Clinical trial NCT04331990: The Distraction of Knee Joint to Alleviate osteoArthritic Pain (DiKAP) Trial
Official title: Efficacy of Adding Mechanical Nonsurgical Knee Traction to Standard Physical Therapy Rehabilitation of Knee Osteoarthritis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee
Osteoarthritis
Pain
Joint distraction
Lead sponsor: Prince Sultan Military College of Health Sciences
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 198
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial examining the short- and long-term effects of mechanical nonsurgical knee joint traction on knee pain, function, and quality of life.

Detailed description: Knee OA symptoms are known to be impacted by increased joint loading and reduced joint space width between the articulating bones.

Objectives:

* Primary objective: Investigate the short- and long-term efficacy of adding nonsurgical knee joint distraction to standard multimodal physical therapy treatment on pain, joint function and quality of life in patients with knee OA compared with standard physical therapy treatment alone.
* Secondary objective: examine whether the efficacy of mechanical traction would differ based on the mode of application (continuous vs. intermittent traction).

Design and Subjects: A prospective, active control, three-parallel-group, investigator-blinded, randomized controlled trial. 198 subjects will be recruited and randomly assigned to one of three study groups at a 1:1:1 allocation ratio (66 participants per group): a) Standard care only, b) continuous mechanical traction plus standard care, and c) intermittent mechanical traction plus standard care.

Intervention: Participants in the standard care only group will receive 16 treatment sessions (2sessions/week) over 8 weeks, followed by 4 booster sessions (1session/2months) during the one-year period of the trial. Mechanical traction groups will receive standard care in addition to 20-minute knee traction (continuous or intermittent) using an external weight applying knee traction force.

Outcome measures: The primary outcomes are physical function and pain assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include the Numeric Pain Rating Scale, quality of life, Timed Up and Go, 40m fast-paced walk, and 30s chair stand tests, patient's self-perceived efficacy of treatment and patient's global assessment.

Data Analysis: Data will be analyzed using the intension-to-treat (ITT) analysis with multiple imputations. The per-protocol analysis will be carried out and reported if its findings are different from those of the primary ITT analysis. The primary analysis of the primary outcomes at two- and six-month follow-up time points will be carried out using analysis of covariance (ANCOVA) test with adjustment for a set of pre-specified baseline covariates. Secondary analysis using ANCOVA test for the primary outcomes at the 12-month time point, and secondary outcomes at all follow-up time points will also be carried out.

Eligibility criteria: Inclusion Criteria:

* ≥40 years of age;
* having knee pain;
* having at least three of the following additional symptoms: a-morning stiffness ≤ 30 minutes, b-crepitation, c-bone margin tenderness, d-bony enlargement or e-no palpable warmth;
* willing to provide informed consent

Exclusion Criteria:

* rheumatoid arthritis;
* serious pathological conditions (inflammatory arthritis and malignancy); total or partial arthroplasty of the affected knee joint, or on waiting list for joint replacement surgery;
* recent surgical procedure of the lower extremities in the previous 6 months;
* uncontrolled hypertension and unstable cardiovascular problems that could subject the participant to increased risk with exercise and physical exertion;
* physical incapability to safely perform exercises, walking or stationary cycling, as in: debilitating visual defects, neurological problems, exaggerated low back pain, advanced osteoporosis, and inability to walk 10 meters without an assistive device;
* use of prescribed analgesics, corticosteroid or analgesic injection intervention for knee pain within the previous 30 days;
* lack of clear comprehension of study procedures or inability to comply with instructions;
* stated inability to attend or complete the proposed course of intervention and follow-up schedule.

Primary outcomes:
measure: Change in pain score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, 2, 6 and 12 months follow-up
measure: Change in physical function score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, 2, 6 and 12 months follow-up
Secondary outcomes:
measure: Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)
timeFrame: Baseline, 2, 6 and 12 months follow-up
measure: Change in Patient's Global Assessment
timeFrame: 2, 6, 12 months follow-up
measure: Change in Health-related Quality of Life score using the Arabic version of the Short Form 36 (SF-36) scale
timeFrame: Baseline, 2, 6 and 12 months follow-up
measure: Change in the time taken to complete the Timed Up and Go (TUG)
timeFrame: Baseline, 2, 6 and 12 months follow-up
measure: Change in the wakling speed for the 40m fast-paced walk test
timeFrame: Baseline, 2, 6 and 12 months follow-up
measure: Change in number of repetitions during the 30s chair stand test
timeFrame: Baseline, 2, 6 and 12 months follow-up
measure: change in the Patient's Self-perceived Efficacy of treatment
timeFrame: 2, 6 and 12 months follow-up
measure: Change in other subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS (Symptoms, Sport and Recreation Function, and knee-related Quality of Life).
timeFrame: Baseline, 2, 6 and 12 months follow-up
Other outcomes:
measure: Number of sessions attended by the patient
timeFrame: 2, 6, 12 months follow-up
Locations:
Study officials:
affiliation: Prince Sultan Military College of Health Sciences
name: Ahmed Farrag, PhD
role: PRINCIPAL_INVESTIGATOR
References: