- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07701174
Weighted Dangling Exercises vs Vastus Medialis Oblique Muscle Neuromuscular Stimulation for Knee Osteoarthritis
Effectiveness of Weighted Dangling Exercises Versus Vastus Medialis Oblique Muscle Neuromuscular Stimulation in Patients With Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ishaq Ahmed, PhD PT
- Phone Number: 03344066463
- Email: ishaq.ahmed@uipt.uol.edu.pk
Study Contact Backup
- Name: Ashfaq Ahmed, PhD PT
- Phone Number: 03009449192
- Email: ashfaq.ahmed@uipt.uol.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- University of Lahore Teaching Hospital, Lahore, Pakistan
-
Contact:
- Asim Arif, PhD PT*
- Phone Number: 03216597727
- Email: asim.arif@uipt.uol.edu.pk
-
Contact:
- Mahnoor Fatima, MS MSK*
- Phone Number: 03164247896
- Email: 70174837@student.uol.edu.pk
-
Principal Investigator:
- Mahnoor Fatima, MS MSK
-
Principal Investigator:
- Hafiza Sana Ashraf, PhD PT*
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Both genders and aged between 40 and 60 years. Symptoms of unilateral knee pain and crepitus persist for at least 6 months during ascending and descending motion. Radiographic KOA; grade 2 or more according to Kellgren and Lawrence scale. Patient referred by an orthopedic physician Those who have taken oral corticosteroids within the last month or who received intra-articular corticosteroid injection or analgesic injection intervention for hip or knee pain within the last 3 month
Exclusion Criteria:
- Recent surgery (within three months) history of hip or knee joint replacement, tibial osteotomy, orthoses with systemic arthritis, history of trauma such as knee fracture and other with muscular disease of neurological disorders that would affect lower extremity function is excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: interventional group A
The experimental group A will receive weighted dangling exercise.
A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down
|
This group receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO).
The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical.
The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF
|
|
Active Comparator: interventional group B
Experimental group B receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO).
The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical.
The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF
|
The one group will receive weighted dangling exercise.
A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity (Numeric Pain Rating Scale)
Time Frame: baseline,4 weeks and 8 weeks
|
Pain in this study is defined as subjective discomfort in the knee joint caused by osteoarthritis.
It was evaluated using the Numeric Pain Rating Scale (NPRS), which is a reliable and proven technique for quantifying pain intensity.
Participants score their discomfort on an 11-point scale, with 0 indicating "no pain" and 10 representing "the worst pain imaginable.
|
baseline,4 weeks and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional disability:(WOMAC)
Time Frame: Baseline 4 weeks and 8 weeks
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which is a well-used and validated questionnaire.
The WOMAC measures three dimensions: pain (5 things), stiffness (2 items), and physical function (17 items).
Each item is assessed on a scale of 0 (no difficulty) to 4 (severe difficulty), with a total WOMAC score of 0-96.
Higher scores indicate greater functional disability.
The questionnaire examines pain while walking or ascending stairs, stiffness in the morning or later in the day, and difficulty with sitting, standing, and lifting objects.
|
Baseline 4 weeks and 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mahnoor Fatima, MS MSK*, University Institute of Physical Therapy, University of Lahore
- Principal Investigator: Hafiza Sana Ashraf, PhD PT*, University Institute of Physical Therapy, University of Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL/IREB/25/15/03/26 (Other Identifier: University Of Lahore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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