A single-center, randomized controlled trial is currently underway to compare the efficacy of Fu's subcutaneous needling (FSN) and electroacupuncture (EA) in treating knee osteoarthritis (OA). The study, registered with the Chinese Clinical Trial Registry (ChiCTR2300073615), aims to evaluate the impact of these acupuncture techniques on lower limb muscle stiffness, pain relief, and functional recovery in patients with knee OA.
The trial, hosted at the Shandong Provincial Third Hospital, commenced in December 2023 and is projected to run until June 2025. Sixty eligible patients will be randomly assigned to either the FSN or EA treatment arm, each receiving a four-week intervention followed by a one-month follow-up observation. The study adheres to the Declaration of Helsinki’s tenets and has received ethics committee approval (No. KYLL-2023047).
Study Design and Methods
Participants aged 45 to 75 years, diagnosed with unilateral or bilateral knee OA according to the American College of Rheumatology criteria, are being recruited. Key inclusion criteria include chronic knee pain for more than three months, a Numeric Rating Scale (NRS) score > 3, and X-ray confirmation of knee osteoarthritis (Kellgren and Lawrence grade II or III within six months). Exclusion criteria encompass a history of lower extremity trauma or surgery, intra-articular injections, neurological disorders, and the use of medications affecting muscle tone.
Patients are randomly assigned in a 1:1 ratio to either the FSN or EA groups. While patient and practitioner masking are unfeasible, evaluators, statisticians, and sonographers remain blind to group distribution. The primary outcome is lower limb muscle stiffness, measured via shear wave elastography (SWE) at three intervals: pre-first treatment, immediately post-first treatment, and after the four-week treatment period.
Interventions
In the FSN group, three insertion points are used: (A) the upper one-third spot of the line joining the anterior superior iliac spine and superior edge of the patella; (B) the midpoint of the line joining the inferior aspect of the patella to the lateral malleolus; (C) the midpoint of the popliteal fossa and the heel. The FSN needle is inserted into the subcutaneous layer, followed by a swaying movement and reperfusion approach (RA), which involves specific exercises targeting the treated muscles.
In the EA group, acupoints such as Dubi (ST35), Neixiyan (EX-LE5), Liang qiu (ST34), Yang ling quan (GB34), Xuehai (SP10), Yinlingquan (SP9), and Ashi point are selected. Sterilized, single-use needles are inserted 15–30 mm in depth, and an electronic acupuncture apparatus administers a 30-minute session of 2 Hz continuous wave stimulation.
Both treatment modalities are administered thrice weekly for the first two weeks, followed by twice-weekly sessions, totaling ten sessions. Tylenol is reserved for intolerable pain and will be documented if used. Patients are precluded from receiving additional treatments to preserve the study’s validity.
Outcome Measurements
The primary outcome, lower limb muscle stiffness, is measured using SWE. Four specific lower limb muscles are imaged: Rectus femoris (RF), Vastus lateralis (VL), Tibialis anterior (TA), and Gastrocnemius (medial and lateral). Secondary outcomes include the response rate (defined as a minimum two-point reduction on the NRS and a six-point improvement on the WOMAC function subscale score), quality of life assessment using the 12-item short-form (SF-12) survey, and safety assessments.
Statistical Analysis
An intention-to-treat principle will be followed, with statistical significance set at p < 0.05. A linear mixed-effects model will be used to analyze muscle stiffness, accounting for repeated measures and potential confounding factors. Logistic regression will be used to compare the odds of response between the two groups.
Expected Outcomes and Clinical Significance
This study aims to elucidate the impact of FSN on lower limb muscle stiffness in patients with knee OA, as measured by SWE. The results are anticipated to ascertain the relative efficacy of FSN and EA in providing swift pain alleviation, which could inform clinical decision-making and future research directions. The trial also seeks to standardize the protocol for assessing muscle stiffness in knee OA patients using SWE.
