scholarly journals Comparative study of the efficacy and safety of minimally invasive interlaminar full-endoscopic discectomy versus conventional microscopic discectomy in single-level lumbar herniated intervertebral disc (ENDO-F Trial): A multicenter, prospective, randomized controlled trial protocol

2021 ◽  
Author(s):  
Jin-Sung Kim ◽  
Jun Ho Lee ◽  
Junseok Bae ◽  
Dong Chan Lee ◽  
Sang-Ha Shin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Satisfaction ◽  
Minimally Invasive ◽  
Controlled Trial ◽  
Lumbar Disc ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Post Surgery ◽  
Endoscopic Discectomy ◽  
Multicenter Randomized Controlled Trial

Abstract BackgroundAdvances in minimally invasive surgery have expanded the indications for interlaminar full-endoscopic discectomy. Although the clinical outcomes for this approach may be equivalent to those of conventional microscopic discectomy, the supporting evidence is based on small, single-center, prospective, and retrospective studies. Therefore, a multicenter, randomized controlled trial is warranted.MethodsThis will be a prospective, multicenter, randomized controlled trial comparing the efficacy and safety of interlaminar full-endoscopic discectomy to those of conventional microscopic discectomy. The trial will enroll 100 participants with a lumbar disc herniation, 50 in each group. The primary outcome will be the Oswestry Disability Index (ODI) score at 12 months post-surgery. Secondary outcomes will be: back and leg pain (visual analog scale); the ODI; the EuroQol-5-Dimension score; patient satisfaction; and walking distance/time and time to return to daily activities post-surgery. Surgical outcomes will include postoperative drainage, operative time, duration of hospital stay, postoperative creatine kinase level as an indicator of muscle injury, and postoperative scarring. Postoperative magnetic resonance imaging, computed tomography, and simple radiography will be performed to evaluate radiographic outcomes between the two surgical approaches. Surgery-related complications and adverse effects will be evaluated as safety outcomes. A single assessor at each participating hospital, blinded to group allocation, will assess the enrolled participants at baseline, 2 weeks and 3, 6, and 12 months postoperatively.DiscussionThis trial is designed to determine whether interlaminar full-endoscopic discectomy is clinically comparable to microscopic discectomy to treat lumbar disc herniations. All efforts will be made to reduce bias, including adequate sample sizes, blinded analyses, and multicenter prospective registration. The outcomes will inform practice, providing the evidence needed for the use of interlaminar full-endoscopic over microscopic discectomy by confirming the potential of this technique to improve patient satisfaction and clinical outcomes.Trial registrationClinical Research Information Service; cris.nih.go.kr. (KCT0006277); protocol version (v1, June 8, 2021)

scholarly journals Study on Efficacy and Safety of Shi’s Manual Therapy Treatment for Lumbar Disc Herniation with Radiculopathy: Study Protocol for A Multicenter Randomized Controlled Trial

2021 ◽  
Author(s):  
Huihao Wang ◽  
Yuan Weian ◽  
Yu Zhongxiang ◽  
Wang Xiang ◽  
Zhao Xinxin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Lumbar Disc Herniation ◽  
Manual Therapy ◽  
Controlled Trial ◽  
Lumbar Disc ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Straight Leg Raising ◽  
Post Operation

