Sinew Acupuncture for de Quervain's Tenosynovitis
1 other identifier
interventional
68
1 country
1
Brief Summary
Background: Prevalence of de Quervain's Tenosynovitis (dQt) is estimated at 0.5% among men and 1.3% among women. As there is an increasing length of time in smart phone usage, the prevalence is believed to be higher in the future. However, the public has a common avoidance of corticosteroid usage. Although the surgical treatment of the disease is reported to be effective in providing long term relief, its complications include radial sensory nerve injury, incomplete decompression, and volar subluxation of the tendons. The above factors raised the need of alternative treatments. Sinew Acupuncture is a new acupuncture technique developed based on the Jing-jin theory from "Huangdi Neijing" the tradition Chinese Medicine classic literature. Previous observational studies indicated that sinew acupuncture had the immediate analgesic effect on soft tissue injuries at various locations. It is a subcutaneous and transverse needling which minimizes the pain, sore, swelling sensations of acupuncture. A controlled study includes longer follow-up is needed for providing evidence for this alternative treatment , which is safe and with the least undesired sensation. Aims:
- 1.To determine whether sinew acupuncture can reduce pain (measured by Visual Analogue Scale VAS) of dQt patients.
- 2.To determine whether sinew acupuncture can reduce disability (measured by pinch strength, grip strength and the Quick Disabilities of the Arm, Shoulder, and Hand Q-DASH questionnaire ) of dQt patients.
- 3.To determine whether sinew acupuncture can improve life quality (measured WHOQOL-BREF Quality of Life Questionnaire) of dQt patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
March 21, 2018
CompletedStudy Start
First participant enrolled
June 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJuly 29, 2022
May 1, 2018
1.2 years
March 5, 2018
July 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale (VAS)
The horizontal VAS is a pain scale consisting of a 100-mm long horizontal line with the anchors "no pain" on the left side (0 mm) and "worst imaginable pain" on the right side (100 mm).
2 weeks
Secondary Outcomes (5)
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire
up to 12 weeks
Pinch strength
up to 12 weeks
Grip strength
up to 12 weeks
Quality of Life Questionnaire
up to 12 weeks
Adverse events
2 weeks
Study Arms (2)
Sinew Acupuncture
EXPERIMENTALWaitlist
NO INTERVENTIONInterventions
Subjects will receive Sinew Acupuncture 2-3 times in two weeks, a total of 5 sessions. Needles will be inserted into the Sinew Acupoints on the affected wrist and forearm. Needles will be inserted along the subcutaneous level, nearly parallel to the skin, and the tip of needles pointing towards the painful spot at the radial styloid. 4-6 sinew acupoints will be used.
Eligibility Criteria
You may qualify if:
- people aged ≥18 years who have clinically diagnosed de Quervain's Tenosynovitis on one or both wrists based on the discrete tenderness of the first extensor compartment and a positive Finkelstein test.
- pain persisting for ≥3 months,
- with an average ≥40 mm in VAS in the week prior to the screening visit.
You may not qualify if:
- subjects who have possible traumatic or neoplastic origin of symptoms, subjects who have uncontrolled concomitant disease (such as diabetes mellitus or coagulopathy),
- prior treatment in the last 4 weeks with acupuncture, Tuina, physiotherapy, extracorporeal shock wave therapy, low-level laser therapy, steroid injection and/or surgery at the same anatomical location,
- inability to fill in follow-up forms or absence of self-determination in the participating patient.
- subjects who are pregnant.
- serious mental problem, SLUMS≤19
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hong Kong Tuberculosis, Association The University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine
Aberdeen, Hong Kong
Related Publications (1)
Leung K, Ma OC, Qin Z, Ting H, Lau AH, Lun KK, Chan HY, Wen GY, Ng JT, Chow L, Chu CY, Ho TS, Tsang K, Ng BFL, Fok MWM, Fang CXS, Lao L, Chen H. Acupuncture for de Quervain's tenosynovitis: A randomized controlled trial. Phytomedicine. 2022 Sep;104:154254. doi: 10.1016/j.phymed.2022.154254. Epub 2022 Jun 14.
PMID: 35728386RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haiyong Chen, PhD
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2018
First Posted
March 21, 2018
Study Start
June 6, 2018
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
July 29, 2022
Record last verified: 2018-05