Mulligan Mobilization in Lateral Elbow Tendinopathy

Istanbul Kent University

Status: Not yet enrolling

Conditions: Lateral Elbow Tendinopathy (Tennis Elbow)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07589725

E-83460662-050.04-1627561

Details and patient eligibility

About

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.

Full description

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

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

MWM + Exercise Group

Experimental group

Description:

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

Treatment:

Other: Exercise

Other: Mobilization with Movement (MWM)

Sham MWM + Exercise Group

Sham Comparator group

Description:

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

Treatment:

Other: Exercise

Other: Sham Mobilization with Movement (Sham MWM)

Exercise Group

Experimental group

Description:

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

Treatment:

Other: Exercise