- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06739837
Comparison of the Effect of a Non-immersive VRE and CT in Patients With Tennis Elbow
December 14, 2024 updated by: Muhammad Naveed Babur, Superior University
Comparison of the Effect of a Non-immersive Virtual Reality Environment and Conventional Treatment in Patients With Tennis Elbow
This study investigates the comparative effectiveness of non-immersive virtual reality (VR) therapy and conventional physiotherapy in managing tennis elbow (lateral epicondylitis).
Tennis elbow is a painful condition often characterized by chronic pain, reduced grip strength, and limited functionality.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Conventional treatment approaches, including manual therapy and strengthening exercises, have been widely used but may not fully address the long-term rehabilitation needs of every patient.
Virtual reality, an emerging tool in rehabilitation, has the potential to enhance patient engagement and adherence by providing an interactive therapeutic environment.
Participants will be divided into two groups: one receiving VR therapy and the other conventional therapy, with each intervention lasting six weeks.
Outcome measures include pain intensity (VAS), functional disability (DASH), patient satisfaction (PRTEE), grip strength, range of motion (ROM), and adherence rates.
This study aims to determine if VR therapy can offer superior benefits over conventional
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Azad Kashmir
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Kashmir, Azad Kashmir, Pakistan
- Samahni, Near thq hospital samahni azad kashmir
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults aged 25 to 50 years.
- Patient diagnosis with lateral epicondylitis.
- Patients that a medical doctor will be formally diagnosed to have tennis elbow, that is, lateral epicondylitis.
- Patients who have specific pain and function impairment associated with tennis elbow.
- Patients giving written consent to participate in the study. Willing to participate and provide informed consent.
Exclusion Criteria:
- Patients with neurological conditions whereby they have abnormal functioning of their arms.
- Any previous surgical intervention for tennis elbow The presence of other significant musculoskeletal diseases in the upper extremity Severe cardiovascular or neurological disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional group I
|
Participants in this arm will undergo traditional physiotherapy exercises for managing tennis elbow.
|
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Active Comparator: Interventional group II
|
Participants undergo a VR-based rehabilitation program targeting tennis elbow symptoms.
Sessions last 30 minutes, conducted 3 times per week for 6 weeks.
Exercises focus on improving grip strength, wrist flexibility, and functional movement through interactive VR environments that visually engage the affected arm, promoting adherence and motivation without full immersion.
The VR setup includes headsets or screens that enable visual interaction, enhancing the rehabilitation experience.
The goal is to alleviate pain, increase range of motion, and restore muscle strength.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: 12 Months
|
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain.
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
|
12 Months
|
|
Handheld Dynamometer
Time Frame: 12 Months
|
This instrument is scored using force production in kilograms (0-90) or pounds (0-200).
Standardized procedure for positioning of instrumen
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Actual)
September 1, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
December 14, 2024
First Submitted That Met QC Criteria
December 14, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 14, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall22/759
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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