- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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 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.
Přehled studie
Postavení
Detailní popis
Lateral elbow tendinopathy (LET) is a common tendon pathology that develops as a result of excessive and repetitive use of the forearm extensor muscles or direct trauma to the lateral epicondyle [1]. The extensor carpi radialis brevis is most frequently affected, and it is clinically characterized by pain over the lateral epicondyle and increased tenderness during gripping activities [2], [3]. The annual incidence is approximately 3%, increasing to 7-10% in individuals aged 40-60 years [4]. A higher prevalence (29%) has been reported in occupations requiring intensive hand and wrist use [5], [6]. Physiotherapy is recommended as a first-line and cost-effective treatment approach in LET [7], [8]. Among manual therapy applications, Mobilization with Movement (MWM) is an intervention specific to the Mulligan concept that combines mobilization with active movement [9], [10], [11].
The positive effects of MWM added to exercise on pain and functionality in the short and medium term have been reported [12], [13]. However, the influence of contextual factors on outcomes and methodological limitations in sham intervention protocols have been emphasized [14], [15]. There is still a need for high-quality studies evaluating the effects of manual therapy independent of placebo [16]. In addition, the effects of manual therapy interventions on proprioceptive outcomes and the mechanical properties of muscles have not been sufficiently investigated. This study aims to contribute to the literature by examining the effectiveness of MWM added to exercise across different time periods using a placebo-controlled design.
Furthermore, while the effects of exercise and manual therapy interventions in LET are mostly evaluated through clinical outcomes such as pain and function, studies investigating their effects on wrist joint position sense and the mechanical properties of the muscle-tendon unit (stiffness, tone, elasticity, relaxation time, and creep) are limited [17], [18]. The objective assessment of these parameters may contribute to a better understanding of the neurophysiological and mechanical processes underlying clinical improvement.
This study is designed as a three-arm randomized placebo-controlled trial to investigate the short-, medium-, and long-term effects of Mulligan Mobilization with Movement (MWM) added to an exercise program on pain, functionality, grip strength, pressure pain threshold, kinesiophobia, wrist joint position sense, and the mechanical properties of the extensor muscles in individuals with LET, compared with sham mobilization and exercise-only interventions.
The study will be conducted between May 2026 and May 2027 in patients with LET who are referred by an orthopedic specialist to the Laboratory of the Department of Physiotherapy and Rehabilitation at Istanbul University-Cerrahpaşa. Written informed consent will be obtained from all individuals who meet the inclusion criteria and agree to participate.
Participants who meet the inclusion criteria will be assigned to three groups using a random number list generated by an independent researcher through an online randomization program (www.randomizer.org). A simple randomization method will be applied, and each participant will have an equal probability of being allocated to one of the three groups. Allocation concealment will be ensured using sealed, opaque, and sequentially numbered envelopes prepared in advance. Participants will be assigned to their respective groups after baseline assessment.
The first group will be the MWM + Exercise Group, in which Mulligan Mobilization with Movement will be applied in addition to exercise; the second group will be the Sham MWM + Exercise Group, in which sham mobilization will be applied in addition to exercise; and the third group will be the Exercise Group, in which only an exercise program will be applied. The physiotherapist (KB) who will administer the intervention will be informed of the group allocation prior to treatment.
Demographic and clinical data of the participants will be recorded in a case report form. All assessments will be performed before treatment, immediately after treatment, and at the 3rd and 6th months.
The primary outcome measure is pain intensity, assessed using the Numeric Pain Rating Scale. Secondary outcome measures include pressure pain threshold assessed with a pressure algometer, maximum and pain-free grip strength measured using a hand dynamometer, functionality evaluated with the Patient-Rated Tennis Elbow Evaluation, kinesiophobia assessed using the Tampa Scale for Kinesiophobia, mechanical properties of the extensor carpi radialis brevis muscle measured using a Myoton device, and wrist joint position sense assessed using a digital goniometer.
Sample size calculation was performed using G*Power (version 3.1, Heinrich-Heine University Düsseldorf, Germany). A medium effect size (f = 0.25) was assumed. The Type I error rate was set at α = 0.05, and statistical power was set at 90%. Considering a possible dropout rate of 15%, a total of 45 participants will be included in the study.
Eligibility 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
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Kubra Bali, Master Science
- Telefonní číslo: 90+5449765584
- E-mail: kubra.tufekci@hotmail.com
Studijní záloha kontaktů
- Jméno: Ipek Yeldan, Professor
- E-mail: ipek.yeldan@iuc.edu.tr
Studijní místa
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Istanbul, Turecko (Türkiye)
- Istanbul Unıversity Cerrahpasa, Faculty of Health Sciences
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Kontakt:
- Kubra Bali, Master Science Physiotherapist
- Telefonní číslo: 90+5449765584
- E-mail: kubra.tufekci@hotmail.com
-
Vrchní vyšetřovatel:
- Kubra Balı, Master Science
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Dílčí vyšetřovatel:
- Ipek Yeldan, Professor
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Falešný srovnávač: 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.
|
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Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain Intensity
Časové okno: 1 minute
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Numeric Pain Rating Scale
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1 minute
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pressure Pain Threshold
Časové okno: 1 minute
|
Algometer
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1 minute
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Maximum Grip Strength
Časové okno: 1 minute
|
Hand Dynamometer
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1 minute
|
|
Pain-free Grip Strength
Časové okno: 1 minute
|
Hand Dynamometer
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1 minute
|
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Functionality
Časové okno: 5 minute
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Patient-Rated Tennis Elbow Evaluation
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5 minute
|
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Kinesiophobia
Časové okno: 5 minute
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Tampa Scale for Kinesiophobia
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5 minute
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Mechanical Properties of the Extensor Carpi Radialis Brevis Muscle
Časové okno: 3 minute
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MyotonPro
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3 minute
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Wrist Joint Position Sense
Časové okno: 2 minute
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Dijital Goniometer
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2 minute
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Tendinopatie loktů
- Zranění lokte
- Nemoci pohybového aparátu
- Svalová onemocnění
- Rány a zranění
- Poranění šlach
- Zranění paže
- Tendinopatie
- Chování
- Tenisový loket
- Motorická aktivita
- Motorická aktivita
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Fyziologické jevy
- Cvičení
- Hnutí
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