Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

NCT03299439 | Completed

• 1 other identifier: 20178159950025
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 4

Brief Summary

The investigators plan to investigate the effectiveness of acupuncture at highly sensitive points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in improving pain, joint function and quality of life, among patients with KOA. The safety of acupuncture will also be assessed during the study period.

Conditions

Acupuncture; Knee Osteoarthritis; Sensitive Acupoints; Tender Points

Outcome Measures

Primary Outcomes (1)

• The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks

  It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function.

  Assessments will be conducted at baseline and 16 weeks after randomization

Secondary Outcomes (3)

• The change of Short Form (SF)-12 health survey score from baseline to 16 weeks

  Assessments will be conducted at baseline and 16 weeks after randomization

• The changes of knee ranges of motion (ROMs) from baseline to 16 weeks

  Assessments will be conducted at baseline and 16 weeks after randomization

• The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks

  Assessments will be conducted at baseline and 16 weeks after randomization

Study Arms (3)

acupuncture at highly sensitive points

EXPERIMENTAL

Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five highly sensitive points.

Other: acupuncture

acupuncture at lowly/non-sensitive points

ACTIVE COMPARATOR

Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five low/non-sensitive points.

Other: acupuncture

no acupuncture (waiting-list)

NO INTERVENTION

Patients in the waiting-list group will not receive any acupuncture intervention during the study.

Interventions

acupuncture OTHER

a stimulation of the body or auricular points

acupuncture at highly sensitive points; acupuncture at lowly/non-sensitive points

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 40 years or older and diagnosed with mild or moderate knee osteoarthritis(KOA) are eligible to participate in the study
• The following criteria are used for diagnosis of KOA:
• refractory knee pain for most days in the last month;
• joint space narrowing, sclerosis or cystic change in subchondral bone (as demonstrated in X-ray);
• laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count \< 2000/mm3;
• morning stiffness continues less than 30 minutes;
• bone sound exists when joints was taking flexion and/or extension. If a patient meets criteria 1 and 2, or criteria 1, 3, 4, and 5, a diagnosis of KOA is confirmed.

You may not qualify if:

• Patients will be excluded if they meet any of the following:
• diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of the knee joint and rheumatoid arthritis;
• present sprain or trauma in the lower limb;
• unable to walk properly due to foot deformity or pain;
• present with mental disorders;
• present with comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease;
• females who are pregnant or lactating;
• using physiotherapy treatments for osteoarthritis knee pain;
• have used intra-articular injection of glucocorticoid or viscosupplementation in the past six months;
• received knee-replacement surgery;
• diagnosed with severe (stage 4, according to Kellgren and Lawrence radiographic classification) or late clinical stage of KOA;
• have a swollen knee or positive result of floating patella test; or'
• are participating or have participated in the other clinical trials.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (4)

the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450003, China

Location

Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital

Wuhan, Hubei, 430022, China

Location

Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

Related Publications (2)

• Liu J, Li Y, Li L, Luo X, Li N, Yang X, Zhang H, Liu Z, Kang D, Luo Y, Liu Y, Jia Y, Ren Y, Yao M, Wang Y, Chen J, Maiji M, Zou K, Zhao L, Liang F, Sun X. Effects of acupuncture at acupoints with lower versus higher pain threshold for knee osteoarthritis: a multicenter randomized controlled trial. Chin Med. 2022 Jun 8;17(1):67. doi: 10.1186/s13020-022-00626-3.

  PMID: 35676697 DERIVED

• Tang L, Jia P, Zhao L, Kang D, Luo Y, Liu J, Li L, Zheng H, Li Y, Li N, Guyatt G, Sun X. Acupuncture treatment for knee osteoarthritis with sensitive points: protocol for a multicentre randomised controlled trial. BMJ Open. 2018 Oct 2;8(10):e023838. doi: 10.1136/bmjopen-2018-023838.

  PMID: 30282686 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Xin Sun, Phd

  West China Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 3, 2017
• Study Start: October 25, 2017
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)