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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
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE March 28, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date December 13, 2018
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
Pain intensity measured by VAS [ Time Frame: Week 4 ]
Pain intensity will be measured by VAS
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • 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 ]
    SF-36
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sinew Acupuncture for Knee Osteoarthritis
Official Title  ICMJE Sinew Acupuncture for Knee Osteoarthritis (KOA): A Randomized, Sham Controlled, Patient and Assessor Blinded, Pilot Trial
Brief Summary The study aims to exam whether sinew acupuncture can relieve pain and symptoms of KOA and improve functional movement by Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up & Go Test (TUG) and 8-step Stair Climb Test (SCT) assessment, and Quality of life by Short Form-36 (SF-36). A randomized, sham acupuncture controlled, patient and assessor blinded, pilot study will be employed.
Detailed Description

Objective:

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.

Design:

A randomized, subject- and assessor-blind, sham acupuncture-controlled clinical trial

Participants:

Subjects (N=86) will be randomized into sinew acupuncture or sham acupuncture group (in 1:1 ratio).

Study instrument:

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).

Intervention:

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.

Data analysis:

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.

Expected results:

Sinew acupuncture treatment can significantly reduce knee pain intensity, and improve knee function and quality of life without obvious side effects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A randomized sham controlled, single blinded trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Sinew acupuncture
    Subject in the arm will receive real acupuncture intervention.
    Intervention: Other: Sinew acupuncture
  • Sham Comparator: Sham acupuncture
    Subject in the arm will receive sham acupuncture intervention.
    Intervention: Other: Sham acupuncture
Publications * Au KY, Chen H, Lam WC, Chong CO, Lau A, Vardhanabhuti V, Mak KC, Jiang F, Lam WY, Wu FM, Chan HN, Ng YW, Ng BF, Ziea ET, Lao L. Sinew acupuncture for knee osteoarthritis: study protocol for a randomized sham-controlled trial. BMC Complement Altern Med. 2018 Apr 23;18(1):133. doi: 10.1186/s12906-018-2195-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2017)
86
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hong Kong permanent residents aged on or above 50, both male and female;
  • meet the Clinical Classification Criteria for Osteoarthritis of the Knee by history, physical examination and radiographic findings (recommended by the American College of Rheumatology): history and physical examination: pain in the knee and one of the following (1. Over 50 years of age; 2. Less than 30 minutes of morning stiffness; 3. Crepitus on active motion and osteophytes) and radio graphical findings (Kellgren and Lawrence Grades 2-4):
  • with unilateral knee pain or bilateral knee pain;
  • in chronic stage (pain of at least 6 month's duration);
  • with rated knee pain >40 mm on a visual analog scale (VAS; 0 to 100 mm) within 7 days;
  • with X-ray or other radiographic reports are preferable (not necessary);
  • who volunteer to participate and sign the consent form;
  • able to write and read Chinese.

Exclusion Criteria:

  • Patients who are unable to walk;
  • with serious infection of knee;
  • with suspected tears of ligaments, menisci or acute inflammation of synovial capsule;
  • with trauma, ligament damage, fracture, or surgery on the knee(s) within 6 months, as the cause of pain or functional problems (history of knee replacement will be excluded);
  • with history of local tumor/malignancy at knee;
  • with physical or laboratory findings indicating infection, presence of autoimmune disease or inflammatory arthritis;
  • with knee pain caused by radiculopathy / herniation of intervertebral disc;
  • with end-stage of diseases and other suspected severe conditions such as deep vein thrombosis of the lower limb, edema related to cancer or cancer treatment, severe blood coagulation disorders, uncontrolled systemic arterial hypertension and severe diabetes;
  • with history of prolotherapy, with injections of hyaluronic acid or cortisone within 3 months;
  • received acupuncture, electro-acupuncture, Tui-na therapy, massage, physiotherapy for 8 weeks prior to the trial;
  • with more severe pain in other regions;
  • have severe mental disorders;
  • oversensitive to needles;
  • insensitive to pain due to advanced diabetes, neuropathy or using strong painkillers;
  • fail to be complaint with the treatment protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099317
Other Study ID Numbers  ICMJE UHongKong-UW16-2007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account The University of Hong Kong
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP