOA will be recruited from the outpatients of the acupuncture and moxibustion clinics of the 4 hospitals. We will include participants who have average daily pain over 40 points (on a 0- to 100-point scale) and have been diagnosed with idiopathic KOA according to the clinical guidelines of the American College of Rheumatology. The guidelines include patients currently experiencing pain in one or both knees with at least 3 of the following 6 conditions: 1) aged 50 to 70 years, 2) morning stiffness within 30 minutes of waking, 3) crepitus, 4) bony tenderness, 5) bony enlargement, and 6) no palpable warmth.
Participants will be excluded if they are experiencing or have a history of the following: inflammatory diseases, including rheumatoid arthritis; cancer; traumatic injury that might be related to the current knee pain; autoimmune disease; uncontrolled hypertension; diabetes mellitus requiring insulin injection; life-threatening cardiovascular or neurological events within the past year; chronic respiratory disease; a haemorrhagic disorder; alcohol or drug addiction; an active infectious disease, including tuberculosis; keloidosis; a significant knee joint deformity; knee replacement surgery for the affected knee; knee arthroscopy within the past 2 years; steroid injection in the knee joints within the past 3 months; viscosupplement injections in the knee joints within the past 6 months; joint fluid injection within the past 6 months; and acupuncture, moxibustion, cupping, or herbal medicine within the past 4 weeks.
Randomisation and allocation concealment
Randomisation will be performed using a computerised random number generator through the stratified block randomisation method of the SAS package (Version 9.1.3; SAS institute Inc., Cary, NC, USA) for sequence generation prepared by a statistician (KWK) with no clinical involvement in this trial. According to the Kellgren/Lawrence Scale of anterior-posterior (AP) and lateral standing knee radiographs, a random number will be stratified using a random block size of 4. Sequentially numbered, opaque, sealed assignment envelopes will be delivered to each research centre. Random allocation will be performed at the second visit for participants who provide informed consent and meet the criteria for inclusion. If a participant can be included in the study, the researcher will open the corresponding envelope in front of the participant. The corresponding envelopes will be opened only after the enrolled participants have completed all baseline assessments. Although participants and practitioners will be aware of the allocation arm according to the routine care setting, the outcome assessors and the data analysts will be kept blinded to the allocation.
Moxibustion treatment
Moxibustion treatment will be performed by DKMs who are certified by the Korean Ministry of Health and Welfare. They will have at least 2 years of clinical experience and will have received more than 6 years of oriental medicine college education. The treatment will be performed under the supervision of professors who specialise in acupuncture and moxibustion. All treatment regimens and outcome assessment methods will be standardised between the 4 centres, and basic information about this study and the monitoring process will be disseminated through workshops before the beginning of the study. This study is designed to evaluate moxibustion treatment as it is used in normal practice. The practitioner will therefore be allowed to maintain a patient-practitioner relationship similar to a normal clinical situation. There will be no restrictions in the careful observation and questioning of participants.
In the moxibustion group, 3 moxibustion sessions per week will be performed during a 4-week period for a total of 12 sessions. The treatment will be conducted after sterilising the skin surface at the acupuncture points with the participant lying in a supine position at a room temperature of 22°C to 28°C. After the top of the moxibustion is sufficiently combusted without attachment to the points for approximately 5 to 10 seconds, the moxibustion will be attached at each point. When a participant believes that their heat tolerance has reached its maximum, the practitioners will place a new moxibustion at the same point. However, to prevent burns, the attached point can be changed to within a 1 cm diameter according to the discretion of the practitioners. A total of 3 moxibustions will be attached at each point at every visit. We will use smokeless indirect moxibustions made of mugwort with a paper cylinder (Manina, Haitnim Co., Korea) (Figure 2). This moxibustion has an adhesive on the bottom that can be used to attach it to the skin, and its effect lasts approximately 5 to 10 minutes. The expected total time of each treatment session will be 20 to 30 minutes. The treatment points were selected in a consensus process by professors and researchers who have an acupuncture and moxibustion specialist license in Korea based on a text book [24], literature reviews [12, 14, 25], and the points used in our previous pilot study. The moxibustion group will receive moxibustion treatment on the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) plus up to 2 points of 'ashi', if needed, according to the determination of the practitioners (Figure 3). The moxibustion group will also receive the care provided to the usual care group.
Moxibustion device. A photograph of the moxibustion device that will be used in this trial. This moxibustion device is a sticker-type disposable moxa, which functions for 5–10 minutes and is used for local acupuncture points. M: the upper part of the carbonised mugwort, A: adhesive sticker, H: height (2.1 cm), D: distance (1.9 cm).
Acupuncture points of treatment. The right knee will be treated at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10). The left knee will be treated with an additional point of 'ashi', which is located between ST35 and Ex-LE04. A: additional points of 'ashi' according to the determination of the practitioner. A Written consent for the picture was obtained from the pictured subject. Photograph by Seunghoon Lee.
