Back to resultsThe Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear
Primary Purpose
Rotator Cuff Tears, Shoulder Pain, Myofascial Trigger Point Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ischemic compression
IASTM
Rehabilitation Program
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears focused on measuring ischemic compression, instrument assisted soft tissue mobilization, trigger point
Eligibility Criteria
Inclusion Criteria:
- Being between 40-65 years old
- Having been diagnosed with partial RM rupture
- RM rupture in MRI image
- At least 3 ATNs in the shoulder complex
- Hawkins-Kennedy and Empty Can tests positive Symptoms for at least 3 months
Exclusion Criteria:
- Sensory problems in the back and shoulders,
- Shoulder instability
- Osteoarthritis in the shoulder joint area
- Glenoid or bone fracture
- Frozen shoulder pathology
- Massive RM rupture
- Rheumatological joint problems
- Shoulder surgery history
Sites / Locations
- Istanbul Aydin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Ischemic compression and rehabilitation program applied to the group 1
IASTM and rehabilitation program applied to the group 2
Outcomes
Primary Outcome Measures
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
This is a questionnaire that identifies both functionality and symptoms that can be used in arm, elbow and hand problems. High scores of individuals mean that functional dysfunction is high. Ratings are made between 0 and 100.
Secondary Outcome Measures
Visual Analogue Scale (VAS)
The levels of pain felt at rest / activity / night were measured using Visual Analogue Scale (VAS).
Shoulder Range of Motion (ROM)
EHA evaluations of flexion, abduction, internal rotation and external rotation of the shoulder joint were performed in the supine position using the universal goniometer.
Active trigger points
Active trigger points were evaluated by palpation method according to Travell and Simons criteria. Scalene, upper trapezius, levator scapula, supraspinatus, infraspinatus, subskapularis, teres minor, teres major, deltoid anterior and posterior group fibers, pectoralis major, pectoralis minor, biceps brachii muscles were evaluated with palpation method in terms of trigger point presence.
Pain Pressure Threshold (PPT)
Wagner Force One ™ FDIX" digital algometer was used to evaluate the pain threshold. Measurements were recorded in kg / cm².
The American Shoulder and Elbow Surgeons Standardized Shoulder Assesment Form (ASES)
This score consists of 1 questioning pain and 10 questions questioning daily life activities.The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Emotional state
The emotional states of the cases were evaluated using the Hospital Anxiety and Depression Scale (HAD), which consists of 14 questions. (HAD). This scale has a 7-question anxiety (HAD-A) subscale that evaluates the anxiety state, and a 7-question depression (HAD-D) subscale that evaluates the state of depression, and a four-point likert scale is used to answer the questions. For the total score of each sub-score, 0-7 points are normal, 8-10 points are at the border, and 11 points are defined as abnormal
Global Rating of Change (GRC) scale
Patient Satisfaction was assessed Global Rating of Change (GRC) scale. The scale used included 5 points (-2: I am much worse. -1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).
Full Information
NCT ID
NCT04319250
First Posted
March 19, 2020
Last Updated
February 25, 2021
Sponsor
Istanbul Aydın University
1. Study Identification
Unique Protocol Identification Number
NCT04319250
Brief Title
The Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear
Official Title
The Effectiveness Of Ischemic Compression And Instrument Assisted Soft Tissue Mobilization In Trigger Point Treatment In Patients With Rotator Cuff Tear
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Aydın University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to determine the effects of ischemic compression and IASTM techniques on pain, EHA, functionality, anxiety and depression in patients with the diagnosis of RM tear and presence of ATN. In addition, ischemic compression and EDYDM methods were aimed to compare and to reveal which application would be more useful.
