Patient Adherence to a Physical Activity Advice
Patient Adherence to a Physical Activity Advice
Low back pain is worldwide a common musculoskeletal condition with a high number of
 recurrences. Recurrence rate and the number of recurrences could be reduced and time to a
 next episode could be prolonged by advising an active lifestyle. Advising regular physical
 activity is the mainstay in physical therapy treatment. This includes an appeal to patients
 to adhere to an activity advice. Patient adherence to an activity advice is poor. In this
 study an intervention consisting of treatment of illness perceptions with or without
 organizing social support to increase adherence to an activity advice will be investigated.

 The primary objective of this study is to investigate whether social support by a partner or
 friend and treatment of patients' illness perceptions influences the rate of adherence to an
 activity advice compared to treatment of patients' illness perceptions alone in patients
 suffering non-specific low back pain. Secondary objectives are; a) whether 'treatment of
 illness perceptions' changes patients' maladaptive illness perceptions into realistic ones,
 b) whether maladaptive illness perceptions, comorbidity and/or overweighed/obesity and/or
 rate of recurrences of non-specific low back pain and/or attitude and intention to physical
 activity influences patient's adherence .

 This study is a multi-centre randomized two-arm controlled clinical trial. Patients ≥18 years
 presenting with at least a second episode of non-specific low back pain.

 Patients in the intervention and control group will be asked to perform a physical activity
 advice. During two physiotherapy treatment sessions treatment of illness perceptions is
 performed in both groups. In the intervention group organizing social support by a partner or
 friend is added.

 Twenty-five percent absolute improvement of walking and/or cycling according the NNGB in the
 intervention group is clinically relevant.

 During four appointments several questionnaires have to be filled in and during two
 physiotherapy treatment sessions half an hour treatment of illness perceptions will be
 performed. Social support by a partner or friend will be organized during the same
 physiotherapy treatment sessions in the intervention group. During three separate weeks
 patients have to wear an activity monitor. Patients will be treated according to the Dutch
 Low Back Pain guideline; no adverse effects will be expected.
Objective of the study:

 The primary objective of this study is to investigate whether social support by a partner or
 friend and treatment of patients' illness perceptions influences the rate of adherence to an
 activity advice compared to treatment of patients' illness perceptions alone in patients
 suffering non-specific low back pain. Secondary objectives are; 1) Whether 'treatment of
 illness perceptions' changes patients' maladaptive illness perceptions into realistic ones,
 2) Whether maladaptive illness perceptions, comorbidity and/or obesity and/or rate of
 recurrences of non-specific low back pain and/or attitude and intention to physical activity
 influences patient's adherence to an activity advice.

 Study design:

 This study is a multicentre randomized two arm, controlled clinical trial. During a
 twelve-week intervention period, one group of patients will receive an activity advice added
 to usual treatment including 'treatment of illness perceptions' (C-group). The other group
 will receive an activity advice and the intervention addressing social support by a partner
 or friend added to usual treatment including 'treatment of illness perceptions'
 (SoSup-group). Patients will be assessed at baseline, and after one, 6 and 12 weeks.
 Recruitment is scheduled from October 2016 to July 2017. The study will be performed in 12
 centres for physiotherapy in the province Zuid-Holland, the Netherlands.

 Study population:

 It is mentioned that individuals with recurrent non-specific low back pain score more
 unfavourable on lifestyle risk factors including physical inactivity than individuals without
 or first time non-specific low back pain (van Oostrom et al., 2012). To include potential
 physically inactive non-specific low back pain sufferers, patients ≥18 years presenting with
 at least a second episode of non-specific low back pain who are not physical active in
 accordance with the NNGB are recruited for the study.

 Intervention (if applicable):

 In both the C- and SoSup-group an activity advice will be added to usual treatment. The
 advised activities will be walking and/or cycling outdoors, meeting the Dutch Standard
 Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007). In both groups cognitive
 treatment on illness perceptions according to the common sense model to the patient in the
 presence of the partner or friend will be given. During a maximum of two half-hour contacts
 in a standardised dialogue on maladaptive beliefs and feelings about identity, time-line,
 causes, controllability, and curability of low back pain are mapped, maladaptive perceptions
 are challenged, alternative perceptions are formulated (Siemonsma et al., 2013). The
 intervention in the SoSup-group (intervention group), organizing social support by a partner
 or friend depending on patient's preferences, will be added. During a maximum of two
 half-hour contacts (one for explanation and one for evaluation), in a standardised discussion
 the partner or friend will be stimulated to support the patient in executing the activity
 advice. During 12 weeks the social support by a partner or friend will be executed for at
 least 5 times a week.

 Primary study parameters/outcome of the study:

 The primary outcome measure will be walking and/or cycling according to the NNGB and social
 support.

 Secundary study parameters/outcome of the study (if applicable):

 Other outcomes will be 1. measures of illness perceptions. 2. measures of comorbidity, BMI,
 number of recurrences of non-specific low back pain, measures of attitude and intention to
 physical activity 3. measures of refusal of the study.

 Nature and extent of the burden and risks associated with participation, benefit and group
 relatedness (if applicable):

 The social support described in this study is designed for better outcomes of physical
 activity levels patients suffering low back pain, and has no proven advantage on better
 outcomes on pain and disability in non-specific low back pain sufferers. Therefore we
 consider there is no disadvantage in the SoSup-group versus the C-group because patients in
 both groups receive concomitant best evidence healthcare according to the Dutch guideline for
 low back pain (Staal et al., 2013). No adverse effects of the interventions are expected.
 There are no ethical implications to be expected as a result of this study, treatment of all
 patients during the intervention period will be according to the Dutch guideline for low back
 pain.
Inclusion Criteria:

 • Non-specific low back pain

 Exclusion Criteria:

 -  Patients physical active in accordance with the Dutch Standard Healthy Physical
 Activity (NNGB) (Hildebrandt et al., 2007)

 -  Patients with specific low back pain

 -  Onset of the low back pain after age 50 years,

 -  Continuous pain regardless of posture or movement,

 -  Nocturnal pain,

 -  General malaise,

 -  History of malignancy,

 -  Unexplained weight loss,

 -  Elevated erythrocyte sedimentation rate (ESR)

 -  Previous vertebral fracture,

 -  Older person with hip fracture,

 -  Prolonged use of corticosteroids,

 -  Onset of low back pain before age 20 years,

 -  Iridocyclitis,

 -  History of unexplained peripheral arthritis or inflammatory bowel disease,