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Effect Of Instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome (SIS)

Primary Purpose

Shoulder Impingement

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

About this trial

This is an interventional treatment trial for Shoulder Impingement focused on measuring instrumented assisted soft tissue mobilization, shoulder impingement syndrome

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with impingement syndrome from both genders.
  • Age range from 25-40 years
  • Body mass index 18.5-24.9 kg/m2
  • Subjects are non-smokers.
  • Shoulder impingement symptoms lasting at least 6 weeks

Exclusion Criteria:

  1. Hand truma, present pain or other kinds of complaints in the hand area.
  2. History of deformities, fractures, or surgery of the tested upper extremity joints affecting hand grip strength within the last 6 months.
  3. Presence of cardiopulmonary, hormonal disorder, central or peripheral neurological deficits or any condition that can influence the results.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    instrumented assisted soft tissue mobilization

    traditional therapy

    Arm Description

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

    the patients will receive traditional therapy three times a week for eight 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 30 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

    shoulder range of motion
    inclinometer will be used to assess shoulder range of motion.
    shoulder proprioception
    inclinometer will be used to assess shoulder proprioception
    rounded shoulder
    tape measure will be used to assess the rounded shoulder

    Full Information

    First Posted
    September 15, 2022
    Last Updated
    September 15, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05546177
    Brief Title
    Effect Of Instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome
    Acronym
    SIS
    Official Title
    Effect Of Instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome. A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 25, 2022 (Anticipated)
    Primary Completion Date
    April 30, 2023 (Anticipated)
    Study Completion Date
    April 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 investigate instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome
    Detailed Description
    Shoulder impingement is a clinical syndrome in which soft tissues become painfully entrapped in the area of the shoulder joint. Patients present with pain on elevating the arm or when lying on the affected side. Shoulder pain is the third most common musculoskeletal complaint in orthopedic practice, and impingement syndrome is one of the more common underlying diagnoses. On the pathophysiological level, it can have various functional, degenerative, and mechanical causes. The impingement hypothesis assumes a pathophysiological mechanism in which different structures of the shoulder joint come into mechanical conflict. The decision to treat conservatively or surgically is generally made on the basis of the duration and severity of pain, the degree of functional disturbance, and the extent of structural damage. The goal of treatment is to restore pain-free and powerful movement of the shoulder joint.Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment for myofascial restriction which is applied using specially designed instruments to provide a mobilizing effect to soft tissue (e.g., scar tissue and myofascial adhesion) to decrease pain and improve range of motion (ROM) and function. eighty patients will be allocated randomly into two equal groups; the experimental one will receive IASTM and the control will receive traditional therapy for eight weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Impingement
    Keywords
    instrumented assisted soft tissue mobilization, shoulder impingement syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    instruments assisted soft tissue mobilization and traditional therapy
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    opaque sealed envelop
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    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 eight weeks
    Arm Title
    traditional therapy
    Arm Type
    Active Comparator
    Arm Description
    the patients will receive traditional therapy three times a week for eight weeks
    Intervention Type
    Other
    Intervention Name(s)
    instrumented assisted soft tissue mobilization
    Intervention Description
    The subject will be treated with instrumented assisted soft tissue mobilization, applied to the upper and lower fibers of Pectoral, Trapezius (upper, middle and lower), Rhomboids major , Rhomboids minor, Teres minor, Teres major, and Latissimus dorsi muscles. The IASTM technique was performed for 20 seconds parallel to the muscle fibers followed by 20 seconds perpendicular to the muscle fibers of each one of the selected muscle
    Intervention Type
    Other
    Intervention Name(s)
    traditional therapy
    Intervention Description
    the patients will receive Transcutaneous electrical nerve stimulation (TENS) to manage the pain,Ultrasound , Exercise including (Range of motion exercises, stretching exercises, and strengthening exercises (Scapular stabilization exercises and rotator cuff strengthening exercises)
    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 eight 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 30 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 eight weeks
    Secondary Outcome Measure Information:
    Title
    shoulder range of motion
    Description
    inclinometer will be used to assess shoulder range of motion.
    Time Frame
    up to eight weeks
    Title
    shoulder proprioception
    Description
    inclinometer will be used to assess shoulder proprioception
    Time Frame
    up to eight weeks
    Title
    rounded shoulder
    Description
    tape measure will be used to assess the rounded shoulder
    Time Frame
    up to eight weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with impingement syndrome from both genders. Age range from 25-40 years Body mass index 18.5-24.9 kg/m2 Subjects are non-smokers. Shoulder impingement symptoms lasting at least 6 weeks Exclusion Criteria: Hand truma, present pain or other kinds of complaints in the hand area. History of deformities, fractures, or surgery of the tested upper extremity joints affecting hand grip strength within the last 6 months. Presence of cardiopulmonary, hormonal disorder, central or peripheral neurological deficits or any condition that can influence the results.

    12. IPD Sharing Statement

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