NCT07589725

Brief Summary

The aim of this study is to investigate the short-, medium-, and long-term effects of Mulligan Mobilization with Movement (MWM) added to an exercise program on pain, functionality, and biomechanical parameters in individuals with lateral elbow tendinopathy, compared to sham mobilization and exercise-only interventions. The primary hypothesis is that the addition of true MWM to exercise will result in greater improvements in pain intensity, grip strength, pressure pain threshold, kinesiophobia, wrist joint position sense, and the mechanical properties of the extensor muscles compared to placebo (sham MWM) and exercise alone. This study is designed as a three-arm randomized placebo-controlled trial. A total of 45 participants will be allocated to one of three groups: MWM plus exercise, sham MWM plus exercise, and exercise alone. Assessments will be conducted at baseline, immediately post-intervention, and at 3- and 6-month follow-ups. The primary outcome measure is pain intensity. Secondary outcomes include functionality, grip strength, pressure pain threshold, kinesiophobia, wrist proprioception, and the mechanical properties of the extensor carpi radialis brevis muscle assessed using Myoton. This study aims to determine the effects of manual therapy independent of placebo and to evaluate the sustainability of these effects over time. Additionally, by objectively assessing the mechanical and proprioceptive characteristics of the muscle-tendon unit alongside clinical outcomes, the study is expected to provide a novel contribution to the literature. The findings are anticipated to enhance the understanding of the mechanisms underlying conservative treatment approaches in lateral elbow tendinopathy and to support evidence-based clinical decision-making.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Oct 2027

First Submitted

Initial submission to the registry

May 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

mulligan mobilizationlateral elbow tendinopathyplaceboexercise

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    Numeric Pain Rating Scale

    1 minute

Secondary Outcomes (7)

  • Pressure Pain Threshold

    1 minute

  • Maximum Grip Strength

    1 minute

  • Pain-free Grip Strength

    1 minute

  • Functionality

    5 minute

  • Kinesiophobia

    5 minute

  • +2 more secondary outcomes

Study Arms (3)

MWM + Exercise Group

EXPERIMENTAL

Participants will receive Mulligan Mobilization with Movement combined with a structured exercise program targeting the extensor muscles.

Other: Mobilization with Movement (MWM)Other: Exercise

Sham MWM + Exercise Group

SHAM COMPARATOR

Participants will receive sham Mulligan Mobilization combined with the same structured exercise program targeting the extensor muscles.

Other: Sham Mobilization with Movement (Sham MWM)Other: Exercise

Exercise Group

EXPERIMENTAL

Participants will receive only a structured exercise program targeting the extensor muscles without any manual therapy intervention.

Other: Exercise

Interventions

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.

MWM + Exercise Group

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.

Sham MWM + Exercise Group

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.

Exercise GroupMWM + Exercise GroupSham MWM + Exercise Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Unıversity Cerrahpasa, Faculty of Health Sciences

Istanbul, Turkey (TĂ¼rkiye)

Location

Related Publications (18)

  • 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

    BACKGROUND
  • 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.

    PMID: 29657450BACKGROUND
  • 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.

    PMID: 38802121BACKGROUND
  • Bisset L, Coombes B, Vicenzino B. Tennis elbow. BMJ Clin Evid. 2011 Jun 27;2011:1117.

    PMID: 21708051BACKGROUND
  • 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.

    PMID: 25656546BACKGROUND
  • 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.

    PMID: 22019808BACKGROUND
  • 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.

    PMID: 28349041BACKGROUND
  • 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.

    PMID: 31956543BACKGROUND
  • 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.

    PMID: 37422752BACKGROUND
  • 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.

    PMID: 28459190BACKGROUND
  • 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.

    PMID: 39593689BACKGROUND
  • 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.

    PMID: 31104005BACKGROUND
  • 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.

    PMID: 30630623BACKGROUND
  • 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.

    PMID: 29705077BACKGROUND
  • 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.

    PMID: 26036675BACKGROUND
  • 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.

    PMID: 34397403BACKGROUND
  • 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.

    PMID: 21663849BACKGROUND
  • 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.

    PMID: 26361816BACKGROUND

MeSH Terms

Conditions

Tennis ElbowMotor Activity

Interventions

MovementExercise

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesBehavior

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMotor Activity

Central Study Contacts

Kubra Bali, Master Science

CONTACT

Ipek Yeldan, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to group allocation through the use of a sham intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three-arm randomized placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 15, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations