Tennis ElbowNCT06739837
Comparison of the Effect of a Non-immersive VRE and CT in Patients With Tennis Elbow
A study testing traditional physiotherapy and Non-immersive VR therapy in people with Tennis Elbow, run by Superior University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- traditional physiotherapy and Non-immersive VR therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Samahni, Near thq hospital samahni azad kashmir
Kashmir, Azad Kashmir
About this study
Official title: 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.
Read the 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
- Conditions
- Tennis Elbow
- Being tested
- traditional physiotherapy, Non-immersive VR therapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional physiotherapyDiagnostic test
Participants in this arm will undergo traditional physiotherapy exercises for managing tennis elbow.
Non-immersive VR therapyCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group I | Experimental | Not described Receives: Diagnostic Test: traditional physiotherapy |
| Interventional group II | Active comparator | Not described Receives: Combination Product: Non-immersive VR therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
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.
Measured: 12 Months
Handheld Dynamometer
This instrument is scored using force production in kilograms (0-90) or pounds (0-200). Standardized procedure for positioning of instrumen
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739837
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/759
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of a Non-immersive Virtual Reality Environment and Conventional Treatment in Patients With Tennis Elbow
- ClinicalTrials.gov ID
- NCT06739837
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/759
- Conditions
- Tennis Elbow
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group I | Experimental | Diagnostic Test: traditional physiotherapy |
| Interventional group II | Active comparator | Combination Product: Non-immersive VR therapy |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional physiotherapyParticipants in this arm will undergo traditional physiotherapy exercises for managing tennis elbow. | Diagnostic test | Interventional group I |
| Non-immersive VR therapyParticipants 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. | Combination product | Interventional group II |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional physiotherapy and Non-immersive VR therapy in people with Tennis Elbow, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.