NCT06965985

Brief Summary

Lateral epicondylitis (LE), recognized as one of the most prevalent causes of elbow pain, has an estimated incidence ranging from 1% to 3%. It most commonly presents in individuals between the ages of 40 and 50 and tends to affect the dominant limb more frequently. In the adult population, LE is the leading cause of lateral elbow pain. To date, more than 40 different treatment modalities have been described for the management of LE, primarily aiming to alleviate pain and enhance functional outcomes. However, a universally accepted standard treatment has yet to be established. The objective of this thesis is to compare the clinical effectiveness of the Mulligan mobilization technique and the myofascial release technique-both commonly utilized in the treatment of LE-through a prospective clinical study.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

May 2, 2025

Last Update Submit

May 2, 2025

Conditions

Keywords

Lateral EpicondylitisMobilization TechniquesMyofascial ReleaseExercise Therapy

Outcome Measures

Primary Outcomes (2)

  • VAS pain (0-10)

    0 no pain; 10 unbearable/max. pain

    baseline, week 4 and week 8

  • grip strength

    using a Jamar® dynamometer (in kilograms)

    baseline, week 4 and week 8

Secondary Outcomes (4)

  • The Disabilities of the Arm, Shoulder, and Hand (DASH)

    baseline, week 4 and week 8

  • Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)

    baseline, week 4 and week 8

  • The Short Form-36 (SF-36) quality of life index

    baseline, week 4 and week 8

  • Patient satisfaction/benefit scale (The Roles and Maudsley score)

    week 4 and week 8

Study Arms (3)

Mulligan mobilization techniqu

EXPERIMENTAL

Will receive Mulligan mobilization therapy three times per week for four weeks (a total of 12 sessions), along with a home exercise program

Other: Mulligan mobilization therapy

Myofascial release therapy

EXPERIMENTAL

will receive myofascial release therapy three times per week for four weeks (a total of 12 sessions), in combination with a home exercise program.

Other: Myofascial release therapy

Exercise Therapy

ACTIVE COMPARATOR

Will follow only the home exercise program, three times per week for four weeks (12 sessions total).

Other: Exercise Therapy

Interventions

While the mobilization belt is placed around the patient's proximal forearm and looped over the therapist's shoulder, the distal humerus will be stabilized with one hand. A lateral glide will be applied to the forearm through the belt and maintained for approximately 5 to 10 seconds. The patient will perform repeated wrist extensions against the manual resistance provided by the therapist's hand. Once a pain-free wrist extension is achieved, the lateral glide will be released. A total of 6 repetitions will be performed with 15-second rest intervals between repetitions. This protocol will be applied three times per week for two weeks.

Mulligan mobilization techniqu

The patient will be placed in a supine position with the shoulder internally rotated, the elbow in pronation and approximately 15 degrees of flexion, and the palm resting flat on the table. The therapist will stand beside the table at the level of the patient, facing the patient's ipsilateral arm and shoulder. The treatment will be administered for 10 minutes, three sessions per week for two weeks. The therapist will begin the treatment from just proximal to the lateral epicondyle, on the humerus, and proceed distally along the path of the common extensor tendon to the extensor retinaculum of the wrist. Using the fingertips, the therapist will engage the periosteum and maintain contact as the technique continues along the common extensor tendon and further distally along the extensor retinaculum of the wrist.

Myofascial release therapy

All patients will be provided with a home exercise program consisting of eccentric strengthening exercises targeting the wrist extensors, with resistance gradually increased each week. Patients will be instructed in strengthening exercises for the wrist extensors as well as forearm pronation and supination. The home program will consist of 3 sets of 10 repetitions per day. The exercises will be demonstrated in person by the physician, and each patient will receive a printed handout detailing how to perform the exercises. During weekly treatment sessions and after the treatment period, patients will be contacted by phone to assess adherence to the exercise program and to reinforce the importance of compliance. Patients with exercise compliance below 75-80% will be excluded from the study.

Exercise Therapy

Eligibility Criteria

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

You may qualify if:

  • Aged between 18 and 65 years
  • Diagnosed with unilateral lateral epicondylitis (LE)

You may not qualify if:

  • Younger than 18 or older than 65 years
  • Communication difficulties
  • History of injection, surgery, or physical therapy in the elbow region within the past 6 months
  • Pain originating from the cervical spine (e.g., radiculopathy, spinal stenosis), shoulder problems, or other elbow pathologies unrelated to LE
  • History of elbow osteoarthritis or previous elbow fracture
  • History of polyneuropathy
  • Uncontrolled systemic diseases (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic disorders)
  • Uncontrolled systemic endocrine disorders (e.g., diabetes mellitus, hyperthyroidism)
  • History of major psychiatric disorders
  • History of rheumatic diseases such as fibromyalgia, polymyalgia rheumatica, ankylosing spondylitis, or rheumatoid arthritis
  • Presence of bleeding disorders or use of anticoagulant medications
  • Neurological deficits
  • Posterior interosseous nerve (PIN) syndrome
  • Current or past use of wrist resting splints or elbow braces

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Beyhekim Eğitim ve Araştırma Hastanesi

Konya, Selçuklu, 42060, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Myofascial Release TherapyExercise Therapy

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 11, 2025

Study Start

January 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

May 11, 2025

Record last verified: 2025-05

Locations