Clinical trial NCT03099317: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Sinew Acupuncture
Pain
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized sham controlled, single blinded trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity measured by VAS
timeFrame: Week 4
Secondary outcomes:
measure: WOMAC
timeFrame: Weeks 0, 1, 2, 3, 4, 6 and 10
measure: TUG
timeFrame: Weeks 0, 2, 4, 6 and 10
measure: 8-step SCT
timeFrame: Weeks 0, 2, 4, 6 and 10
measure: Quality of life measured by SF-36
timeFrame: Weeks 0, 4, and 10
Other outcomes:
Locations:
city: Wan Chai
country: Hong Kong
facility: The Hong Kong Tuberculosis, Association The University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine (Wan Chai)
Study officials:
affiliation: The University of Hong Kong
name: Haiyong Chen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of the University of Hong Kong
name: Kwok Yin Au, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.