Usual care
According to pragmatic design, the control group will not use a placebo procedure. Both the moxibustion and usual care groups will be allowed to use any type of treatment desired, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. However, the participants will be asked to inform the research investigators of any new treatments performed after entry into the trial. Educational materials explaining KOA and self-exercise will be provided to each group. The participants in both groups will perform self-exercise, which consists of 1) stretching the hamstrings, biceps femoris, and ankles on both sides 3 times per day and 2) muscle exercises for the hamstrings and biceps femoris (including isometric and isotonic exercises) on both sides according to the disease status during the trial period.
Primary outcome measurement
The primary outcome with respect to the effectiveness on KOA will be the mean change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) from baseline to 5 weeks. The WOMAC is one of the most widely used instruments and is composed of 24 questions to assess disability related to osteoarthritis. It includes 3 subscales to measure pain (5 questions), stiffness (2 questions), and physical function (17 questions) in KOA, and higher scores indicate more severe impairment [26, 27]. There is a Korean version of the WOMAC (K-WOMAC), and Bae et al. confirmed its reliability, validity, and responsiveness [28]. We will therefore assess participants at the second visit (before starting moxibustion treatment) and at 5 weeks and 13 weeks from baseline using the K-WOMAC.
Secondary outcome measurements
Secondary outcomes include the mean changes in the WOMAC subscales (pain, stiffness, and function) at 5 and 13 weeks from baseline. As such, we will investigate which subscales affect the global scale value of the WOMAC, which is the primary outcome measurement.
Health-related quality of life (HRQL) will be assessed by the Short-Form 36v2 Health Survey (SF-36) at 5 and 13 weeks from baseline. The SF-36 is used to measure the general health status and quality of life of patients and non-patients. It comprises a total of 36 questions in 8 categories, and higher scores indicate a better level of function. Han et al. developed a Korean version of the SF-36 and assessed its reliability and validity for use in health-related quality of life measurements for elderly Korean patients [29].
Depression will be assessed by a mean change in Beck Depression Inventory (BDI) scores at 5 and 13 weeks from baseline. The BDI, developed by Beck AT in 1967, is a 21-question multiple-choice questionnaire that is one of the most widely used scales for measuring the severity of depression. It is composed of items related to the depression symptoms of hopelessness and irritability, cognition (such as guilt and feelings of being punished), and physical symptoms (such as fatigue and weight loss); higher total scores indicate more severe depressive symptoms [30].
To assess physical activity, a physical performance test will be performed at 5 and 13 weeks from baseline. The physical performance test is composed of the timed stand, standing balance, and 6-minute walk tests. 1) The timed stand test evaluates lower extremity muscle power by measuring the time required to complete 10 full stands from a sitting position. 2) The standing balance test assesses balance in particular positions, such as tandem, semi-tandem, side-by side, and one-legged stands. 3) The 6-minute walk test measures the distance walked at the greatest speed possible within 6 minutes to assess the functional exercise capacity of patients [31].
Global knee pain will be assessed using the patient global assessment and numerical rating scale (NRS). The patient global assessment score is a self-reported 5-point measurement used to evaluate overall improvement after treatment. Participants individually evaluate their improvement from baseline by selecting one of 5 options (much improved, minimally improved, no change, minimally worse, or much worse) at 5 and 13 weeks from baseline. The pain NRS (0 = no pain and 10 = worst possible pain) is a standard instrument in chronic pain studies that is used to measure pain intensity [32]. We will evaluate the mean change in the NRS within 7 days of the study visits at 5 and 13 weeks from baseline.
The treatment expectancy of participants will be evaluated by the Treatment Expectancy Questionnaire (1 = not at all, 5 = somewhat and 9 = very much), which has been transformed and translated into Korean from the "Credibility and Expectancy Questionnaire" [33]. Participants will be asked "How much do you feel moxibustion therapy will help to reduce your symptoms?" at the first visit.
A blood sample will be obtained at baseline and 5 weeks from baseline to measure the C-reactive protein (CRP) levels and the erythrocyte sedimentation rate (ESR). We will therefore evaluate inflammation and tissue damage after moxibustion treatment. The detailed outcome measurement time points are provided in Table 1.
Table 1 Schedule for treatment and outcome measurements
We calculated the sample size according to our previous pilot study. A 2-sided 5% significance level and 80% power were considered to detect a mean difference in the WOMAC of -6.65 with a standard deviation (SD) of 15.4. Approximately 84 participants in each group were calculated to be required. Assuming a dropout rate of 20%, the sample size will be n = 106 for each group (total n = 212). A total of 32 participants will be assigned at the Korea Institute of Oriental Medicine (Daejeon University Hospital), and the remaining 180 participants will be equally assigned at the other 3 study hospitals. To recruit this number of participants, a 6-month study period is anticipated based on our pilot study.
