Application of a Wearable Wrist Moxibustion Device for Radial Styloid Stenosing Tenosynovitis

Summary

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.

Abstract

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.

Introduction

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 population². DQD is often associated with a prolonged recovery course, and there remains a lack of standardized treatment consensus in clinical practice, resulting in a substantial burden on both individuals and society³.

Current treatment strategies for DQD primarily include splint immobilization, oral nonsteroidal anti-inflammatory drugs (NSAIDs), local corticosteroid injection, and surgical intervention^4,5,6. However, prolonged splint use is often associated with poor adherence, NSAIDs may cause notable adverse effects and do not address the underlying pathology, local injections may lead to skin-related complications and systemic effects such as altered blood glucose levels, and surgical intervention is costly and may result in permanent scarring⁷. These limitations reduce the ability of existing treatments to adequately address pain and functional impairment. Therefore, there is a need to develop more effective, convenient, and minimally invasive therapeutic approaches for the clinical management of DQD. Among complementary and non-pharmacological therapies attracting increasing interest for musculoskeletal disorders, moxibustion has shown potential analgesic and anti-inflammatory effects.

Moxibustion is a traditional therapeutic modality in which moxa, typically derived from Artemisia argyi, is burned to generate thermal stimulation at specific acupoints or targeted body regions. Through the combined effects of heat stimulation and bioactive components, and via meridian-mediated conduction, moxibustion is considered to promote circulation of qi and blood and restore physiological balance⁸. Modern studies have demonstrated that moxibustion may exert analgesic and anti-inflammatory effects by activating relevant signaling pathways, increasing local blood perfusion, and downregulating the expression of pro-inflammatory mediators^9,10,11. Given that pain and tendon sheath inflammation are central features of DQD, these reported analgesic and anti-inflammatory effects suggest that moxibustion may have therapeutic potential for this condition.

However, moxibustion is currently used primarily as an adjunctive therapy for musculoskeletal disorders and has not been widely applied as a standalone treatment for DQD. Conventional moxibustion methods typically require continuous manual adjustment to maintain appropriate temperature, which can be labor-intensive and operator-dependent. These challenges have limited their broader clinical application in DQD management.

This study presents a pilot protocol demonstrating the use of an innovative wearable wrist moxibustion device for the treatment of DQD. Conventional moxibustion tools have notable limitations for focal wrist conditions: heating pads deliver non-specific warmth without the bioactive components of moxa combustion; fixed-position boxes require the patient to remain stationary and depend on an attendant to monitor temperature; handheld moxa sticks are operator-dependent and may deliver variable heat. The present device was developed based on the design hypothesis that these practical challenges could be addressed through three integrated structural features. First, if the flexible wrist fixation component of the device is used to secure the combustion unit above the first dorsal extensor compartment on the dorsal-radial side of the wrist, the positioning accuracy during treatment could thereby be improved. Similarly, if the adjustable air inlet is used to regulate the combustion intensity of the moxa cone, the stability of thermal stimulation could be further improved. In addition, the wristwatch-like wearable structure allows the device to remain stably fixed on the wrist during treatment, thereby improving operational convenience. Therefore, this device-based therapeutic approach may provide a more standardized and practical method for applying moxibustion in the treatment of radial styloid stenosing tenosynovitis. This protocol describes device setup, treatment delivery, and safety monitoring, and adopts an exploratory design to preliminarily assess feasibility and short-term outcomes, providing a foundation for future large-scale investigations.

Protocol

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. Recruitment of patients

1. Screen participants for eligibility according to the diagnostic criteria for radial styloid stenosing tenosynovitis outlined in Practical Orthopedics¹² and Traditional Chinese Medicine Tendon Injury Science¹³, confirmed by a positive Finkelstein test.
2. Include participants who meet all of the following criteria: age 18–65 years, regardless of sex; unilateral wrist involvement affecting the dominant hand; symptom duration of ≥1 week and ≤6 months; visual analog scale (VAS) pain score >3 during wrist movement within the past 24 h; and no prior treatment for the current episode, including NSAIDs, corticosteroid injection, splinting, or physical therapy.
3. Exclude participants who meet any of the following criteria: bilateral wrist involvement or involvement of the non-dominant hand; open soft tissue injury, fracture, or previous surgery of the affected wrist; rheumatoid arthritis, gouty arthritis, psoriatic arthritis, or other inflammatory arthropathies; palpable tendon sheath cysts, trigger finger, or other clinically evident space-occupying lesions of the affected wrist; joint tuberculosis or septic arthritis; severe osteoporosis or other significant joint disorders that may interfere with wrist function assessment; skin disease, scarring, or compromised skin integrity at the treatment site; pregnancy or lactation; known allergy to moxa smoke or celecoxib; or participation in another clinical trial within the previous 3 months.

