de Quervain's TenosynovitisNCT03472443
Sinew Acupuncture for de Quervain's Tenosynovitis
A study testing acupuncture in people with de Quervain's Tenosynovitis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- de Quervain's Tenosynovitis
- What is being tested?
- acupuncture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Jun 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Tuberculosis, Association The University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine
Aberdeen
About this study
Official title: Sinew Acupuncture for de Quervain's Tenosynovitis: a Randomised Controlled Trial
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.
Read more
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.
- Conditions
- de Quervain's Tenosynovitis
- Being tested
- acupuncture
- Medical subject headings
- De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sinew Acupuncture | Experimental | Not described Receives: Other: acupuncture |
| Waitlist | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Secondary outcomes (5)
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.
Measured: up to 12 weeks
Pinch strength
Pinch strength will be assessed by a Jamar Hydraulic Pinch Gauge. The value is presented in kilogram.
Measured: up to 12 weeks
Grip strength
Grip strength will be assessed by a Jamar dynamometer. The value is presented in kilogram.
Measured: up to 12 weeks
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.
Measured: up to 12 weeks
Adverse events
Adverse events and safety issues
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start6 Jun 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for de Quervain's TenosynovitisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haiyong Chen, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472443
- Sponsor's protocol ID
- UW 18-013
- Status last verified
- May 2018
- First submitted
- 5 Mar 2018
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will share the data after the publication.
Publications
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.
PubMed 35728386
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinew Acupuncture for de Quervain's Tenosynovitis: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03472443
- Acronym / sponsor ID
- UW 18-013
- Conditions
- de Quervain's Tenosynovitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinew Acupuncture | Experimental | Other: acupuncture |
| Waitlist | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureSubjects 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. | Other | Sinew Acupuncture |
Primary outcome
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).
5 secondary outcomes
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire
Time frame: up to 12 weeks
Pinch strength
Time frame: up to 12 weeks
Grip strength
Time frame: up to 12 weeks
Quality of Life Questionnaire
Time frame: up to 12 weeks
Adverse events
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Results publication: PubMed 35728386Leung 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Will share the data after the publication.
Related trials for de Quervain's Tenosynovitis
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
RecruitingPhase 4
Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis
De Quervain Tenosynovitis
Recruiting
De Quervain's Disease in the Acute Phase:a Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy.
De Quervain Disease, Hand Tenosynovitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyong Chen, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with de Quervain's Tenosynovitis, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03472443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.