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The Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319250
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Büşra Aksan Sadıkoğlu, Istanbul Aydın University

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Shoulder Pain Myofascial Trigger Point Pain Other: ischemic compression Other: IASTM Other: Rehabilitation Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effectiveness Of Ischemic Compression And Instrument Assisted Soft Tissue Mobilization In Trigger Point Treatment In Patients With Rotator Cuff Tear
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Active Comparator: Group 1
Ischemic compression and rehabilitation program applied to the group 1
Other: ischemic compression
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.

Other: Rehabilitation Program
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.

Active Comparator: Group 2
IASTM and rehabilitation program applied to the group 2
Other: IASTM

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.


Other: Rehabilitation Program
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 Measures :
  1. Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) [ Time Frame: Change from Baseline at 6 weeks ]
    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 :
  1. Visual Analogue Scale (VAS) [ Time Frame: Change from Baseline at 6 weeks ]
    The levels of pain felt at rest / activity / night were measured using Visual Analogue Scale (VAS).

  2. Shoulder Range of Motion (ROM) [ Time Frame: Change from Baseline at 6 weeks ]
    EHA evaluations of flexion, abduction, internal rotation and external rotation of the shoulder joint were performed in the supine position using the universal goniometer.

  3. Active trigger points [ Time Frame: Change from Baseline at 6 weeks ]
    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.

  4. Pain Pressure Threshold (PPT) [ Time Frame: Change from Baseline at 6 weeks ]
    Wagner Force One ™ FDIX" digital algometer was used to evaluate the pain threshold. Measurements were recorded in kg / cm².

  5. The American Shoulder and Elbow Surgeons Standardized Shoulder Assesment Form (ASES) [ Time Frame: Change from Baseline at 6 weeks ]
    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.

  6. Emotional state [ Time Frame: Change from Baseline at 6 weeks ]
    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

  7. Global Rating of Change (GRC) scale [ Time Frame: After 6 weeks treatment ]
    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).



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319250


Locations
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Turkey
Istanbul Aydin University
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Aydın University
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Responsible Party: Büşra Aksan Sadıkoğlu, Principal Investigator (MSc), Istanbul Aydın University
ClinicalTrials.gov Identifier: NCT04319250    
Other Study ID Numbers: Büşra Aksan Sadıkoğlu
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Büşra Aksan Sadıkoğlu, Istanbul Aydın University:
ischemic compression
instrument assisted soft tissue mobilization
trigger point
Additional relevant MeSH terms:
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Shoulder Pain
Myofascial Pain Syndromes
Rotator Cuff Injuries
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Muscular Diseases