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Effects of spinal manipulation and pain education on pain in patients with chronic low back pain: a protocol of randomized sham-controlled trial.

ABSTRACT: Background:Low back pain (LBP) has more than doubled in the last 20 years, probably influenced by biopsychosocial factors. Noninvasive treatments have been applied in individuals with chronic nonspecific LBP as spinal manipulation and pain education. However, the neurophysiological effects of these treatments are not clear. The aim of this research is to verify the pain control, functional and neurophysiological effects of spinal manipulation, and pain education in individuals with chronic nonspecific LBP. Methods:This research is an assessor and subject blinded, 2-arm, randomized sham-controlled trial and will be conducted at Governador Celso Ramos Hospital, Florianópolis, Brazil. One hundred and twenty-eight individuals with chronic nonspecific LBP will be recruited for this study. Individuals will be randomly allocated into one of the two groups: (1) spinal manipulation plus pain education or (2) sham treatment plus pain education. Each group will be received two sessions per week over six weeks of treatment. The measures will be applied at baseline, six weeks, and three months after randomization. The primary outcome will be a pain intensity at six weeks postrandomization. Secondary outcomes will be pressure pain threshold, disability, fear and avoidance beliefs, kinesiophobia, risk of poor prognosis, quality of life, and inflammatory biomarkers. Discussion:Evidence has shown that psychosocial factors are more involved in chronic pain than we thought a few years ago. Then, studies investigating both functional and neurophysiological effects of these interventions to evaluate the effectiveness of treatment and what else is happening at the cellular level in nervous system are needed.

SUBMITTER: Vier C

PROVIDER: S-EPMC6160616 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Effects of spinal manipulation and pain education on pain in patients with chronic low back pain: a protocol of randomized sham-controlled trial.

Vier Clécio C Bracht Marcelo Anderson MA Neves Marcos Lisboa ML Junkes-Cunha Maíra M Santos Adair Roberto Soares ARS

Integrative medicine research 20180510 3

<h4>Background</h4>Low back pain (LBP) has more than doubled in the last 20 years, probably influenced by biopsychosocial factors. Noninvasive treatments have been applied in individuals with chronic nonspecific LBP as spinal manipulation and pain education. However, the neurophysiological effects of these treatments are not clear. The aim of this research is to verify the pain control, functional and neurophysiological effects of spinal manipulation, and pain education in individuals with chron ...[more]

PMID: 30271716

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Project description:There have been no full-scale trials of the optimal number of visits for the care of any condition with spinal manipulation.To identify the dose-response relationship between visits to a chiropractor for spinal manipulation and chronic low back pain (cLBP) outcomes and to determine the efficacy of manipulation by comparison with a light massage control.Practice-based randomized controlled trial.Four hundred participants with cLBP.The primary cLBP outcomes were the 100-point modified Von Korff pain intensity and functional disability scales evaluated at the 12- and 24-week primary end points. Secondary outcomes included days with pain and functional disability, pain unpleasantness, global perceived improvement, medication use, and general health status.One hundred participants with cLBP were randomized to each of four dose levels of care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for 6 weeks. At sessions when manipulation was not assigned, they received a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks.For the primary outcomes, mean pain and disability improvement in the manipulation groups were 20 points by 12 weeks and sustainable to 52 weeks. Linear dose-response effects were small, reaching about two points per six manipulation sessions at 12 and 52 weeks for both variables (p<.025). At 12 weeks, the greatest differences from the no-manipulation control were found for 12 sessions (8.6 pain and 7.6 disability points, p<.025); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points, p<.025).The number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.

Project description:INTRODUCTION:Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10?kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10?kHz SCS for this population. METHODS:This is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10?kHz SCS plus usual care (intervention group) or to sham 10?kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5?L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1?month, 3?months and 6?months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient. DISCUSSION:The outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10?kHz SCS for use in patients with CNLBP who have not had surgery. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03470766. Registered on 20 March 2018. DISCLAIMER:The views expressed here are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The NIHR had no role in the study design, writing of the manuscript or the decision to submit for publication. ROLES AND RESPONSIBILITIES:AK, SP, DP, SW, RST, AC, SE, LM, RD and JF all contributed to the trial design and to securing trial funding. AK, JR, SP, DP, and SE are involved in the recruitment, the intervention and the follow-up. SW will perform data collection and analysis. RST will be responsible for the statistical analysis, and RD will be responsible for the health economic analysis. All authors read and approved the final manuscript.

Project description:BackgroundChronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations.Methods/designThis study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records.DiscussionThis study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities.Trial registrationClinicalTrials.gov: NCT02224183.

Project description:Chronic non-specific low back pain is the most common medical problem for which patients seek complementary and alternative medical treatment, including bee venom acupuncture. However, the effectiveness and safety of such treatments have not been fully established by randomized clinical trials. The aim of this study is to determine whether bee venom acupuncture is effective for improving pain intensity, functional status and quality of life of patients with chronic non-specific low back pain.This study is a randomized, double-blinded, sham-controlled clinical trial with two parallel arms. Fifty-four patients between 18 and 65 years of age with non-radicular chronic low back pain experiencing low back pain lasting for at least the previous three months and ? 4 points on a 10-cm visual analog scale for bothersomeness at the time of screening will be included in the study. Participants will be randomly allocated into the real or sham bee venom acupuncture groups and treated by the same protocol to minimize non-specific and placebo effects. Patients, assessors, acupuncturists and researchers who prepare the real or sham bee venom acupuncture experiments will be blinded to group allocation. All procedures, including the bee venom acupuncture increment protocol administered into predefined acupoints, are designed by a process of consensus with experts and previous researchers according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Bothersomeness measured using a visual analogue scale will be the primary outcome. Back pain-related dysfunction, pain, quality of life, depressive symptoms and adverse experiences will be measured using the visual analogue scale for pain intensity, the Oswestry Disability Index, the EuroQol 5-Dimension, and the Beck's Depression Inventory. These measures will be recorded at baseline and 1, 2, 3, 4, 8 and 12 weeks.The results from this study will provide clinical evidence on the efficacy and safety of bee venom acupuncture in patients with chronic non-specific low back pain.This study is registered with the United States National Institutes of Health Clinical Trials Registry: NCT01491321.

Dataset Information

Effects of spinal manipulation and pain education on pain in patients with chronic low back pain: a protocol of randomized sham-controlled trial.

Publications

Effects of spinal manipulation and pain education on pain in patients with chronic low back pain: a protocol of randomized sham-controlled trial.

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