- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06812377
Comparative Study Between Different Mobilization Techniques for Patients With Chronic Tennis Elbow (RCT)
Background: Tennis elbow is a common musculoskeletal disorder affecting the functional activities of daily living through common extensor tendinopathy. There is a limited knowledge about neural restriction as a source of movement limitation in patients with tennis other than enriched joint mobilization techniques knowledge.
Objectives: This study will be designed to determine the efficacy of adding different mobilization techniques along with eccentric exercises on elbow pain intensity, functional disability, hand grip strength and pain pressure in patients with chronic tennis elbow.
Methods: Forty five patients with lateral epicondylitis with their ages ranged from 18 and 45 more than six weeks will be randomly assigned into three groups. Group A will receive Maitland joint mobilization techniques. Patients in group B will receive Mulligan mobilization techniques while patient in group C will receive radial nerve mobilization.. Both groups will receive eccentric exercises for wrist extensors . Patients will be treated three session per week for four week and they will be evaluated pre and post treatment for pain severity using by visual analogue scale, level of functionality by DASH questionnaire, hand grip strength by hand held dynamometer and pressure pain threshold(PPT) by pressure algometer.
Results: All the outcome variables will be assessed at baseline and 4weeks following the treatment period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Al Kharj, Saudi Arabia, 16242
- Prince Sattam Bin Abdulaziz University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- This study will include individuals between the ages of 18 and 45 who have been diagnosed with lateral epicondylitis based on positive results from the Mill's and Cozen's tests. The participants must also have complaints of local tenderness at the elbow that lasts longer than six weeks. Additionally, to complete the assessment and get treatment, the participants' elbow must have a full extension range of motion
Exclusion Criteria:
- Individuals diagnosed with cervical radiculopathy, upper thoracic outlet syndrome, rheumatoid arthritis, myositis ossificans, carpal tunnel syndrome, recent upper limb trauma, elbow immobilization, steroid injection administration within the previous six months, and any history of physical therapy administered within the previous six months were excluded from the study. Furthermore, participation will not be permitted for anyone who has previously experienced discomfort because of their profession
Study Plan
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 |
|---|---|
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Active Comparator: group A
maitland mobilization Posteroanterior mobilization of the radial head in motion.
This method is gliding over the radial head posteriorly to anteriorly while the patient executes (and relaxes) the painful action (e.g., clutching).
Repeat the method six to ten times if there is a noticeable increase in your ability to grip without pain
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Posteroanterior mobilization of the radial head in motion.
This method is gliding over the radial head posteriorly to anteriorly while the patient executes (and relaxes) the painful action (e.g., clutching).
Repeat the method six to ten times if there is a noticeable increase in your ability to grip without pain
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Active Comparator: Group (B)
mulligan mobilization Using this approach, the patient performs (and relaxes) the painful action (e.g., clutching) while a lateral humeroulnar auxiliary glide is applied and maintained.
If you notice a noticeable increase in your ability to grip without pain, repeat the method six to ten times.
You can use a belt to help you glide.Three sets of it were performed, with a 30-second break in between [44].
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Using this approach, the patient performs (and relaxes) the painful action (e.g., clutching) while a lateral humeroulnar auxiliary glide is applied and maintained.
If you notice a noticeable increase in your ability to grip without pain, repeat the method six to ten times.
You can use a belt to help you glide.Three sets of it were performed, with a 30-second break in between
|
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Experimental: Group (c)
radial nerve mobilization
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The subjects will be placed in a reclining supine position.
The arm will be internally rotated, the wrist, thumb, and fingers will be flexed, the shoulder girdle will be depressed, and the elbow will be stretched.
Elbow flexion and wrist extension will be used to maintain shoulder depression after the radial nerve will be strained by these motions.
Before beginning the gentle elbow extension test, the subject's wrist and fingers will be stabilized.
The elbow will be then gently extended for about two seconds, just into the range where the participant felt tension but no pain, and then flexed.
In a single session, three sets of six to eight oscillations will be executed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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elbow pain
Time Frame: At baseline and after 4 weeks
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Assessment of pain intensity will be measured by visual analogue scale (VAS) which consists of a vertical line (0-10) where one end refers to no pain while the other end refers to great pain.)
It is a reliable test for literate and illiterate patients 0.94I,0.71
respectively)
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At baseline and after 4 weeks
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Hand grip strength
Time Frame: At baseline and after 4 weeks
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To assess hand grip strength, In order to assess grip strength painlessly, the patient will comfortably sit with their arm at their side, their shoulder adducted and neutrally rotated, their elbow flexed to 90 degrees [38], their forearm in a neutral position, their wrist between 0 and 30 degrees of extension, and their ulnar deviation between 0 and 15 degrees.
The greatest grip contraction, expressed in kilograms, shall be noted when no discomfort is felt.
The patient will squeeze for three to five seconds, as hard as they can.
Multiple trials will be conducted, with an average of three repetitions recorded and a gap of approximately 15 seconds between each trial, to mitigate the possible effect of muscle fatigue
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At baseline and after 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain pressure threshold
Time Frame: At baseline and after 4 weeks
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Pain Pressure Threshold (PPT) will be measured by pressure algometer by applying the probe tip on the most sensitive poin. Also, three trials will be given, and the average will be taken [39]. A portable device called a pressure algometer is used to measure the pressure-pain threshold. The lowest pressure value at which a person feels pain is known as the pressure-pain threshold [40]. One accurate way to gauge someone's level of discomfort is by using their pressure-pain threshold [41]. A force gauge with a spring-operated plunger is called an algometer. The gauge is fastened to a short metal pole with a rubber tip that is circular and has a diameter of 1 cm. The unit of calibration for the instrument is kilograms of pressure per square centimeter (kg/cm2). The gauge measures between 0 and 10 kg/cm^2. The gadget can be reset to 0 to take a new measurement once one has been taken |
At baseline and after 4 weeks
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functionality
Time Frame: At baseline and after 4 weeks
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Assessment of level of functionality: A 30-item disability/symptom scale that evaluates the patient's health during the preceding week is the main component of the DASH [36]. The questions include how difficult it is to perform different physical activities due to an arm, shoulder, or hand problem (21 items), how severe each pain symptom is, how much pain, tingling, weakness, or stiffness is related to a particular activity (5 items), and how the problem affects social activities, work, sleep, and one's self-image (4 items). For every item, there are five possible responses. A scale score ranging from 0 (no impairment) to 100 (full disability) (most severe disability) is then obtained by adding the scores for each component |
At baseline and after 4 weeks
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Collaborators and Investigators
Publications and helpful links
General Publications
- Vicenzino B, Paungmali A, Teys P. Mulligan's mobilization-with-movement, positional faults and pain relief: current concepts from a critical review of literature. Man Ther. 2007 May;12(2):98-108. doi: 10.1016/j.math.2006.07.012. Epub 2006 Sep 7.
- Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.
- Dorf ER, Chhabra AB, Golish SR, McGinty JL, Pannunzio ME. Effect of elbow position on grip strength in the evaluation of lateral epicondylitis. J Hand Surg Am. 2007 Jul-Aug;32(6):882-6. doi: 10.1016/j.jhsa.2007.04.010.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCBR-393/2024
- 2024/03/31970 (Other Grant/Funding Number: Prince Sattam bin Abdulaziz University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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