2. Randomization and group allocation

1. Generate a random allocation sequence using a computer random number generator, assigning the numbers 1 to 40 to "intervention group" and "control group" in a 1:1 ratio (20 assignments each).
2. An investigator who is not involved in outcome assessment should prepare 40 sequentially numbered, opaque, sealed, and tamper-evident envelopes. Prepare 40 identical cards (5 cm x 5 cm), with 20 labeled "intervention group" and 20 labeled "control group." Insert a card into each envelope in the order generated. Seal the envelopes such that any attempt to open them would leave visible damage.
3. Assign eligible participants to one of two parallel groups: a control group receiving oral celecoxib capsules (0.2 g per dose, once daily, for 7 consecutive days) and an intervention group receiving treatment with a wearable wrist moxibustion device (once daily for approximately 30 min per session, for 7 consecutive days).
   NOTE: In this study, a total of 40 outpatients were recruited from the Guoyitang Clinic of Anhui University of Chinese Medicine in Hefei, Anhui Province, between January 2025 and January 2026.
4. Obtain written informed consent and complete all baseline assessments for each enrolled participant.
5. After all baseline assessments for a participant are completed and recorded, take the next sequentially numbered envelope.
6. Open the envelope in the participant's presence, reveal the group assignment, and immediately record the assigned group in the participant's case report form. Adhere strictly to the sequential numbering; skipping or reordering of envelopes is not permitted.

