- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06674434
Comparative Effects of Sustained Stretch and Mobilization With Movement in Patient With Tennis Elbow
November 3, 2024 updated by: Riphah International University
Comparative Effects of Sustained Stretch and Mobilization With Movement on Pain, Range of Motion, Muscle Strength and Functional Disability in Patient With Tennis Elbow.
Tennis elbow, clinically known as lateral epicondylitis, is a prevalent musculoskeletal issue marked by pain and tenderness on the outer part of the elbow.
It primarily affects the extensor tendon at the lateral epicondyle and is commonly linked to repetitive arm movements and overuse.
Various treatment options are available for this condition, with two notable methods being sustained stretching and Mobilization with Movement (MWM).
Sustained stretching involves holding the affected muscles and tendons in an extended position for a prolonged time to ease muscle tightness and enhance flexibility.
Conversely, MWM integrates specific joint movements with the active involvement of the patient to improve joint mobility and reduce pain.
Muscle strength plays a crucial role in the overall function of the upper limb, and enhancing this can positively affect daily activities.
Furthermore, functional disability indicates how tennis elbow impacts a person's capacity to carry out everyday tasks.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This randomized clinical trial will be conducted at Riphah Rehab center over duration of eight months.
The sample size will consist of 58 participants.
Participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique.
29 Participants will be assigned to Group A 29 to group B. Data will be collected using various assessment tools, including NPRS, ULFI, Universal Goniometer, Hand Held Dynamometer.
Pre-intervention assessments will be conducted for groups.
Data analysis will be performed by using SPSS 26 software.
Study Type
Interventional
Enrollment (Estimated)
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 Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad, Phd
- Phone Number: 051-5481826
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54500
- Riphah Rehab center.
-
Contact:
- Ali Raza
- Email: aliraza@riphah.edu.pk
-
Principal Investigator:
- Laiba Manzoor, MS-OM
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both males and females are affected. diagnosed with tennis elbow, characterized by pain and weakness on the outer side of the elbow.
- The pain has persisted for at least 4 to 6 months.
- Individuals experience difficulty gripping and lifting objects due to elbow pain.
- Positive results were observed in both the Mills and Cozen tests.
Exclusion Criteria:
- Presence of nerve injuries or neuropathies in the arm or hand.
- No history of recent trauma or fracture to the elbow.
- No neurological conditions affecting the arm or hand
- Acute inflammation or signs of infection in the elbow joint.
- Presence of cervical radiculopathy, thoracic outlet syndrome any systemic diseases
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
The group will engage in traditional tennis elbow exercises and mobilization through movement.
|
Mobilization with Movement (MWM) is a manual therapy technique that combines active, patient-directed movements with passive joint mobilization to treat tennis elbow.
To find joint restrictions or dysfunctions, a comprehensive patient assessment is the first step in the process.
While the patient was in a supine position with the elbow fully extended and the forearm pronated, the therapist applied a sustained lateral glide of the forearm and stabilized the distal portion of the arm.
While the patient asked to make a fist, the therapist kept up the lateral glide.
Each session included three sets of movement-based mobilizations, each with ten repetitions.
The entire course of treatment consists of twelve sessions.
|
|
Active Comparator: Group B
The group will be given a prolonged stretch along with conventional tennis elbow exercises.
|
The basic concept of stretching involves lengthening the tendon during a state of relaxation.
To stretch the Extensor Carpi Radialis Brevis tendon, the following position should be adopted: the elbow should be extended, the forearm in a pronated position, the wrist flexed, and the wrist should also be ulnar deviated, based on the patient's comfort level.
This position should be maintained for 30 to 45 seconds and repeated three times before and after exercises in each treatment session, with a 30-second rest period in between.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain: Numeric Pain Rating Scale (NPRS)
Time Frame: 4th week
|
The most widely used pain rating scale, the Numeric Rating Scale (NPRS), has a range of 0 (no pain) to 10 (worst pain).
The NPRS will be used to measure the degree of pain.
For patients with tennis elbow, it will serve as an outcome measure.
The NPRS is regarded as a valid, responsive, and dependable pain scale.
|
4th week
|
|
Function: Upper Limb Functional Index (ULFI)
Time Frame: 4th week
|
Twenty-five items on the ULFI measure how patients with ULMSDs perceive their own limitations in their activities.
