Tennis ElbowNCT05039827
Mobilition With Movement and Soft Tissue Mobiiztion in Tennis Elbow
A study testing Mobilization with movement and Soft Tissue Mobilization in people with Tennis Elbow, run by Riphah International University at 1 site in Pakistan.
Trial summary
Lateral epicondylitis or tennis elbow is one of the most common lesions of the arm. This injury is a major challenge, as it is difficult to treat, prone to recurrence and may last for several weeks or months, with an average duration of a typical episode which has been reported to be between six months to two years. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Mobilization with movement and Soft Tissue Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Oct 2020to 15 Jul 2021
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Tennis players.
- Age group between 15-30 years.
- Positive specific tests.(cozen and mills test)
- Subjects having lateral epicondylitis pain for at least 4 weeks, muscle power for wrist muscle should be increase with activity against resistance, average pain level of 3-cm or more on a 10-cm Numerical pain rating scale
Who cannot join
- Any neurological disorder.
- Other elbow deformity or joint pathology. fracture of upper limb
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Hidayat Gillani Orthopedic Complex Sahiwal
Sahiwal, Punjab Province, 57000
About this study
Official title: Comparison Of Mobilization With Movement And Soft Tissue Mobilization On Pain Severity , Hand Grip Strength And Functional Activity Tennis Elbow Patients.
Lateral epicondylitis or tennis elbow is one of the most common lesions of the arm. This injury is a major challenge, as it is difficult to treat, prone to recurrence and may last for several weeks or months, with an average duration of a typical episode which has been reported to be between six months to two years. This is an RCT study. Subjects who fulfilled inclusion criteria will be taken for the study. Before conducting the actual method for subjects, lateral epicondylitis evaluation is done. First day before treatment, pain evaluation were done by using Numeric Pain Rating Scale. Muscle power was assessed by MMT (Manual Muscle Testing) and the function level are tested by Patient-Related Tennis Elbow Evaluation (PRTEE) questionnaire and asked to mark the results. Subjects will be divided into 2 groups randomly by lottery method. Each group consists of 15 patients. Group A will be given MWM; Group B will be given soft tissue mobilization. Both groups will be given with the above said methods for alternative days in a week as per 3 sessions per week for 4 weeks. At the end of program subjects will be reassessed by recording muscle strength, pain intensity and functional level. Finally pre and post recordings will be compared and analyzed statistically.
- Conditions
- Tennis Elbow
- Being tested
- Mobilization with movement, Soft Tissue Mobilization
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization with movementOther
Heating fermentation was done for 10 minutes as baseline treatment. MWM with wrist extension was given for alternative days in a week as per 3 sessions per week for 4 weeks.
Soft Tissue MobilizationOther
Heating fermentation was done for 10 minutes as baseline treatment. Parallel and longitudinal massage was given for alternative days in a week as per 3 sessions per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| MWM GROUP | Experimental | Mobilization with movement with wrist extension Receives: Other: Mobilization with movement |
| SOFT TISSUE MOBILIZATION GROUP | Active comparator | Parallel and perpendicular soft tissue massage at common extensor origin Receives: Other: Soft Tissue Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 4 Week
Grip Strength
Manual muscle testing as used to test grip strength. It involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly[1]:
Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance
Measured: 4 week
Functional activity
Patient Related Tennis Elbow Evaluation (PRTEE) was used.The PrTEEQ is a 15-item questionnaire, it's designed to measure forearm pain and disability in patients with lateral epicondylitis. The patients have to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales. There is the pain subscale (0 = no pain, 10 = worst imaginable) en the function subscale (0 = no difficulty, 10 = unable to do)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start14 Oct 2020
- Primary completion30 Jun 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Shafique, tDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039827
- Sponsor's protocol ID
- REC/RCR & AHS/21/0420
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bisset L, Paungmali A, Vicenzino B, Beller E. A systematic review and meta-analysis of clinical trials on physical interventions for lateral epicondylalgia. Br J Sports Med. 2005 Jul;39(7):411-22; discussion 411-22. doi: 10.1136/bjsm.2004.016170.
PubMed 15976161Castillo-Lozano R, Casuso-Holgado MJ. Incidence of musculoskeletal sport injuries in a sample of male and female recreational paddle-tennis players. J Sports Med Phys Fitness. 2017 Jun;57(6):816-821. doi: 10.23736/S0022-4707.16.06240-X. Epub 2016 Feb 12.
PubMed 26954572Lucado AM, Dale RB, Vincent J, Day JM. Do joint mobilizations assist in the recovery of lateral elbow tendinopathy? A systematic review and meta-analysis. J Hand Ther. 2019 Apr-Jun;32(2):262-276.e1. doi: 10.1016/j.jht.2018.01.010. Epub 2018 Apr 26.
PubMed 29705077Ahmed A, Ibrar M, Arsh A, Wali S, Hayat S, Abass S. Comparing the effectiveness of Mulligan mobilization versus Cyriax approach in the management of patients with subacute lateral epicondylitis. J Pak Med Assoc. 2021 Jan;71(1(A)):12-15. doi: 10.47391/JPMA.186.
PubMed 33484510Coombes BK, Connelly L, Bisset L, Vicenzino B. Economic evaluation favours physiotherapy but not corticosteroid injection as a first-line intervention for chronic lateral epicondylalgia: evidence from a randomised clinical trial. Br J Sports Med. 2016 Nov;50(22):1400-1405. doi: 10.1136/bjsports-2015-094729. Epub 2015 Jun 2.
