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

Primary Purpose

Lateral Epicondylitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mulligan mobilization
instrumented assisted soft tissue mobilization
conventional treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring instrumented assisted soft tissue mobilization, Mulligan Mobilization, lateral epiconylitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    mulligan mobilization

    instrumented assisted soft tissue mobilization

    conventional treatment

    Arm Description

    the patients will receive mulligan mobilization three times a week for four weeks

    the patients will receive instrumented assisted soft tissue mobilization three times a week for four weeks

    the patients will receive conventional treatment three times a week for four weeks

    Outcomes

    Primary Outcome Measures

    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)
    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

    Secondary Outcome Measures

    range of motion
    elbow and wrist range of motion will be measured by universal goniometer
    hand grip strength
    Hand held dynamometer will be used to measure hand grip strength

    Full Information

    First Posted
    March 10, 2023
    Last Updated
    March 10, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05780528
    Brief Title
    Mulligan Mobilization Versus Instrument Assissted Soft Tissue Mobilization In Chronic Iateral Epicondylitis
    Acronym
    IASTM
    Official Title
    Mulligan Mobilization Versus Instrument Assissted Soft Tissue Mobilization In The Treatment Of Chronic Iateral Epicondylitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 25, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lateral Epicondylitis
    Keywords
    instrumented assisted soft tissue mobilization, Mulligan Mobilization, lateral epiconylitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    mulligan mobilization and instrumented-assisted soft tissue mobilization
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    opaque sealed envelop
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mulligan mobilization
    Arm Type
    Experimental
    Arm Description
    the patients will receive mulligan mobilization three times a week for four weeks
    Arm Title
    instrumented assisted soft tissue mobilization
    Arm Type
    Experimental
    Arm Description
    the patients will receive instrumented assisted soft tissue mobilization three times a week for four weeks
    Arm Title
    conventional treatment
    Arm Type
    Active Comparator
    Arm Description
    the patients will receive conventional treatment three times a week for four weeks
    Intervention Type
    Other
    Intervention Name(s)
    mulligan mobilization
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    instrumented assisted soft tissue mobilization
    Intervention Description
    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)
    Intervention Type
    Other
    Intervention Name(s)
    conventional treatment
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    pain intensity
    Description
    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)
    Time Frame
    up to four weeks
    Title
    shoulder disability
    Description
    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
    Time Frame
    up to four weeks
    Secondary Outcome Measure Information:
    Title
    range of motion
    Description
    elbow and wrist range of motion will be measured by universal goniometer
    Time Frame
    up to four weeks
    Title
    hand grip strength
    Description
    Hand held dynamometer will be used to measure hand grip strength
    Time Frame
    up to four weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Mulligan Mobilization Versus Instrument Assissted Soft Tissue Mobilization In Chronic Iateral Epicondylitis

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