Three possible answers are provided for each item: "Yes" (1 point), "Partly" (0.5 points), and "No" (0 points).
The maximum disability is determined by multiplying the total points (ranging from 0 to 25) by 4. The patient's functional score in relation to their maximum or pre-injury function is then calculated by subtracting this total score from 100 (0% represents maximum limitation, 100% represents normal or pre-injury function).
The total rating can be calculated with no more than two missing responses.
|
4th week
|
|
ROM: Universal Goniometer
Time Frame: 4th week
|
A double-arm plastic goniometer with a semicircular scale is the most common goniometer for determining range of motion.
We will measure the following wrist and elbow movements: wrist flexion, extension, radial and ulnar deviation, and elbow extension and pronation.
Three measurements of each movement will be made, and the average will be computed for the outcome analysis.
|
4th week
|
|
Strength: Handheld Dynamometer:
Time Frame: 4th week
|
A handheld dynamometer (CAMRY EH 101 Electronic Handheld Dynamometer) was used to measure grip strength.
The American Society of Hand Therapists' measurement protocols were modified to place participants in a high sitting position, maintain an elbow at a slight 40° flexion, and adjust the handle to the second position.
After thoroughly explaining the procedure, the patient was instructed to exert the greatest amount of force possible on the handle and maintain that position for three to five seconds.
|
4th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali Raza, MS, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Reyhan AC, Sindel D, Dereli EE. The effects of Mulligan's mobilization with movement technique in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2020;33(1):99-107. doi: 10.3233/BMR-181135.
- Ma KL, Wang HQ. Management of Lateral Epicondylitis: A Narrative Literature Review. Pain Res Manag. 2020 May 5;2020:6965381. doi: 10.1155/2020/6965381. eCollection 2020.
- Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19.
- Karbowiak M, Holme T, Thambyrajah J, Di Mascio L. Management of lateral epicondylitis (tennis elbow). BMJ. 2023 May 18;381:e072574. doi: 10.1136/bmj-2022-072574. No abstract available.
- Cutts S, Gangoo S, Modi N, Pasapula C. Tennis elbow: A clinical review article. J Orthop. 2019 Aug 10;17:203-207. doi: 10.1016/j.jor.2019.08.005. eCollection 2020 Jan-Feb.
- Johns N, Shridhar V. Lateral epicondylitis: Current concepts. Aust J Gen Pract. 2020 Nov;49(11):707-709. doi: 10.31128/AJGP-07-20-5519.
- Kjaer M. Role of extracellular matrix in adaptation of tendon and skeletal muscle to mechanical loading. Physiol Rev. 2004 Apr;84(2):649-98. doi: 10.1152/physrev.00031.2003.
- Pathan AF, Sharath HV. A Review of Physiotherapy Techniques Used in the Treatment of Tennis Elbow. Cureus. 2023 Oct 26;15(10):e47706. doi: 10.7759/cureus.47706. eCollection 2023 Oct.
- Girgis B, Duarte JA. Efficacy of physical therapy interventions for chronic lateral elbow tendinopathy: a systematic review. Physical Therapy Reviews. 2020;25(1):42-59.
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 (Estimated)
November 1, 2024
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
November 3, 2024
First Submitted That Met QC Criteria
November 3, 2024
First Posted (Estimated)
November 5, 2024
Study Record Updates
Last Update Posted (Estimated)
November 5, 2024
Last Update Submitted That Met QC Criteria
November 3, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/ RCR & AHS/24/0133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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
Clinical Trials on Mobilization with Movement
-
Eleuterio Atanasio Sánchez RomeroCompletedChronic Low-back PainSpain
-
Natália Maria Oliveira CampeloCompletedPathologic Processes | Musculoskeletal Diseases | Joint Disease | Osteoarthritis Hip
-
University of South CarolinaCompleted
-
Federal University of Health Science of Porto AlegreCompletedRotator Cuff Injuries | Shoulder PainBrazil
-
Riphah International UniversityCompletedImpingement SyndromePakistan
-
The Hong Kong Polytechnic UniversityActive, not recruiting
-
César Fernández-de-las-PeñasUniversity of SalamancaCompleted
-
Escola Superior de Tecnologia da Saúde do PortoCompleted
-
Université Catholique de LouvainCompleted
-
Universidad Rey Juan CarlosNot yet recruiting