Exercise Therapy for Osteoarthritis Pain: How Does it Work?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Vrije Universiteit Brussel
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Knee pain as primary study outcome
Study Overview
Brief Summary
International guidelines recommend exercise as the first choice treatment for knee osteoarthritis (KOA). Muscle strengthening training (MST) and behavioural graded activity (BGA) show comparable effects on KOA pain, but the mechanisms of action are unclear. Understanding these mechanisms is necessary to tailor exercise therapy towards specific mediators and thereby optimize treatment effects. Based on previous studies, both exercise-induced anti-inflammation and endogenous analgesia are promising pathways for pain reduction after exercise therapy. This study aims to examine (anti)-inflammation and endogenous analgesia as mediators for the effect of MST and/or BGA on pain in patients with KOA. Therefore, a 3-arm randomized clinical trial is established: 12 weeks of muscle strengthening training, behavioural graded activity or control. Mediator analysis will be performed. Unravelling the mechanisms of action of exercise therapy in KOA will not only be extremely valuable for researchers, but also for exercise immunology and pain scientists. The results of this research will also find their way into clinical practice: thanks to the current project, tailoring exercise therapy programs towards specific mechanistic factors and thereby optimizing treatment effects will be at the horizon for patients suffering from KOA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
Outcome assessors will be blinded to the maximal extent possible. With regard to this, patients will be asked not to communicate with the assessors about the intervention received. The researcher who is responsible for the acute measurements, is not blinded for group allocation but the researcher responsible for the basal measurements is. Both researchers are blinded for the outcome analyses. Furthermore, at the end of each assessment, the success of assessor blinding will be examined by asking whether the assessor thought the participant had received the experimental or control intervention, including the percentage of certainty. The physiotherapists providing BGA will not be involved in providing MST, and vice versa. Additionally, the physiotherapists will be blinded for outcome measures. The statistician will be blinded to the allocation of the treatment groups and statistical analyses will be performed in a blinded manner.
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •KOA according to the clinical American College of Rheumatology (ACR) criteria. The clinical ACR criteria for KOA are: knee pain and at least 3 of the 6 following features: age ≥50, morning stiffness <30 minutes, crepitus, bony tenderness, bony enlargement, no palpable warmth. KOA will be confirmed with radiographs, including anterior-posterior (AP) and medio-lateral (ML) radiographs for imaging the tibiofemoral joint, and an axial view for imaging the patellofemoral joint. Kellgren and Lawrence (K&L) grading system for OA will be applied, with K&L grade 2 or higher defined as OA; radiographic KOA is defined as definite osteophytes and possible joint space narrowing.
- •pain, nominated by the patient as 3 /10 or higher on a visual analogue scale on most days of the last 3 months
- •aged ≥ 50 years.
Exclusion Criteria
- •treatment with exercise therapy or joint infiltrations (e.g., corticosteroids, hyaluronic acid) in the preceding 6 months;
- •being on a waiting list for knee replacement;
- •any contra-indication for exercise therapy as established by the treating physician;
- •corticosteroid infiltrations in the last 6 months;
- •cognitive impairment (unable to understand the test instructions and/or Mini Mental State Examination score <23/30);
- •unable to understand the Dutch language;
- •inflammation unrelated to OA (e.g. due to acute or chronic infection) established by CRP>10mg/L.
- •presence of a disorder and/or medication that influences pain and/or the immune system
Outcomes
Primary Outcomes
Knee pain as primary study outcome
Time Frame: post-intervention: week 64
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Secondary Outcomes
- Different subtypes of pain: pain(Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64))
- Treatment compliance(During the intervention (week 1-12) and at week 13)
- Function in daily living (KOOS subscale)(Baseline, post-intervention (week 13, 26 and 64))
- Health care cost effectiveness(Assessed at baseline, at week 13, 26 and 64)
- Different subtypes of pain: constant pain(Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64))
- Function in daily living (PGA)(Assessed at baseline and post-intervention (at week 13, 26 and 64))
- Different subtypes of pain: intermittent pain(Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64))
- Different subtypes of pain: central sensitization(Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64))
- Treatment adherence(During the intervention (week 1-12) and at week 13)
Investigators
Prof. Ivan Bautmans
Prof. dr.
Vrije Universiteit Brussel