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Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Thunder-fire moxibustion originated in China and contains traditional Chinese medicine. It can produce strong firepower, infrared thermal radiation, and medicinal effects when burning on the acupoints. Thunder-fire moxibustion is commonly used in patients with neck pain, but its efficacy has rarely been systematically demonstrated. We designed a randomized trial of thunder-fire moxibustion on cervical spondylotic radiculopathy (CSR) to investigate whether it is more effective than ibuprofen sustained-release capsules. METHODS:One hundred patients will be recruited and randomly divided into thunder-fire moxibustion and ibuprofen groups. The intervention consists of ten treatments and will last for 2 weeks. The Yasuhisa Tanaka 20 Score Scale is used as the primary outcome measure. It contains a combination of the self-conscious symptom in patients, objective clinical evaluation from doctors, and social evaluation (the ability to work and live). The objective and comprehensive evaluation of CSR patients before and after treatment is particularly needed. The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2), Neck Disability Index score scale (NDI), and the Quality of Life Assessment (SF-36) are applied as secondary outcome measures. The assessment will take place at the baseline and the first and second weekends of treatment. If an adverse event (AEs) occurs, it will be reported. DISCUSSION:The aim of this trial is to determine whether thunder-fire moxibustion is more effective than ibuprofen in the treatment of patients with CSR. TRIAL REGISTRATION:Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR1800018820. Registered on 11 October 2018.

SUBMITTER: Huang Y

PROVIDER: S-EPMC7006377 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial.

Huang Yunxuan Y Zhang Jiabi J Xiong Buhui B Huang Ruina R Zhao Wenjing W Zhou Mengxue M Chen Qi Q Xu Danghan D Chen Xinghua X

Trials 20200206 1

<h4>Background</h4>Thunder-fire moxibustion originated in China and contains traditional Chinese medicine. It can produce strong firepower, infrared thermal radiation, and medicinal effects when burning on the acupoints. Thunder-fire moxibustion is commonly used in patients with neck pain, but its efficacy has rarely been systematically demonstrated. We designed a randomized trial of thunder-fire moxibustion on cervical spondylotic radiculopathy (CSR) to investigate whether it is more effective ...[more]

PMID: 32029008

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Project description:BackgroundCervical spondylosis is a very common disorder and cervical spondylotic radiculopathy (CSR) is the most common form of spinal degenerative disease. Its clinical manifestations focus on pain and numbness of the neck and arm as well as restricted movement of the neck, which greatly affect the patient's life and work. The orthopedic of traditional Chinese medicine (TCM) theory holds that the basic pathologic change in spinal degenerative diseases is the imbalance between the dynamic system and the static system of the cervical spine. Based on this theory, some Chinese physicians have developed a balance chiropractic therapy (BCT) to treat CSR, which has been clinically examined for more than 50 years to effectively cure CSR. The purpose of this study is to evaluate the therapeutic effect and safety of BCT on CSR and to investigate the mechanism by which the efficacy is achieved.Methods/designWe propose a multicenter, parallel-group, randomized controlled trial to evaluate the efficacy and safety of BCT for CSR. Participants aged 18 to 65 years, who are in conformity with the diagnostic criteria of CSR and whose pain score on a Visual Analog Scale (VAS) is more than 4 points and less than 8 points, will be included and randomly allocated into two groups: a treatment group and a control group. Participants in the treatment group will be treated with BCT, while the control group will receive traction therapy (TT). The primary outcome is pain severity (measured with a VAS). Secondary outcomes will include cervical curvature (measured by the Borden Index), a composite of functional status (measured by the Neck Disability Index, NDI), patient health status (evaluated by the SF-36 health survey) and adverse events (AEs) as reported in the trial.DiscussionIf BCT can relieve neck pain without adverse effects, it may be a novel strategy for the treatment of CSR. Furthermore, the mechanism of BCT for CSR will be partially elucidated.Trial registrationClinical Trials.gov Identifier: NCT02705131 . Registered on 9 March 2016.