PubMed 26036675
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Mobilization With Movement And Soft Tissue Mobilization On Pain Severity , Hand Grip Strength And Functional Activity Tennis Elbow Patients.
- ClinicalTrials.gov ID
- NCT05039827
- Acronym / sponsor ID
- REC/RCR & AHS/21/0420
- Conditions
- Tennis Elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 10 Sep 2021 (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.
Lateral epicondylitis or tennis elbow is one of the most common lesions of the arm. This injury is a major challenge, as it is difficult to treat, prone to recurrence and may last for several weeks or months, with an average duration of a typical episode which has been reported to be between six months to two years. This is an RCT study. Subjects who fulfilled inclusion criteria will be taken for the study. Before conducting the actual method for subjects, lateral epicondylitis evaluation is done. First day before treatment, pain evaluation were done by using Numeric Pain Rating Scale. Muscle power was assessed by MMT (Manual Muscle Testing) and the function level are tested by Patient-Related Tennis Elbow Evaluation (PRTEE) questionnaire and asked to mark the results. Subjects will be divided into 2 groups randomly by lottery method. Each group consists of 15 patients. Group A will be given MWM; Group B will be given soft tissue mobilization. Both groups will be given with the above said methods for alternative days in a week as per 3 sessions per week for 4 weeks. At the end of program subjects will be reassessed by recording muscle strength, pain intensity and functional level. Finally pre and post recordings will be compared and analyzed statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWM GROUP | Experimental | Other: Mobilization with movementMobilization with movement with wrist extension |
| SOFT TISSUE MOBILIZATION GROUP | Active comparator | Other: Soft Tissue MobilizationParallel and perpendicular soft tissue massage at common extensor origin |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Tennis players.
- Age group between 15-30 years.
- Positive specific tests.(cozen and mills test)
- Subjects having lateral epicondylitis pain for at least 4 weeks, muscle power for wrist muscle should be increase with activity against resistance, average pain level of 3-cm or more on a 10-cm Numerical pain rating scale
Key exclusion criteria (2 listed)
- Any neurological disorder.
- Other elbow deformity or joint pathology. fracture of upper limb
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 |
|---|---|---|
| Mobilization with movementHeating fermentation was done for 10 minutes as baseline treatment. MWM with wrist extension was given for alternative days in a week as per 3 sessions per week for 4 weeks. | Other | MWM GROUP |
| Soft Tissue MobilizationHeating fermentation was done for 10 minutes as baseline treatment. Parallel and longitudinal massage was given for alternative days in a week as per 3 sessions per week for 4 weeks | Other | SOFT TISSUE MOBILIZATION GROUP |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 Week
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Grip Strength
Time frame: 4 week
Manual muscle testing as used to test grip strength. It involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly[1]: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance
Functional activity
Time frame: 4 weeks
Patient Related Tennis Elbow Evaluation (PRTEE) was used.The PrTEEQ is a 15-item questionnaire, it's designed to measure forearm pain and disability in patients with lateral epicondylitis. The patients have to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales. There is the pain subscale (0 = no pain, 10 = worst imaginable) en the function subscale (0 = no difficulty, 10 = unable to do)
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 10 Sep 2021.
- Background: PubMed 15976161Bisset L, Paungmali A, Vicenzino B, Beller E. A systematic review and meta-analysis of clinical trials on physical interventions for lateral epicondylalgia. Br J Sports Med. 2005 Jul;39(7):411-22; discussion 411-22. doi: 10.1136/bjsm.2004.016170.
- Background: PubMed 26954572Castillo-Lozano R, Casuso-Holgado MJ. Incidence of musculoskeletal sport injuries in a sample of male and female recreational paddle-tennis players. J Sports Med Phys Fitness. 2017 Jun;57(6):816-821. doi: 10.23736/S0022-4707.16.06240-X. Epub 2016 Feb 12.
- Background: PubMed 29705077Lucado AM, Dale RB, Vincent J, Day JM. Do joint mobilizations assist in the recovery of lateral elbow tendinopathy? A systematic review and meta-analysis. J Hand Ther. 2019 Apr-Jun;32(2):262-276.e1. doi: 10.1016/j.jht.2018.01.010. Epub 2018 Apr 26.
- Background: PubMed 33484510Ahmed A, Ibrar M, Arsh A, Wali S, Hayat S, Abass S. Comparing the effectiveness of Mulligan mobilization versus Cyriax approach in the management of patients with subacute lateral epicondylitis. J Pak Med Assoc. 2021 Jan;71(1(A)):12-15. doi: 10.47391/JPMA.186.
- Background: PubMed 26036675Coombes BK, Connelly L, Bisset L, Vicenzino B. Economic evaluation favours physiotherapy but not corticosteroid injection as a first-line intervention for chronic lateral epicondylalgia: evidence from a randomised clinical trial. Br J Sports Med. 2016 Nov;50(22):1400-1405. doi: 10.1136/bjsports-2015-094729. Epub 2015 Jun 2.
- 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.
Sidra Shafique, tDPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization with movement and Soft Tissue Mobilization in people with Tennis Elbow, run by Riphah International 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 4 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: finished, as of the sponsor's last update on 10 Sep 2021. 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?
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?
Numeric Pain Rating Scale (time frame: 4 Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05039827, which also lists 5 linked publications.
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 10 Sep 2021.