Lateral EpicondylitisNCT06317545
Effects of Nerchal Exercises on Lateral Epicondylitis.
A study testing Mulligan Taping in people with Lateral Epicondylitis, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Painful condition of lateral epicondyle of the humerus characterized by the inflammation of the tendons during loading of the wrist extensor muscles is a common musculoskeletal presentation in men and women between 35 and 54 years of age. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Mulligan Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Nov 2023to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pain and tenderness over lateral epicondyle
- at least two out of three tests for the lateral epicondylitis including Cozen's test, Mill's maneuver, or resisted middle finger extension positive
Who cannot join
- Individuals with a history of recent trauma of upper limbs
- Recent administration of platelet-rich plasma containing growth factors,
- Patients which had taken physical therapy of any sort in the past 6 months
- occupation-related pain were ruled out.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
BARKI Advanced Physiotherapy Center
Multan, Punjab Province, 60000
KAIMS Physiotherapy and Rehabilitation Center
Multan, Punjab Province, 60000
About this study
Official title: Effects of Nirschl Exercises With and Without Mulligan Taping in Lateral Epicondylitis
Painful condition of lateral epicondyle of the humerus characterized by the inflammation of the tendons during loading of the wrist extensor muscles is a common musculoskeletal presentation in men and women between 35 and 54 years of age. The above symptom is associated with a clinical diagnosis of lateral elbow tendinopathy (LET), also known as tennis elbow or lateral epicondylalgia the two effective treatment approaches for lateral epicondylitis are Nirschl exercises and Mulligan taping. This study aims to evaluate the effectiveness of Nirschl exercises with or without Mulligan taping in treating lateral epicondylitis. The study design for this project employs a randomized controlled trial and a sample of individuals with lateral epicondylitis randomly assigned in one of the two groups i.e., Nirschl exercises only and Nirschl exercises with Mulligan taping. Nirschl exercises involve the eccentric strengthening of the wrist extensor muscles and forearm. The participants in both groups will receive Nirschl exercises while the second group will also receive Mulligan taping, which involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons. Different outcome measures including pain intensity, functional disability, grip strength, range of motion will be evaluated using, PRTEE Scale, Visual Analogue Scale (VAS) and Calibrated Jammer hand held dynamometer. Statistical analysis, including independent t-tests or chi-square tests, will be conducted to compare the outcomes between the two groups. The significance level will be set at p < 0.05. This study will contribute to the evidence base regarding the efficacy of Nirschl exercises and Mulligan taping in managing lateral epicondylitis and will help the clinicians and patients in deciding the best treatment approach for lateral epicondylitis.
- Conditions
- Lateral Epicondylitis
- Being tested
- Mulligan Taping
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan TapingOther
Mulligan taping involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons.
| Study group | Role | What they receive |
|---|---|---|
| Nirshl exercise with Mulligan Taping | Experimental | This group will be treated with Nirshl exercises with Mulligan taping Receives: Other: Mulligan Taping |
| Nirshl exercise without Mulligan taping | No intervention | This group will be treated with Nirshl exercises only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain will be measured using Visual Analogue Scale (VAS), min0 and max 10
Measured: 3 week consist of 6 sessions
Grip strength
It will be measured using calibrated Jammer hand-held dynamometer.
Measured: 3 week consist of 6 sessions
Secondary outcomes (1)
Disability
It will be measured using PRTEE scale. 0-10 scale
Measured: 3 week consist of 6 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Nov 2023
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sana ullah, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317545
- Sponsor's protocol ID
- REC/RCR&AH/23/0167/shan ali
- Status last verified
- Apr 2024
- First submitted
- 28 Jan 2024
- Last updated
- 19 Apr 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nirschl Exercises With and Without Mulligan Taping in Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06317545
- Acronym / sponsor ID
- REC/RCR&AH/23/0167/shan ali
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 19 Mar 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.
Painful condition of lateral epicondyle of the humerus characterized by the inflammation of the tendons during loading of the wrist extensor muscles is a common musculoskeletal presentation in men and women between 35 and 54 years of age. The above symptom is associated with a clinical diagnosis of lateral elbow tendinopathy (LET), also known as tennis elbow or lateral epicondylalgia the two effective treatment approaches for lateral epicondylitis are Nirschl exercises and Mulligan taping. This study aims to evaluate the effectiveness of Nirschl exercises with or without Mulligan taping in treating lateral epicondylitis. The study design for this project employs a randomized controlled trial and a sample of individuals with lateral epicondylitis randomly assigned in one of the two groups i.e., Nirschl exercises only and Nirschl exercises with Mulligan taping. Nirschl exercises involve the eccentric strengthening of the wrist extensor muscles and forearm. The participants in both groups will receive Nirschl exercises while the second group will also receive Mulligan taping, which involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons. Different outcome measures including pain intensity, functional disability, grip strength, range of motion will be evaluated using, PRTEE Scale, Visual Analogue Scale (VAS) and Calibrated Jammer hand held dynamometer. Statistical analysis, including independent t-tests or chi-square tests, will be conducted to compare the outcomes between the two groups. The significance level will be set at p < 0.05. This study will contribute to the evidence base regarding the efficacy of Nirschl exercises and Mulligan taping in managing lateral epicondylitis and will help the clinicians and patients in deciding the best treatment approach for lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nirshl exercise with Mulligan Taping | Experimental | Other: Mulligan TapingThis group will be treated with Nirshl exercises with Mulligan taping |
| Nirshl exercise without Mulligan taping | No intervention | –This group will be treated with Nirshl exercises only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pain and tenderness over lateral epicondyle
- at least two out of three tests for the lateral epicondylitis including Cozen's test, Mill's maneuver, or resisted middle finger extension positive
Key exclusion criteria (4 listed)
- Individuals with a history of recent trauma of upper limbs
- Recent administration of platelet-rich plasma containing growth factors,
- Patients which had taken physical therapy of any sort in the past 6 months
- occupation-related pain were ruled out.
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 |
|---|---|---|
| Mulligan TapingMulligan taping involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons. | Other | Nirshl exercise with Mulligan Taping |
Primary outcome
Pain intensity
Time frame: 3 week consist of 6 sessions
Pain will be measured using Visual Analogue Scale (VAS), min0 and max 10
Grip strength
Time frame: 3 week consist of 6 sessions
It will be measured using calibrated Jammer hand-held dynamometer.
1 secondary outcome
Disability
Time frame: 3 week consist of 6 sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 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.
Sana ullah, MSPT principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan Taping in people with Lateral Epicondylitis, run by Riphah International University at 2 sites 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain intensity (time frame: 3 week consist of 6 sessions). 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 19 Apr 2024.