Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial

Abstract

Purpose

Knee osteoarthritis (KOA) is regarded as one of the leading musculoskeletal diseases. Although the efficacy is under exploration, fire needling therapy is considered an effective alternative for KOA. This trial aims to investigate the effectiveness of different frequencies of fire needling therapy in attenuating pain and promoting function in KOA patients.

Methods

This is a study protocol for a pilot, three-arm, single-center, randomized controlled trial. A total of 90 participants with KOA will be recruited and randomly assigned to the high-frequency fire needling group (3 sessions per week, for 6 weeks), the low-frequency fire needling group (1 session per week, for 6 weeks) or the positive control group (Diclofenac Diethylamine Emulgel, 3 times per day, for 6 weeks) in a 1:1:1 ratio. Participants will accomplish the trial at Week 14 after a follow-up evaluation. The response rate will be set as the primary outcome that the proportion of participants obtaining a minimal clinically important difference, which is identified as ≥2 units on the numerical rating scale (NRS) and ≥6 units on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at Week 6 compared with Week 0. Secondary outcomes are NRS, WOMAC, Brief Pain Inventory, Short-Form Health Survey-12, Timed Up and Go Test, and pain threshold.

Discussion

This is the first standardized protocol comparing fire needling therapy and positive control drugs. This trial may provide reliable evidence for the effectiveness of fire needling therapy and dose–effect property of it in KOA. Trial registration: The trial has been registered on Chinese Clinical Trial Registry (Registered number: ChiCTR2100043041), registered on 4 February 2021.

Keywords:

• knee osteoarthritis
• fire needling therapy
• different frequencies
• dose–effect property

Abbreviations

BPI, Brief Pain Inventory; ITT, Intention-to-treat; KOA, Knee osteoarthritis; MWT, Mechanical withdrawal threshold; NRS, Numerical rating scale; NSAIDs, Non-steroidal anti-inflammatory drugs; OA, Osteoarthritis; PGIC, Patient’s general impression of change; SF-12, Short-Form Health Survey-12; PPT, Pressure pain threshold; TUG, Timed Up and Go Test; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

Data Sharing Statement

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 merely, and the trial database will be anonymized. The aggregated research findings will be submitted for publication in a peer-reviewed clinical journal to have widespread dissemination. The original paper files and electronic data will be preserved for at least 5 years after publication, which can be accessible from the corresponding author with appropriate reasons.

Ethical Approval and Consent to Participate

The study followed the ethical standards established in the 1961 Declaration of Helsinki. This protocol has been registered in Chinese Clinical Trial Registry and approved by Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University Research Ethics Committee (number: 2021BL02-001-01). 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.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

This work was supported by 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).