Acupuncture of different treatment frequency in knee osteoarthritis: a protocol for a pilot randomized clinical trial

Lu-Lu Lin, Jian-Feng Tu, Jia-Kai Shao, Xuan Zou, Tian-Qi Wang, Li-Qiong Wang, Jing-Wen Yang, Ning Sun, Cun-Zhi Liu, Lu-Lu Lin, Jian-Feng Tu, Jia-Kai Shao, Xuan Zou, Tian-Qi Wang, Li-Qiong Wang, Jing-Wen Yang, Ning Sun, Cun-Zhi Liu

Abstract

Background: This study aims to determine whether 3 sessions per week of acupuncture treatment is superior to 1 session per week of acupuncture treatment for symptomatic outcomes in knee osteoarthritis.

Methods/design: This is a two parallel-group, assessor-blinded, randomized controlled trial. Sixty patients with knee osteoarthritis (Kellgren-Lawrence grade II or III) will be recruited and randomly allocated to receive 24 or 8 sessions (group M or group L) of acupuncture treatment in a 1:1 ratio. Patients in group M will receive 3 sessions per week of acupuncture for 8 weeks. Patients in group L will receive acupuncture once per week for 8 weeks. The primary outcome is the response rate-the percentage of patients achieving a decrease ≥ 2 points on a numerical rating pain scale and a decrease ≥ 6 points in the Western Ontario and McMaster Universities Osteoarthritis Index function score at 8 weeks compared with baseline. Secondary outcomes include pain, function, overall effect, quality of life, and treatment credibility and expectancy.

Discussion: Three sessions per week of acupuncture treatment may be superior to 1 session per week of acupuncture treatment for symptomatic outcomes in knee osteoarthritis. Results of the study will be of great importance for the guidelines of clinical therapy.

Trial registration: Clinicaltrials.gov, NCT03359603 . Registered on 1 December 2017.

Keywords: Acupuncture; Clinical trial; Knee osteoarthritis; Treatment frequency.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial flow chart: Consolidated Standards of Reporting Trials CONSORT diagram. OA osteoarthritis
Fig. 2
Fig. 2
Template of content for the schedule of enrolment, interventions and assessments. AFT after first treatment; NRS numerical rating scale; SF-12 Medical Outcomes Study 12-item Short-Form Health Survey; WOMAC Western Ontario and McMasters Universities Osteoarthritis Index

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Source: PubMed

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