Joint Pain, Knee Pain, Hip Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
Conditions
Keywords
Joint pain, Context effects, Placebo effect, Exercise treatment
Brief summary
The study is designed to investigate the effect of physical surroundings on the effect of exercise therapy for knee and hip pain.
Detailed description
Context effect have been shown to be influential in health-care settings, such as hospitals. This study investigates if context effects can be caused by the physical surroundings of exercise. The study is designed as a double-blind randomized controlled clinical trial. Patients with knee and/or hip pain with a duration of a least 3 months are included in the trial and randomly assigned to 3 groups. 1. Exercise in pre-existing, standard room 2. Exercise in contextually enhanced room. 3. Waiting list. The intervention consists markedly different between the two exercise rooms. The physical surroundings are described by factors such as acoustics, light source and intensity, decorations and air quality. The exercise program applied is based on a previously investigated neuromuscular exercise program, NEMEX. The same program is performed in both exercise rooms. Consequently, only the physical surroundings differ between intervention groups. Patients' global perceived effect is used as the primary outcome assessed at 8 weeks follow-up.
Interventions
OTHERContextually enhanced physical surroundings of exercise
Different physical surroundings of exercise may affects the patients differently and consequently influence the effect of exercise. The exercise rooms are different from each other on parameters such as source of lighting, acoustics, materials and decorations. The differences with the physical surroundings of exercise is the primary intervention for this study.
The neuromuscular exercise program is the same across the two exercise groups. Consequently, this intervention is not the primary intervention of this study. The exercise program is based on the previously reported NEMEX program designed for patients with hip or knee osteoarthritis, originally published by Ageberg et al, 2010 in BMCMusculoskeletal Disorders.
Sponsors
The Swedish Research Council
The Danish Rheumatism Association (funding)
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: 35 years or older * Self-report of knee and/or hip pain within the last 3 months. * Willing and able to attend exercise therapy at the University of Southern Denmark, Odense M twice weekly.
Exclusion criteria
* Co-morbidities or contraindication prohibiting to participation in exercise therapy. * Unable to fill-out questionnaires, or to speak, read or understand Danish. * Already participating in exercise therapy\*, having had surgery to the hip/knee within the last 3 months or on waiting list for joint surgery within the coming 6 months. (\*defined as supervised exercise program by physiotherapist, systematic strength training etc. with duration of 6 weeks or more)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients' Global Perceived Effect | 8 weeks | Patients indicate their perception of the global effect of the intervention on a 7 point likert scale ranging from substantially worse to no change to substantially improved. The scale is balanced around the 'no change' response with 3 steps in each direction, respectively deterioration or improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in KOOS (The Knee injury and Osteoarthritis Outcome Score) or HOOS (The Hip Dysfunction and Osteoarthritis Score), respectively | Baseline, 4 weeks, 8 weeks | — |
| Change from baseline in The 36-item Short-Form Health Survey (SF-36) | Baseline, 4 weeks, 8 weeks | — |
| Change from baseline in Arthritis Self-Efficacy Scale | baseline, 4 weeks, 8 weeks. | A modified version of the Arthritis Self-Efficacy Scale consisting of 11 items scoring patient reported self-efficacy |
| Patient satisfaction with physical surroundings | 8 weeks | Patients are asked to indicate their level of satisfaction with different elements of the physical surroundings. |
Other
| Measure | Time frame |
|---|---|
| Change from baseline in muscle strength, MVC knee extension | baseline, 8 weeks |
| Change from baseline in functional test: Single limb mini squat | Baseline, 8 weeks |
| Change from baseline in aerobic capacity measured by a submaximal bicycle test by Aastrand & Saltin | Baseline, 8 weeks |
| change from baseline in muscle strength, MVC, hip abduction | baseline, 8 weeks |
| Change from baseline in functional test: Maximal number of knee bendings pr. 30 sec. | baseline, 8 weeks |
| Change from baseline in functional test: Number of chair stands per. 30 sec. | baseline, 8 weeks |
| Change from baseline in functional test: Timed 40 m walking test | baseline, 8 weeks |
| Change from baseline in functional test: One leg hop for distance | Baseline, 8 weeks, |
Countries
Denmark
Outcome results
None listed