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Effects of MWM and ESWT on Pain and Function in LE PatientsNCT06955949

Comparison Of Mobilization With Movement And ESWT Treatment Modalities In Patients With Lateral Epicondylopathy

A study testing ESWT Group, Mobilization movement group and Combined MWM-ESWT in people with Effects of MWM and ESWT on Pain and Function in LE Patients, run by Istinye University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
ESWT Group, Mobilization movement group and Combined MWM-ESWT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Aug 2022to 12 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istinye University

    Istanbul, Türkiye, 34160

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Being tested
Control Group, ESWT Group, Mobilization movement group, Combined MWM-ESWT
Keywords
Lateral Epicondylopathy, ESWT, Mobilization with Movement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control GroupOther

    The control classes applied the drugs by doing home training with eccentric strengthening exercises with dumbbells (3 sets of 10 repetitions). They were asked to flex the wrist while the wrist was fully extended. Weights were given to strengthen the wrist extensor muscles with 0.5 kg in the first week, 1 kg in the second week and 1.5 kg in the third week. In addition, stretching exercises for the wrist extensor muscles (3 sets of 20 seconds) were performed and 20 seconds of rest were given between sets. After the exercises, we applied cold therapy for 15 minutes. All treatment types were treated by the same physiotherapist in accordance with the treatment protocols and treatment sessions were performed twice a week for 3 weeks. One session lasted between 35-45 minutes.

  • ESWT GroupOther

    Extracorporeal Shock Wave Therapy (ESWT) is palpated at the starting areas of the extensor carpi radialis brevis and longus muscles, at tender points, and placed at the bone-tendon junctions. This budget was set at 90 Hz, and the pulse rate was determined as 10 pulses:1500.

  • Mobilization movement groupOther

    Mobilization Technique (lateral glide) was recorded from the Mulligan method. Patients were placed in supine positions, height was recorded together and the application was done with a belt method. During this glide movement, the patient was asked to actively perform 3 sets of 10 repetitions of wrist extension. 15-20 seconds of rest was given between sets.

  • Combined MWM-ESWTOther

    In addition to mobilization with movement and ESWT treatment, this group applied home training by doing eccentric exercises with dumbbells (3 sets of 10 repetitions). 15-20 seconds of rest was given between sets. In addition, stretching exercises (3 sets of 20 seconds) were performed to strengthen the wrist extensor muscles and 20 seconds of rest was given between sets. During the exercises, a position was given such that the elbow was in extension, the forearm was in pronation and the wrist was in ulnar deviation. We apply cold therapy for 15 minutes after the exercises.

Study groups in NCT06955949
Study groupRoleWhat they receive
Control groupActive comparatorEccentric strengthening exercises (3 sets of 10 repetitions) with dumbbells were performed as distributed in the control groups.
Receives: Other: Control Group
ESWT groupActive comparatorESWT group will receive Extracorporeal Shock Wave Therapy, a noninvasive treatment that uses acoustic waves to promote healing and reduce pain in musculoskeletal disorders
Receives: Other: ESWT Group
MWMActive comparatorMobilization with Movement Technique Group "MWM is a manual therapy technique that includes active movement combined with mobilization applied by the therapist to reduce fragmentation and pain.
Receives: Other: Mobilization movement group
Combined MWM-ESWT groupActive comparatorMobilization with Movement and ESWT Group The combined MWM + ESWT group will receive Mobilization with Movement (MWM), a manual therapy technique for comprehensive function and pain reduction, and Extracorporeal Shock Wave Therapy (ESWT), a noninvasive treatment that uses acoustic waves to promote healing and reduce musculoskeletal pain.
Receives: Other: Combined MWM-ESWT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10 cm line on which participants mark their perceived pain level, ranging from "no pain" (0) to "worst imaginable pain" (10). Both resting pain and nighttime pain will be evaluated.

    Measured: Baseline (Pre-treatment) and Week 3 (Post-treatment)

Secondary outcomes (2)
  1. Functional Status (PRTEE-T)

    Functionality will be evaluated using the Patient-Rated Tennis Elbow Evaluation - Turkish version (PRTEE-T) questionnaire. This tool assesses pain and functional limitations associated with lateral epicondylopathy. Scores range from 0 to 100, with higher scores indicating greater disability.

    Measured: Baseline (Pre-treatment) and Week 3 (Post-treatment)

  2. Upper Extremity Performance (Y-Balance Test)

    Upper extremity performance will be assessed using the Upper Extremity Y-Balance Test. Participants reach in three directions (medial, inferolateral, superolateral) while in a push-up position. Reach distances are measured in centimeters and used to calculate a composite score that reflects dynamic balance and functional performance

    Measured: Baseline (Pre-treatment) and Week 3 (Post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2025
  2. Study start5 Aug 2022
  3. Primary completion10 Oct 2022
  4. Study completion12 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06955949
Sponsor's protocol ID
LE-MWM-ESWT-2025-01
Status last verified
Apr 2025
First submitted
15 Apr 2025
Last updated
2 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ESWT Group, Mobilization movement group and Combined MWM-ESWT in people with Effects of MWM and ESWT on Pain and Function in LE Patients, run by Istinye University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Baseline (Pre-treatment) and Week 3 (Post-treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.

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