The Effects Of Jaw Sensorimotor System In The Treatment Of Neck Pain And Dysfunction
The Effects Of Jaw Sensorimotor System In The Treatment Of Neck Pain And Dysfunction
The study will be focused on non- specific chronic neck pain patients. The primary objective
 is to study the effects of jaw sensorimotor system in the treatment of patients with neck
 pain and dysfunction. It will be randomized controlled trail with the estimated sample size
 of 80 with both genders. The experimental group will be performed Jaw opening-closing
 movements with active neck flexion and extension movements and control group will be
 performed active neck flexion and extension movements. Both groups will be received isometric
 strengthening exercises, Postural Advice and Home Exercise Program with Dairy. Numeric Pain
 Rating scale (NPRS), Neck disability Index (NDI), Neck Proprioception tests and Neck muscles
 endurance test will be used as outcome measures at day 0 and week 6 for treatment effect in
 both groups. Tables and graphs will used for demographic descriptions and appropriate
 statistical tests will be applied to establish treatment effect within and between groups.
Study Design : Randomized Controlled Trial

 Settings: This part of research will be held at the IPM&R (Institute of Physical Medicine and
 Rehabilitation). This institute is a part of Dow University of Health Sciences
 (Karachi-Pakistan). All subjects will be selected after evaluation by Neurologist /
 Neurosurgeon, Orthopedic, Physiatrists and Rheumatologist to rule out any severe pathology
 and diagnosis with non specific chronic neck pain.

 Duration of study: 18 months after IRB approval

 Sample population: Non-specific chronic neck pain

 Sample size calculation Using carried out using PASS Version 11 two sample t test with 95%
 confidence of interval and 80% power of test, mean of NDI (experimental 16.83± 2.3 and 19.13
 ± 2.2) calculated sample size is 16 per group which we have increased up to 40 in each group
 (Experimental & Control) including 8 patients as a dropout rate per group (makes at least 32
 patients per group).

 Sampling technique: Non probability random technique

 Inclusion criteria:

 -  Both genders

 -  18 years to 50 years

 -  Participants with history neck of more than 3 months with no related conditions

 -  Non radiating pain to arms

 -  Diagnosed as Nonspecific Chronic Neck pain by consultants

 -  NPRS-Numeric Pain Rating Scale score 3 to 8

 -  NDI- Neck Disability Index : score 5 to 34

 -  No TMJ pain or dysfunction

 Exclusion

 -  NPRS-Numeric Pain Rating Scale Score 1 & 2 and score 9 & 10 (Score 1 & 2 mild pain and
 Score 9 & 10 worst pain)

 -  NDI- Neck Disability Index : Score 0 to 4 (no disability) and score 35 to 50(Complete
 disability)

 -  Specific or nonspecific Acute Neck pain (Less than 7 days)

 -  Neck pain- Specific or nonspecific Sub acute (pain history more than seven days however
 less than three months)

 -  Neck pain- Specific Chronic (pain history more than 3 months)

 -  TMJ Dysfunction

 -  WAD (Whiplash Associated Disorders)

 -  Cervical spondylosis

 -  Rheumatoid arthritis

 -  Instability of spine

 -  Facial injury or dental infection

 -  Any type of infection of body

 -  Neck or spinal segment fracture

 -  Spinal tumor or any type of tumor/cancer

 -  Unexplained headache

 -  Post cervical spine surgical cases

 -  Signs and symptoms of Cervical spine stenosis

 -  Signs and symptoms of disc bulge or herniation of cervical spine

 -  Radiating neck pain or Radiculopathy of cervical spine

 -  Cognitive impairment

 -  Neurological conditions (MS/PD/CVA/MND)

 -  Application of injection therapy in cervical spine

 -  Red flags ( Episode of Double vision, Dysarthria, Dysphasia, Drop Attack Dizziness,
 Double vision, Gait disturbance)

 Assessments: After consent filling form, a physiotherapy assessment form will be completed.

 Outcome measures (Variables):

 i. NPRS ii. NDI iii. Neck Proprioception test iv. Neck Muscles Endurance Test

 Treatment assignment (allocation):

 In this study, the treatment assignment will be completed using randomization technique.

 -  In this study, based on inclusion and exclusion criteria, required numbers of sample
 size participants will recruit first as mentioned earlier using non probability sampling
 technique.

 -  Estimated total 80 patients (40 patients per group including dropout rate) (makes at
 least 32 patients per group) will be selected.

 -  Total 80 study population will be divided further out in two groups based on gender for
 giving equal opportunity to participate in this study. 40 male patients (20 for
 experimental and 20 for control group) and 40 female patients (20 for experimental and
 20 for control group) via simple randomization technique using computer generated
 Microsoft Excel sheet.

 -  The above mentioned process will be run for male and female parallel or separately
 depending on the frequency of the patients.

 Patients will not be selected in this study based on inclusion criteria, refer to the
 physiotherapy OPD for assessment and treatment.

