Clinical trial NCT06955949: Comparison Of Mobilization With Movement And ESWT Treatment Modalities In Patients With Lateral Epicondylopathy
Official title: Comparison Of Mobilization With Movement And ESWT Treatment Modalities In Patients With Lateral Epicondylopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of MWM and ESWT on Pain and Function in LE Patients
Keywords: Lateral Epicondylopathy
ESWT
Mobilization with Movement
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Abstract Our study aimed to compare the effects of mobilization with movement (MWM) and extracorporeal shock wave therapy (ESWT) on pain and functionality in patients with lateral epicondylopathy. A total of 57 volunteers aged 18-65 years, diagnosed with lateral epicondylopathy and referred to the clinic, were divided into groups. In the mobilization with movement group, patients performed active wrist extension exercises using a dumbbell (3 sets of 10 repetitions) while lateral glide mobilization was maintained. In the ESWT group, the therapy was administered at a frequency of 90 Hz and a pulse rate of 10 pulses per 1500. A separate group received a combination of mobilization with movement and ESWT. Additionally, strengthening and stretching exercises, along with cold pack application (15 minutes), were provided twice a week for three weeks to all groups, including the control group. Pain intensity was assessed using the Visual Analog Scale (VAS), and functionality was evaluated using the PRTEE-T (Patient Rated Tennis Elbow Evaluation- Turkish Version ) questionnaire. The Upper Extremity Y-Balance Test was also performed before and after treatment, and all measurements were recorded.

The findings of our study revealed that, in between-group comparisons, the mobilization with movement group demonstrated superior outcomes in pain reduction (resting and nighttime), PRTEE, and Upper Extremity Y-Balance Test performance compared to other groups.

Keywords: Lateral Epicondylopathy, ESWT, Mobilization with Movement

Detailed description: Introduction Lateral epicondylopathy was first described by Dr. Runge in 1873 as "tennis elbow" . Although previously referred to as "lateral epicondylitis" in earlier research, recent studies have updated the term to "lateral epicondylopathy" .

The exact cause of lateral epicondylopathy remains unclear, but it is thought to result from overuse of the forearm extensor muscles, leading to microtears in the extensor carpi radialis brevis tendon or direct trauma .

Difficulties experienced during daily activities are among the most common complaints of patients. The diagnosis of lateral epicondylopathy can be easily made through specific tests and a detailed patient history. Severe pain during resisted wrist extension, third finger extension, and passive wrist flexion, as well as movement restriction, tenderness at the lateral epicondyle, and reduced grip strength, are among the findings supporting the diagnosis .

The primary goal of treating lateral epicondylopathy is to reduce the patient's current pain and enable them to return to daily activities as soon as possible. Conservative treatment methods achieve a 95% success rate. These approaches include rest, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, intermittent ultrasound (US), transcutaneous electrical nerve stimulation (TENS), orthotic devices, myofascial release techniques, transverse friction massage, mobilization, kinesiology taping (KT), cold application, and extracorporeal shock wave therapy (ESWT) Treatments for lateral epicondylopathy are generally classified as either surgical or non-surgical.

One of the conservative treatment methods, ESWT, has been used for years in the treatment of orthopedic disorders. The primary goal of this method is to enhance circulation and activate healing mechanisms by focusing high-intensity sound waves on the target area . Although many studies in the literature support the efficacy of ESWT, some randomized controlled trials have suggested that this treatment may be ineffective or no different from a placebo effect. For example, in a study by Bryan Chung et al., ESWT was compared with forearm stretching exercises, and no significant difference was found between the two methods .

The Mobilization with Movement (MWM) technique is an innovative manual therapy method developed by Mulligan. This technique is widely preferred for correcting improper elbow positioning. Unlike traditional treatments, this method involves lateral gliding mobilization while ensuring pain-free grip and wrist extension, ultimately improving elbow functionality. The Mulligan technique can be safely applied to the musculoskeletal and nervous systems, integrating multiple treatment approaches. Its main advantage is that it provides both short-term and long-term functional mobility improvements.

This study aims to compare the effectiveness of the MWM technique and ESWT in patients with lateral epicondylopathy and to evaluate the effects of these methods on pain, movement restriction, and functionality.

Methods Participants and Study Design This study aimed to compare the effects of the mobilization with movement (MWM) technique and extracorporeal shock wave therapy (ESWT) treatment modalities on pain, movement restriction, and functionality in patients with lateral epicondylopathy. The research included 57 voluntary patients aged 18-65 who were diagnosed with lateral epicondylopathy and admitted to the Physical Therapy Clinic of Yalova Çınarcık State Hospital.

The inclusion criteria included complaints persisting for at least three months, tenderness in the lateral epicondyle region, decreased strength in the extensor carpi radialis brevis (ECRB) muscle, increased pain during resisted wrist extension, pain on the lateral side of the elbow, and discomfort triggered by repetitive rotational movements. The exclusion criteria included the presence of multiple elbow problems, previous elbow joint surgery, tendon rupture, joint movement restriction due to humerus, radius, or ulna fractures, cervical radiculopathy, difficulty in cooperation, or refusal to participate in the study.

