Table 2 WHO trial registration data
Data category | Information |
|---|---|
Primary registry and trial identifying number | ClinicalTrials.gov ChiCTR2000036515 |
Date of registration in primary registry | 13 November 2020 |
Secondary identifying numbers | ChiMCTR2000003660 |
Source(s) of monetary or material support | Clinical Research Plan of SHDC (No. SHDC2020CR1051B) |
Primary sponsor | Hongsheng Zhan |
Secondary sponsor(s) | N/A |
Contact for public queries | Hongsheng Zhan, Ph.D., Professor, E-mail address: shgsyjs@139.com |
Contact for scientific queries | Hongsheng Zhan, Ph.D., Professor Shi's Center of Orthopedics and Traumatology (Institute of Traumatology, Shuguang Hospital), Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China |
Public title | A multicenter clinical research on the treatment of lumbar intervertebral disc herniation with nerve root adhesion with integrated traditional Chinese and minimally invasive spine surgery |
Scientific title | Study on the efficacy and safety of the combination of Shi’s manual therapy and percutaneous endoscopic lumbar diskectomy for lumbar disc herniation with radiculopathy: Study Protocol for a Multicenter Randomized Controlled Trial |
Countries of recruitment | China |
Health condition(s) or problem(s) studied | lumbar disc herniation with radiculopathy |
Intervention(s) | Shi’s manual therapy (SMT) |
percutaneous endoscopic lumbar discectomy (PELD) | |
Key inclusion and exclusion criteria | Ages eligible for study: 20 to 70 years old; Sexes eligible for study: both; Accepts healthy volunteers: no |
Inclusion criteria: meet the diagnostic criteria of lumbar disc herniation with radiculopathy; ODI ≥ 10; The course of the condition is more than 3 months and has not improved with conservative therapy for more than 6 weeks; Voluntarily participated in this trial and signed the informed consent form. | |
Exclusion criteria: Tuberculosis, cancer, severe osteoporosis, acute infectious diseases, acute suppurative inflammation, severe cardiovascular, cerebrovascular, liver, kidney, hematopoietic, digestive system diseases or mental disorders.; Definite lumbar segmental instability or developmental lumbar spinal stenosis; Current pregnancy or is prepared to get pregnant; Received other treatment at the same time; Those who participated in other clinical trials within 3 months. | |
Rejection criteria: The researcher considered unsuitable for participating in the trial, (for example, unable to correctly understand the questionnaires, inconvenient to follow-up for living in other provinces); The subjects disobeyed the trial plan and combined with other drugs; Serious adverse reactions; The patients’ complaints continued to increase, which proved that trial participation was not suitable. | |
Study type | Interventional |
Allocation: randomized; Intervention model: parallel assignment; Masking: unblinded treatment and blinded outcome assessment | |
Primary purpose: efficacy and safety | |
Date of first enrolment | 24 February 2021 |
Target sample size | 510 |
Recruitment status | Recruiting |
Primary outcome(s) | Recurrence rate of herniation at the same level and on the same side (time frame: 1-year; not designated as safety issue) |
Key secondary outcomes | ODI Index; VAS of lumbar and lower limb pain; Straight leg raising angle of the affected side (time frame: 1-year; not designated as safety issue) |