The statistical analysis will be performed on the intention-to-treat basis with a 95% confidence interval using SAS (Version 9.1.3; SAS institute Inc., Cary, NC, USA). Missing data will be replaced according to the principle of the last observation carried forward (LOCF) method. The null hypothesis is that there will be no difference in the change in the primary outcome between the moxibustion group and the usual care group after 5 weeks of treatment. The baseline characteristics will be shown as the mean ± SD for continuous data (e.g., age and duration of disease) and n (%) for categorical data (e.g., gender and Kellgren/Lawrence Scale).
To analyse the baseline characteristics, we will perform a 2-sample t-test or a Wilcoxon rank sum test for continuous data and a chi-squared test or Fisher's exact test for categorical data, according to whether the data are normally distributed. An analysis of covariance (ANCOVA) will be performed for the primary endpoint (global scale value of WOMAC) and secondary endpoints (WOMAC subscales (pain, stiffness, and function), HRQL, depression, physical activity, and patient global assessment) at 5 weeks and 13 weeks from baseline. The ANCOVA model will include group as a fixed effect and baseline measurements and centres as covariates. The mean difference from baseline values to the end of treatment in each group will be examined using a paired t-test or a Wilcoxon signed rank test. To identify a trend, we will also perform a repeated measures analysis of variance.
Additional analyses
The economic evaluation will be conducted from a social perspective, and all costs and consequences of the competing interventions will be considered regardless of who pays for or benefits from them. All cost data will be collected through a cost questionnaire that participants will complete at 5 weeks and 13 weeks after baseline. Researchers will explain these to all of the participants, and obtain the consent before collecting economic data. The costs considered in the present analysis will include the direct healthcare-related costs of moxibustion treatment, physician visits, hospital stays (without consideration of private billings), and any drugs (including patient co-payments). In addition to health insurance costs, the indirect costs caused by lost workdays will also be taken into account. Health utility will be measured in quality-adjusted life years calculated for each patient using the SF-36 at 5 weeks and 13 weeks after baseline, and the K-WOMAC pain subscale will also be used to analyse cost-effectiveness. The cost-utility and cost-effectiveness analyses will be performed through a decision analysis. The analysis period will be 5 weeks, and the trend will also be evaluated at 13 weeks.
We will also conduct a qualitative study based on the grounded theory to elucidate the meaning of the experiences of moxibustion treatment for KOA. Sixteen KOA patients who will be selected by convenience sampling will be included in the qualitative study if they consent to give a recorded face-to-face interview. We will conduct individual in-depth interviews using open-ended questions at a site where they feel comfortable. The interviewer will ask the participants the key question, "Tell me about your experiences with obtain moxibustion treatment for treating KOA", and additional questions, such as "What is the most difficult activity due to KOA?", "Why did you choose moxibustion treatment? What was your motivation?", "What was your expectation when you participated?", "What types of changes did you feel after you received moxibustion? Were there any symptom changes after moxibustion treatment?", "Did you have any difficulties or problems during the moxibustion treatment? What did you do to overcome these troubles?", "Will you choose moxibustion treatment again when you have a similar or other symptom?", and "Will you recommend moxibustion treatment to others?". The data will be transcribed from the recording and analysed using the coding scheme, and researchers will then categorise them according to the process for qualitative research methods.
Data and safety monitoring
Regular monitoring that will be clarified in a standard operating procedure will be conducted at each site to ensure good data quality. Monitors will evaluate whether the case report forms are properly written and whether the recruiting and treatment procedures are adequately performed according to the protocol. Investigators from each site will be contacted to discuss whether it is necessary to revise the study protocol or inclusion criteria and other important issues. The investigators and independent researchers will assess the progress of the clinical trial and severe adverse events and determine whether they are acceptable and whether it will be necessary for the trial to be modified or stopped.
All unexpected and unintended responses that are not necessarily related to moxibustion treatment will be reported by the participants and practitioners at every visit. The adverse events known to occur following moxibustion treatment include blisters, redness, itching, burns, and respiratory symptoms. To avoid potential adverse events, the treatment day will be modulated within 3 days if the practitioner judges that the participant is not suitable for moxibustion treatment or the participant indicates moderate fatigue or an abnormal health condition.
Participant protections and ethics
To protect human participants, the protocol was written according to general ethical guidelines, such as the Declaration of Helsinki and Korean Good Clinical Practice and was approved by the institutional review board of each trial centre (Daejeon University Hospital, Kyungwon University Gil Oriental Medical Hospital, Dongshin University Gwangju Oriental Hospital, and Semyung University Oriental Medicine Hospital). The Korea Institute of Oriental Medicine certified the ethics approval of the clinical centres as above. The study participant consent process includes information about potential risks, benefits, alternatives, and responsibilities during the trial. Before participants agree to participate in this trial, researchers will explain this information in detail in person.
