- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07589725
Mulligan Mobilization in Lateral Elbow Tendinopathy
Effects of Mulligan Mobilization With Movement Technique on Pain, Muscle Stiffness, Grip Strength, and Function in Patients With Lateral Elbow Tendinopathy
The aim of this randomized placebo-controlled trial is to investigate the effects of Mulligan Mobilization with Movement (MWM) combined with an exercise program in individuals with lateral elbow tendinopathy. The study will compare MWM plus exercise with sham MWM plus exercise and exercise alone.
A total of 45 participants will be randomly allocated to one of the three intervention groups. The study will evaluate whether adding MWM to exercise provides greater improvements in pain, physical function, muscle performance, proprioception, and biomechanical outcomes than sham mobilization or exercise alone. Assessments will be performed at baseline, 2 days after completion of the 4-week intervention, and 24 weeks after completion of the intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lateral elbow tendinopathy (LET) is a common musculoskeletal condition characterized by pain and tenderness over the lateral epicondyle, particularly during gripping and resisted wrist or finger extension. The extensor carpi radialis brevis is frequently involved. Conservative management is generally recommended as the first-line approach, with exercise and manual therapy commonly used to reduce symptoms and improve function.
Mobilization with Movement (MWM), a manual therapy technique within the Mulligan Concept, combines a sustained accessory joint glide with active movement. Previous studies have reported improvements in pain and function following MWM in individuals with LET. However, contextual and placebo-related effects associated with manual therapy may contribute to observed clinical outcomes, and the specific contribution of MWM when added to exercise remains unclear. Placebo-controlled investigations are therefore needed to better distinguish the effects of MWM from nonspecific treatment effects.
In addition to conventional clinical outcomes, alterations in proprioception and the mechanical characteristics of the involved musculature may be relevant to LET. Wrist joint position sense and mechanical properties of the extensor carpi radialis brevis, including muscle tone, stiffness, elasticity, relaxation time, and creep, may provide additional information regarding neuromuscular and mechanical changes associated with treatment. These parameters have received comparatively limited attention in previous studies of conservative management for LET.
This study is a three-arm randomized, placebo-controlled trial designed to investigate the effects of adding MWM to an exercise program in individuals with LET. Participants will be allocated to an MWM plus exercise group, a sham MWM plus exercise group, or an exercise-only group. This design will allow the effects of MWM to be examined in comparison with both a sham manual therapy intervention and exercise alone.
The study will be conducted at the Laboratory of the Department of Physiotherapy and Rehabilitation at Istanbul University-Cerrahpasa. Participants will be randomly allocated in equal proportions to the three study groups using a computer-generated randomization sequence prepared by an independent researcher. Allocation concealment will be maintained using sequentially numbered, sealed, opaque envelopes that will be opened after completion of the baseline assessment.
The intervention period will last 4 weeks. Outcomes will be assessed at baseline, 2 days after completion of the 4-week intervention, and 24 weeks after completion of the intervention. The study will evaluate clinical outcomes together with measures of muscle performance, mechanical pain sensitivity, proprioception, and muscle mechanical properties to determine both the short- and long-term effects of the interventions.
The sample size was calculated using G*Power version 3.1. A medium effect size (f = 0.25), a Type I error rate of 0.05, and statistical power of 90% were used for the calculation. Allowing for an anticipated dropout rate of 15%, a total of 45 participants are planned to be included.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kubra Bali, Master Science
- Phone Number: 90+5449765584
- Email: kubra.tufekci@hotmail.com
Study Contact Backup
- Name: Ipek Yeldan, Professor
- Email: ipek.yeldan@iuc.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul Unıversity Cerrahpasa, Faculty of Health Sciences
-
Contact:
- Kubra Bali, Master Science Physiotherapist
- Phone Number: 90+5449765584
- Email: kubra.tufekci@hotmail.com
-
Principal Investigator:
- Kubra Balı, Master Science
-
Sub-Investigator:
- Ipek Yeldan, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Inclusion Criteria
- Age between 18 and 60 years
- Presence of unilateral lateral elbow pain and tenderness for at least 3 months
- Diagnosis of lateral elbow tendinopathy confirmed by the following four criteria:
- Local tenderness over the lateral epicondyle
- Positive Cozen's test
- Positive Maudsley's test
- Positive Mill's stretch test
Exclusion Criteria:
- History of surgery around the elbow
- History of elbow dislocation, fracture, or extensor tendon rupture
- History of fracture of the humerus, ulna, or radius within the past year
- Receipt of any treatment for LET within the past 6 months (e.g., physiotherapy, exercise, manual therapy, dry needling, orthosis)
- Presence of cervical referred pain and/or radiculopathy (positive Spurling test)
- Signs of peripheral nerve involvement
- Corticosteroid injection within the past 6 months
- History of rheumatologic disease
- Presence of cancer or tumor
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 |
|---|---|
|
Experimental: MWM + Exercise Group
Participants will receive Mulligan Mobilization with Movement combined with a structured exercise program targeting the extensor muscles.
|
MWM is a manual therapy technique in which a therapist applies a sustained lateral glide to the radial head using a belt while the patient performs active gripping movements.
