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Sinew Acupuncture for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Sinew acupuncture
Sham 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 Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Sinew Acupuncture, Pain

Eligibility Criteria

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

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Sinew acupuncture

Sham acupuncture

Arm Description

Subject in the arm will receive real acupuncture intervention.

Subject in the arm will receive sham acupuncture intervention.

Outcomes

Primary Outcome Measures

Pain intensity measured by VAS
Pain intensity will be measured by VAS

Secondary Outcome Measures

WOMAC
Western Ontario and McMasters University Osteoarthritis Index
TUG
Timed up and go test
8-step SCT
Stair Climb Test
Quality of life measured by SF-36
Short Form-36

Full Information

First Posted
March 28, 2017
Last Updated
December 11, 2018
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03099317
Brief Title
Sinew Acupuncture for Knee Osteoarthritis
Official Title
Sinew Acupuncture for Knee Osteoarthritis (KOA): A Randomized, Sham Controlled, Patient and Assessor Blinded, Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (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
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Sinew Acupuncture, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized sham controlled, single blinded trial
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sinew acupuncture
Arm Type
Experimental
Arm Description
Subject in the arm will receive real acupuncture intervention.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
Subject in the arm will receive sham acupuncture intervention.
Intervention Type
Other
Intervention Name(s)
Sinew acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity measured by VAS
Description
Pain intensity will be measured by VAS
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
WOMAC
Description
Western Ontario and McMasters University Osteoarthritis Index
Time Frame
Weeks 0, 1, 2, 3, 4, 6 and 10
Title
TUG
Description
Timed up and go test
Time Frame
Weeks 0, 2, 4, 6 and 10
Title
8-step SCT
Description
Stair Climb Test
Time Frame
Weeks 0, 2, 4, 6 and 10
Title
Quality of life measured by SF-36
Description
Short Form-36
Time Frame
Weeks 0, 4, and 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
First Name & Middle Initial & Last Name & Degree
Kwok Yin Au, PhD
Organizational Affiliation
The Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of 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 (Wan Chai)
City
Wan Chai
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34126097
Citation
Lam WC, Au KY, Qin Z, Wu FM, Chong CO, Jiang F, He Y, Ng BFL, Yeung WF, Lao L, Chen H. Superficial Needling Acupuncture vs Sham Acupuncture for Knee Osteoarthritis: A Randomized Controlled Trial. Am J Med. 2021 Oct;134(10):1286-1294.e2. doi: 10.1016/j.amjmed.2021.05.002. Epub 2021 Jun 11.
Results Reference
derived
PubMed Identifier
29685141
Citation
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.
Results Reference
derived

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Sinew Acupuncture for Knee Osteoarthritis

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