Lateral Elbow Tendinopathy (Tennis Elbow)
Conditions
Keywords
mulligan mobilization, lateral elbow tendinopathy, placebo, exercise
Brief summary
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.
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.
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.
OTHERSham Mobilization with Movement (Sham MWM)
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.
OTHERExercise
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.
Sponsors
Istanbul Kent University
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants were blinded to group allocation through the use of a sham intervention
Intervention model description
Three-arm randomized placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum 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. | 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. |
| 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. | 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. |
| Functionality | 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. |
| Kinesiophobia | 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. |
| Mechanical Properties of the Extensor Carpi Radialis Brevis Muscle | 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. |
| 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. | 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. |
| Upper Extremity Movement Strategy During Maximum Voluntary Grip | 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. |
| Pressure Pain Threshold | 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. |
| Isometric 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 | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTKubra Bali, Master Science
CONTACTIpek Yeldan, Professor
Outcome results
None listed