Evaluating Effectiveness of Fu’s Subcutaneous Needling for the Pain Nature and Quality of Life in Patients with Knee Osteoarthritis: A Study Protocol of Randomized Clinical Trial

Abstract

Background: Knee osteoarthritis (OA) is a common clinical disease. Knee pain is the major symptom of knee OA and the primary reason why patients seek treatment. Fu's subcutaneous needling (FSN) has been used to treat knee OA for more than 20 years. However, the establishment of treatment methods and rigorous evaluation of FSN's efficacy are still lacking. A randomized single-blind clinical trial will be conducted to evaluate whether FSN treatment can immediately alleviate pain due to knee OA surrounding the patella and the curative effective of 1-week and 2-week treatments. In addition, the feasibility and initial effect of FSN treatment for patients with knee OA will be discussed. Materials and Methods: Patients with confirmed knee OA, as diagnosed by doctors using X-ray films or from clinical symptoms, who are over 50 years old will be participants recruited. They will be randomly assigned either FSN treatment or transcutaneous electrical nerve stimulation treatment. In addition, their pressure pain threshold, muscle tone of lower leg muscle, and physical ability will be measured. Participants will be asked to complete the questionnaires of Western Ontario and McMaster Universities Osteoarthritis Index and Lequesne' index as the measurements for quality of life. Results:The findings of this study will reveal whether FSN or transcutaneous electrical nerve stimulation is clinically efficacious for treating pain due to knee OA, with respect to muscle stiffness, gait, dynamic balance, the pressure pain threshold, and quality of life before and after treatment.

Efficacy of Fu’s Subcutaneous Needling in Treating Soft Tissue Pain of Knee Osteoarthritis: A Randomized Clinical Trial

“…From July 2020 to December 2020, we screened 125 patients with knee OA and 36 of them who met the inclusion criteria were included and randomly assigned. The original estimate was 90 subjects in our study protocol [ 22 ]. We called for early trial termination in order to conduct the interim analysis [ 40 ].…”

“…This trial was a randomized, single-blind clinical study, and the trial protocol was approved by the Human Trials Committee and registered with the ClinicalTrials.gov Protocol Registration and Results System (NCT04356651). The protocol for this study was published in detail beforehand [ 22 ].…”

Evaluating Effectiveness of Fu’s Subcutaneous Needling for the Pain Nature and Quality of Life in Patients with Knee Osteoarthritis: A Study Protocol of Randomized Clinical Trial [Letter]

“…We are very happy to read Chiu et al's paper published in the Journal of Pain Research , entitled “Evaluating Effectiveness of Fu’s Subcutaneous Needling for the Pain Nature and Quality of Life in Patients with Knee Osteoarthritis: A Study Protocol of Randomized Clinical Trial.” 1 That is one small paper for the journal, one giant leap for Fu’s Subcutaneous Needling (FSN).…”

Evaluating Effectiveness of Fu’s Subcutaneous Needling for the Pain Nature and Quality of Life in Patients with Knee Osteoarthritis: A Study Protocol of Randomized Clinical Trial [Response to Letter]

“…We appreciate the Editor-in-Chief for giving us the opportunity to respond to comments from Xu et al We also express our appreciation to Xu et al for the attention on our study entitled “Evaluating Effectiveness of Fu’s Subcutaneous Needling (FSN) for the Pain Nature and Quality of Life in Patients with Knee Osteoarthritis: A Study Protocol of Randomized Clinical Trial”. 1 Hereby, we provide a point-by-point response to the comments raised by Xu et al from the following aspects.…”