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Table 1 All items from the World Health Organization Trial Registration Data Set (SPIRIT checklist, item 2b)

From: Crossbow needle therapy of the Miao ethnic minority group for knee osteoarthritis: study protocol for a randomized controlled trial

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)