Mulligan Mobilization Versus Instrument Assissted Soft Tissue Mobilization In Chronic Iateral Epicondylitis (IASTM)

Mulligan Mobilization Versus Instrument Assissted Soft Tissue Mobilization In The Treatment Of Chronic Iateral Epicondylitis

this study will be conducted to compare between mulligan mobilization and instrument assisted soft tissue mobilization on pain intensity, range of motion, hand grip strength, and hand function in the treatment of chronic lateral epicondylitis

Study Overview

• Status: Not yet recruiting
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Other: mulligan mobilization; Other: conventional treatment; Other: instrumented assisted soft tissue mobilization

Detailed Description

Lateral epicondylitis is one of the elbow conditions that affects about 1-3% of the population at large. It produces a heavy burden of workdays lost and residual impairments. Although many treatment modalities are used, few of them rest on scientific evidence and none has been proven more effective than the others. This lack of evidence on treatments for lateral epicondylitis may stem from several sources, including the possible self-limiting nature of the condition, the lack of pathophysiological data, the methodological shortcomings of available studies, and the existence of numerous factors influencing the outcome. The physiotherapeutic treatment has been shown to be effective. In general, it must include manual therapy to relieve the pain and improve the joint's range of motion (ROM), taking into account that it must be performed under the pain threshold. Mulligan mobilization with movement (MWM) is a modern technique developed by Mulligan for treating lateral epicondylitis (LE). Instrument-assisted soft tissue mobilization is a form of augmented soft tissue mobilization (IASTM) in which stainless steel instruments are utilized to apply controlled microtrauma to the affected soft tissues. sixty patients will be allocated randomly to three groups; the first one will receive mulligan mobilization with movement, the second one will receive instrument-assisted soft tissue mobilization and the third one will receive traditional therapy three times a week for four weeks

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All patients will be diagnosed with chronic lateral epicondylitis from both genders.

Patients with chronic lateral epicondylitis were diagnosed by orthopedists. Positive clinical manifestation in all patients. Patients' age will be ranged from 18 to 80 years, Pain onset is more than 3 months. All participants must be medically stable and not be treated with analgesics or any medication which may cause misleading results.

All patients have a body mass index between 18.5 and 29.9 kg/m2.

Exclusion Criteria:

Patients who received an intra-articular injection for a duration of less than 3 months.

Patients receiving oral or injected corticosteroids for the last 3 months at least.

History of elbow surgery/fracture. Acute synovitis/arthritis including infectious. Presence of malignancy. Pregnancy. Patients with, topical lesions, contact dermatitis, and a history of cutaneous hypersensitivity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mulligan mobilization; the patients will receive mulligan mobilization three times a week for four weeks	Other: mulligan mobilization; The patients will receive mobilization with movement technique of lateral glide. the patients will be in supine subject and pronate forearm, during the application of the lateral glide by the physiotherapist, each patient was asked to perform the closure of the fist (provocative but painless gesture in the execution of the technique) for 3 sets of 10 repetitions.; Other: conventional treatment; the patients will receive conventional treatment in the form of Ultrasound therapy, conventional transcutaneous electrical nerve stimulation (TENS) - hot pack - stretching and strengthening exercises and wrist rest splints
Experimental: instrumented assisted soft tissue mobilization; the patients will receive instrumented assisted soft tissue mobilization three times a week for four weeks	Other: conventional treatment; the patients will receive conventional treatment in the form of Ultrasound therapy, conventional transcutaneous electrical nerve stimulation (TENS) - hot pack - stretching and strengthening exercises and wrist rest splints; Other: instrumented assisted soft tissue mobilization; the participant will receive instrumented assisted soft tissue mobilization. The participant's elbow will rest on a table. A lubricant (Vaseline) will be applied to the skin around the elbow prior to treatment and the blade will be cleaned with an alcohol pad. First, the blade will be used to find the exact areas of restriction in the common extensor origin. Then the M2T blade will be used in the treatment planes 1, 2, and 3, to apply slow strokes along the muscle, without causing any discomfort or pain, from the muscle origin to its insertion (sweeping technique)
Active Comparator: conventional treatment; the patients will receive conventional treatment three times a week for four weeks	Other: conventional treatment; the patients will receive conventional treatment in the form of Ultrasound therapy, conventional transcutaneous electrical nerve stimulation (TENS) - hot pack - stretching and strengthening exercises and wrist rest splints

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain)	up to four weeks
shoulder disability	The Arabic version of Disabilities of arm, shoulder, and hand (DASH) will be used for assessing shoulder function.DASH questionnaire includes 11 items with score from 0 to 100. A score of 0 represents no disability, while a score of 100 represents the most sever	up to four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion	elbow and wrist range of motion will be measured by universal goniometer	up to four weeks
hand grip strength	Hand held dynamometer will be used to measure hand grip strength	up to four weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 25, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: instrumented assisted soft tissue mobilization; Mulligan Mobilization; lateral epiconylitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: P.T.REC/012/004235

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No