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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04319250
Other study ID # Büsra Aksan Sadikoglu
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date August 30, 2019

Study information

Verified date February 2021
Source Istanbul Aydin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date August 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility 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

Study Design


Intervention

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.
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.
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.

Locations

Country Name City State
Turkey Istanbul Aydin University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Aydin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from Baseline at 6 weeks
Secondary Visual Analogue Scale (VAS) The levels of pain felt at rest / activity / night were measured using Visual Analogue Scale (VAS). Change from Baseline at 6 weeks
Secondary 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. Change from Baseline at 6 weeks
Secondary 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. Change from Baseline at 6 weeks
Secondary Pain Pressure Threshold (PPT) Wagner Force One ™ FDIX" digital algometer was used to evaluate the pain threshold. Measurements were recorded in kg / cm². Change from Baseline at 6 weeks
Secondary 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. Change from Baseline at 6 weeks
Secondary 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 Change from Baseline at 6 weeks
Secondary 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). After 6 weeks treatment
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