Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| no acupuncture (waiting-list) | No Intervention | Patients in the waiting-list group will not receive any acupuncture intervention during the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | a stimulation of the body or auricular points |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
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:
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xin Sun, Phd | West China Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine | Zhengzhou | Henan | 450003 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35676697 | Derived | 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. | |
| 30282686 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2017 | Dec 21, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2017 | Dec 21, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Assessments will be conducted at baseline and 16 weeks after randomization |
| 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 |
| 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 |
| Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital |
| Wuhan |
| Hubei |
| 430022 |
| China |
| Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan | 610075 | China |
| 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. |
| D012216 |
| Rheumatic Diseases |