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; ChiCTR2000038725 |
Date of registration in primary registry | 29 September 2020 |
Secondary identifying numbers | - |
Source(s) of monetary or material support | National Key Research and Development Project of China (2019YFC1708403) |
Primary sponsor | Institute of Chinese Medical History and Literature, China Academy of Chinese Medical Sciences |
Secondary sponsor(s) | - |
Contact for public queries | Jing Fu; 1040684089@qq.com |
Contact for scientific queries | Jing Fu, Guizhou University of Traditional Chinese Medicine, Guiyang 550002, China. |
Public title | Folk diagnosis and treatment technology in lumbar disc herniation study |
Scientific title | Ma’s bamboo-based medicinal moxibustion therapy of low back pain in lumbar disc herniation: study protocol for a randomized controlled trial |
Countries of recruitment | China |
Health condition(s) or problem(s) studied | Lumbar disc herniation, low back pain |
Intervention(s) | Ma’s bamboo-based medicinal moxibustion group |
Key inclusion and exclusion criteria | Inclusion criteria Patients who meet all of the following criteria will be enrolled in the trial: (1) patients who meet the above diagnostic criteria and pathological classification, with the lesion located in L3–S1; (2) patients aged 18–65 years, males or females; (3) patients with the course of disease ≥6 months; (4) drug users with drug withdrawal for 4 weeks, and non-drug users with discontinued treatment for 2 weeks; (5) patients with 3 ≤VAS scores ≤6; (6) willingness to sign written informed consent. Exclusion criteria Patients who meet any of the following criteria will be excluded from the trial: (1) patients with acute onset of low back pain in lumbar disc herniation; (2) patients with low back pain caused by other causes; (3) patients with other diseases requiring combined treatment using anti-inflammatory and analgesic drugs; (4) patients during pregnancy,lactation or pregnancy preparation; (5) patients with rash, skin damage, ulcers or other infectious diseases at the waist; (6) patients with serious diseases of the heart, liver, kidney,blood system, etc.; (7) patients with mental disorders or communication disorders who could not cooperate; (8) patients with high fever and yin deficiency. |
Study type | Multicentre prospective randomized trial |
Date of first enrolment | 11 November 2020 |
Target sample size | 312 |
Recruitment status | Recruiting |
Primary outcome(s) | Visual analog scale (VAS) |
Key secondary outcomes | Oswestry disability index (ODI); modified Japanese Orthopaedic low back pain (M-JOA) score; serum β-endorphin (β-EP); serum substance P (SP) |