Sinew Acupuncture for Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03099317|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Other: Sinew acupuncture Other: Sham acupuncture||Not Applicable|
The proposal aims to examine the efficacy and safety of sinew acupuncture for knee osteoarthritis (KOA).
Hypothesis to be tested:
Sinew acupuncture can reduce pain intensity, and improve knee function and health-related quality of life without significant side effects for KOA subjects compared to a sham acupuncture.
A randomized, subject- and assessor-blind, sham acupuncture-controlled clinical trial
Subjects (N=86) will be randomized into sinew acupuncture or sham acupuncture group (in 1:1 ratio).
Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up & Go Test (TUG), 8-step Stair Climb Test (SCT) assessment, and the Short Form-36 (SF-36).
Sinew acupuncture group will receive 10 sessions of needling in 4 weeks. Sham group will receive the non-invasive intervention with the same procedures. All subjects are followed up for 6 weeks.
Main outcome measures:
VAS for knee pain intensity at week 4 serves as the primary outcome. VAS at other time points, WOMAC score, TUG, SCT and SF-36 will be analyzed as the secondary outcomes.
Analysis will be on the 'intention to treat' principle. T-test and mixed-effect model analysis will be used to measure primary and secondary outcomes respectively.
Sinew acupuncture treatment can significantly reduce knee pain intensity, and improve knee function and quality of life without obvious side effects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized sham controlled, single blinded trial|
|Masking:||Double (Participant, Outcomes Assessor)|
Participants will be randomized into sinew acupuncture group and sham acupuncture group in a 1:1 ratio.
Assessors will perform the assessment but not be involved in acupuncture treatment.
|Official Title:||Sinew Acupuncture for Knee Osteoarthritis (KOA): A Randomized, Sham Controlled, Patient and Assessor Blinded, Pilot Trial|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||September 30, 2018|
|Actual Study Completion Date :||September 30, 2018|
Experimental: Sinew acupuncture
Subject in the arm will receive real acupuncture intervention.
Other: Sinew acupuncture
Sinew acupuncture: subject will sit on chair with knee joint flexion with a most comfortable angle nearest to 90 degrees. Acupoints (1-2cm away from the point of tenderness or pain) near the knee will be punctured through the skin by using sterile needles of size 0.30mm × 40mm at the angle of 0-10 degrees pointing along the pain direction and meridian sinew. Immediately, needles will be retreated back just under the skin and inserted 10mm-20mm forward smoothly with minimal pain sensation. Walking and stepping will be advised and governed during acupuncture. The acupoint will be covered with non-allergic bandages to ensure sufficient blinding to the subject. The treatment will last 20 minutes for each session.
Sham Comparator: Sham acupuncture
Subject in the arm will receive sham acupuncture intervention.
Other: Sham acupuncture
Sham acupuncture: subject will receive the same procedures as the sinew acupuncture without penetrating the skin. The needle will be used to puncture on the acupoint slightly without passing through the skin. The acupoint will be covered with non-allergic bandages to ensure sufficient blinding to the subject.
- Pain intensity measured by VAS [ Time Frame: Week 4 ]Pain intensity will be measured by VAS
- WOMAC [ Time Frame: Weeks 0, 1, 2, 3, 4, 6 and 10 ]Western Ontario and McMasters University Osteoarthritis Index
- TUG [ Time Frame: Weeks 0, 2, 4, 6 and 10 ]Timed up and go test
- 8-step SCT [ Time Frame: Weeks 0, 2, 4, 6 and 10 ]Stair Climb Test
- Quality of life measured by SF-36 [ Time Frame: Weeks 0, 4, and 10 ]Short Form-36
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): NCT03099317
|The Hong Kong Tuberculosis, Association The University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine (Wan Chai)|
|Wan Chai, Hong Kong|
|Principal Investigator:||Haiyong Chen, PhD||The University of Hong Kong|
|Principal Investigator:||Kwok Yin Au, PhD||The Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of the University of Hong Kong|