Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

NCT ID: NCT03299439

Last Updated: 2021-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 666 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2020-11-20

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.

Detailed Description

Participants in the high sensitization group receive acupuncture treatment at the five highly sensitive points; Participants in the low/non-sensitization group receive acupuncture treatment at the five low/non-sensitive points and all other treatment settings will be the same as in the high sensitization group. Patients in the waiting-list group will receive standard acupuncture treatment after the study is completed.

Conditions

Acupuncture; Knee Osteoarthritis; Sensitive Acupoints; Tender Points

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

acupuncture at highly sensitive points

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.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

a stimulation of the body or auricular points

acupuncture at lowly/non-sensitive points

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.

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: OTHER

a stimulation of the body or auricular points

no acupuncture (waiting-list)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

a stimulation of the body or auricular points

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sun Xin

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Sun, Phd

Role: STUDY_CHAIR

West China Hospital

Locations

the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital

Wuhan, Hubei, China

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

Chengdu, Sichuan, China

the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35676697 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30282686 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20178159950025

Identifier Type: -

Identifier Source: org_study_id