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Sinew Acupuncture for de Quervain's Tenosynovitis

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ClinicalTrials.gov Identifier: NCT03472443
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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

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.


Condition or disease Intervention/treatment Phase
de Quervain's Tenosynovitis Other: acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Sinew Acupuncture for de Quervain's Tenosynovitis: a Randomised Controlled Trial
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Sinew Acupuncture Other: acupuncture
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.

No Intervention: Waitlist



Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: 2 weeks ]
    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 :
  1. Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire [ Time Frame: up to 12 weeks ]
    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.

  2. Pinch strength [ Time Frame: up to 12 weeks ]
    Pinch strength will be assessed by a Jamar Hydraulic Pinch Gauge. The value is presented in kilogram.

  3. Grip strength [ Time Frame: up to 12 weeks ]
    Grip strength will be assessed by a Jamar dynamometer. The value is presented in kilogram.

  4. Quality of Life Questionnaire [ Time Frame: up to 12 weeks ]
    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.

  5. Adverse events [ Time Frame: 2 weeks ]
    Adverse events and safety issues



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472443


Contacts
Contact: Haiyong Chen, PhD 39176413 haiyong@hku.hk

Locations
Hong Kong
The Hong Kong Tuberculosis, Association The University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine Recruiting
Aberdeen, Hong Kong
Contact: Haiyong Chen, PhD       haiyong@hku.hk   
Contact: Kin King Leung       leungkinking@gmail.com   
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Haiyong Chen, PhD The University of Hong Kong

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03472443     History of Changes
Other Study ID Numbers: UW 18-013
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will share the data after the publication.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tenosynovitis
De Quervain Disease
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Entrapment