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.

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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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.

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:BackgroundDegenerative 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/designThis 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.DiscussionThis 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 registrationClinical Research Information Service of Republic of Korea (CRIS- KCT0004804), March 6, 2020.

Project description:BackgroundCentral obesity is considered as a significant health threat to individuals. Scientific research has demonstrated that intra-abdominal fat accumulation is associated with higher metabolic and cardiovascular disease risks independent of Body Mass Index (BMI). This study aimed to evaluate the efficacy and safety of electro-acupuncture in treating central obesity compared with sham acupuncture.MethodThis was a patient-assessor blinded, randomized, sham-controlled clinical trial. One hundred sixty eight participants aged between 18 and 65 years old with BMI ≥ 25 kg/m2 and waist circumference (WC) of men ≥ 90 cm / women ≥ 80 cm were enrolled and allocated to the acupuncture or sham acupuncture group equally. For the acupuncture group, disposable acupuncture needles were inserted into eight body acupoints, including Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) with electrical stimulation. For the control group, Streitberger's non-invasive acupuncture needles were utilized at the same acupoints with identical stimulation modalities. The treatment duration was 8 weeks with 2 sessions per week and the follow-up period was 8 weeks. The primary outcome was the change in WC before and after the treatment. The secondary outcomes were the changes in hip circumference, waist-to-hip circumference ratio, BMI, and body fat percentage during the treatment and follow-up period.ResultsThe acupuncture group displayed a significant change in WC compared to the sham group both treatment and follow-up period (MD = -1.1 cm, 95% CI = -2.8 to 4.1). Significant change in body fat percentage was recorded for both groups after treatment but no significance was observed during the follow-up period (MD = -0.1%, 95% CI = -1.9 to 2.2). The changes in hip circumference were also significant both treatment and follow-up period for the acupuncture group (MD = -2.0 cm, 95% CI = -3.7 to -1.7). Compared with sham acupuncture, the body weight (MD = -1 kg, 95% CI = -3.3 to 5.3), BMI (MD = -0.5, 95% CI = -0.7 to 1.9) also decreased significantly within and between groups. The incidence of adverse events was similar in the two groups.ConclusionThis study provided evidence that electro-acupuncture could be effective in treating central obesity by reducing WC, hip circumference, body weight, BMI, and waist-to-hip circumference ratio.Trial registrationClinicalTrials.gov Identifier: NCT03815253, Registered 24 Jan 2019.

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.

Background

Method/design

Discussion

Trial registration

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.

Similar Datasets

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