NCT06664632

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 28, 2024

Last Update Submit

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

EXPERIMENTAL
Behavioral: Exp

Control Group

ACTIVE COMPARATOR
Diagnostic Test: control

Interventions

ExpBEHAVIORAL

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.

Exp Group
controlDIAGNOSTIC_TEST

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.

Control Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

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

Locations