Moxibustion and acupuncture have been widely used to treat the pain and functional limitations of KOA in Korea [20]. Some trials [11–14, 34] have been conducted to evaluate the effectiveness of moxibustion in treating KOA in Korea and China. Moxibustion and NSAIDs were compared in 3 RCTs [11–13], combination therapy (moxibustion plus NSAIDs) and NSAIDs were compared in 1 RCT [14], and moxibustion and a hot pack were compared in 1 RCT [34]. According to these trials, single or combination moxibustion therapies increased the total response rate and decreased symptoms of pain in KOA patients. However, the processes of random sequence generation and allocation concealment were not reported in 4 trials [11, 13, 14, 34]. Moreover, none of the trials used valid and reliable assessment tools, such as the WOMAC, and assessor blinding was not described. It is therefore not possible to exclude the possibility of a high risk of bias and determine the effectiveness of moxibustion treatment for KOA.
Concealment is the most critical factor of the allocation process, and a high risk of bias is generated by unconcealed allocation [35, 36]. In a recent well-designed systematic review of acupuncture for chronic pain, only RCTs that used an unambiguous method of allocation concealment were included [37]. Therefore, we designed our protocol with adequate methodology of random sequence generation and allocation concealment using validated assessment tools, such as the WOMAC, SF-36, and BDI, and monitors will regularly evaluate whether the trial is being conducted according to the planned protocol.
Mixed-method research is the most recent systematic approach of using 2 or more research methods to answer a single research question. This approach has the advantages of expanding the understanding of the procedure's effects and verifying results from another perspective compared to an approach using a single method because the supplemental component enhances the validity of the study [36, 38]. This method has been used to determine the effectiveness of interventions in recent studies on complementary and alternative medicine [39–41]. To comprehensively understand the effectiveness of moxibustion for KOA patients, we will conduct not only a quantitative data analysis but also economic and qualitative data analyses. A nested economic evaluation and qualitative research within a pragmatic clinical trial will be used as a mixed-methods approach to answer the question from various perspective on the reasons for using moxibustion for KOA.
One limitation of this study is the possibility of a high risk of bias regarding blinding because we will use usual care as a control instead of a sham procedure. One study [42] on functional constipation used sham moxibustion to blind participants to evaluate the efficacy of moxibustion, but a blinding test was not performed, and it is necessary to cover the eyes with a patch to successfully blind participants to the sham moxibustion device [43]. The researchers who designed this protocol agreed that it would be difficult to blind participants using any previously developed sham device [17, 43, 44], and that a sham device is difficult to use because of the high prevalence of moxibustion in Korea and there are technical challenges associated with developing a sham device. Additionally, it is more appropriate to use a pragmatic design to answer our research question, which is whether moxibustion treatment is effective in treating KOA in real practice. Therefore, we used the pragmatic approach of comparing treatment to usual care, permitting additional treatment points as well as standard treatment points, and using patient-centred outcomes in multiple centres.
This pragmatic randomised controlled trial using the mixed-methods approach may provide rigorous evidence for the effectiveness of moxibustion in treating KOA.
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Bae SC, Lee HS, Yun HR, Kim TH, Yoo DH, Kim SY: Cross-cultural adaptation and validation of Korean western Ontario and McMaster universities (WOMAC) and lequesne osteoarthritis indices for clinical research. Osteoarthr Cartil. 2001, 9 (8): 746-750. 10.1053/joca.2001.0471.
Han CW, Lee EJ, Iwaya T, Kataoka H, Kohzuki M: Development of the Korean version of short-form 36-item health survey: health related QOL of healthy elderly people and elderly patients in Korea. Tohoku J Exp Med. 2004, 203 (3): 189-194. 10.1620/tjem.203.189.
Beck AT: Depression; causes and treatment. 2006, University of Pennsylvania Press, Philadelphia
Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, Okparavero A, McAlindon T: Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial. BMC Musculoskelet Dis. 2008, 9: 108-10.1186/1471-2474-9-108.
Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM: Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001, 94 (2): 149-158. 10.1016/S0304-3959(01)00349-9.
Devilly GJ, Borkovec TD: Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000, 31 (2): 73-86. 10.1016/S0005-7916(00)00012-4.
Doh MH, Kim TY: Effects of the moxibustion therapy on the pain decrease and joint recovery with degenerative knee arthritis. Korean J Orient Prevent Med. 2009, 13 (1): 88-92.
Schulz KF, Chalmers I, Hayes RJ, Altman DG: Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995, 273 (5): 408-412.
Witt CM, Linde K: Clinical research in complementary and integrative medicine: a practical training book. 2011, Elsevier, Munich, 147-152. 1
Vickers AJ, Cronin AM, Maschino AC, Lewith G, Macpherson H, Foster NE, Sherman KJ, Witt CM, Linde K, for the Acupuncture Trialists C: Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012, 172 (19): 1444-1453.
Morse JM, Niehaus L: Mixed method design. 2009, Left Coast Press, Walnut Creek, California, 13-22.
Kim TH, Kang JW, Kim KH, Kang KW, Shin MS, Jung SY, Kim AR, Jung HJ, Lee SD, Choi JB: Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol. Trials. 2010, 11: 107-10.1186/1745-6215-11-107.
