Electroacupuncture with or without combined warm needling for tinnitus: Study protocol for a randomized, waitlist-controlled trial.

BACKGROUND: Tinnitus is a common auditory condition that can lead to serious problems. Clinically, acupuncture and moxibustion have been commonly applied to treat tinnitus in China, with potential therapeutic effects but with limitations in study methodology and high-quality evidence. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of either electroacupuncture alone or combined with warm needling for reducing tinnitus loudness and improving quality of life. METHODS: This study is a prospective, multicenter, assessor-blind, 3-arm, parallel-group, randomized, waitlist-controlled trial. In total, 90 patients will be randomly assigned to the electroacupuncture, electroacupuncture and warm needing, or waitlist control group in a 1:1:1 ratio. Patients in the 2 treatment groups will be treated twice a week for a total of 5 weeks. Patients in the control group will not receive treatment during the study period and will be informed that they can receive it for free after a 10-week waiting period. The duration of intervention for this study will be 5 weeks, followed by another 5 weeks for the posttreatment assessment. The primary outcome is the change in the visual analog scale score for tinnitus loudness from baseline until the end of treatment. The secondary outcome is the tinnitus discomfort assessment measured using the Tinnitus Handicap Inventory. Outcome parameters will be assessed at baseline and at weeks 5 and 10. Any adverse events will be observed and recorded for safety assessment. Linear mixed models for repeated measures will be applied in the analysis. DISCUSSION: Acupuncture and moxibustion could be potentially effective treatment alternatives for tinnitus. The study results will provide evidence to determine the efficacy and safety of electroacupuncture with or without warm needling for tinnitus.

Efficacy of electroacupuncture plus warm needling therapy for plantar heel pain: a randomised waitlist-controlled trial.

OBJECTIVE: To investigate the therapeutic effects of electroacupuncture plus warm needling (EAWN) therapy on pain and foot function in adults with plantar heel pain (PHP). METHODS: This prospective, randomised, parallel-group, waitlist-controlled trial was conducted at a Chinese medicine centre in Hong Kong between May 2018 and February 2019. Eighty eligible community-dwelling subjects with PHP (mean age 59.7 years; 85% female) were equally randomised to receive EAWN therapy or remain on a waitlist. The treatment group received six 30-min sessions of standardised EAWN therapy over 4 weeks; the control group received no treatment. The outcome measures were the visual analogue scale (VAS) score for first-step pain, foot function index (FFI) scores and global rating of change (GRC) scale scores. Assessments were made at baseline, week 2 and week 4 (primary endpoint). The treatment group underwent additional assessments at week 8. Outcomes were evaluated by intention-to-treat analysis. RESULTS: Patients who received EAWN therapy exhibited greater improvements in the mean first-step pain VAS and all FFI scores than did those in the control group at weeks 2 and 4, with significant between-group differences (all P < 0.001). Compared with baseline, there were significant decreases in mean first-step pain VAS scores at weeks 2 and 4, and FFI scores at week 4, in the treatment group but not in the control group. The improvements in the treatment group continued until week 8. GRC scores at week 4 indicated improvement in all treated patients and only 22.5% of the control group patients (P < 0.001). There were no study-related adverse events. CONCLUSION: EAWN therapy could be an effective treatment for PHP in middle-aged and older adults. TRIAL REGISTRATION NUMBER: ChiCTR1800014906 (Chinese Clinical Trials Registry).

Efficacy and safety of electroacupuncture plus warm needling therapy for heel pain: study protocol for a randomized controlled trial.

BACKGROUND: Heel pain is a common foot disorder that causes pain and functional limitations. The prevalence of disabling foot pain will increase as the population ages. Previous studies have reported the positive therapeutic effects of electroacupuncture, warm needling, or the combination of both for heel pain but with limitations in the study methodologies. The current study is a rigorously designed randomized controlled trial that aims to evaluate the clinical efficacy and safety of electroacupuncture plus warm needling therapy in patients with heel pain. METHODS/DESIGN: The study protocol describes a prospective, open-label, parallel-group, randomized controlled trial to be conducted in Hong Kong. Eighty patients aged 50-80 years who have reported heel pain and first-step pain equal to or exceeding 50 mm on the 100-mm visual analog scale (VAS) will be recruited. They will be randomly assigned (1:1 ratio) to the electroacupuncture plus warm needling therapy (i.e., treatment) group or the waitlist (i.e., control) group. The treatment group will undergo six treatment sessions in 4 weeks. The control group will receive no treatment during the study period. The primary outcome measure is a mean change in the first-step pain VAS score from the baseline to week 4. Secondary outcome measures include a mean change in first-step pain VAS score from the baseline to week 2, a mean change in Foot Function Index (FFI) subscale scores and the total score from the baseline to week 2 and week 4, and patients' self-reported level of improvement at week 4. Additional week 8 follow-up assessments with first-step pain VAS and FFI measurements will be arranged for the treatment group. Any adverse events will be recorded throughout the study to evaluate safety. An intention-to-treat approach will be used to analyze the study results. DISCUSSION: This study will provide evidence on the efficacy and safety of electroacupuncture plus warm needling therapy as an alternative treatment method for heel pain. The findings will determine whether the treatment protocol is efficacious in relieving pain and improving foot function among older adults with heel pain. The study will also provide information for subsequent large-scale randomized controlled trials in the future. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800014906 . Registered on 12 February 2018.