- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293702
IASTM Effects on Pain, Functionality, and Proprioception in Subacromial Impingement
**Effect of Instrument-Assisted Soft Tissue Mobilization on Pain, Functionality, and Proprioception in Individuals With Subacromial Impingement Syndrome**
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study will be to investigate the effects of Instrument-Assisted Soft Tissue Mobilization (IASTM), applied in addition to a conventional exercise program, on pain, range of motion, proprioception, functionality, and quality of life in individuals with Subacromial Impingement Syndrome (SIS).
A total of 38 participants will be included in the study and will be randomly assigned to either the Conventional Exercise Group or the IASTM Group. Both groups will receive treatment for 4 weeks, three sessions per week, for a total of 12 sessions.
Before the intervention, both groups will be assessed for pain (VAS), range of motion (goniometer), joint position sense (goniometer), functionality (Disabilities of the Arm, Shoulder and Hand - DASH), and quality of life (Rotator Cuff Quality of Life - RC-QoL).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Burak Menek, PhD
- Phone Number: 05444761640
- Email: bmenek@medipol.edu.tr
Study Contact Backup
- Name: Ahmet Mesut Zan
- Phone Number: 05444761640
- Email: ahmetmesutzan@gmail.com
Study Locations
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-
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Istanbul, Turkey (Türkiye), 34820
- Recruiting
- İstanbul Medipol University
-
Contact:
- BURAK MENEK, PhD
- Phone Number: +905444761640
- Email: bmenek@medipol.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals diagnosed with SIS by MRI
- Men and women between 40 and 60 years of age
- Individuals with symptoms persisting for at least one month
- Individuals with a minimum of 60° of shoulder flexion and abduction range of motion
Exclusion Criteria:
- Individuals with a history of surgery on the affected arm
- Individuals with an open wound on the arm
- Individuals with an active infection
- Individuals with inflammatory joint disease
- Individuals with malignant or benign tumors were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional exercise group
Conventional exercises will be applied.
|
All participants will receive a standardized electrotherapy program in a clinical setting, consisting of TENS (100 Hz, 30 minutes), ultrasound (1.5 W/cm², 8 minutes), and a 15-minute cold-pack application, delivered three times per week for four weeks.
In addition to electrotherapy, participants in the conventional exercise group will perform a physiotherapist-guided exercise program aimed at improving shoulder flexion, abduction, internal and external rotation through stretching and range-of-motion exercises.
The program will include Codman exercises, wand exercises, finger-ladder activities, and condition-appropriate strengthening exercises, progressed according to each participant's pain level and tolerance.
|
|
Experimental: IASTM group
In addition to the conventional exercises, Instrument-Assisted Soft Tissue Mobilization (IASTM) will be applied.
|
All participants will receive a standardized electrotherapy program in a clinical setting, consisting of TENS (100 Hz, 30 minutes), ultrasound (1.5 W/cm², 8 minutes), and a 15-minute cold-pack application, delivered three times per week for four weeks.
In addition to electrotherapy, participants in the conventional exercise group will perform a physiotherapist-guided exercise program aimed at improving shoulder flexion, abduction, internal and external rotation through stretching and range-of-motion exercises.
The program will include Codman exercises, wand exercises, finger-ladder activities, and condition-appropriate strengthening exercises, progressed according to each participant's pain level and tolerance.
Participants in the IASTM group will receive Instrument-Assisted Soft Tissue Mobilization in addition to the conventional treatment program, three days per week for four weeks, for a total of 12 sessions. The IASTM technique will be applied to the subscapularis, anterior deltoid, biceps brachii, upper trapezius, supraspinatus, infraspinatus, teres major, teres minor, and posterior deltoid muscles. For each muscle group, the treatment will be administered for 20 seconds in a parallel direction and 20 seconds in a perpendicular direction, using sweep and brush techniques at an angle of approximately 45 degrees. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: From enrollment to the end of treatment at 4 weeks
|
The Visual Analog Scale (VAS) is a tool used to measure pain intensity as a single-dimensional construct across different adult populations.
It typically consists of a horizontal or vertical line measuring 10 cm in length.
On this scale, a score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.
|
From enrollment to the end of treatment at 4 weeks
|
|
Range of motion
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Shoulder flexion, abduction, internal rotation, and external rotation range of motion will be assessed using a universal goniometer while the patient is positioned in supine and performs the movements actively.
|
From enrollment to the end of treatment at 4 weeks
|
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The Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: From enrollment to the end of treatment at 4 weeks
|
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a scale that evaluates functional status and capability following injuries or disorders affecting the upper extremity.
The DASH consists of 30 items.
These items assess difficulties encountered during specific tasks, as well as pain, numbness, stiffness, weakness, sleep problems, self-confidence, and participation in social activities.
Scores range from 0 to 100, with higher scores indicating greater impairment in upper extremity function.
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From enrollment to the end of treatment at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint position sense
Time Frame: From enrollment to the end of treatment at 4 weeks
|
To evaluate shoulder proprioception, joint position sense will be measured at 60° of shoulder flexion and 60° of shoulder abduction.
During the assessment, participants will be positioned in standing and guided to the target angles by the physiotherapist using a goniometer.
In each position, participants will be asked to maintain 60° of flexion or 60° of abduction for 10 seconds with their eyes open and to memorize the perceived position.
They will then be instructed to reproduce the same movement with their eyes closed.
The difference between the angle measured with eyes open and the angle reproduced with eyes closed will be recorded as the joint position sense error (error angle).
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From enrollment to the end of treatment at 4 weeks
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Rotator cuff quality of life Index
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Quality of life in individuals with shoulder pathology was evaluated using the Rotator Cuff Quality of Life (RC-QoL) questionnaire.
The RC-QoL consists of 34 items and five subscales.
Results are interpreted in a positive direction; as the RC-QoL score increases, the individual's shoulder-related quality of life is considered to have improved, and symptoms are regarded as reduced.
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From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Burak Menek, PhD, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-6969
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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