Intervention

Patients will receive 24 acupuncture treatment sessions over 12 weeks (twice a week). Hwato brand single-use acupuncture needles (size 0.35×25 mm or 0.35×40 mm), pragmatic placebo needles (size 0.30×25 mm) and SDZ-V electroacupuncture apparatuses will be used.

For the acupuncture group (figure 2), acupuncture needles will be placed at acupoints Baihui (DU20), Shengting (DU24), Fengfu (DU16), Fengchi (GB20), Danzhong (RN17), Zhongwan (RN12), Qihai (RN6), Neiguan (PC6), Tongli (HT5), Xuehai (SP10), Zusanli (ST36), Zhaohai (KI6), Xinshu (BL15) and Yixi (BL45). After skin disinfection in patients in the supine position, the adhesive pads are pasted on the acupoints surface except for Baihui (DU20) and Shengting (DU24). Then, the acupuncture needles will be inserted through the adhesive pads into the skin depending on the location of the needle. The locations are shown in table 1. Manual acupuncture by acupuncturists using small, equal manipulations of twirling, lifting and thrusting will be performed on all needles to reach deqi. The patients will feel the deqi sensation, such as soreness, numbness, distention, heaviness and other sensations. Paired electrodes from the electroacupuncture apparatus will be attached to the needle holders of the DU20 and DU24. A dilatational wave of 2–100 Hz and a current intensity of 1–5 mA will be performed according to the degree of needle handle shivering, ignoring the patients’ feelings. The needles will be extracted after 20 min for each treatment. The acupoints of DU16, BL15 and BL45 will achieve deqi in patients in a sitting position without retaining the needle.

Location of acupoints used in the acupuncture group

*Dubi location: when the knee is flexed, the point is at the knee, below the patella, in the depression from the patella ligament.

Location of acupoints or sham acupoints in the trial. BL15, Xinshu; BL45, Yixi; DU16, Fengfu; DU20, Baihui; DU24, Shengting; GB20, Fengchi; HT5, Tongli; KI6, Zhaohai; PC6, Neiguan; RN6, Qihai; RN12, Zhongwan; RN17, Danzhong; SA, sham acupoint; SP10, Xuehai; ST36, Zusanli.

For the sham acupuncture group, sham acupoints at locations away from known acupuncture points will be used to minimise physiological effects, and the locations of sham acupoints are shown in table 2. Patients will receive non-insertive acupuncture using the pragmatic placebo needles (Hwato brand, size 0.35×25 mm; online supplementary figure 1). Similar to the acupuncture group, the adhesive pads are initially pasted on the sham acupoints surface except for sham acupoint 1. The pragmatic placebo needles with a blunt tip will be placed on the adhesive pads. In order to minimise the physiological effect, acupuncturists will be instructed to lightly place the sham needles with a blunt tip on the adhesive pads with no manipulation. The acupuncture needle will be inserted to a shallow depth at the sham acupoint 1, which does not penetrate below the skin, and needle manipulation for deqi. Sham acupoint 11 and sham acupoint 12 will be inserted with sham needles without retaining the needle. Paired electrodes will be attached to the needle holders of the bilateral sham acupoint 2 but with no electricity output.

Location of sham acupoints used in the sham acupuncture group