White P, Bishop FL, Prescott P, Scott C, Little P, Lewith G: Practice, practitioner, or placebo? a multifactorial, mixed-methods randomized controlled trial of acupuncture. Pain. 2012, 153 (2): 455-462. 10.1016/j.pain.2011.11.007.
DeBar LL, Elder C, Ritenbaugh C, Aickin M, Deyo R, Meenan R, Dickerson J, Webster JA, Jo Yarborough B: Acupuncture and chiropractic care for chronic pain in an integrated health plan: a mixed methods study. BMC Comp Alt Med. 2011, 11: 118-10.1186/1472-6882-11-118.
Park JE, Sul JU, Kang K, Shin BC, Hong KE, Choi SM: The effectiveness of moxibustion for the treatment of functional constipation: a randomized, sham-controlled, patient blinded, pilot clinical trial. BMC Comp Alt Med. 2011, 11: 124-10.1186/1472-6882-11-124.
Park JE, Han CH, Kang KW, Shin MS, Oh DS, Choi SM: A sham moxibustion device and masking test. J Korean Orient Med. 2007, 13: 93-100.
Kim SY, Yi SH, Cho JH, Yin CS, Lee H, Park HJ: Heat stimulation on the skin for medical treatment: can it be controlled?. J Altern Complement Med. 2011, 17 (6): 497-504. 10.1089/acm.2010.0072.
This study is supported by the Development of Acupuncture, Moxibustion and Meridian Standard Health Technology (K11010) of the Korea Institute of Oriental Medicine.
Acupuncture, Moxibustion & Meridian Research Group, Medical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea
Seunghoon Lee, Jung-Eun Kim, Joo-Hee Kim, Kyung-Won Kang, So-Young Jung, Ae-Ran Kim, Hyo-Ju Park, Mi-Suk Shin & Sun-Mi Choi
Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, South Korea
Seunghoon Lee, Joo-Hee Kim & Jung Won Kang
Department of Acupuncture & Moxibustion Medicine, Korean Medicine Hospital, Pusan National University, Pusan, South Korea
Kun Hyung Kim
Mokhuri Neck and Back Hospital, Seoul, South Korea
Tae-Hun Kim
Department of Acupuncture & Moxibustion, College of Oriental Medicine, Daejeon University, Daejeon, South Korea
Kwon-Eui Hong
Department of Acupuncture & Moxibustion, College of Oriental Medicine, Gachon University, Incheon, South Korea
Ho-Sueb Song
Department of Oriental Rehabilitation Medicine, College of Oriental Medicine, Dong-Shin University, Gwangju, South Korea
Jin-Bong Choi
Department of Oriental Gynaecology, College of Oriental Medicine, Se-Myung University, Jecheon, South Korea
Hyung-Jun Kim
Seunghoon Lee
Jung-Eun Kim
Joo-Hee Kim
Jung Won Kang
Kyung-Won Kang
So-Young Jung
Ae-Ran Kim
Hyo-Ju Park
Mi-Suk Shin
Sun-Mi Choi
Correspondence to Sun-Mi Choi.
SL wrote the study protocol and drafted this manuscript. KHK made a substantial contribution to designing the study protocol. THK participated in the study design of the qualitative study and in critical revision. JEK, JHK, and JWK participated in the critical revision of the manuscript. KWK participated in the design of the statistical analysis and the cost-effectiveness analysis. SYJ, ARK, HJP, and MSS participated in the design of the outcome measurements and assessing the outcomes. KEH, HSS, JBC, and HJK helped to draft the manuscript. SMC had final responsibility for the decision to submit for publication. All of the authors read and approved the final manuscript.
Lee, S., Kim, K.H., Kim, TH. et al. Moxibustion for treating knee osteoarthritis: study protocol of a multicentre randomised controlled trial. BMC Complement Altern Med 13, 59 (2013). https://doi.org/10.1186/1472-6882-13-59
Numerical Rating Scale
Usual Care Group
Oriental Medicine
Patient Global Assessment

redpajama_set_name: RedPajamaCommonCrawl


The report presents new conceptual and methodological approaches to developing models to interrelate airline schedules, airport-based employee work-shift schedules, and airport access ground traffic volumes in any time period for a given report. The results of a survey of ground travel at the Dallas/Fort Worth Regional Airport are presented and analyzed. Specific ground transportation impacts of the installation of this relatively new airport are assessed. Models are described which (1) express volumes of automobiles carrying airline passengers and visitors as a function of airline schedules and (2) transform existing or future employee work-shift schedules into estimates of incoming and outgoing employee vehicle volumes in any time interval. Preliminary research toward the development of a model to estimate public transit passenger volumes as a function of airline passenger volumes is also described.


Adar is the last, twelveth one among the months of the year, if counting them from the spring month of Nisan, as Biblical law requires. The constellation of Pisces corresponds to Adar as far as it is exactly on this month that breeding for most fish in rivers and lakes takes place. The constellation of Pisces is the symbol of blessing coz fish is hidden from alien looks under the water and no evil eye has power over it. No damnation has power over it as well. Fish survived even during World-Wide Flood coz it kept on behaving the way it was preset to it. In general, fish never couples but with fish of its own species.
