A randomized clinical trial to validate the clinical effectiveness and safety of thread embedding therapy for the treatment of chronic rotator cuff disease

Study on Clinical Effectiveness and Safety of Thread Embedding Therapy for Chronic Rotator Cuff Disease; Randomized, Patient-Assessor Blind, Clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002563

Enrollment

Registered

2017-11-29

Start date

2017-11-30

Completion date

Unknown

Last updated

2023-12-19

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 : Thread-embedding therapy (TET) group and sham thread-embedding therapy (STET) group will be treated once a week for 8 weeks, using 29G x 40mm TET on predefined 6 acupoints selected

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Change from baseline 100mm pain VAS (visual analogue scale)	—

Secondary

Measure	Time frame
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	—

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