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
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
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.
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
NCT ID
NCT05546177
First Posted
September 15, 2022
Last Updated
September 15, 2022
Sponsor
Cairo University
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
Learn more about this trial
Effect Of Instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome
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