Exercise Therapy for Osteoarthritis Pain: How Does it Work? (KOA-PAIN)

Vrije Universiteit Brussel

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Behavioral: Behavioral graded activity; Other: Muscle Strengthening Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04362618

G040919N_KOA_PAIN

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. pain, nominated by the patient as 3 /10 or higher on a visual analogue scale on most days of the last 3 months
3. aged ≥ 50 years.

Exclusion criteria

1. treatment with exercise therapy or joint infiltrations (e.g., corticosteroids, hyaluronic acid) in the preceding 6 months;
2. being on a waiting list for knee replacement;
3. any contra-indication for exercise therapy as established by the treating physician;
4. corticosteroid infiltrations in the last 6 months;
5. cognitive impairment (unable to understand the test instructions and/or Mini Mental State Examination score <23/30);
6. unable to understand the Dutch language;
7. inflammation unrelated to OA (e.g. due to acute or chronic infection) established by CRP>10mg/L.
8. presence of a disorder and/or medication that influences pain and/or the immune system

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Muscle Strengthening Training (MST)-group

Experimental group

Description:

Subjects allocated to the MST group (n=30) will perform a muscle strengthening training program of 12 weeks.

Treatment:

Other: Muscle Strengthening Training

Behavioral Graded Activity (BGA)-group

Experimental group

Description:

Subjects allocated to the BGA group (n=30) will perform a rehabilitation program according to the principles of behavioural graded activity for a period of 12 weeks.

Treatment:

Behavioral: Behavioral graded activity

Control group

No Intervention group

Description:

Subjects allocated to the control group (n=30) have to maintain their current life-style and treatment (if any) and to refrain from other new interventions during 24 weeks.