Table 1 All items from the World Health Organization Trial Registration Data Set (SPIRIT checklist, item 2b)
Data category | Information |
|---|---|
Primary registry and trial identifying number | http://www.chictr.org.cn; ChiCTR-INR-16008032 |
Date of registration in primary registry | 12 March 2016 |
Secondary identifying numbers | – |
Source(s) of monetary or material support | Special research project of traditional Chinese medicine in 2015 (201507006–01) |
Primary sponsor | Institute of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences |
Secondary sponsor(s) | – |
Contact for public queries | Yuexi Wang; wangyue_xi@l26.com |
Contact for scientific queries | Yuexi Wang, Institute of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100,700, China. |
Public title | Miao medicine in knee osteoarthritis study |
Scientific title | Crossbow needle therapy of the Miao ethnic minority group on knee osteoarthritis: study protocol for a multicenter, randomized controlled trial |
Countries of recruitment | China |
Health condition(s) or problem(s) studied | knee osteoarthritis, pain/ankylosis/joint function disturbance |
Intervention(s) | Crossbow needle therapy of the Miao ethnic minority group |
Key inclusion and exclusion criteria | Inclusion criteria Patients who meet all of the following criteria will be enrolled in the trial: (1) aged 40–75 years; (2) meeting the above diagnostic criteria 1 and 2 (patients graded 1, 2, or 3 osteoarthritis by Kellgren-Lawrecne scale); (3) meeting the above diagnostic criteria 1, 4, 5, and 6; (4) the more affected side to be included when KOA is present on both sides; (5) no intervention performed 1 week before enrollment; (6) aware of all the tasks involved in the trial and prepared to comply with treatment; (7) willingness to sign written informed consent. Exclusion criteria Patients who meet any of the following criteria will be excluded from the trial: (1) failed to meet the diagnostic criteria and inclusion criteria; (2) women in pregnancy or lactation; (3) susceptible to allergy; (4) other knee disorders; (5) contusion or sprain in ankle or foot, or other disorders that affect normal walking; (6) ankle/foot deformity or pain; (7) skin disorders or deep swelling at the treated site; (8) other severe primary diseases or complications. |
Study type | Multicenter prospective randomized trial |
Date of first enrolment | 13 April 2016 |
Target sample size | 306 |
Recruitment status | Recruiting |
Primary outcome(s) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
Key secondary outcomes | The visual analogue scale (VAS); the Japanese Orthopedic Association (JOA) score; the MOS 36-item short-form health survey (SF-36) |