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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Pakistan

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 groups in NCT05039827
Study groupRoleWhat they receive
MWM GROUPExperimentalMobilization with movement with wrist extension
Receives: Other: Mobilization with movement
SOFT TISSUE MOBILIZATION GROUPActive comparatorParallel 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.

  1. 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

  2. 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

  3. 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.

  1. First posted10 Sep 2021
  2. Study start14 Oct 2020
  3. Primary completion30 Jun 2021
  4. Study completion15 Jul 2021

Resources

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)
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 15976161

  • Castillo-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 26954572

  • Lucado 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 29705077

  • Ahmed 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 33484510

  • Coombes 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

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.

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