3. Outcome assessment

1. Perform all outcome assessments at two time points: 1) Baseline: within 24 h before the first treatment session; 2) Post-treatment: immediately after completion of the final (7th) treatment session (within 30 min of device removal for the intervention group, or within 30 min of the last dose for the control group).
2. Visual analog scale (VAS) for pain assessment
   1. Use a 10 cm VAS ruler to assess pain intensity. Label one ends as "0" (no pain) and the other end as "10" (worst imaginable pain). Display only the anchor descriptors on the front side; mark numerical graduations on the reverse side to minimize bias from visual cues.
   2. Conduct the assessment in a quiet environment. Present the front side of the scale and instruct the participant: "Please indicate the intensity of your wrist pain at its worst over the past 24 h by marking a vertical line on the scale."
   3. Read the corresponding value in millimeters (0–100 mm) from the reverse side. Convert to a 0–10 score by dividing by 10 and record the result.
   4. If the participant is unable to mark the scale independently (e.g., due to hand dysfunction), obtain a verbal rating and document this in the case report form. Use a new VAS scale for each assessment to avoid bias from prior markings (see Figure 3A).
3. Cooney wrist score
   1. Assess wrist function using the modified Cooney wrist scoring system (total score: 100 points), which comprises four domains.
      1. Pain (25 points): Assess pain severity and assign a score according to the following criteria: assign 25 points for no pain; 20 points for mild pain occurring only during vigorous activities; 15 points for pain during moderate activities; 10 points for pain during light activities; 5 points for pain at rest; and 0 points for severe pain at rest requiring analgesic medication.
         NOTE: In this study, the VAS score obtained in step 3.2 was used to standardize the assignment of the Cooney pain subscale. A VAS score of 0 was assigned 25 points, VAS scores of >0–2 were assigned 20 points, VAS scores of >2–4 were assigned 15 points, VAS scores of >4–6 were assigned 10 points, VAS scores of >6–8 were assigned 5 points, and VAS scores of >8–10 were assigned 0 points.
      2. Functional status (25 points): Evaluate the participant’s ability to perform daily activities and assign a score as follows: assign 25 points for normal function with no activity limitation; 20 points for mild limitation while remaining able to perform most activities; 15 points for moderate limitation with the ability to perform some activities; 10 points for severe limitation requiring assistance; 5 points for very severe limitation with inability to perform most activities; and 0 points for complete loss of function.
      3. Range of motion (25 points): Measure wrist ulnar deviation using a goniometer and calculate the percentage relative to the contralateral side. Assign 25 points if the value is 100% of the contralateral side, 20 points if 75–99%, 15 points if 50–74%, 10 points if 25–49%, 5 points if 1–24%, and 0 points if no motion is present.
      4. Grip strength (25 points): Measure grip strength using a calibrated hand dynamometer and calculate the percentage relative to the contralateral side. If the contralateral side is affected, use age- and sex-matched normative values. Assign 25 points if grip strength is 100% of the contralateral or normative value, 20 points if 75–99%, 15 points if 50–74%, 10 points if 25–49%, 5 points if 1–24%, and 0 points if no measurable grip strength is present.
   2. Calculate the total Cooney wrist score by summing the four subscale scores: pain, functional status, range of motion, and grip strength. The total score ranges from 0 to 100 points, with higher scores indicating better wrist function.
   3. Evaluate functional status by asking participants about their ability to perform six daily activities (e.g., opening a bottle, writing, lifting objects). Assign 25 points for normal function, 20 for mild limitation, 15 for preserved function with inability to complete daily activities, and 0 if activities cannot be completed due to pain; apply proportional scaling as appropriate.
   4. Measure range of motion with the participant seated, elbow flexed at 90°, and forearm in neutral position. Use a goniometer to measure ulnar deviation and calculate the percentage relative to the contralateral side. Assign scores according to the scale criteria. (see Figure 3B)
      NOTE: Ulnar deviation is measured as the representative range of motion parameter for the Cooney score and is also reported separately as an independent secondary outcome. For the Cooney score, ulnar deviation is expressed as a percentage relative to the contralateral side; for the independent analysis, the absolute angle (in degrees) is used. This dual reporting is pre-specified to capture both composite wrist function and the Finkelstein-related impairment specific to radial styloid stenosing tenosynovitis.
   5. Measure grip strength using a calibrated hand dynamometer with the participant seated, shoulder adjusted, elbow flexed at 90°, and forearm and wrist in neutral position. Perform three consecutive measurements, record the maximum value, and calculate the percentage relative to the contralateral side. Use age- and sex-matched normative values if the contralateral side is also affected. (see Figure 3C)
   6. Ensure that two trained assessors who are not involved in treatment administration independently perform all measurements and record the average value. Because the interventions are visibly different (wearable device vs. oral capsule), neither the participants nor the treating investigator can be blinded. To minimize detection bias, the assessors remain unaware of group allocation and do not communicate with the treating investigator regarding treatment assignments during assessments
4. Classify the overall clinical efficacy for each participant at the post-treatment assessment using the following criteria based on the Cooney wrist score improvement rate: Improvement rate = (Post-treatment Cooney score − Pre-treatment Cooney score) / (100 − Pre-treatment Cooney score) x 100%.
   1. Classify participants as clinically cured if the improvement rate is ≥90% and pain is completely or nearly completely resolved with restoration of normal wrist function. Classify participants as improved if the improvement rate is ≥30% but <90%, accompanied by a noticeable reduction in pain and partial improvement in wrist function.
   2. Classify participants as ineffective if the improvement rate is <30%, with minimal or no pain relief and no meaningful functional improvement.
   3. Calculate the total effective rate as follows: Total effective rate = (Number of clinically cured participants + Number of improved participants) / Total number of participants × 100%.