Detailed Description
In this study participants were randomly divided into two groups. While ischemic compression was applied to one group for the determined active trigger points, instrument assisted soft tissue mobilization (IASTM) was applied to the other group for active trigger points. In addition to the treatment, both groups were subjected to a joint rehabilitation program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Shoulder Pain, Myofascial Trigger Point Pain
Keywords
ischemic compression, instrument assisted soft tissue mobilization, trigger point
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Ischemic compression and rehabilitation program applied to the group 1
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
IASTM and rehabilitation program applied to the group 2
Intervention Type
Other
Intervention Name(s)
ischemic compression
Intervention Description
ATNs detected in a total of 13 muscles around the shoulder were applied constant pressure at the level of pain tolerated with the thumb (discomfort severity level 7 to 8 out of 10) and for 90 seconds. This method was applied twice a week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
IASTM
Intervention Description
In order to apply EDYDM in the treatment of ATN, titanium plated stainless steel was divided into two parts, front and back, with two tools. The sweep was applied to the anterior muscle fibers at an angle of 45 ° for 40 seconds.
For each TN, continuous pressure was applied with swivel movement at tolerable pain level (discomfort severity level 7 to 8 out of 10) for 1 minute. The back group muscles were applied in the same way.
Intervention Type
Other
Intervention Name(s)
Rehabilitation Program
Intervention Description
A rehabilitation program consisting of exercises and manual therapy used in the conservative treatment of rotator cuff tear for both groups was applied twice a week for 6 weeks.
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
Description
This is a questionnaire that identifies both functionality and symptoms that can be used in arm, elbow and hand problems. High scores of individuals mean that functional dysfunction is high. Ratings are made between 0 and 100.
Time Frame
Change from Baseline at 6 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
The levels of pain felt at rest / activity / night were measured using Visual Analogue Scale (VAS).
Time Frame
Change from Baseline at 6 weeks
Title
Shoulder Range of Motion (ROM)
Description
EHA evaluations of flexion, abduction, internal rotation and external rotation of the shoulder joint were performed in the supine position using the universal goniometer.
Time Frame
Change from Baseline at 6 weeks
Title
Active trigger points
Description
Active trigger points were evaluated by palpation method according to Travell and Simons criteria. Scalene, upper trapezius, levator scapula, supraspinatus, infraspinatus, subskapularis, teres minor, teres major, deltoid anterior and posterior group fibers, pectoralis major, pectoralis minor, biceps brachii muscles were evaluated with palpation method in terms of trigger point presence.
Time Frame
Change from Baseline at 6 weeks
Title
Pain Pressure Threshold (PPT)
Description
Wagner Force One ™ FDIX" digital algometer was used to evaluate the pain threshold. Measurements were recorded in kg / cm².
Time Frame
Change from Baseline at 6 weeks
Title
The American Shoulder and Elbow Surgeons Standardized Shoulder Assesment Form (ASES)
Description
This score consists of 1 questioning pain and 10 questions questioning daily life activities.The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Time Frame
Change from Baseline at 6 weeks
Title
Emotional state
Description
The emotional states of the cases were evaluated using the Hospital Anxiety and Depression Scale (HAD), which consists of 14 questions. (HAD). This scale has a 7-question anxiety (HAD-A) subscale that evaluates the anxiety state, and a 7-question depression (HAD-D) subscale that evaluates the state of depression, and a four-point likert scale is used to answer the questions. For the total score of each sub-score, 0-7 points are normal, 8-10 points are at the border, and 11 points are defined as abnormal
Time Frame
Change from Baseline at 6 weeks
Title
Global Rating of Change (GRC) scale
Description
Patient Satisfaction was assessed Global Rating of Change (GRC) scale. The scale used included 5 points (-2: I am much worse. -1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).
Time Frame
After 6 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being between 40-65 years old
Having been diagnosed with partial RM rupture
RM rupture in MRI image
At least 3 ATNs in the shoulder complex
Hawkins-Kennedy and Empty Can tests positive Symptoms for at least 3 months
Exclusion Criteria:
Sensory problems in the back and shoulders,
Shoulder instability
Osteoarthritis in the shoulder joint area
Glenoid or bone fracture
Frozen shoulder pathology
Massive RM rupture
Rheumatological joint problems
Shoulder surgery history
Facility Information:
Facility Name
Istanbul Aydin University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear
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