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Sinew Acupuncture for de Quervain's Tenosynovitis

Primary Purpose

de Quervain's Tenosynovitis

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
acupuncture
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for de Quervain's Tenosynovitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • The Hong Kong Tuberculosis, Association The University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sinew Acupuncture

Waitlist

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire
The Q-DASH is a 11-item questionnaire to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb, scored 0 (no disability) to 100.
Pinch strength
Pinch strength will be assessed by a Jamar Hydraulic Pinch Gauge. The value is presented in kilogram.
Grip strength
Grip strength will be assessed by a Jamar dynamometer. The value is presented in kilogram.
Quality of Life Questionnaire
WHOQOL-BREF Quality of Life Questionnaire comprises 26 items, which measure the four domains: physical health, psychological health, social relationships, and environmental health. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a five-point likert scale. The scores are then transformed linearly to a 0-100-scale. The higher total scores denote higher quality of life.
Adverse events
Adverse events and safety issues

Full Information

First Posted
March 5, 2018
Last Updated
July 27, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03472443
Brief Title
Sinew Acupuncture for de Quervain's Tenosynovitis
Official Title
Sinew Acupuncture for de Quervain's Tenosynovitis: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: To determine whether sinew acupuncture can reduce pain (measured by Visual Analogue Scale VAS) of dQt patients. 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. To determine whether sinew acupuncture can improve life quality (measured WHOQOL-BREF Quality of Life Questionnaire) of dQt patients Design: A randomised subject trial will be employed. A total of 68 cases will be recruited in the study and allocated into study and wait-list control group under ratio 1:1. Treatment group participants will receive 5 treatments in 2 weeks and follow-up sessions after 6 and 12 weeks. Wait-list control group participants will receive same treatment and assessment after waiting and follow-up period. Both groups will receive health education session on dQt. The subjects are prohibited from receiving corticosteroid injection for treating de Quervain's Tenosynovitis. The subjects are recommended not to receive any other treatments for dQt during the trial period; Rescue medication for pain is allowed if patients have intolerant pain. Any treatments or medications for dQt received should be reported and recorded. Setting: The Hong Kong Tuberculosis Association - The University of Hong Kong Chinese Medicine Centre for Training and Research (Aberdeen) Participants: 68 subjects with dQt Treatment: According to the theory of Sinew Acupuncture, acupoints are chosen based on 3 criteria, 1. the tender spots, 2.the spots which induce relief of symptoms and 3.the "knots" (elevated spots of the soft tissues, can be located by Chinese Medicine Practitioner (CMP) with Sinew Acupuncture training), these spots should locate along the "Jing-Jin" where the diseased spot lies, in this case the "Jing-Jin" of the Lung meridian and the Large Intestine meridian. Acupoints chosen for Sinew Acupuncture should lie within the forearm area. Subcutaneous acupuncture with the needle tips pointing towards the radial styloid activates the "Wei-Qi" to achieve analgesic effect and to promote healing. Measures: Primary outcome: change of Visual Analogue Scale (VAS) score in the 5th treatment (week 2) from baseline. secondary outcome: Q-DASH (Quick Disabilities of the Arm, Shoulder, and Hand), WHOQOL-BREF Quality of Life Questionnaire, pinch strength, grip strength and averse events. Data analysis: The scores of VAS and Q-DASH at different time points are reported as means ± standard deviation. The scores are analysed by the intent-to-treat analysis. The last observation carried forward analyses will be employed for missing value. The difference between two groups at a time point or the difference between the two time-points in a group is tested by the student t-test. The level of the statistical significance is set P<0.05. Subgroup analysis and multiple regression analysis will be conducted to eliminate the possible bias due to the length of waiting time, the use NSAIDs, or other factor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
de Quervain's Tenosynovitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sinew Acupuncture
Arm Type
Experimental
Arm Title
Waitlist
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire
Description
The Q-DASH is a 11-item questionnaire to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb, scored 0 (no disability) to 100.
Time Frame
up to 12 weeks
Title
Pinch strength
Description
Pinch strength will be assessed by a Jamar Hydraulic Pinch Gauge. The value is presented in kilogram.
Time Frame
up to 12 weeks
Title
Grip strength
Description
Grip strength will be assessed by a Jamar dynamometer. The value is presented in kilogram.
Time Frame
up to 12 weeks
Title
Quality of Life Questionnaire
Description
WHOQOL-BREF Quality of Life Questionnaire comprises 26 items, which measure the four domains: physical health, psychological health, social relationships, and environmental health. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a five-point likert scale. The scores are then transformed linearly to a 0-100-scale. The higher total scores denote higher quality of life.
Time Frame
up to 12 weeks
Title
Adverse events
Description
Adverse events and safety issues
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haiyong Chen, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Tuberculosis, Association The University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine
City
Aberdeen
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Will share the data after the publication.
Citations:
PubMed Identifier
35728386
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35728386/
Description
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Sinew Acupuncture for de Quervain's Tenosynovitis

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