Sinew Acupuncture for Knee Osteoarthritis

NCT03099317 | Completed DMC

• 1 other identifier: UHongKong-UW16-2007
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Sinew Acupuncture; Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity measured by VAS

  Pain intensity will be measured by VAS

  Week 4

Secondary Outcomes (4)

• WOMAC

  Weeks 0, 1, 2, 3, 4, 6 and 10

• TUG

  Weeks 0, 2, 4, 6 and 10

• 8-step SCT

  Weeks 0, 2, 4, 6 and 10

• Quality of life measured by SF-36

  Weeks 0, 4, and 10

Study Arms (2)

Sinew acupuncture

EXPERIMENTAL

Subject in the arm will receive real acupuncture intervention.

Other: Sinew acupuncture

Sham acupuncture

SHAM COMPARATOR

Subject in the arm will receive sham acupuncture intervention.

Other: Sham acupuncture

Interventions

Sinew acupuncture OTHER

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.

Sinew acupuncture

Sham acupuncture OTHER

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.

Sham acupuncture

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

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

Location

Related Publications (2)

• 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.

  PMID: 34126097 DERIVED

• 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.

  PMID: 29685141 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized sham controlled, single blinded trial

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: June 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

HK (1)