- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03848117
Effects of Mulligan and Cyriax Approach in Patients With Subacute Lateral Epicondylitis.
November 12, 2019 updated by: Sammar Abbas, Isra University
Lateral epicondylitis (LE) is a pain causing musculoskeletal disease which mainly occurs due to the over exertion or over use of extensors of wrist mainly ECRB and pain is felt at the origin of common extensor tendon.
This study was focused to assess the effectiveness of cyriax approach and mulligan approach to improve the functional status of sub acute lateral epicondylitis patients through patient related tennis elbow evaluation form.
Study Overview
Status
Completed
Conditions
Detailed Description
A total of 39 athletes with knee pain were recruited and randomly divided into two groups.
30 subjects fulfilled the inclusion criteria and were part of this trial, 15 in each group.The data was collected through general demographic questionnaire, PRTEE questionnaire to determine the level of pain and functional disability and Hand grip strength chart to measure grip strength while having epicondylitis.
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan
- Sammar Abbas
-
-
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
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age group 20-50 years of both gender.
- Vas < 7
- Positive mills test and cozens test.
- Local tenderness on palpation over lateral epicondyle of the humerus.
- From sub-acute to chronic more than 2 weeks.
Exclusion Criteria:
- Any previous pathology of bone around elbow.
- Corticosteroid injection in the preceeding 3 months.
- Absence of clinical signs of tennis elbow.
- Any other systemic illness like metabolic, metastatic, infective disorders.
- Any other neurological abnormalities.
- Allergies to Mulligan tape.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: (DTF massage & Mill's manipulation)(Group 1)
For any given subject in group 1, PRTEE pain and functional disability evaluations and Hand grip strength were completed on the same day.
Then each subject in 1st group completed 4 weeks of physical therapy sessions which were aimed to decrease pain, increase functional activity level, and improve hand grip strength.
Each subject was evaluated for changes in symptoms on 1st week, 2nd week, 3rd week and 4th week.
|
Each patient in group I i.e.
Cyriax group was given 20-minute session.
Each session started in sitting position and initially deep transverse friction massage was done at lateral compartment of the elbow joint and immediately after that mill's manipulation at elbow joint with flexion at wrist joint in pronated arm position.
This session was repeated three times a week for one month (Total 12 sessions/ one month).
|
|
Active Comparator: ( Taping & MWM) (Group 2).
For any given subject in group 2, PRTEE pain and functional disability evaluations and Hand grip strength were completed on the same day.
Then each subject in second group completed 4 weeks of physical therapy sessions which were aimed to decrease pain, increase functional activity level, and improve hand grip strength.
Each subject was evaluated for changes in symptoms on 1st week, 2nd week, 3rd week and 4th week.
|
Each patient in group II i.e.
Mulligan group was given 30 to 45-minute session.
Each session started in sitting position and it included mobilization with movement which was given in such a way that initially lateral glide at elbow joint was performed and after holding it, I asked the patient to make a fist and open the fist.
In this way, I repeated this procedure 36 times and after 12 repetitions, a short rest period was given.
Taping was applied after mobilization around the elbow joint over extensor carpi radialis muscles.
This session was repeated three times a week for one month (Total 12 sessions/ one month).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient related tennis elbow evaluation pain scale
Time Frame: Upto 4 weeks
|
Pain associated with daily tasks is measured through Patient related tennis elbow evaluation pain scale with categories as "0" for no pain and "10" for worst imaginable pain.
|
Upto 4 weeks
|
|
Patient related tennis elbow evaluation functional disability scale
Time Frame: Upto 4 weeks
|
Degree of difficulty in performing daily tasks associated with elbow joint is measured through Patient related tennis elbow evaluation functional disability scale in categories as "0" for no difficulty in task and "10" for unable to do a task.
|
Upto 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand grip strength chart index
Time Frame: Upto 4 weeks
|
It is also measured through hand grip dynamo meter with reference values according to gender description.
|
Upto 4 weeks
|
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, 2019
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
October 15, 2019
Study Registration Dates
First Submitted
January 26, 2019
First Submitted That Met QC Criteria
February 19, 2019
First Posted (Actual)
February 20, 2019
Study Record Updates
Last Update Posted (Actual)
November 13, 2019
Last Update Submitted That Met QC Criteria
November 12, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIRS-1702-M.Phil OPT-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
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.
Clinical Trials on Lateral Epicondylitis
-
Hospital for Special Surgery, New YorkCompletedLateral Epicondylitis | Lateral Epicondylitis, Unspecified Elbow | Lateral Epicondylitis, Left Elbow | Lateral Epicondylitis, Right Elbow | Lateral Epicondylitis (Tennis Elbow) Bilateral | Medial Epicondylitis | Medial Epicondylitis, Right Elbow | Medial Epicondylitis, Left ElbowUnited States
-
Centre Mutualiste de Rééducation et de Réadaptation...RecruitingLateral Epicondylitis of the ElbowFrance
-
Haseki Training and Research HospitalCompletedLateral Epicondylitis (Tennis Elbow)Turkey
-
Gaziler Physical Medicine and Rehabilitation Education...CompletedLateral Epicondylitis | Lateral Epicondylitis (Tennis Elbow)Turkey (Türkiye)
-
Cairo UniversityRecruitingLateral Epicondylitis | Tennis Elbow | Lateral Epicondylitis, Unspecified ElbowLebanon
-
Singapore General HospitalNot yet recruitingLateral Epicondylitis, Unspecified Elbow
-
McMaster UniversityArthrex, Inc.; The Physicians' Services Incorporated Foundation; Radiological...TerminatedLateral Epicondylitis (Tennis Elbow)Canada, United States
-
Konya Beyhekim Training and Research HospitalRecruitingLateral Epicondylitis (Tennis Elbow)Turkey
-
Siddharth Padia, MDRecruiting
-
University of CadizNot yet recruitingElbow Tendinopathy | Epicondylitis | Epicondylitis, Lateral | Epicondylitis of the Elbow