The intervention is designed to restore pain-free movement by combining joint mobilization with functional activity.
The exercise program targets the extensor carpi radialis brevis muscle and includes isometric, concentric, and eccentric strengthening exercises.
Exercises are performed in a structured manner and progressed according to a pain-monitoring model allowing mild tolerable pain.
|
|
Sham Comparator: Sham MWM + Exercise Group
Participants will receive sham Mulligan Mobilization combined with the same structured exercise program targeting the extensor muscles.
|
The exercise program targets the extensor carpi radialis brevis muscle and includes isometric, concentric, and eccentric strengthening exercises.
Exercises are performed in a structured manner and progressed according to a pain-monitoring model allowing mild tolerable pain.
Sham MWM involves positioning the Mulligan belt in the same manner as the active intervention; however, no therapeutic joint mobilization force is applied.
Participants perform active gripping movements while receiving a non-therapeutic simulation of mobilization.
|
|
Experimental: Exercise Group
Participants will receive only a structured exercise program targeting the extensor muscles without any manual therapy intervention.
|
The exercise program targets the extensor carpi radialis brevis muscle and includes isometric, concentric, and eccentric strengthening exercises.
Exercises are performed in a structured manner and progressed according to a pain-monitoring model allowing mild tolerable pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
Pain intensity was assessed using an 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
|
Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold
Time Frame: Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
Pressure pain threshold was assessed using a pressure algometer.
Pressure was gradually increased over the assessment site until the participant first reported that the sensation of pressure became painful.
Higher values indicate a higher pressure pain threshold and lower pain sensitivity.
|
Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
|
Maximum Grip Strength
Time Frame: Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
Maximum grip strength was assessed using a hand dynamometer.
Participants were instructed to squeeze the dynamometer as strongly as possible, and the maximum force generated was recorded.
Higher values indicate greater grip strength.
|
Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
|
Pain-free Grip Strength
Time Frame: Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
Pain-free grip strength was assessed using a hand dynamometer.
Participants were instructed to gradually increase their grip force and stop when pain was first experienced.
The maximum force produced without pain was recorded.
Higher values indicate greater pain-free grip strength.
|
Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
|
Functionality
Time Frame: Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
Pain and functional disability were assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE).
The total score ranges from 0 to 100, with 0 indicating no pain or disability and 100 indicating the greatest pain and functional disability.
Higher scores indicate a worse outcome.
|
Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
|
Kinesiophobia
Time Frame: Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
Kinesiophobia was assessed using the 17-item Tampa Scale for Kinesiophobia (TSK-17).
Total scores range from 17 to 68, with higher scores indicating greater fear of movement or reinjury and therefore a worse outcome.
|
Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
|
Mechanical Properties of the Extensor Carpi Radialis Brevis Muscle
Time Frame: Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
Mechanical properties of the extensor carpi radialis brevis muscle were assessed non-invasively using the MyotonPRO device.
The device provides quantitative measurements of muscle mechanical properties, including muscle tone, stiffness, elasticity, relaxation time, and creep.
|
Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
|
Wrist Joint Position Sense
Time Frame: Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
Wrist joint position sense was assessed using a digital goniometer.
Participants were asked to actively reproduce a predetermined target wrist position without visual feedback.
The absolute difference between the target angle and the reproduced angle was recorded in degrees as the joint position error.
Lower error values indicate better wrist joint position sense.
|
Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention.
|
|
Upper Extremity Movement Strategy During Maximum Voluntary Grip
Time Frame: Baseline, 2 days after completion of the 4-week intervention, and 24 weeks after completion of the intervention
|
Upper extremity movement strategies during maximum voluntary grip will be assessed using two-dimensional video analysis with Kinovea software.
Shoulder flexion, shoulder abduction, elbow flexion, and wrist extension angles will be measured during a 5-second maximum voluntary grip performed with a Jamar hand dynamometer.
For each joint, the angular change from the initial position to the maximum angle reached during gripping will be calculated in degrees (Δ angle = maximum angle - initial angle).
Greater angular changes indicate greater use of the corresponding movement strategy during maximum voluntary grip.
|
Baseline, 2 days after completion of the 4-week intervention, and 24 weeks after completion of the intervention
|
|
Isometric Wrist Extensor Muscle Strength
Time Frame: Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention
|
Isometric wrist extensor muscle strength will be assessed using a Lafayette handheld digital dynamometer during maximum voluntary isometric contraction.
Participants will perform wrist extension against the stationary dynamometer using a make-test procedure.
Three 5-second maximal contractions will be performed, and the mean of the three measurements will be used for analysis.
