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Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial.

ABSTRACT: BACKGROUND:A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes lower back pain and neurological symptoms that manifest as radiating pain. Several studies have reported that thread-embedding acupuncture (TEA) is effective in the treatment of LHIVD. However, these studies were of low quality and there is therefore little clinical evidence for the effectiveness of TEA in this regard. The aim of the present study is to establish the clinical evidence regarding the efficacy and safety of TEA in the treatment of pain, function, and quality of life in patients with LHIVD. The study uses a rigorously designed, full-scale, randomized clinical trial (RCT) protocol. METHOD/DESIGN:This is a multicenter, randomized, patient-assessor blinded, sham-controlled trial with two parallel arms. Seventy patients with LHIVD who have lower back pain more severe than 40 mm on the 100-mm visual analogue scale (VAS), and who are aged 19-70 years, will be recruited and randomly allocated to a TEA group and sham TEA (STEA) group. Both groups will receive treatment on 23 predefined acupoints once a week for eight weeks; needles with the thread removed will be used in the STEA group, while normal TEA will be employed in the TEA group. Changes in the 100-mm VAS for lower back pain after eight weeks will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry Disability Index, Roland-Morris disability questionnaire, EuroQol 5 Dimensions 5 Levels, and global perceived effect will be measured and analyzed as secondary outcomes. All outcomes will be assessed at baseline and at 4, 8, 12, and 16 weeks after screening. DISCUSSION:The results of this trial will help to establish the clinical evidence regarding TEA in the treatment of patients with LHIVD. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03236753 . Registered on August 2, 2017. Clinical Research Information Service of the Republic of Korea, KCT0002439 . Registered on August 1, 2017.

SUBMITTER: Goo B

PROVIDER: S-EPMC6131792 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial.

Goo Bonhyuk B Ryoo Dek-Woo DW Kim Eun-Jung EJ Nam Dongwoo D Lee Hyun-Jong HJ Kim Jae-Soo JS Park Yeon-Cheol YC Baek Yong-Hyeon YH Seo Byung-Kwan BK

Trials 20180910 1

<h4>Background</h4>A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes lower back pain and neurological symptoms that manifest as radiating pain. Several studies have reported that thread-embedding acupuncture (TEA) is effective in the treatment of LHIVD. However, these studies were of low quality and there is therefore little clinical evidence for the effectiveness of TEA in this regard. The aim of the present study is to establish the clinical evidence regard ...[more]

PMID: 30201029

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Project description:BACKGROUND:Degenerative knee osteoarthritis (KOA) shows an increase in morbidity with improvement in the living conditions and extended lifespans. Treatment for degenerative KOA has been gaining attention since it significantly affects the life of the elderly population and is also associated with increased expenses for medical services and high socioeconomic costs. Treatments for degenerative KOA include nondrug therapy, drug therapy, and surgical treatment. For cases that show little response to conservative treatment but have not involved severe deformation of the knee, procedures such as arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation can be performed. However, effective treatment is required for patients experiencing sustained knee pain after surgery. Although studies confirming the therapeutic effects of acupuncture or thread-embedding acupuncture (TEA) treatment for degenerative KOA have been reported, clinical studies on a combination of TEA and electroacupuncture (EA) in patients complaining of knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation have not yet been reported. Therefore, this study aimed to evaluate the effectiveness and safety of this combination treatment in patients with persistent knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation. METHODS/DESIGN:This study has been designed as a 2-group, parallel, single-center, randomized, controlled, assessor-blinded trial. Thirty-six patients with degenerative KOA who complained of pain even after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation will be randomized to either the (TEA?+?EA?+?Usual care) group or the (Usual care only) group in a 1:1 ratio. The patients in the (TEA?+?EA?+?Usual care) group will receive TEA treatment once a week for 4 weeks for a total of 4 sessions and EA twice a week for a total of 8 sessions while continuing usual care. The (Usual care only) group will only receive usual care for 4 weeks. To assess the efficacy of the TEA and EA combination treatment, the visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol 5-Dimension 5-Level, and the doses of the rescue drug taken will be evaluated at baseline (1W) and weeks 2 (2W), 4 (4W), 6 (6W), and 8 (8W). The primary efficacy endpoint is the mean change in visual analogue scale at week 4 (4W) compared to baseline. Adverse events will be assessed at every visit. DISCUSSION:This study will provide useful data for evaluating the clinical efficacy and safety of TEA and electroacupuncture combination treatment for improving pain and quality of life after surgery for degenerative KOA. TRIAL REGISTRATION:Clinical Research Information Service of Republic of Korea (CRIS- KCT0004804), March 6, 2020.