4. Intervention procedures

1. Treat participants in the intervention group once daily for approximately 30 min per session (until complete combustion of the moxa cone), for 7 consecutive days^14,15,16 (see Figure 1).
2. Treat participants in the control group with oral celecoxib capsules (0.2 g per dose, once daily) for 7 consecutive days.
3. Moxa material specifications. Use standard moxa cones (1.5 cm x 1.5 cm) made of pure moxa floss. Each cone weighs approximately 1.5–2.0 g. Use one new cone per treatment session.
4. Place the cone in the combustion unit such that the supporting spacer maintains a fixed distance of approximately 2.0 cm between the cone and the skin surface. Under standard conditions, one cone burns for approximately 25–30 min.
5. Clean the local skin area over the radial styloid region with an alcohol swab before treatment. After skin disinfection, wait until the skin surface is visibly dry and any alcohol vapor has fully dissipated before igniting the moxa cone or bringing any open flame or heated device component near the treatment area.
6. Do not use heat, flame, or the moxibustion device to accelerate drying. If erythema, rash, pruritus, or other signs of skin irritation occur after disinfection, discontinue the intervention immediately and record the event in the case report form (see Figure 4A).
   CAUTION: Alcohol-based disinfectants and used alcohol swabs are highly flammable. Keep unused and used alcohol swabs, alcohol containers, gauze, paper, fabrics, and other combustible materials away from the ignition area, open flame, and heated combustion unit. Ensure that alcohol swabs are removed from the treatment field before moxa ignition. Used alcohol swabs should be discarded in an appropriate clinical waste container away from the combustion area. Operators should wear appropriate personal protective equipment, including a laboratory coat or clinical gown, disposable gloves, and eye protection, when performing skin disinfection and handling combustion-related materials.
7. Prepare the device by removing the moxibustion combustion unit from the hollow flexible band. Open the combustion unit, place a lit moxa cone inside, and secure it firmly in position (see Figure 4B).
   ​CAUTION: This step involves open-fire ignition and active moxa combustion. Perform the procedure only in a well-ventilated treatment room. Keep a fire extinguisher or a container of water readily accessible. Do not leave a lit moxa cone unattended. Operators should use heat-resistant forceps or equivalent tools when handling lit moxa cones or heated device components and should wear appropriate personal protective equipment, including a laboratory coat or clinical gown, disposable gloves, and eye protection.
8. Apply the device by wrapping the wrist fixation component around the affected wrist, positioning the moxibustion combustion unit over the painful region at the radial styloid process.
9. Tighten the hollow flexible band and secure it by attaching fastener 1 to fastener 2. Adjust the tension to a comfortable level, and initiate timing using a timer (see Figure 4C).
10. Regulate combustion and temperature. Rotate the control knob on the moxibustion combustion unit to adjust the air inlet and maintain stable burning of the moxa cone.
11. Reduce the air inlet opening when the temperature feels too high to the patient; increase airflow during the late combustion stage to promote complete burning. Throughout the session, adjust the temperature according to the patient's tolerance.
12. Ensure that moxa smoke and heat are released through the moxibustion outlet, and that the supporting spacer maintains a gap between the outlet and the skin surface (see Figure 4D).
13. Terminate the treatment when the preset time is reached. Detach fastener 1 from fastener 2, then remove the hollow, flexible band from the wrist. Disassemble the moxibustion combustion unit only after confirming that the moxa cone has completely stopped burning.
14. Extinguish any remaining ember completely before disposal. Collect used moxa cones, residual ash, and any contaminated flammable waste, including used alcohol swabs or gauze, in a designated non-combustible waste container after they have cooled. Dispose of these materials according to the institutional safety procedures for combustion-related and flammable clinical waste. Do not reuse moxa cones; each cone is for single use only. Wipe the combustion unit with a dry cloth after each use. Inspect the supporting spacer and air inlet regularly for ash accumulation and clean as needed (see Figure 4E).
15. Control group treatment.
    1. Prior to enrollment, exclude participants with contraindications to celecoxib, those with known hypersensitivity to celecoxib or sulfonamides; history of asthma or allergic reactions after taking aspirin or other NSAIDs; active peptic ulcer or gastrointestinal bleeding; severe hepatic or renal impairment; established cardiovascular disease or uncontrolled hypertension.
    2. Administer oral celecoxib capsules (0.2 g per dose, once daily, taken after breakfast) for 7 consecutive days. All doses are administered on-site under the investigator's direct observation.
    3. Instruct the participants not to use other NSAIDs, analgesics, corticosteroids, antiplatelet agents, splinting, or physical therapy on the affected wrist unless approved by the investigator, during the 7-day treatment period.
       NOTE: If a participant experiences intolerable pain between scheduled visits, a single dose of acetaminophen (0.5 g) may be administered on-site as rescue medication at the investigator's discretion.
    4. Record any rescue medication used in the case report form. Participants requiring more than one rescue dose should be evaluated for withdrawal.
    5. Monitor participants for gastrointestinal symptoms (nausea, dyspepsia, abdominal pain, black stool), cardiovascular symptoms (chest pain, palpitations, edema), renal symptoms (reduced urine output), and allergic reactions (rash, urticaria, dyspnea).
    6. At each visit, inquire about these symptoms using a standardized checklist. Grade any reported adverse events according to the adverse-event classification criteria described in the Safety Considerations section and record them in the case report form.