Ethical approval was obtained from the İstinye University Clinical Research Ethics Committee (3/2022.K-09), and written informed consent forms were collected from all participants. The study was designed as a randomized parallel-controlled experimental trial. Sample size calculation was performed using G-Power analysis, targeting 56 participants with 80% power, a 5% type 1 error rate, and a moderate effect size (0.40). A total of 60 individuals meeting the criteria were initially included, but three participants were unable to complete the final assessment due to personal reasons. The study was ultimately completed with 57 individuals.

Participants were divided into four groups, each consisting of 15 individuals:

* Mobilization with Movement (MWM) group
* ESWT group
* Combined MWM + ESWT group
* Control group Evaluation and Test Protocols

  1. Pain Assessment Pain assessment was conducted using the Visual Analog Scale (VAS), a widely used technique for measuring pain intensity. Patients marked their pain levels on a 10 cm-long line, where 0 represented no pain, and 100 represented maximum pain .
  2. PRTEE (Patient-Rated Tennis Elbow Evaluation) Questionnaire for Functional Assessment The PRTEE questionnaire was used to assess functional levels in patients with lateral epicondylopathy. This questionnaire consists of two main sections evaluating pain and functional limitations in the affected arm. Pain and function scores range from 0-50 each, with a total score ranging from 0 to 100, where higher values indicate worse conditions.
  3. Upper Extremity Y-Balance Test The Y-Balance Test was used to assess dynamic balance. The test involves reaching movements in three directions (medial, inferolateral, and superolateral). Participants assumed a push-up position and attempted to reach designated points with the tested hand. The reached distances were recorded in centimeters, and the composite score was calculated as follows: Composite Score = (Medial + Inferolateral + Superolateral Reach Distance) / Arm Length × 100 .

Treatment Protocols

All patients participating in the study were informed about the movements they should avoid during the treatment period. These movements include wringing clothes, prolonged computer use, gardening, and heavy lifting.

Mobilization with Movement Technique Group

The mobilization technique (lateral glide) from the Mulligan method was used. Patients were placed in a supine position, in a pain-free position, and the application was performed with the assistance of a belt. During this glide movement, the patient was asked to actively perform 3 sets of 10 repetitions of wrist extension. Rest periods of 15-20 seconds were given between sets.

ESWT Group

Extracorporeal Shock Wave Therapy (ESWT) was applied at the bone-tendon junctions of the extensor carpi radialis brevis and longus muscles' origin areas, where sensitive points were palpated. In this application, the frequency was set to 90 Hz, and the pulse rate was set to 10 pulses:1500.

Mobilization with Movement and ESWT Group

This group, in addition to mobilization with movement and ESWT treatment, performed eccentric strengthening exercises with dumbbells (3 sets of 10 repetitions) as homework. Rest periods of 15-20 seconds were given between sets. Additionally, stretching exercises (3 sets of 20 seconds) were performed to strengthen the wrist extensor muscles, with rest periods of 20 seconds between sets. During exercises, a position was given where the elbow was extended, the forearm was pronated, and the wrist was in ulnar deviation. After the exercises, 15 minutes of cold therapy was applied.

Control Group

Patients in the control group performed eccentric strengthening exercises with dumbbells (3 sets of 10 repetitions) as homework. While the wrist was in full extension, they were asked to perform wrist flexion with 0.5 kg in the first week, 1 kg in the second week, and 1.5 kg in the third week, to strengthen the wrist extensor muscles. Additionally, stretching exercises (wrist extensors) were performed for 3 sets of 20 seconds, with 20-second rest periods between sets. After the exercises, 15 minutes of cold therapy was applied.

All treatment groups were treated by the same physiotherapist according to the treatment protocols, with treatment sessions twice a week for 3 weeks. Each session lasted between 35-45 minutes.

Eligibility criteria: Inclusion Criteria:

* Continuation of complaints for at least 3 months
* Tenderness over the lateral epicondyle
* Decreased ECRB muscle strength
* İncreased pain during resisted extension of the wrist
* Pain complaints on the lateral side of the elbow
* Pain resulting from repetitive and especially rotational movements

Exclusion Criteria:

* Having a different elbow problem or more than one elbow problem
* Having had elbow joint surgery
* Having tendon rupture
* Having a history of humerus
* Radius or ulna fractures
* Having limited range of motion known
* Having cervical radiculopathy
* Having difficulty in cooperation and refusing to participate in the study

Primary outcomes:
measure: Pain intensity, assessed by the Visual Analog Scale (VAS) Because pain reduction (resting and nighttime) is the most emphasized and statistically analyzed main outcome in the study, it is considered the primary outcome.
timeFrame: Baseline (Pre-treatment) and Week 3 (Post-treatment)
Secondary outcomes:
measure: Functional Status (PRTEE-T)
timeFrame: Baseline (Pre-treatment) and Week 3 (Post-treatment)
measure: Upper Extremity Performance (Y-Balance Test)
timeFrame: Baseline (Pre-treatment) and Week 3 (Post-treatment)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istinye University
state: Türkiye
Study officials:
References: