Rui Xie1, Long Liang1, Kaiming Li1, Jie Yu2, Minshan Feng1,3, Jiawen Zhan4, Xu Wei5, Kexin Yang1, Zhefeng Jin1, He Yin1, Xin Chen1, Xunlu Yin1, Zhiwei Liu1, Wenkang Dai1, Liguo Zhu6,7. 1. Department of Spine, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, 100102, China. 2. Department of Spine, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, 100102, China. doctoryujie@aliyun.com. 3. Beijing Key Laboratory of Orthopedics of Traditional Chinese Medicine, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, China. 4. Department of Rehabilitation, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, China. 5. Office of Academic Research, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, China. 6. Department of Spine, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, 100102, China. zhlg95@aliyun.com. 7. Beijing Key Laboratory of Orthopedics of Traditional Chinese Medicine, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing, China. zhlg95@aliyun.com.
Abstract
BACKGROUND: Degenerative lumbar instability (DLI) is a common disease that causes low back pain (LBP) in clinic. It is difficult to completely recover from DLI, and it occurs repeatedly, which seriously affects the quality of life of patients. The epidemiological survey showed that 20-30% of low back pain was related to lumbar instability. Increasing evidence shows that seated lumbar rotation manipulation can effectively improve the clinical symptoms of patients with low back pain. The primary aim of this clinical trial is to observe the intervention effect of seated lumbar rotation manipulation on DLI patients. METHOD/ DESIGN: A total of 60 participants with DLI will be recruited and randomly allocated into the seated lumbar rotation manipulation group (the intervention group) or lumbar traction in supine position group (the control group) in this prospective, outcome assessor-blind, two-arm randomized controlled clinical trial. The treatment of the two groups lasted for 3 weeks, and the manipulation of the intervention group would be carried out once every other day, three times a week, a total of 9 times; the control group would be given lumbar traction once a day, five times a week, a total of 15 times. JOA (Japanese Orthopaedic Association) and VAS (Visual Analogue Scales) scores will be recorded as the primary outcomes before the treatment and at the 1st, 3rd, 5th, 8th, 10th, 12th, 15th, 17th, and 19th days after treatment and follow-up visit at the first, third, and sixth months. JOA efficacy evaluation standard will be used to evaluate the overall efficacy as the secondary outcomes. DISCUSSION: The results of this prospective, randomized controlled trial will provide a clinical evidence for the treatment of DLI with seated lumbar rotation manipulation. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000032017 . Registered on 18 April 2020, Prospective registration.
RCT Entities:
BACKGROUND: Degenerative lumbar instability (DLI) is a common disease that causes low back pain (LBP) in clinic. It is difficult to completely recover from DLI, and it occurs repeatedly, which seriously affects the quality of life of patients. The epidemiological survey showed that 20-30% of low back pain was related to lumbar instability. Increasing evidence shows that seated lumbar rotation manipulation can effectively improve the clinical symptoms of patients with low back pain. The primary aim of this clinical trial is to observe the intervention effect of seated lumbar rotation manipulation on DLI patients. METHOD/ DESIGN: A total of 60 participants with DLI will be recruited and randomly allocated into the seated lumbar rotation manipulation group (the intervention group) or lumbar traction in supine position group (the control group) in this prospective, outcome assessor-blind, two-arm randomized controlled clinical trial. The treatment of the two groups lasted for 3 weeks, and the manipulation of the intervention group would be carried out once every other day, three times a week, a total of 9 times; the control group would be given lumbar traction once a day, five times a week, a total of 15 times. JOA (Japanese Orthopaedic Association) and VAS (Visual Analogue Scales) scores will be recorded as the primary outcomes before the treatment and at the 1st, 3rd, 5th, 8th, 10th, 12th, 15th, 17th, and 19th days after treatment and follow-up visit at the first, third, and sixth months. JOA efficacy evaluation standard will be used to evaluate the overall efficacy as the secondary outcomes. DISCUSSION: The results of this prospective, randomized controlled trial will provide a clinical evidence for the treatment of DLI with seated lumbar rotation manipulation. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000032017 . Registered on 18 April 2020, Prospective registration.
Authors: An-Wen Chan; Jennifer M Tetzlaff; Douglas G Altman; Andreas Laupacis; Peter C Gøtzsche; Karmela Krleža-Jerić; Asbjørn Hróbjartsson; Howard Mann; Kay Dickersin; Jesse A Berlin; Caroline J Doré; Wendy R Parulekar; William S M Summerskill; Trish Groves; Kenneth F Schulz; Harold C Sox; Frank W Rockhold; Drummond Rennie; David Moher Journal: Ann Intern Med Date: 2013-02-05 Impact factor: 25.391