Fire Needling Therapy versus Manual Acupuncture in Post-Stroke Complex Regional Pain Syndrome of the Upper Limb: Study Protocol for a Pilot Randomised Controlled Trial

Abstract

Introduction

Post-stroke complex regional pain syndrome (CRPS) is a devastating disease that causes severe physical and emotional consequences. Conventional therapies are limited due to the insufficient benefits and side effects, and fire needling therapy is considered an alternative for post-stroke CRPS of the upper limb.

Methods and Analysis

This is a study protocol for a pilot randomised, two-arm, single-centre, clinical trial at Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University. The trial started in March 2023 and is expected to end in December 2024. A total of 60 patients (aged 40–75 years, male or female) with post-stroke CRPS of the upper limb will be randomly assigned to treatment group (fire needling therapy, 5 sessions per week for 2 weeks) or control group (manual acupuncture, 5 sessions per week for 2 weeks) in a 1:1 ratio using block randomisation and opaque envelopes. Fire needling therapy or manual acupuncture will be performed in ten acupoints. Participants will complete the trial by visiting the research centre at Week 14 for a follow-up assessment. The primary outcome is the response rate. Secondary outcomes include FMA, Barthel Scale/Index (BI), pain threshold (PPT), and muscle elasticity modulus (using shear wave elastography [SWE]). A chi-squared test will be used for response rate. A mixed-effects linear model and a mixed-effects model will be used for FMA, BI, PPT, and SWE, respectively.

Discussion

This is the first standardised protocol to compare the effectiveness of fire needling therapy and manual acupuncture. We will use a rigorous methodology to minimise bias and set up supervising committees to ensure the quality of our study, thus providing trustworthy evidence for better understanding of fire needling therapy in treating post-stroke CRPS of the upper limb.

Keywords:

• post-stroke complex regional pain syndrome
• upper limb
• fire needling therapy
• manual acupuncture

Ethics and Dissemination

This protocol has been registered with the Chinese Clinical Trial Registry and approved by Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University Research Ethics Committee (number: 2022BL02-076-02). The Ethics Committee will audit the trial every 3 months to decide on any premature closure of the study. Written informed consent will be obtained from all participants. The CRFs will be preserved in a locked cabinet at the participating hospitals and can be accessed by the research team only. Patient identifiable data will be used to provide clinical care and follow-up only, and the trial database will be anonymised. The aggregated research findings will be submitted for publication in a peer-reviewed clinical journal so as to ensure widespread dissemination. The original paper files and electronic data will be preserved for at least 5 years after publication, which will be available from the corresponding author with appropriate reasons.

Patient Consent for Publication

Obtained.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

This work was supported by Beijing Municipal Administration of Hospitals Incubating Program (code: PZ2022012); Young Elite Scientists Sponsorship Program by BAST (BeiJing Association For Science and Technology) (grant number: BYESS202337); Beijing Traditional Chinese Medicine Science and Technology Development Fund Youth Project (grant number: QN-2020-28); China National Natural Science Foundation (grant number: 82004452; 82074547; 82205246).