Effectiveness of Knee Sync Partner and Strengthening Exercises Versus Strengthening Exercises in Knee Osteoarthritis.RCT
1 other identifier
interventional
22
1 country
1
Brief Summary
This study explores the effectiveness of a novel treatment approach for knee osteoarthritis (OA) by comparing the combined use of a new device, "Knee Sync Partner," which provides electrical knee traction with stimulation and strengthening exercises, to traditional strengthening exercises alone. Knee osteoarthritis is a leading cause of chronic pain and disability worldwide, significantly impacting the quality of life for many individuals, especially with the growing elderly population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 28, 2024
CompletedFirst Posted
Study publicly available on registry
October 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2024
CompletedOctober 29, 2024
October 1, 2024
7 months
October 28, 2024
October 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
WOMAC Scale
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score
12 Months
Study Arms (2)
Exp Group
EXPERIMENTALControl Group
ACTIVE COMPARATORInterventions
Participants in this group will receive treatment using the Knee Sync Partner, a novel portable device designed to provide electrical traction and stimulation specifically for the knee joint. controlled mechanical traction to the knee joint to reduce joint contact pressure, enhance synovial fluid flow, and increase joint space. This is expected to alleviate pain and improve mobility.
This will include a combination of isometric and isotonic exercises aimed at strengthening the knee musculature, enhancing joint stability, and reducing pain. The exercise regimen will focus on major muscle groups supporting the knee, such as the quadriceps, hamstrings, and calf muscles.
Eligibility Criteria
You may qualify if:
- having pain in knee for more than 3 months in most days of week
- age between 40 and 70 years
- patient who filled Kellgren-Lawrence radiographic criteria
You may not qualify if:
- joint injection in the previous three months.
- osteoarthritis of the hips.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 28, 2024
First Posted
October 29, 2024
Study Start
November 1, 2023
Primary Completion
June 1, 2024
Study Completion
November 15, 2024
Last Updated
October 29, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share