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

NCT04331990 | Unknown

• 1 other identifier: PT-2020-02
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Keywords

Knee; Osteoarthritis; Pain; Joint distraction

Outcome Measures

Primary Outcomes (2)

• Change in pain score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)

  A 5-point Likert scale comprised of 42 questions across 5 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  Baseline, 2, 6 and 12 months follow-up

• Change in physical function score using the Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS)

  A 5-point Likert scale comprised of 42 questions across 5 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  Baseline, 2, 6 and 12 months follow-up

Secondary Outcomes (8)

• Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)

  Baseline, 2, 6 and 12 months follow-up

• Change in Patient's Global Assessment

  2, 6, 12 months follow-up

• Change in Health-related Quality of Life score using the Arabic version of the Short Form 36 (SF-36) scale

  Baseline, 2, 6 and 12 months follow-up

• Change in the time taken to complete the Timed Up and Go (TUG)

  Baseline, 2, 6 and 12 months follow-up

• Change in the wakling speed for the 40m fast-paced walk test

  Baseline, 2, 6 and 12 months follow-up

Other Outcomes (1)

• Number of sessions attended by the patient

  2, 6, 12 months follow-up

Study Arms (3)

Standard Physical Therapy

ACTIVE COMPARATOR

Control group for the study. Intervention in the form of warm-up and strengthening, stretching and neuromuscular control exercises.

Other: Standard Physcial Therapy

Intermittent Mechanical Traction

EXPERIMENTAL

Standard care in addition to intermittent mechanical distraction of the knee joint.

Other: Intermittent Mechanical Traction

Continuous Mechanical Traction

EXPERIMENTAL

Standard care in addition to continuous mechanical distraction of the knee joint

Other: Continuous Mechanical Traction

Interventions

Standard Physcial Therapy OTHER

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.

Standard Physical Therapy

Intermittent Mechanical Traction OTHER

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.

Intermittent Mechanical Traction

Continuous Mechanical Traction OTHER

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.

Continuous Mechanical Traction

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince Sultan Military College of Health Sciences: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Farrag, PhD

  Prince Sultan Military College of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Farrag, PhD

CONTACT

+966 38440000; afarrag@psmchs.edu.sa

Ahmed Farrag

CONTACT

ahmedfarrag77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both the outcome assessors and the study statistician will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 2, 2020
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share