The month running under the sign of blessing brings happiness for the peoples of the world as well. As fish lives in the water as world is plunged in Tora which is compared to Aqua Vitae.
Besides, the constellation name of Dagim (Pisces - Biblical language translation) represents the only plural noun among other constellation names of all other Biblical months - the hint for the fact there can be not only one but two months of Adar.


text:
The Natomas Buzz
Natomas News & Information
Cops Log
You are here: Home / education / NUSD Race: Following Through on Programs
NUSD Race: Following Through on Programs
October 31, 2014 by bboyd Leave a Comment
THE NATOMAS BUZZ | @natomasbuzz
SEVENTH IN A SERIES
THE NATOMAS BUZZ invited the four candidates running for the Natomas Unified school board to participate in a series of articles wherein they answer questions submitted by readers. Today's question asked,
"There have been programs brought into a school and the money spent. Unfortunately they are not ever brought off the ground and sometimes even shelved altogether with the equipment shoved into a closet (ie. Science Lab at Heron School). What steps can you take to ensure that the program is brought into the school and follow through to ensure that it is implemented?" -Anthony Edmonds
Here are the answers submitted by the deadline, in the order they were received:
Jag Bains
Our District has hosed away millions of dollars on programs that looked great on a PowerPoint presentation, but flopped during implementation. The HOSTS program and Restorative Justice are two prominent examples of this phenomenon. Reports of brand new equipment and plastic-wrapped textbooks stashed in utility closets show that top-down leadership does not work. When parents and teachers on the front lines lead the way, we have wonderful successes like the International Baccalaureate (IB) program at Inderkum High School. By appointing an independent Parent Advocate, I would empower parents to take initiative in the interest of our students. We need less red tape and more graduation gowns in Natomas. Finally, we need to fully utilize our School Site Councils! These are comprised of parents, teachers and classified employees who volunteer their time and know how to prevent wasteful spending before it ever starts. New programs should be vetted with our Councils.
Lisa Kaplan
The successful implementation of programs in our schools, which help students thrive academically, is very important. The responsibility of a Board member is to set policy and budget direction for the District. At a school site, the responsibility for leadership, program implementation and accountability is given to a Principal. Programs succeed and are correctly implemented, when the Principal, along with teachers, school site council leaders, PTA, parents and District work together. As your board member in order to ensure accountability, I would request information on programs approved for implementation and their status. Thereafter, I would request the data on the success of the programs. Based on information received, I would then work with the Superintendent and my fellow board members to ensure we take steps to improve the programs, or provide support to make them successful. Finally, I will ultimately hold our district accountable to ensure appropriate implementation.
Teri Burns
Most programs are successfully launched, for example the Natomas Gateways Middle School 1:1 computing program, the rolling computer carts at elementary schools, increased instrumental music programs and more. Steps to ensure follow through include listening to teachers and parents who have first-hand knowledge about the progress of implementation. It also involves monitoring the proper training teachers and administrators on the program, ensuring that the necessary infrastructure is in place to implement the program (such as remodeled science labs), ensuring that sufficient resources are in place to fully implement the program and holding administrators accountable for managing the roll-out and day-to-day use of the program. Finally, we need to communicate clearly to all stakeholders if a program has been delayed or shelved. The board should expect regular reports back on district approved programs.
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text:
Deirdre Verney
Published: Fri 24 Jul 2020, 7:44 PM
Plans for Lissywollen housing project to be lodged next month
A total of 170 new social housing units will come on stream in Lissywollen, should a major 500-plus house project garner planning approval from An Bord Pleanála, it's been revealed.
ABOVE: The site outlined in red, with other local landmarks identified.
A formal application is due to be lodged with the planning board in mid-August by Alanna Roadbridge Developments Ltd as part of the Strategic Housing Development (SHD) process, the fast-track scheme for large scale developments which bypass the local authority.
At Monday's Westmeath County Council meeting, Director of Service Mark Keaveney, who has responsibility for housing, told members that they anticipate that the planning application for the Lissywollen housing proposal will be lodged in mid-August by the developers. Should approval come through, Mr Keaveney said he could see construction beginning there in the early part of quarter one next year.
In October last, Alanna Roadbridge Developments Ltd signalled their intentions by submitting pre-application consultation plans to An Bord Pleanála for 547 housing units at Lissywollen, made up of 279 houses and 268 apartments, two creches, and associated site works. 70% of the housing would be private with the remaining 30% social housing.
The overall 39.5-acre site for the proposed development surrounds the existing Brawney estate in Lissywollen and extends east towards the ESB facility in Garrycastle.
The project involves, and is dependent on, the development of a controversial link road between the Ballymahon Road roundabout and Garrycastle Road first before the development of the housing element.
Cllr Frankie Keena (FF) stressed the need at Monday's meeting to continue to link in with the residents on the plans before a full application goes into An Bord Pleanála.
