Pilot Study of Thread-Embedding Acupuncture for Shoulder Instability
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0005921
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
(1) age 18–43 years of both sexes
(2) severity of pain during activity (daily activity or light exercise) greater than 3/10 and lesser than 7/10 on a 0-100 mm pain visual analogue scale (VAS)
(3) radiological evidence of subluxation of the humeral head on stress view
(4) visually observed instability on physical examination—Apprehension test and Drawer test
(5) correspondence with involuntary shoulder instability
(6) ability to communicate sufficiently with the researcher and complete the questionnaire
(7) pledge not to receive any treatment other than the prescribed treatment during the study period
(8) agreement to participate after providing written informed consent.
(1) severity of pain at rest greater than 7/10 on a 0-100 mm pain VAS
(2) correspondence with voluntary shoulder instability
(3) history of shoulder surgery
(4) radiological evidence of fracture, osteoarthritis, or calcific tendinitis
(5) systemic pathology, including inflammatory joint disease or neoplastic disorder
(6) radiculopathy from spinal disorders related to cervical spine
(7) intraarticular steroid injections in the previous 3 months
(8) anti-inflammatory drugs administration in the previous 2 weeks
(9) diagnosis of mental illness that impedes compliance with clinical tests
(10) musculoskeletal disorders that may affect efficacy assessment, or any joint disease that makes it impossible for the individuals to participate in the clinical trial
(11) judged by the researchers to be inappropriate to participate in the clinical trial.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Shoulder Pain and Disability Index (SPADI)
- Secondary Outcome Measures
Name Time Method 100mm pain VAS (visual analogue scale) ;Range of motion (ROM) of shoulder;Rotator cuff quality of life (RC-QoL) ;EuroQol 5-dimension 5 levels (EQ-5D-5L) ;Safety outcomes;Evaluation of treatment satisfaction;Economic evaluation