Study on Clinical Effectiveness and Safety of Chuna Manual Therapy Combined with Acupuncture and Cupping for Frozen Shoulder(Adhesive Capsulitis)
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0002300
- Lead Sponsor
- Wonkwang University, Gwangju Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
1) Males and females aged 25 to 65 years old, one side-shoulder pain for 6 weeks to 12 months, with a significant pain of visual analogue scale(VAS) 50mm-100mm, with more than 25% limitation of motion of range in two or more movements compared to the unilateral side, who can be diagnosed as frozen shoulder (adhesion capsulitis) by excluding simple fracture, dislocation, degenerative arthropathy, and calcific tendinitis in plain radiography.
2) Those who have minimal help with the nature of the pain and are able to communicate sufficiently with the researcher and write a questionnaire.
3) Those who have pledged not to receive treatment other than the prescribed treatment within the period of study.
4) Agreed with written informed consent voluntarily.
1) History of major shoulder injury or surgery
2) Patients with disorders of the cervical spine or other upper extremity that has a significant impact on the shoulder
3) Patients who complain of shoulder pain accompanied by stroke, spinal cord injury, or other surgery
4) Patients with fracture, dislocation, degenerative arthropathy and calcific tendinitis of the shoulder in plain radiography
5) Patients with positive findings in physical examination(drop arm test, empty can test) for exclusion of rotator cuff tear
6) ALT(SGPT), AST (SGOT) measured at a screening visit is greater than twice the normal upper limit (ULN)
7) Serum creatinine and BUN (blood urea nitrogen) measured at a screening visit is greater than twice the normal upper limit (ULN)
8) Patients with concomitant disorders contraindicated to Acetaminophen or hypersensitivity to Acetaminophen(Acetaminophen is relief medication in this study)
9) Pregnant or breastfeeding patients
10) Patients who are taking medicines after being diagnosed with mental disorders
11) Patients with all other joint diseases that are associated with musculoskeletal disorders that may affect efficacy assessment, or that are considered to be unacceptable for this trial (eg. septic arthritis, inflammatory joint disease, gout, recurrent pseudogout, Paget's disease, joint fracture, exogenous ochronosis, acromegaly, hematochromatosis, Wilson's disease, primary osteochondrosis, hereditary disorder(eg. hyperkinetic), collagen gene abnormality, etc.)
12) Patients who were considered as unsuitable for participation by the researcher
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 Quality of life scales(Rotator cuff quality of life, EuroQoL-5 Dimensions);Amount and frequency of relief medicine(Acetaminophen);100mm Visual analogue scale(VAS) of shoulder pain;Passive range of motion(ROM) of shoulder ;Korean shoulder scoring system(KSS) ;Patient's satisfaction;Cost-effectiveness