This method provides a reproducible framework for applying a wearable wrist moxibustion device and assessing short-term clinical outcomes in patients with radial styloid stenosing tenosynovitis.
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Method Article
* These authors contributed equally
This method provides a reproducible framework for applying a wearable wrist moxibustion device and assessing short-term clinical outcomes in patients with radial styloid stenosing tenosynovitis.
This protocol describes the standardized procedure for using a wearable wrist moxibustion device in patients with radial styloid stenosing tenosynovitis. The study is designed as a small-sample, exploratory randomized controlled trial. Participants meeting the diagnostic criteria for radial styloid stenosing tenosynovitis are enrolled and randomly allocated in a 1:1 ratio to either the control group receiving oral celecoxib capsules or the intervention group receiving the wearable wrist moxibustion device. The primary outcome measure is the change in pain intensity, assessed using the visual analog scale (VAS) before and after treatment. Secondary outcomes include the Cooney wrist function score, wrist ulnar deviation angle, and overall clinical response. Adverse events are monitored throughout the study. Preliminary short-term outcomes indicate that the moxibustion group showed greater improvements in pain relief and wrist range of motion compared with the control group. This protocol provides step-by-step guidance for applying a wearable wrist moxibustion device in patients with radial styloid stenosing tenosynovitis. It also represents an exploratory integration of traditional moxibustion therapy with modern wearable device design, offering preliminary evidence to support future studies with larger sample sizes and long-term follow-up.
De Quervain’s disease (DQD), also known as radial styloid stenosing tenosynovitis, is a common musculoskeletal disorder affecting the wrist. It is typically characterized by pain at the radial styloid process accompanied by localized tenderness. Clinically, diagnosis is based on the presence of pain, tenderness, and swelling over the radial styloid region. The key diagnostic criterion is a positive Finkelstein test (i.e., pain elicited during ulnar deviation of the wrist with the thumb enclosed in the fist)1.
Epidemiological studies have reported an overall prevalence of approximately 1.3% of the general popula....
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This protocol outlines a clinical study investigating the use of a wearable wrist moxibustion device for the treatment of radial styloid stenosing tenosynovitis. The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Anhui University of Chinese Medicine (Approval No. 2023AH-53). Written informed consent was obtained from all participants. The wearable wrist moxibustion device and moxa cones used in this protocol are shown in Figure 1, and the schematic structure and main components of the device are shown in Figure 2.
1. R....
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A total of 40 eligible participants with radial styloid stenosing tenosynovitis were enrolled and randomly assigned in a 1:1 ratio to the intervention group (wearable wrist moxibustion device, n = 20) and the control group (oral celecoxib capsules, n = 20). All 40 participants completed the 7-day treatment and post-treatment assessments. The analysis was performed per protocol, including all participants who completed the assigned treatment and both baseline and post-treatment assessments. No participants withdrew; there.......
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In this study, the wearable wrist moxibustion protocol relieved pain symptoms, improved wrist function, and increased ulnar deviation angle in patients with radial styloid stenosing tenosynovitis over a 7-day treatment period. All participants completed the assigned treatment, and no adverse events were observed during the study period. These preliminary findings suggest that the wearable wrist moxibustion device is a feasible and well-tolerated conservative option under the specified study conditions.
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The wearable wrist moxibustion device used in this study is a self-developed device covered by Chinese Invention Patent Application No. 202610340535.6, listing Wen Gu, Fang Hu, Shuqing Yuan, Wenyuan Xu, Shengbing Wu, Meiqi Zhou, and Nenggui Xu as inventors. Among the authors, Wen Gu, Fang Hu, Shengbing Wu, Meiqi Zhou, and Nenggui Xu are co-inventors of this patent application. The other authors declare no competing interests.
This work was supported by the “Open Competition Mechanism” (Project No. 2023CXMMTCM010) from the Institute of Xin’an Medicine and Modernization of Traditional Chinese Medicine, Hefei Comprehensive National Science Center Institute of Health, and by the Major Scientific Research Project of Higher Education Institutions in Anhui Province (Project No. 2023AH040113).
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| Name | Company | Catalog Number | Comments |
|---|---|---|---|
| Alcohol swabs | Hygeian Medical | GA10710119-35243 (registration no.) | For skin disinfection prior to treatment |
| Celecoxib capsules | Pfizer | NDC 00025-1525-31 | 0.2 g per capsule, oral administration |
| Dry cloth | N/A | N/A | For cleaning the combustion unit after each use |
| Goniometer | NVE | N/A | For measuring ulnar deviation angle |
| Hand dynamometer | Sammons Preston | JAMAR 5030J1 | Calibrated, for measuring grip strength |
| Moxa cones | Nanyang Aifangjia | N/A | Standard (1.5 cm × 1.5 cm), made of pure moxa floss |
| Timer | Traceable | 5001 | For timing the 30-minute treatment session |
| VAS ruler | Self-fabricated | N/A | 10 cm visual analog scale for pain assessment |
| Wearable wrist moxibustion device | Self-fabricated | N/A | Self-developed (Chinese Invention Patent Application No. 202610340535.6; inventors: Wen Gu, Fang Hu, Shuqing Yuan, Wenyuan Xu, Shengbing Wu, Meiqi Zhou, Nenggui Xu); comprises combustion unit, hollow flexible band with fasteners (fastener 1 and fastener 2), supporting spacer, and control knob for air inlet regulation |