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NCT Number: NCT07701174

Weighted Dangling Exercises vs Vastus Medialis Oblique Muscle Neuromuscular Stimulation for Knee Osteoarthritis

This randomized controlled trial aims to compare the effectiveness Weighted dangling exercises versus vastus medialis oblique muscle neuromuscular electrical stimulation(VMO+NMES) in patients with knee osteoarthritis. The study will recruit 48 participants (accounting for 10% attrition), aged 40-60 years, from University of Lahore Teaching Hospital using convenience sampling. Participants will be randomly allocated into two groups: an interventional group receiving WDE and other interventional group undergoing VMO strength training with NMES. Both interventions will be administered three times per week for 8 weeks under professional supervision. Outcome measures including pain intensity (NPRS), Functional Disability (Western Ontario and McMaster Universities Osteoarthritis Index),Muscle Strength (MMT) will be assessed at baseline, 4 weeks, and 8 weeks. Data will be analyzed using SPSS, with appropriate parametric or non-parametric tests applied after checking data normality. Ethical approval will be obtained, informed consent will be secured, and participant confidentiality will be strictly maintained.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lahore Teaching Hospital, Lahore, Pakistan

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Asim Arif, PhD PT*

CONTACT

[email protected]

03216597727

Hafiza Sana Ashraf, PhD PT*

PRINCIPAL_INVESTIGATOR

Mahnoor Fatima, MS MSK

PRINCIPAL_INVESTIGATOR

Mahnoor Fatima, MS MSK*

CONTACT

[email protected]

03164247896

About this study

This study is a single-blinded randomized controlled trial designed to evaluate and compare the therapeutic effectiveness Weighted dangling exercises versus vastus medialis oblique muscle neuromuscular electrical stimulation(VMO+NMES) in patients with knee osteoarthritis. The study will recruit 48 participants (accounting for 10% attrition), aged 40-60 years, from University of Lahore Teaching Hospital over a duration of 9 months following synopsis approval. A total sample size of 48 participants (24 per group) has been determined using epitool software, based on theWestern Ontario and McMaster Universities Osteoarthritis Index) , with a confidence level of 95%, power of 80%, and a 10% attrition allowance. Participants aged 40-60 years, of both genders, with clinically confirmed knee osteoarthritis. Symptoms of unilateral knee pain and crepitus persist for at least 6 months during ascending and descending motion. Radiographic Knee osteoarthritis examination. Exclusion includes recent surgery (within three months) history of hip or knee joint replacement, tibial osteotomy, or those 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. Eligible participants will be enrolled after providing written informed consent and randomized using a computer-generated block randomization method, with allocation concealment ensured through sealed opaque envelopes. Outcome assessors will be blinded to group allocation to minimize assessment bias. 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. Other 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. Sessions will be conducted three times weekly for 8 weeks, totaling 24 supervised sessions. Primary and secondary outcome measures include pain intensity (Numeric Pain Rating Scale),theWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC), muscle strength, assessed at baseline, 4 weeks, and 8 weeks post-intervention. Data will be analyzed using SPSS (version 25/27). Descriptive statistics will summarize participant characteristics, while inferential statistics will be applied based on data distribution, with significance determined accordingly. Ethical considerations will strictly adhere to the guidelines of the Institutional Research Ethics Board (IREB), University of Lahore. Participant confidentiality, voluntary participation, right to withdraw, and safety monitoring will be ensured throughout the study. No serious adverse effects are anticipated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

interventional group A

Behavioral

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

interventional group B

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashfaq Ahmed, PhD PT

CONTACT

[email protected]

03009449192

Ishaq Ahmed, PhD PT

CONTACT

[email protected]

03344066463

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

Effectiveness of Weighted Dangling Exercises Versus Vastus Medialis Oblique Muscle Neuromuscular Stimulation in Patients With Knee Osteoarthritis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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