It comes he said on foot of a recent virtual meeting using Microsoft Teams between locals, the council, and the developers in relation to concerns about aspects of the road development and green space. Some tweaks have already been made to designs on foot of the consultation with local people in Brawney and he hopes there will be further consultation before the application is lodged with An Bord Pleanála, Cllr Keena said afterwards.
Green Party Cllr Louise Heavin praised the nature of the recent consultation between all sides in Brawney, describing it as "first-class."
Later, Mr Keaveney said the developers are finalising details of the scheme and have been back to discuss it with some people in Brawney, in particular, the school.
He told the meeting that the indicated date for the application to go into An Bord Pleanála is mid-August.
Full planning applications for SHDs, once lodged with An Bord Pleanála, must be decided within a mandatory 16-week period, which also includes public consultation and submission of a report by the planning authority.
It's understood the Covid-19 crisis may have some implications for meeting these timelines in the future.
Back in 2018, Westmeath County Council sought expressions of interest to develop the site at Lissywollen, with Alanna Roadbridge the bidder picked following a tender process the following year.
As part of the deal agreed with the council, the consortium will pay €2.4m to purchase the land on which the private houses will be built.
The former defender signed a three-and-a-half year deal when he took the job in November, but picked up only two points from seven league games.
Labour's Duncan Smith told the Dáil that Camhs had 'to fight, to compete with other health services for funding'


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text:
MuzeRoom launches app to deliver news for the artist you're listening to [EXCLUSIVE]
MuzeRoom, the world's first smart content curation platform for music, has launched its app to deliver music news for the artist you're listening to.
Founded in 2015 the Australian-based start-up delivers music news for over 220,000 artists, pulling news from the top 150 music blogs and publications including Rolling Stone, Billboard, Pitchfork, Tone Deaf, and Don't Bore Us.
MuzeRoom app
When streaming through Spotify, Apple Music, or Google Play MuzeRoom will automatically display music news for the artist that is currently playing.
A companion service to streaming services, MuzeRoom features over 400,000 curated articles, offering an average of 685 a day.
Co-founder Ronan Mason said he created MuzeRoom to change the way people interact with music:
"I love using the likes of Spotify and Apple Music, but they don't offer me much more than the music itself. With MuzeRoom we wanted to change that – offering music fans up to the minute music news, new releases, music videos, and tour announcements for the artist they are listening to. We think that's the kind of offering music fans are crying out for, but that's not currently available."
The app arrives in timely fashion. Facebook announced in January that users would "see less public content posts from businesses, brands and media" due to an update in its algorithm.
In the announcement, Mark Zuckerburg wrote:
"We started making changes in this direction last year, but it will take months for this new focus to make its way through all our products. The first changes you'll see will be in News Feed, where you can expect to see more from your friends, family and groups.
"As we roll this out, you'll see less public content like posts from businesses, brands, and media.
"And the public content you see more will be held to the same standard — it should encourage meaningful interactions between people."
Not only will users of MuzeRoom see more news updates from artists they're interested in, the knock-on effect means artists are able to better communicate tour and release announcements with their fans.
MuzeRoom users will see more news updates from artists they're interested in at the time they are most interested – whilst listening. Ultimately that's a win for the artist as well as their fans.
MuzeRoom is available to download now via Apple app store and Google Play.
Meet the 23-year-old Melbourne writer behind the biggest pop song in the US


Before & After. Merge photos in full resolution.
This application will merge your photos and images in full resolution. Use existing photos from your gallery or take photos with the custom built in camera.
Pictures can be stored either as a merged image (half-half) or combined (side-by-side).
The application is easy to use. Start by creating a new image, select the before and/or after image, finalize the image or save your current progress. You can continue on your before/after image at any time and you can have several images in progress at the same time.
Fishing Report. Your best fishing friend.
Register the fish you catch and the location to come back and catch more fish! Fishing Report makes it simple to log and keep track of your fishing history. Use it as your fisherman diary.
You can record all kinds of detailed information including weather and GPS location data. A lot of information is retrieved automatically to remove time consuming data input. Take a photo or choose an existing image from your gallery and attach it to your catch.
After you have recorded your catches you can run analytics on them to see interresting information about all the fish you have caught.
Marble Catch. Catch the balls.
Cover the playfield to reach the next level and compete with others by registering your final score online. The game is free for everyone to download.
There is both an all time high score and a weekly high score. A score is registered for 7 days in the weekly high score and then removed to make room for new challengers!
The gameplay is similar to the old classics Qix and Jezzball where you trap ball to get points. Just like Jezzball the walls have two sides that individually can be destroyed. You can therefore loose two lives with one ball collision.
Puzzle Jump. Help Mr Cube.
Help mr Cube save his cousins. Find a path through the puzzle before the temperature reaches a 100. While navigating the puzzle the cousin will cheer you on and beg you to save him.
Using on screen controls you must guide the game character through a series of puzzles. Timing and jumping skills are essential. This is a totally free version with 16 levels included.