 Blinding:

 -  Physiotherapist with minimum two years job experience will be selected and
 physiotherapist will receive training on how to perform the assessment.

 -  Treatment blinding will be achieved by asking physiotherapist to complete initial
 assessment forms with all outcome measures (pre- intervention) to all subjects (referred
 patients) with non specific chronic neck pain and dysfunction. The physiotherapists will
 remain unaware about who will be selected as research sample participants including
 unaware about experimental and control groups.

 -  At the time of getting consent, patients will be made aware of the relevant details
 about the research study, however they will remain unaware of their own group
 allocation.

 -  The principal investigator alone will administer the treatment.

 -  The outcome measurements will be taken at day 0 (pre-intervention) and then week 6
 outcome measurements (post intervention) will be recorded by physiotherapist.

 INTERVENTION:TREATMENT REGIMES FOR EXPERIMENTAL AND CONTROL Experimental group A: Jaw
 opening-closing movements Patient seated on a normal standard comfortable chair with proper
 back support and feet placed on the floor with no head support.

 Active jaw movements The patient will then perform maximal Jaw opening-closing movements at a
 pace convenient for his/her for one minute. Three sets with two minutes rest in between will
 be ensured.

 Active neck exercises While performing the above movements of jaws, the patient will actively
 perform active neck exercise (head-neck movements in sagittal plane- Extension- Flexion).

 Head-Neck extension on jaw opening (Mandible moves vertically downward); and then from
 Head-Neck extension to natural flexion movement on jaw closing (Mandible moves vertically
 upward).

 B: Isometric strengthening exercises (Same as control group) C: Postural Advice and Home
 Exercise Program with Dairy (Same as control group)

 Control group:

 A: Active neck exercises Patient seated on a normal standard comfortable chair with proper
 back support and feet placed on the floor with no head support.

 Note: For Active neck exercise (flexion and extension movements of neck), firstly the patient
 will perform maximal Jaw opening-closing movements at a pace convenient for his/her for 5
 times in order to observe (eyeball observation) the neck extension and flexion as reference
 point for each individual. Using this reference points, the patient will ask perform below
 mentioned active neck exercise.

 Active neck exercises: The patient will then perform active neck exercise (flexion and
 extension of neck) at a pace convenient for his/her for one minute. Three sets with two
 minutes rest in between will be ensured.

 Active jaw movements: While performing the above movements of neck, the patient will not
 perform any jaws movements.

 B: Isometric strengthening exercises

 The patients seated on a standard comfortable chair with proper back support and feet placed
 on the floor with no head support. The patient will then perform 15 repetitions of Isometrics
 strengthening exercise with manual resistance with 6 second hold in flexion, extension and
 rotation of neck; details of which are as follows:

 For flexion the starting position will be upright head and neck. The patient will be asked to
 hold this position. Manual resistance will then be applied by the investigator by placing the
 hand on the patient's forehead with 6 second hold. 15 repetitions of this exercise will be
 performed. Three sets with one minute rest in between will be ensured.

 For extension the starting position will be upright head and neck. The patient will be asked
 to hold this position. Manual resistance will then be applied by the investigator by placing
 the hand on the occiput with 6 second hold. 15 repetitions of this exercise will be
 performed. Three sets with one minute rest in between will be ensured.

 For rotation the starting position will be upright head and neck. The patient will be asked
 to hold this position. Manual resistance will then be applied by the investigator by placing
 the hand over the left side of the patient's face with 6 second hold. 15 repetitions of this
 exercise will be performed. Three sets with one minute rest in between will be ensured. The
 same procedure will be performed for the right side by placing hand on the right aspect of
 the patient's face.

 C: Postural Advice and Home Exercise Program with Dairy Postural advice and home exercise
 program

 1. Postural Advise.

 -  Maintain upright posture while sitting.

 -  Avoid prolonged neck bending.

 -  Avoid twisting movement of the neck.

 -  Use a suitable pillow to maintain cervical spine.

 -  Adjust computer screen at eye level.

 -  Avoid constant use of mobile or similar device to prevent excessive strain over
 neck joints and muscles.

 -  Carry light and even weight in both hands while shopping and other chores.

 -  Stay hydrated.

 2. Home Exercise Program (unsupervised) The following home exercise program will be
 instructed to all subjects with request to repeat the program 3 times a day.

 -  Forward flexion (Self Resisted), 6 sec hold, number of repetitions 15

 -  Right side flexion (Self Resisted ), 6 sec hold, number of repetitions 15

 -  Left side flexion (Self Resisted) x 6 sec hold,number of repetitions 15

 -  Backward flexion (Self Resisted) x 6 sec hold, number of repetitions 15

 3. Home Dairy A home dairy will be provided to maintain home exercise program record.

 Frequency and Duration of Treatment:

 Non-specific Chronic Neck Pain (more than 3 months history of pain) Initial Assessment (week
 1) 60 minutes, First treatment session (week1) 40 minutes, 3 treatment sessions per week
 (week- 2) 40 minutes, 3 treatment sessions per week (week- 3) 40 minutes, 3 treatment
 sessions per week (week- 4) 40 minutes, 3 treatment sessions per week (week- 5) 40 minutes,
 Last treatment session (week 6) 40 minutes, Final Assessment (week 6) 60 minutes.

