Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

Knee Osteoarthritis Clinical Trial

Official title:

A Multi-center Randomized Controlled Trial of Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299439
• Other study ID #: 20178159950025
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: November 20, 2020

Study information

• Verified date: December 2021
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 666
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Hypersensitivity
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Sensitive Acupoints
• Tender Points

Intervention

Other:
• acupuncture
a stimulation of the body or auricular points

Locations

Country	Name	City	State
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	Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital	Wuhan	Hubei
China	the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change of Short Form (SF)-12 health survey score from baseline to 16 weeks	It includes 12 items: 2 items on physical functioning, 2 items on role limitations because of physical health problems, 1 item on bodily pain, 1 item on general health perceptions, 1 item on vitality (energy/fatigue), 1 item on social functioning, 2 items on role limitations because of emotional problems, and 2 items on general mental health (psychological distress and psychological well-being).	Assessments will be conducted at baseline and 16 weeks after randomization
Secondary	The changes of knee ranges of motion (ROMs) from baseline to 16 weeks	The knee ROMs will be assessed both actively and passively by using a standard goniometer. It will include flexion, extension, internal rotation and external rotation.	Assessments will be conducted at baseline and 16 weeks after randomization
Secondary	The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks	The pressure-pain threshold of the five selected acupuncture points will be measured using the electronic von Frey detector.	Assessments will be conducted at baseline and 16 weeks after randomization