Use the red control buttons in the lower part of the screen to jump and control the character. Controls can be switched from right to left. Haptic feedback is available in the settings.


text:
George Lucas Educational Foundation
Edutopia
Informal Learning: Facing the Inevitable and Seizing the Advantage
By Terry Heick
Image credit: iStockphoto
Reading recently through Edutopia's resources on informal learning, I found the distinction between formal and informal learning resonating more strongly now than ever.
For a classroom teacher, this difference is an important distinction. Formal learning happens through strategically planned learning experiences -- often direct instruction from teachers. Teacher and school improvement is driven by the notion of improving teaching and schools, which is kind of a circular argument. At best, we'll get better teaching and schools.
Informal learning is the kind of stuff that happens when we let go -- and is thus impossible to control and prescribe.
Experiential learning and constructivism, among other ways of thinking about how students learn, hold that learning is not only available outside the confines of the iconic teacher-student relationship, but is perhaps most powerful there as well. There is nothing (that isn't removable) within the walls of a typical school that makes deep thinking and enduring inquiry impossible, so certainly it's possible that extraordinary learning can happen there. But often, in spite of Herculean effort by teachers and administrators, it does not.
Which is strange, don't you think?
Project-Based Learning as Informal Learning Writ Large
Project-based learning is another "wayward" way to think about how learning happens -- not "doing projects," but learning through the process of project design and management. PBL also works as a vehicle for the planning and learning process itself. Within PBL, the Maker movement, mobile learning and game-based learning (among other trends) are all possible.
In fact, even self-directed learning can occur through the natural skeleton PBL provides. Sociologist Seymour Papert, a perhaps less charismatic precursor to Ken Robinson in terms of editorializing about education, held that that schools were not only screwed together all wrong, but that they were in danger of making themselves obsolete:
I'm saying that it is inconceivable that school as we've known it will continue. Inconceivable. And the reason why it's inconceivable is that little glimmer with my grandson who is used to finding knowledge when he wants to and can get it when he needs it, and can get in touch with other people and teachers, not because they are appointed by the state, but because he can contact them in some network somewhere. These children will not sit quietly in school and listen to a teacher give them predigested knowledge. I think that they will revolt.
Occupy Education?
While there has been no Occupy Education movement in classrooms, the revolt has been more subversive, in the form of disengaged learners who can't or choose not to sustain lasting academic curiosity. That's the kind of curiosity that compels a student to sit with a text, to "roll around in it" (as Sam Anderson described), to ask the right question at the right time for the right reason, to transfer understanding on his or her own, without prompting, or to solve authentic challenges in pursuit of personal and social change.
But perhaps there is hope in informal learning when we see it as the natural departure from pure academia through the rise of countless learning trends crowding the landscape of 21st century learning -- trends that make textbooks look silly, make teachers seem longwinded, and make schools look positively sedentary.
Forbes columnist Jessica Hagy recently explained it better than I can:
Education happens in jail cells. It happens in dark alleys. It happens on the bus and in the shower and in front of the television. Sure, we learn from teachers and mentors and leaders. But we also learn just as much, if not more, from hoodlums and jerks and con artists . . . We learn from books and lectures, but we also learn by eavesdropping and people watching. In school, we learn all the fundamentals: reading, writing, math -- but we're also learning how to dress and talk and get along, and how to wake up early and often. We learn that not all teachers are equally inspiring and that not all guidance counselors know where they're going
. . . But we don't call all of that learning. We call it life . . . Everyone's education (in school or in the so-called real world) is a unique collection of facts and lessons, failed tests and hard-won accolades. Our on-the-job experience of being living, thinking people started on our first birthdays. Underemployed. Overemployed. Partly employed. Reluctantly employed. Happily employed. Stay at home CEOs. Nine to five caregivers. Working under the table, at the kitchen table, or on the operating table -- we all do what we can, when we can. Sadly, you know more than you get credit for knowing. And no matter your job title or lack thereof, you can do more than you're paid to do. There is a massive resource of human capital out there, just waiting to be put to work -- maybe for money, maybe for good, maybe for both. Strange, isn't it? That if we want to make a life for ourselves, we have to learn how to use what we already know.
As educators, we can no longer afford to resist the cultural and technological trends that have already fully disrupted how we access information, connect with one another, and publish the events of our lives. But that's the easy part. The challenge? Insisting that public education, as a system, formally recognize and honor -- on equal terms -- these "lesser" forms of learning. Forms that surrender control, value the role of play, decenter schools and programs, and really, truly teach students how to think for themselves.
And then embrace the struggle and disruption that kind of thinking invites.
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A scene of Nuremberg with the city coat of arms is featured on this 0.5 liter dimpled glass Isar mug. Features hand painted accents.
These 0.5 L undecorated glass beer mugs are the smaller version of the dimpled "Masskrug" 1.0 liter Isar mugs used in Munich's Oktoberfest celebration and are perfect for your own Oktoberfest or Beerfest celebration!