5. Safety considerations

1. Inspect the skin over the radial styloid region before each treatment session. If any erythema, blistering, abrasion, or skin breakdown is present, withhold the treatment until the skin has fully healed.
2. After each session, inspect the treated area for signs of thermal injury. Document any skin changes in the participant's case report form.
3. During treatment, monitor the participant's thermal sensation throughout the session. If the participant reports excessive warmth, reduce the air inlet opening to decrease combustion intensity.
4. Instruct the participant to report any sensation of excessive heat or discomfort immediately. If burning pain is reported, promptly reduce the air inlet opening or remove the device.
5. Moxa combustion produces smoke. Perform all treatment sessions in a well-ventilated room with open windows or a functioning exhaust fan. If the participant reports eye irritation, coughing, or respiratory discomfort, consider repositioning the device or increasing room ventilation.
6. Participants with a history of asthma or chronic respiratory disease should be monitored closely, and treatment should be discontinued if respiratory symptoms develop.
7. Keep flammable materials, including alcohol swabs, gauze, paper, fabrics, and alcohol-containing containers, away from the combustion unit during treatment. Ensure that a fire extinguisher or a container of water is accessible in the treatment room.
8. If the participant experiences severe pain, burning sensation, excessive heat, dizziness, or any other acute discomfort, remove the device immediately. Remove the device as described in Step 4.13. The device can be removed within seconds without requiring special tools.
9. Monitor and record all AEs throughout the study.
   1. Classify AEs as mild, moderate, or severe according to the following criteria: a) Mild- transient erythema, mild pruritus, or slight warmth that resolves spontaneously within 30 min of device removal and does not interfere with daily activities; b) Moderate- erythema lasting > 30 min, blistering, or pain that requires symptomatic treatment; c) Severe- full-thickness burn, infection, or any event requiring hospitalization. Report all moderate and severe AEs to the ethics committee within 24 h.
   2. Permanently discontinue the intervention for a participant if any of the following occur: Any severe AE attributable to the treatment; second occurrence of the same moderate AE; skin burn (even superficial) at the treatment site; participant requests to withdraw; allergic reaction to moxa smoke (e.g., asthma exacerbation, urticaria).
   3. If a mild AE occurs, allow the participant to rest and observe until symptoms resolve. Document the event and continue treatment at a reduced temperature setting in the next session.
   4. If a moderate AE occurs, discontinue the session immediately, provide symptomatic treatment as needed, and withhold subsequent treatment until the event fully resolves. Resume treatment only after clinical assessment confirms that it is safe to do so.
   5. If a severe AE occurs, remove the device immediately, initiate appropriate medical care, and permanently discontinue the participant from the study.
   6. Report the event to the ethics committee within 24 h. All AEs, regardless of severity, must be followed until resolution or until a stable outcome is reached.

6. Statistical analysis

1. Assess normality using the Shapiro-Wilk test. If continuous outcomes meet the assumption of normality (P > 0.05), present them as mean ± standard deviation.
2. Use paired sample t-test for within-group pre- vs. post-treatment comparisons. Use an independent sample t-test for between-group comparisons of post-treatment values and change scores. Report between-group mean difference, 95% confidence interval (CI), and Cohen's d effect size.
3. Compare clinical response rates using the chi-squared test, with the rate difference and report 95% CI.
4. Perform all tests as two-sided tests and report exact P values. Consider P < 0.05 statistically significant.

Results

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...

Discussion

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.

Materials

List of materials used in this article

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