Pilot Study of Thread-Embedding Acupuncture for Shoulder Instability

Thread-Embedding Acupuncture for the Treatment of Shoulder Instability: Protocol for a Randomized, Controlled, Patient-Assessor Blinded Pilot Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005921

Enrollment

Registered

2021-02-22

Start date

2021-09-01

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : In both the groups, the intervention will be administered once a week for 8 weeks using a 29-gauge, 40-mm thread-embedding acupuncture(TEA) or sham TEA (STEA) needle (Hyundae Medit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

Measure	Time frame
Shoulder Pain and Disability Index (SPADI)	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactYeoncheol Park

Kyung Hee University Oriental Medicine Hospital at Gangdong

icarus08@hanmail.net+82-2-440-6275

Outcome results