Clinical trial NCT06965985: Comparison of the Effectiveness of Mulligan Mobilization and Myofascial Release Technique in Patients With Lateral Epicondylitis
Official title: Comparison of the Effectiveness of Mulligan Mobilization and Myofascial Release Technique in Patients With Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis (Tennis Elbow)
Keywords: Lateral Epicondylitis
Mobilization Techniques
Myofascial Release
Exercise Therapy
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-11
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study is designed as a prospective, case-control, hospital-based investigation. A total of 114 patients between the ages of 18 and 65, presenting to our clinic with elbow pain and diagnosed with lateral epicondylitis (LE) based on physical examination findings-including tenderness upon palpation of the lateral epicondyle, pain during resisted wrist extension, and discomfort during stretching of the wrist extensors-will be included in the study. All participants must have experienced elbow pain for at least three months. The diagnosis of LE will be established according to clinical criteria. Specifically, LE will be diagnosed if pain is elicited upon resisted wrist extension, stretching of the wrist extensor muscles, and palpation over the lateral epicondyle of the humerus.

Participants will be fully informed about the procedure, and written informed consent will be obtained.

The study will be conducted in accordance with the principles outlined in the Declaration of Helsinki.

A comprehensive medical history will be obtained from all participants, along with a detailed physical examination.

Sociodemographic and clinical data-including age, sex, height, weight, education level, employment status, and income level-will be collected through standardized questionnaires.A total of 114 patients diagnosed with lateral epicondylitis (LE) will be randomly assigned into three groups.

Group 1 (n=38) will receive Mulligan mobilization therapy three times per week for four weeks (a total of 12 sessions), along with a home exercise program.

Group 2 (n=38) will receive myofascial release therapy three times per week for four weeks (a total of 12 sessions), in combination with a home exercise program.

Group 3 (n=38) will receive only a home exercise program, administered three times per week over four weeks (a total of 12 sessions).

All patients will be evaluated at three time points: before treatment, immediately after the completion of the treatment, and one month post-treatment.

During the evaluation process, the following assessments will be performed:

Maximum hand grip strength, measured using a Jamar dynamometer \[17\].

Pain intensity and localization, assessed using a 0-10 point Visual Analog Scale (VAS) during maximum grip effort and at rest.

Functional disability, measured using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire \[18\].

Pain and functional assessment of the arm over the past week, evaluated with the Patient-Rated Tennis Elbow Evaluation (PRTEE/PRFEQ) \[19\].

Patient satisfaction with treatment, assessed by the Modified Roles and Maudsley Score (Roles NC-32).

Quality of life, measured using the Short Form-36 (SF-36) questionnaire \[20\].

Eligibility criteria: Inclusion Criteria:

Aged between 18 and 65 years

Diagnosed with unilateral lateral epicondylitis (LE)

Exclusion Criteria:

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

Primary outcomes:
measure: VAS pain (0-10)
timeFrame: baseline, week 4 and week 8
measure: grip strength
timeFrame: baseline, week 4 and week 8
Secondary outcomes:
measure: The Disabilities of the Arm, Shoulder, and Hand (DASH)
timeFrame: baseline, week 4 and week 8
measure: Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)
timeFrame: baseline, week 4 and week 8
measure: The Short Form-36 (SF-36) quality of life index
timeFrame: baseline, week 4 and week 8
measure: Patient satisfaction/benefit scale (The Roles and Maudsley score)
timeFrame: week 4 and week 8
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Eğitim ve Araştırma Hastanesi
state: Selçuklu
Study officials:
References: