Mulligan Mobilization in Lateral Elbow Tendinopathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorIstanbul Kent University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion Criteria

Age between 18 and 60 years

Presence of unilateral lateral elbow pain and tenderness for at least 3 months

Local tenderness over the lateral epicondyle

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mobilization with Movement (MWM)

    Other intervention

    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.

  • Sham Mobilization with Movement (Sham MWM)

    Other intervention

    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.

  • Exercise

    Other 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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: MWM + Exercise GroupExperimental treatment 2 interventions
Group B: Sham MWM + Exercise GroupSham comparator 2 interventions
Group C: Exercise GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity

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.

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.

Secondary outcomes

1

Pressure Pain Threshold

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.

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.
2

Maximum Grip Strength

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.

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.
3

Pain-free Grip Strength

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.

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.
4

Functionality

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.

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.

Other outcomes

Sponsors and contacts

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Istanbul Kent University

Lead sponsor

Istanbul University - Cerrahpasa

Collaborator

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