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The Distraction of Knee Joint to Alleviate osteoArthritic Pain (DiKAP) Trial

NCT04331990 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2021-03-10

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Standard Physcial Therapy

Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), muscle strengthening and stretching, and neuromuscular control exercises. Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.

OTHER

Intermittent Mechanical Traction

In addition to the standard treatment, patients in this group will receive intermittent knee joint decompression for 20 minutes. Patients will be lying supine with the knee semiflexed to 30° and supported by a wedge under the knee. A customized leg cuff will be placed around the lower leg and two ropes will be extending horizontally from the cuff to the vertical traction weight using a pulley system to transfer the traction force to the tibiofemoral articulation. The magnitude of the traction force will be between 10-15% of the patient's body weight. The traction force will be applied for 10 application cycles; each cycle comprised of 2 minutes traction followed by 30 seconds relief. This will sum up to 20 minutes of actual joint traction duration. The traction force application and relief time will be controlled manually by the treating therapist. Knee joint traction procedures will be applied at the end of the physical therapy session.

OTHER

Continuous Mechanical Traction

Patients assigned to this group will receive the same treatment protocol as those in the Intermittent Mechanical Traction group. However, the knee traction force will be applied continuously for 20 minutes without intermittent force relief periods.

Sponsors & Collaborators

  • Prince Sultan Military College of Health Sciences

    lead OTHER

Principal Investigators

  • Ahmed Farrag, PhD · Prince Sultan Military College of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331990 on ClinicalTrials.gov