Influence of Social Support and Treatment of Illness Perceptions on Patient's Adherence to a Physical Activity Advice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 240
- Locations
- 2
- Primary Endpoint
- adherence to the activity advice
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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,
Outcomes
Primary Outcomes
adherence to the activity advice
Time Frame: 12 weeks
proportion of patients (non)adhering to the activity advice measured by the Activ8
Secondary Outcomes
- changes in patient's illness perceptions(base line, one week, 6 and 12 weeks)