Higher values indicate greater wrist extensor muscle strength.
|
Baseline, 2 days after completion of the 4-week intervention, 12 weeks after completion of the intervention, and 24 weeks after completion of the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Sanders TL Jr, Maradit Kremers H, Bryan AJ, Ransom JE, Smith J, Morrey BF. The epidemiology and health care burden of tennis elbow: a population-based study. Am J Sports Med. 2015 May;43(5):1066-71. doi: 10.1177/0363546514568087. Epub 2015 Feb 5.
- Shiri R, Viikari-Juntura E. Lateral and medial epicondylitis: role of occupational factors. Best Pract Res Clin Rheumatol. 2011 Feb;25(1):43-57. doi: 10.1016/j.berh.2011.01.013.
- Landesa-Pineiro L, Leiros-Rodriguez R. Physiotherapy treatment of lateral epicondylitis: A systematic review. J Back Musculoskelet Rehabil. 2022;35(3):463-477. doi: 10.3233/BMR-210053.
- Bisset LM, Vicenzino B. Physiotherapy management of lateral epicondylalgia. J Physiother. 2015 Oct;61(4):174-81. doi: 10.1016/j.jphys.2015.07.015. Epub 2015 Sep 8. No abstract available.
- Bisset L, Coombes B, Vicenzino B. Tennis elbow. BMJ Clin Evid. 2011 Jun 27;2011:1117.
- Sevik Kacmaz K, Unver B. Immediate Effects of Mulligan Mobilization on Elbow Proprioception in Healthy Individuals: A Randomized Placebo-Controlled Single-Blind Study. J Manipulative Physiol Ther. 2023 Jan;46(1):59-64. doi: 10.1016/j.jmpt.2023.05.001. Epub 2023 Jul 7.
- Hing W, Bigelow R, Bremner T. Mulligan's mobilization with movement: A systematic review. J Man Manip Ther. 2009;17(2). doi:10.1179/jmt.2009.17.2.39e
- Tarpada SP, Morris MT, Lian J, Rashidi S. Current advances in the treatment of medial and lateral epicondylitis. J Orthop. 2018 Feb 2;15(1):107-110. doi: 10.1016/j.jor.2018.01.040. eCollection 2018 Mar.
- Wallis JA, Bourne AM, Jessup RL, Johnston RV, Frydman A, Cyril S, Buchbinder R. Manual therapy and exercise for lateral elbow pain. Cochrane Database Syst Rev. 2024 May 28;5(5):CD013042. doi: 10.1002/14651858.CD013042.pub2.
- Walker-Bone K, Palmer KT, Reading I, Coggon D, Cooper C. Occupation and epicondylitis: a population-based study. Rheumatology (Oxford). 2012 Feb;51(2):305-10. doi: 10.1093/rheumatology/ker228. Epub 2011 Oct 22.
- Martinez-Cervera FV, Olteanu TE, Gil-Martinez A, Diaz-Pulido B, Ferrer-Pena R. Influence of expectations plus mobilization with movement in patient with lateral epicondylalgia: a pilot randomized controlled trial. J Exerc Rehabil. 2017 Feb 28;13(1):101-109. doi: 10.12965/jer.1732848.424. eCollection 2017 Feb.
- Zhu B, You Y, Xiang X, Wang L, Qiu L. Assessment of common extensor tendon elasticity in patients with lateral epicondylitis using shear wave elastography. Quant Imaging Med Surg. 2020 Jan;10(1):211-219. doi: 10.21037/qims.2019.10.07.
- Bialosky JE, Bishop MD, Penza CW. Placebo Mechanisms of Manual Therapy: A Sheep in Wolf's Clothing? J Orthop Sports Phys Ther. 2017 May;47(5):301-304. doi: 10.2519/jospt.2017.0604.
- Syed AU, Darain H, Rana M. The effects of the addition of Mulligan mobilization with movement to exercise on elbow pain and function associated with lateral elbow tendinopathy. J Bodyw Mov Ther. 2024 Oct;40:872-879. doi: 10.1016/j.jbmt.2024.06.007. Epub 2024 Jun 13.
- Stathopoulos N, Dimitriadis Z, Koumantakis GA. Effectiveness of Mulligan's mobilization with movement techniques on pain and disability of peripheral joints: a systematic review with meta-analysis between 2008-2017. Physiotherapy. 2019 Mar;105(1):1-9. doi: 10.1016/j.physio.2018.10.001. Epub 2018 Oct 15.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Elbow Tendinopathy
- Elbow Injuries
- Musculoskeletal Diseases
- Muscular Diseases
- Wounds and Injuries
- Tendon Injuries
- Arm Injuries
- Tendinopathy
- Behavior
- Tennis Elbow
- Motor Activity
- Motor Activity
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physiological Phenomena
- Exercise
- Movement
Other Study ID Numbers
- E-83460662-050.04-1627561
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
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.