Project description:BackgroundLumbar disc herniation (LDH) is a common disease seen in orthopedics; it is caused by nucleus pulposus herniation. Its clinical manifestations are low back pain, radiating pain of the lower limbs, and cauda equina symptoms that seriously affect patients' quality of life. At present, oral analgesics are commonly used in the treatment of LDH; but they can produce gastrointestinal reactions and other side effects. Thunder-fire moxibustion is a method that is widely used in China to treat pain syndromes. This study aimed to design a randomized controlled trial to explore the effectiveness and safety of thunder-fire moxibustion in the treatment of lumbar disc herniation.MethodsNinety patients will be enrolled and randomly divided into one of two groups: the thunder-fire moxibustion group and the acetaminophen group. The thunder-fire moxibustion group will be treated with moxa sticks at BL25, GV3, BL23, and GV4; and after 15 min of local whirling moxibustion, the contralateral acupoints will be treated with moxibustion for 15 min. The study period will include two 10-day courses of treatment, for a total study duration of 20 days. The acetaminophen group participants will take one acetaminophen sustained-release tablet twice a day for the duration of the study period. In contrast, the thunder-fire moxibustion group participants will be treated with thunder-fire moxibustion every other day for 30 min. The primary outcome will be the Japanese Orthopedic Association (JOA) score. Visual analog scale (VAS) and Oswestry Disability Index (ODI) will be used as the secondary outcome measures. Adverse events (AEs) will also be recorded. Assessments will be conducted at baseline, the end of the first and second courses of treatment.DiscussionThis study will determine whether thunder-fire moxibustion is more effective and safer than acetaminophen in the treatment of patients with LDH.Trial registrationChinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR2000036079.

Project description:BackgroundCervical spondylosis (CS) refers to the degenerative changes in the cervical spinal column, which affect the majority of middle-aged and elderly people. Thunder-fire moxibustion originated from thunder-fire miraculous needle, which has been applied widely for treating pain syndromes for thousands of years. The aim of our research is to provide evidence to assess the efficacy and safety of thunder-fire moxibustion in treating CS. Methods and analysis. Retrieved literature databases included Cochrane Library, MEDLINE, Web of Science, EBSCO, EBASE, Springer, PubMed, WFDP, CNKI, VIP, and CBM. The period of retrieval was from the establishment of the database to December 2018. Randomized controlled trials which compared thunder-fire moxibustion and other therapies in CS were included. The quality of inclusive trials was accessed though a Cochrane risk of bias tool. According to the test results of heterogeneity, a random effect model or fixed effect model was used to analyze the data.ResultsMeta-analysis was conducted for the total effective rate of thunder-fire moxibustion, traditional Chinese medicine syndrome score, pain score, satisfaction score, and score of the symptoms and functional rehabilitation of cervical vertigo. The analysis results were as follows: compared with other therapies, the efficacy of thunder-fire moxibustion was statistically significant, total effective rate increased (OR = 2.48; 95% CI [1.80, 3.41]; P < 0.00001), traditional Chinese medicine syndrome score decreased (SMD = -3.05; 95% CI[-4.18, -1.93]; P < 0.00001), traditional Chinese medicine syndrome score decreased (SMD = -3.05; 95% CI[-4.18, -1.93]; P < 0.00001), traditional Chinese medicine syndrome score decreased (SMD = -3.05; 95% CI[-4.18, -1.93]; P < 0.00001), traditional Chinese medicine syndrome score decreased (SMD = -3.05; 95% CI[-4.18, -1.93]; P < 0.00001), traditional Chinese medicine syndrome score decreased (SMD = -3.05; 95% CI[-4.18, -1.93].ConclusionBased on the existing evidence, the curative effect and safety of thunder-fire moxibustion on CS were statistically significant. We should interpret the results scrupulously because of the low evidence level. Large-scale, high-quality, rigorous RCTs with long-term follow-up should be performed in the future.

Project description:BackgroundLow back pain (LBP) is considered the leading cause of people living with years of disability worldwide. Notably, thunder-fire moxibustion (TFM) is a new type of moxibustion, which has been widely applied to treat pain syndromes for thousands of years. This study aims to provide evidence to evaluate the effect and safety of TFM in treating LBP.MethodsA systematic search of PubMed, Web of Science, the Cochrane Library, Embase, EBSCO, CNKI, Wanfang Data, CBM, and VIP (until April 2021) was used to identify studies reporting pain intensity, disability, Japanese Orthopedic Association (JOA) score, and quality of life in patients with LBP. Randomized controlled trials (RCTs), which compared TFM and other therapies in LBP, were included. Meanwhile, methodological quality was evaluated using the Cochrane criteria for risk of bias, and the level of evidence was rated utilizing the GRADE approach.ResultsTwenty-one RCTs, including 2198 patients, satisfied the inclusion criteria. Compared with other therapies, the effect of TFM was statistically significant, pain intensity decreased (SMD = 0.94; 95% CI (0.74, 1.14); p < 0.00001), disability improved (SMD = 1.39; 95% CI (0.19, 2.59); p=0.02), and the JOA score increased (SMD = -1.34; 95% CI (-1.88, -0.80); p < 0.00001). It was also reported that the patient's quality of life improved after treatment for a period of 4 weeks (SMD = -0.29; 95% CI (-0.42, -0.16); p < 0.0001) and after a follow-up of 1 month (SMD = -0.20; 95% CI (-0.34, -0.07); p=0.003). The evidence level of the results was determined to be very low to low.ConclusionsBased on the existing evidence, it can be concluded that TFM may have a better effect than other treatments on LBP. However, it is not yet possible to assess the safety level of TFM therapy. Due to the universal low quality of the eligible trials and low evidence level, rigorously designed large-scale RCTs must be conducted in order to further confirm the results in this review.

