A randomized clinical trial to validate the clinical effectiveness and safety of thread embedding therapy for the treatment of chronic rotator cuff disease
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0002563
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
1. Male or female aged 18 or over but under 65 years
2. Shoulder pain lasting more than 3 months
3. Severity of pain at activity (daily activity or light exercise) greater thna 3/10 on 0-100mm pain visual analogue scale
4. A positive painful arch of abduction between 60 and 120 degrees
5. A positive shoulder abduction (empty can) stress test or external rotation resistance test
6. Those who can communicate sufficiently with the researcher and write the questionnaire
7. Those who agree to participate after providing written informed consent
1 Pain on rest greater than 7/10 on 0-100mm pain visual analogue scale
2. Greater than 50% restriction of ROM of passive movement in the two or more shoulder planes
3. Suspicion of rotator cuff tear as presence of a positive lag test (internal and external rotation)
4. Previous shoulder surgery
5. Radiological evidence of osteoarthritis, calcific tendinitis or previous fracture
6. Systemic pathology including inflammatory joint disease or neoplastic disorder
7. Referred pain from spinal disease related to cervical spine
8. Intraarticular steroid injections in the previous 3 months
9. Anti-inflammatory drugs in the previous 2 weeks
10. Mental illness that can not follow clinical test compliance
11. Musculoskeletal disorders that may affect efficacy assessment, or all joint disease that is considered impossible to participate in the clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline 100mm pain VAS (visual analogue scale)
- Secondary Outcome Measures
Name Time Method Change from baseline Shoulder Pain and Disability Index (SPADI);Change from baseline shoulder range of motion (ROM);Change from baseline Rotator Cuff Quality of Life (RC-QoL);Change from baseline EuroQol 5-dimension (EQ-5D);Adverse events evaluation;Evaluation of treatment satisfaction