STUDY PROTOCOL: CONTEXT EFFECTS IN EXERCISE THERAPY FOR KNEE AND HIP PAIN - a randomized controlled trial
Louise Fleng Sandal, Jonas Bloch Thorlund, Ewa M Roos.
Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
'Context effects’ can be described as the effects of a given treatment, not directly caused by the treatment itself, but rather caused by the context or environment in which the treatment is delivered. Context effects have caused e.g. less postoperative pain when recovering in a brighter room in hospital settings and reduced stress and anger in office settings with landscape posters.
Exercise is a strongly recommended treatment for knee and hip pain, and first line treatment in international clinical guidelines for osteoarthritis. Although overall moderately effective, variation is seen in size of response to exercise across available RCT studies. Part of this variation may be related to the fact, that exercise interventions are performed in different healthcare settings, which may affect patients differently.
Many exercise treatment facilities are not directly designed for exercise, such as basements in hospitals or windowless rehabilitation clinics with poor acoustics. More appropriate physical contexts may improve compliance to exercise, and may also improve physiological performance, patient-therapist communication, etc. It is plausible, but currently unknown, whether the physical context of exercise can be changed in ways, that enhances the effect of exercise therapy.
The study objective is to investigate the effect of exercise therapy delivered in a contextually enhanced environment, for patients with knee and hip pain.
The study is designed a double-blind randomized controlled clinical trial. Patients will be randomized in a 2:2:1 allocation to one of three intervention groups; 1) Exercise in a contextually enhanced room 2) Exercise in a pre-existing, standard room 3) Waiting list for exercise.
Patients: 35 years or older, with consistent knee and/or hip pain within the last 3 months are eligible. Exclusion criteria: Contraindications to exercise, linguistic problems or surgery or exercise therapy 3 months prior to inclusion.
Interventions: All patients are offered 8 weeks of exercise, regardless of group allocation, based on an existing neuromuscular exercise program (NEMEX). The contextually enhanced room is located in a newly built facility, has large windows providing abundant daylight, overlooks a recreational park and has attractive nature posters chosen based on evidence-based criteria to reduce stress. By contrast, the pre-existing room is placed in the basement, has artificial lighting, poor acoustics, and unadorned walls marked by years of use (i.e. resembling many clinical settings).
Outcomes: The primary outcome is patient´s global perceived effect at 8 weeks follow-up. Patients indicate their perceived change, attributed to their participation in the trial, on a 7 point likert scale. Secondary outcomes include patient-reported outcomes on joint specific and generic health, as well as measures of objective function. Outcomes are obtained at baseline and after 8 weeks exercise, patient-reported outcomes additionally at 4 weeks.
IMPLICATIONS OF FINDINGS:
Context effects may potentially enhance the effect of and compliance to exercise treatment, and consequently benefit the individual patient as well as health care providers as it may postpone the need for further treatment. This trial can form basis for evidence-based design or renovation of exercise facilities in hospitals, rehabilitation clinics and exercise facilities in general.
Document made available 29.07.2015