Abstract Background Lumbar disc herniation (LDH) is a common chronic musculoskeletal disorder that seriously affects quality of life. Percutaneous endoscopic lumbar diskectomy (PELD) technique was developed to address spine nerve root compression by direct visualization of pathological findings while minimizing tissue destruction upon exposure. It is an effective and safe treatment for LDH. However, recurrent LDH is a major concern after lumbar discectomy for primary LDH. A considerable number of clinical studies reported that patients will benefit from manual therapy practice for LDH with radiculopathy patients. Shi's manual therapy (SMT) is established based on the Traditional Chinese medicine (TCM) theory, which has been shown to have a superior effect in alleviating muscle tension and loosen joints to improve lumbar and leg pain, radiculopathy, stiffness, activity discomfort, and related disorders. But there is a lack of high-quality clinical evidences to support the conclusion. The purpose of this study will be to evaluate the efficacy and safety of the combination of Shi’ manual therapy (SMT) for reducing the recurrent rate of LDH with radiculopathy. Methods/design: A multicenter randomized controlled trial (RCT) with a 1years’ follow-up period will be performed. A total of 510 participants with LDH with radiculopathy will be recruited in four clinical centers. Sample size estimation was calculated and statistical analysis will be performed calculated and supervised by biostatisticians from the independent third-party research institution. Two hundred and fifty-five subjects will be randomly allocated to each group. The subject in the control group will undergo the PELD. Participants in the intervention group will be treated with SMT, and the straight leg raising angle will be evaluated. If the patients’ straight leg raising the angle of the affected side is close to the healthy side, and the treatment is finished, if not, the PELD procedure will proceed. The primary outcome will be the recurrence rate of LDH with radiculopathy and the ODI score. The secondary outcome measures will be the VAS score for the pain of lumbar and lower limbs, the straight leg raising angle, the stability of the operated lumbar segment, and SF-36 scores. Assessments will occur at baseline, post-operation, and at 1week, 4 weeks, 13 weeks, 26 weeks and 1year post-operation. In addition, adverse events related to clinical symptoms and signs and results of laboratory tests will be documented during the clinical trials. Discussion This study will provide reliable evidence of the effectiveness and safety of the combination of SMT and PELD for LDH with radiculopathy. If the results are favorable, it is expected that the patients with LDH with radiculopathy will benefit from this study, many patients may have a good alternative treatment for LDH with radiculopathy. Trial registration: ChiCTR, ChiCTR2000036515. Registered on 13 November 2020.

scholarly journals Efficacy and safety of He-He-Shu-Yang Particles plus Anluohuaxian Pills for early liver fibrosis in Chronic Hepatitis B patients: study protocol for a multicenter, randomized controlled trial

2021 ◽  
Author(s):  
Meijie Shi ◽  
Huanming Xiao ◽  
Junmin Jiang ◽  
Pengtao Zhao ◽  
Shuduo Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Chronic Hepatitis ◽  
Placebo Group ◽  
Chinese Medicine ◽  
Liver Fibrosis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Background: In recent years, more and more studies revealed that liver fibrosis progression could happen at early stage in chronic hepatitis B (CHB) patients. However, there is no anti-fibrotic agent available at present in modern medicine.He-He-Shu-YangParticles (HHSYP) and Anluohuaxian Pills (AHP)are two commonly used Traditional Chinese Medicine (TCM) agents for liver fibrosis, but there is no data of them for early liver fibrosis(F1 or F2) in multicenter, randomized controlled trial. Therefore, the aim of this study is to evaluate efficacy and safety ofHHSYP plus AHP for early liver fibrosis in CHB patients. Methods/design: For the 72-week randomized controlled study, 480 CHB patients with early liver fibrosis are randomly assigned at a 2:1 ratio to two groups: the intervention group and the placebo group. The intervention group was treated with HHSYP plus AHP. The placebo group was treated with placebo of HHSYP and AHP. The primary end point is the histological change after 72-week treatment.Discussion: Although previous studies have confirmed the anti-fibrosis efficacy of HHSYP and AHP in CHB patients, the efficacy and safety of their combination treatment for early liver fibrosis is still not clear.Therefore, this will be the first multicenter randomized trial to prove the efficacy and safety of combination TCM treatment of HHSYP and AHP for early liver fibrosis, which will use histological changes as the primary end point. This will provide reliable data for the TCM combination treatment of early liver fibrosis and might give a new direction for further international studies on liver fibrosis.Ethics and dissemination: This study protocol was approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (BF2018-175-01) and all other participating centers (Project number2018ZX10725506-003).The study findings will be published in peer-reviewed journals and presented at the national and international conferences. Trial registration: Chinese Clinical Trial Registration: ChiCTR1900025897, Registered:13 September 2019, http://www.chictr.org.cn/edit.aspx?pid=40222&htm=4

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