Shoulder Pain Clinical Trial
Official title:
The Effectiveness Of Ischemic Compression And Instrument Assisted Soft Tissue Mobilization In Trigger Point Treatment In Patients With Rotator Cuff Tear
| Verified date | February 2021 |
| Source | Istanbul Aydin University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Istanbul Aydin University | Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| Istanbul Aydin University |
Turkey,
| 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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