NCT06955949

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 15, 2025

Last Update Submit

April 30, 2025

Conditions

Keywords

Lateral EpicondylopathyESWTMobilization with Movement

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • Functional Status (PRTEE-T)

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

  • Upper Extremity Performance (Y-Balance Test)

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

Study Arms (4)

Control group

ACTIVE COMPARATOR

Eccentric strengthening exercises (3 sets of 10 repetitions) with dumbbells were performed as distributed in the control groups.

Other: Control Group

ESWT group

ACTIVE COMPARATOR

ESWT group will receive Extracorporeal Shock Wave Therapy, a noninvasive treatment that uses acoustic waves to promote healing and reduce pain in musculoskeletal disorders

Other: ESWT Group

MWM

ACTIVE COMPARATOR

Mobilization 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.

Other: Mobilization movement group

Combined MWM-ESWT group

ACTIVE COMPARATOR

Mobilization 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.

Other: Combined MWM-ESWT

Interventions

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.

Control group

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.

ESWT group

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.

MWM

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.

Combined MWM-ESWT group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Türkiye, 34160, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2025

First Posted

May 2, 2025

Study Start

August 5, 2022

Primary Completion

October 10, 2022

Study Completion

December 12, 2023

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations