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Thread-embedding acupuncture for adhesive capsulitis

Not Applicable
Recruiting
Conditions
Diseases of the musculoskeletal system and connective tissue
Registration Number
KCT0005920
Lead Sponsor
Kyung Hee University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
160
Inclusion Criteria

(1) adult men or women aged 25 to 65 years old
(2) one side-shoulder pain for a period from 6 weeks to 12 months
(3) significant pain of 50–100 mm on a 100-mm pain visual analogue scale (VAS) during activity (daily life movement or light exercise)
(4) restriction of passive ROM more than 25% in two or more motions compared to the healthy side
(5) diagnosis of AC by excluding fracture, dislocation, osteoarthritis, and calcific tendinitis from plain radiography
(6) ability to communicate sufficiently with the researcher and complete the questionnaire
(7) voluntary agreement to participate with written informed consent.

Exclusion Criteria

(1) severe pain at rest for more than 70 on a 100-mm pain VAS
(2) restriction of passive ROM of more than 50% in two or more motions compared to the healthy side
(3) a positive drop arm test or empty can test to rule out a rotator cuff tear
(4) Previous history of surgery or significant injury on shoulder
(5) shoulder pain accompanied with stroke, spinal cord injury, or other surgeries
(6) systemic pathology, including inflammatory joint disease or tumor
(7) cervical spine or other upper limb joint disease which significantly affects the shoulder
(8) intra-articular steroid injections within the previous 3 months
(9) medication history of anti-inflammatory drugs within the previous 2 weeks
(10) musculoskeletal disorders which may affect efficacy assessment or any joint disease which makes it impossible for the individuals to participate in the clinical trial
(11) taking medicine for mental disorders
(12) Women who are pregnant, lactating, or of childbearing age who are unwilling to avoid pregnancy during the trial period
(13) participants deemed by the researchers to be unqualified to participate in the clinical trial.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Shoulder Pain and Disability Index (SPADI) 
Secondary Outcome Measures
NameTimeMethod
100mm pain VAS (visual analogue scale) ;Shoulder range of motion (ROM) ;Rotator cuff quality of life ;EuroQol-5dimensions-5Levels (EQ-5D-5L) ;Safety assessment;Treatment satisfaction evaluation;Economic evaluation
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