Project description:INTRODUCTION:Thread embedding acupuncture (TEA) is a special type of acupuncture that inserts certain medical threads (eg, catgut or polydioxanone) into subcutaneous tissue or muscles at specific points. Although TEA has been widely used for the treatment of musculoskeletal pain in Korea, China and Taiwan, evidence regarding its efficacy is lacking. The aim of this protocol is to evaluate the effectiveness and safety of TEA in the treatment of musculoskeletal pain, by conducting a systematic review and meta-analysis. METHODS AND ANALYSIS:The following 16 databases will be searched from their inception to 14 May 2017: MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the Cumulative Index to Nursing and Allied Health Literature, the Allied and Complementary Medicine Database, three Chinese database (China National Knowledge Infrastructure, the Chongqing VIP Chinese Science and Technology Periodical Database and the Wanfang database) and eight Korean databases (Korean Medical Database, Korean Association of Medical Journal Editors, Korean Studies Information Service System, Korean National Assembly Digital Library, National Digital Science Library, Oriental Medicine Advanced Searching Integrated System, 'Database Periodical Information Academic and Korean Traditional Knowledge Portal'). The WHO International Clinical Trials Registry Platform will also be searched to retrieve the recently completed studies.All randomised controlled studies in which TEA was used on specific points for the treatment of musculoskeletal pain will be included and no restrictions on language will be applied. The risk of bias of each study will be evaluated by the Cochrane risk of bias tool.Mean difference or standardised mean difference for continuous data and risk ratio for dichotomous data will be calculated with 95% CIs using a random effects model or a fixed effects model. Additional subgroup and sensitivity analyses will be conducted according to a predefined protocol. ETHICS AND DISSEMINATION:No ethical issues are predicted. The systematic review will be published in a peer-reviewed journal or conference presentation. These findings will summarise the current evidence of TEA for the treatment of musculoskeletal pain and may provide guidance for clinicians and patients to select TEA for musculoskeletal pain. PROSPERO REGISTRATION NUMBER:CRD42015019046.

Project description:BackgroundThis study aims to demonstrate the effectiveness of using clinical practice guideline (CPG) leaflets as a communication tool between doctors and patients. We evaluated the leaflets as a communication tool in the treatment of lumbar herniated intervertebral discs (HIVDs) in terms of patient and physician satisfaction and ease of treatment.MethodsThis study is a 2-parallel-arm, assessor-blinded, randomized controlled trial at Jaseng Hospital, Seoul, South Korea. We evaluated efficacy through a comparison of satisfaction and clinical outcomes in randomly allocated groups of HIVD lumbar patients visiting Jaseng Hospital of Korean Medicine. We used leaflets on the basis of Korean medicine CPG recommendations as an intervention. The intervention group received treatment and diagnosis using the leaflet, and the control group received the typical intervention, which was provided without the leaflet.ResultsThe levels of patient satisfaction with and understanding of the doctors' explanation was 92% in the leaflet group and 64% in the nonleaflet group, which showed that, compared with patient satisfaction in the nonleaflet group, patient satisfaction was considerably higher by 28% in the leaflet group. In addition, the level of the reliability with treatment was 92% in the leaflet group and 64% in the control group. However, there were no significant differences in statistical analyses. The level of doctors' satisfaction with communicating with patients using the leaflet was 100% in the leaflet group. Given this satisfaction, the ease of persuasion of treatment was highest (84%) and followed the improvement in the patient's understanding of the treatment (16%) in the leaflet group. In addition, in the nonleaflet user group, almost all doctors thought that having a leaflet would be a more effective treatment.ConclusionAlthough this study failed to show significant differences between the intervention and control groups, the leaflet, which included CPG information in the treatment of HIVD patients, was an effective communication tool between patients and doctors. However, further studies with larger samples should be conducted to investigate the effectiveness of the communication tool based on the CPG.Trial registration numberClinical Research Information Service: KCT0001762.

Project description:BACKGROUND:A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes low back pain and radiating pain. The effectiveness of Bosinji, one of the herbal medicines used for low back pain and radiating pain in patient with LHIVD, has been reported in several studies; however, little clinical evidence is available owing to the methodological limitations in previous studies. Hence, the present study aims to establish the clinical evidence regarding the efficacy and safety of Bosinji in improving pain, function, and quality of life in LHIVD patients. METHOD/DESIGN:This is a multicenter, open-label, randomized, controlled, and equivalence trial with 2 parallel arms. A total of 74 patients who have low back pain and radiating pain due to LHIVD will be recruited and randomly allocated to the experimental group and control group. The patients in the experimental group and control group will take 2.5?g of Bosinji granule (1.523?g of Bosinji extract) or Loxonin tablet (60?mg of loxoprofen) 3 times a day for 6 weeks. Additionally, both groups will receive the same acupuncture treatment once a week for 6 weeks as a concurrent treatment. Changes in the 100-mm visual analogue scale (VAS) for low back pain after 6 weeks from baseline will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry disability index (ODI), Roland-Morris disability questionnaire (RMDQ), EuroQol 5 Dimensions 5 Levels (EQ-5D-5L), global perceived effect (GPE), and deficiency syndrome of kidney index (DSKI) will be used to evaluate secondary outcomes. Outcomes will be assessed at baseline and at 3, 6, and 10 weeks after screening. For the safety evaluation, laboratory examinations including complete blood count, liver function test, renal function test, blood coagulation test, inflammation test, and urine analysis will be conducted before and after taking the medications. DISCUSSION:The results of this trial will be used to establish clinical evidence regarding the use of Bosinji with acupuncture treatment in the treatment of patients with LHIVD. TRIAL REGISTRATION NUMBER:NCT03386149 (clinicaltrials.gov) and KCT0002848 (Clinical Research Information Service of the Republic of Korea).

Dataset Information

Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial.

Publications

Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial.

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