Project description:IntroductionCervical spondylotic radiculopathy (CSR) is the most common pattern of cervical spondylosis, which is a serious and common degenerative disease. Both acupotomy and acupuncture have been widely used clinically to treat CSR in China with satisfied efficacy. However, there is no systematic review comparing the effectiveness of these two therapies. The aim of this study is to compare the therapeutic efficacy and safety between acupotomy and acupuncture for patients with CSR to provide evidence for clinical practice.Methods and analysisThe following electronic databases will be searched: Web of Science, PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure , China Biology Medicine disc, Wanfang Database and Chinese Scientific Journal Database (VIP). The randomised controlled trials of acupotomy versus acupuncture with/without additional treatment for CSR will be searched in the databases from their inception to December 2018 by two researchers independently. Visual analogue scale, symptom score and neck disability index will be assessed as the primary outcomes. The total effective rate, curative rate, adverse events and amount of rescue medication used will be assessed as the secondary outcomes. The Review Manager 5.3 will be used for meta-analysis and the evidence level will be assessed by using the method for Grading of Recommendations Assessment, Development and Evaluation. Continuous outcomes will be presented as the weighted mean difference or standardised mean difference with 95% CI, whereas dichotomous data will be expressed as relative risk with 95%?CI. If the included studies have existing heterogeneity (p<0.05), then a random-effects model will be used. Otherwise, we will calculate using a fixed-effects model.Ethics and disseminationEthical approval is not required because no primary data are collected. This review will be published in a peer-reviewed journal and will be presented at an international academic conference for dissemination.Prospero registration numberCRD42019117348.

Project description:Sagittal cervical alignment is a clinically related feature in patients suffering from chronic cervical spondylotic radiculopathy (CSR). We designed this randomized trial to explore the effects of cervical lordosis (CL) correction in thirty chronic lower CSR patients with CL < 20°. Patients were assigned randomly into two equal groups, study (SG) and control (CG). Both groups received neck stretching and exercises and infrared radiation; additionally, the SG received cervical extension traction. Treatments were applied 3× per week for 10 weeks after which groups were followed for 3 months and 2 years. The amplitude of dermatomal somatosensory evoked potentials (DSSEPS), CL C2−C7, and pain scales (NRS) were measured. The SG had an increase in CL post-treatment (p < 0.0001), this was maintained at 3 months and 2 years. No statistical improvement in CL was found for the CG. A significant reduction in NRS for SG after 10 weeks of treatment with non-significant loss of change at 3 months and continued improvement at 2 years was found. CG had less significant improvement in post-treatment NRS; the 3-month and 2-year measures revealed significant worsening in NRS. An inverse linear correlation between increased CL and NRS was found (r = −0.49; p = 0.005) for both groups initially and maintained in SG at the final 2-year follow-up (r = −0.6; p = 0.01). At 10 weeks, we found significant improvements in DSSEPS for both groups (p < 0.0001). We identified a linear correlation between initial DSSEPs and CL for both groups (p < 0.0001), maintained only in the SG at the final follow-up for all levels (p < 0.0001). Improved CL in the SG correlated with significant improvements in nerve root function and pain rating in patients with CSR at short and long-term follow-up. These observed effects indicate that clinicians involved in the treatment of patients with symptoms of cervical degenerative disorders should add sagittal curve correction to their armamentarium of rehabilitation procedures for relevant patient populations.

Project description:Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy.A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients from five sites across China and diagnosed with cervical radiculopathy, according to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck for at least 2 weeks (neck disability index score 25 or more) and accompanying arm pain that radiates distally from the elbow. Qualified participants will be randomly allocated into two groups: Qishe Pill group and placebo group. The prescription of the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive days. The primary outcome is pain severity. Secondary outcomes are functional status, patient satisfaction, and adverse events as reported in the trial.Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to improve on the various symptoms of cervical radiculopathy, especially for neck pain. As it has a potential benefit in treating patients with neck pain, we designed a double-blind, prospective, randomized-controlled trial and would like to publish the results and conclusions later. If Qishe Pill can alleviate neck pain without adverse effects, it may be a unique strategy for the treatment of cervical radiculopathy.This study is registered at ClinicalTrials.gov, NCT01274936.

Dataset Information

Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial.

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Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial.

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