Efficacy, Safety and Cost-Effectiveness of Thread-Embedding Acupuncture for Adhesive Capsulitis (Frozen Shoulder): A Study Protocol for a Multicenter, Randomized, Patient-Assessor Blinded, Controlled Trial

Abstract

Background

The aim of the present study is to confirm the efficacy, safety, and cost-effectiveness of thread-embedding acupuncture (TEA) in the treatment of adhesive capsulitis (AC).

Methods

This is a randomized, sham-controlled, patient-assessor blinded trial with two parallel arms in a 1:1 ratio. A total of 160 participants with AC, also known as frozen shoulder, will be recruited and screened according to the eligibility criteria. Those who meet the eligibility criteria will be randomly allocated to a TEA group or a sham TEA (STEA) group. Both groups will receive either real TEA or thread-removed STEA treatment on nine acupoints once a week for 8 weeks while being blinded to the intervention. The shoulder pain and disability index will be evaluated as a primary outcome measure. In addition, a 100-mm pain visual analogue scale, rotator cuff quality of life scale, European Quality of Life 5-dimension 5-level scale, treatment satisfaction, safety assessment, and economic evaluation will be assessed as secondary outcome measures. Outcome assessments will be conducted for a total of 24 weeks, including a treatment period of 8 weeks and follow-up of 16 weeks, according to the schedule.

Discussion

The results of this trial will provide a clinical basis for the efficacy, safety and cost-effectiveness of TEA in the treatment of patients with AC.

Trial Registration Number

KCT0005920 (Clinical Research Information Service of the Republic of Korea). Registered on 22 February 2021.

Keywords:

• thread-embedding acupuncture
• adhesive capsulitis
• frozen shoulder
• randomized controlled trial
• protocol

Abbreviations

AC, adhesive capsulitis; AE, adverse event; CRF, case report form; EQ 5D-5L, European Quality of Life 5-dimension 5-level; ICUR, incremental cost-utility ratio; IRB, Institutional Review Board; LMM, linear mixed model; PDO, polydioxanone; QALY, quality-adjusted life year; RC-QoL, rotator cuff quality of life; ROM, range of motion; SPADI, shoulder pain and disability index; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; STEA, sham thread-embedding acupuncture; STRICTA, Standards for Reporting Interventions in Clinical Trials of Acupuncture; TEA, thread-embedding acupuncture; VAS, visual analogue scale.

Trial Status

Protocol: version 2.3; 18 December 2020. Recruitment for the trial began on 14 September 2021. The trial is expected to be completed in December 2026.

Ethics Approval and Informed Consent

This study protocol of this study has been approved by the IRB of Kyung Hee University Hospital at Gangdong (reference: KHNMCOH 2020-10-013), and written informed consent form will be completed voluntarily prior to screening. Also, this trial will be conducted in compliance with the ethical guidelines of the Declaration of Helsinki.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

This study was supported by the Traditional Korean Medicine R&D program, which is funded by the Ministry of Health & Welfare through the Korea Health Industry Development Institute (KHIDI) (HF20C0014). The funding source was not involved in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.