 ETHICAL CONSIDERATIONS

 -  It will be gained from the Ethical Committee of the University before study

 -  Written informed consent will be taken from all the patients

 -  All information and collected data will be kept confidential.

 -  Participants will remain anonymous throughout the study.

 -  The Participants will be informed that there are no disadvantages or risks on the
 procedure of the study.

 -  Participants will also be informed that they will be free to withdraw at any time during
 the process of the study.

 DATA COLLECTION Data Collection Procedure

 -  After IRB approval, Data will be collected November 2018 (Subject to approval).

 -  Collection of data will be initiated once approval of synopsis will be taken.

 -  Patients will be recruited from IPM&R and consultants will assess and screen patients as
 indicated and will pass on to physiotherapy department with diagnosed of non specific
 chronic pain.

 -  Initial screening proforma will be completed by a physiotherapist based on inclusion and
 exclusion criteria.

 -  Non probability sampling technique will be used for recruitment of patients

 -  A written consent form will be taken from all participants

 -  Participants will be divided into two groups (Experimental and control groups) as
 mentioned above.

 -  Assessment form including outcome measures will be completed on first visit by a trained
 physiotherapist with experience in the area field of physiotherapy practice at least 2
 years.

 -  The selected outcome measures will be taken on day 0 (pre intervention), and week 6
 (post intervention) will be completed by physiotherapist.

 -  Treatment will be performed for 6 weeks with postural advice and home exercise program
 with dairy record by principal investigator.

 Data Analysis:

 Data will be analyzed using SPSS version 21. For NPRS (Numeric pain rating scale) and NDI
 (Neck disability index) mean ± S.D will be used. For categorical data like gender, etc
 frequency (%) will be calculated.

 To compare mean for quantitative data in both groups independent sample t-test will be
 applied, in cases assumption failure Mann Whitney U test will be applied. NPRS and NDI
 Friedman's test will be used for within group analysis (between sessions analysis) and
 Wilcoxon Signed Rank test (pair wise group analysis). Mann-Whitney test will be used for
 between groups analysis. Neck Proprioception test and Neck endurance test ; Mixed way ANOVA
 and Tukey test (pair wise group comparison) will be used for both between groups as well as
 within group analysis.

 P-value ≤ 0.05 will be considered as significant NOTE: Based on study findings, appropriate
 statistical tests will be considered or used as indicated and will be changed accordingly
Inclusion Criteria:

 -  • Both genders

 -  18 years to 50 years

 -  Participants with history neck of more than 3 months with no related conditions

 -  Non radiating pain to arms

 -  Diagnosed as Nonspecific Chronic Neck pain by consultants

 -  NPRS-Numeric Pain Rating Scale: score 3 to 8 (Score 3 Ending of mild pain, Score
 8 Beginning of worst pain)

 -  NDI- Neck Disability Index: score 5 to 34 (5 to 14 Mild disability,15- 24
 Moderate disability & 25 to 34 Severity disability)

 -  No TMJ pain or dysfunction

 Exclusion Criteria:

 -  • NPRS-Numeric Pain Rating Scale: Score 1 & 2 and score 9 & 10 (Score 1 & 2 mild pain
 and Score 9 & 10 worst pain)

 -  NDI- Neck Disability Index : Score 0 to 4 (no disability) and score 35 to
 50(Complete disability)

 -  Specific or nonspecific Acute Neck pain (Less than 7 days)

 -  Neck pain- Specific or nonspecific Subacute( pain history more than seven days
 however less than three months)

 -  Neck pain- Specific Chronic (pain history more than 3 months)

 -  TMJ Dysfunction

 -  WAD (Whiplash Associated Disorders)

 -  Cervical spondylosis

 -  Rheumatoid arthritis

 -  Instability of spine

 -  Facial injury or dental infection

 -  Any type of infection of body

 -  Neck or spinal segment fracture

 -  Spinal tumor or any type of tumor/cancer

 -  Unexplained headache

 -  Post cervical spine surgical cases

 -  Signs and symptoms of Cervical spine stenosis

 -  Signs and symptoms of disc bulge or herniation of cervical spine

 -  Radiating neck pain or Radiculopathy of cervical spine

 -  Cognitive impairment

 -  Neurological conditions (MS/PD/CVA/MND)

 -  Application of injection therapy in cervical spine

 -  Red flags ( Episode of Double vision, Dysarthria, Dysphasia, Drop Attack,
 Dizziness, Double vision, Gait disturbance)