Sinew Acupuncture for Knee Osteoarthritis (KOA): A Randomized, Sham Controlled, Patient and Assessor Blinded, Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Pain intensity measured by VAS
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (
- •Over 50 years of age;
- •Less than 30 minutes of morning stiffness;
- •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.
Arms & Interventions
Sinew acupuncture
Subject in the arm will receive real acupuncture intervention.
Intervention: Sinew acupuncture (Other)
Sham acupuncture
Subject in the arm will receive sham acupuncture intervention.
Intervention: Sham acupuncture (Other)
Outcomes
Primary Outcomes
Pain intensity measured by VAS
Time Frame: Week 4
Pain intensity will be measured by VAS
Secondary Outcomes
- 8-step SCT(Weeks 0, 2, 4, 6 and 10)
- WOMAC(Weeks 0, 1, 2, 3, 4, 6 and 10)
- TUG(Weeks 0, 2, 4, 6 and 10)
- Quality of life measured by SF-36(Weeks 0, 4, and 10)