Clinical trial NCT03299439: Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points
Official title: A Multi-center Randomized Controlled Trial of Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Knee Osteoarthritis
Sensitive Acupoints
Tender Points
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 666
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
timeFrame: Assessments will be conducted at baseline and 16 weeks after randomization
Secondary outcomes:
measure: The change of Short Form (SF)-12 health survey score from baseline to 16 weeks
timeFrame: Assessments will be conducted at baseline and 16 weeks after randomization
measure: The changes of knee ranges of motion (ROMs) from baseline to 16 weeks
timeFrame: Assessments will be conducted at baseline and 16 weeks after randomization
measure: The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks
timeFrame: Assessments will be conducted at baseline and 16 weeks after randomization
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
city: Wuhan
country: China
facility: Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital
state: Hubei
city: Chengdu
country: China
facility: Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Xin Sun, Phd
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.