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Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial.

ABSTRACT: With growing evidence for the effectiveness of craniosacral therapy (CST) for pain management, the efficacy of CST remains unclear. This study therefore aimed at investigating CST in comparison with sham treatment in chronic nonspecific neck pain patients.A total of 54 blinded patients were randomized into either 8 weekly units of CST or light-touch sham treatment. Outcomes were assessed before and after treatment (week 8) and again 3 months later (week 20). The primary outcome was the pain intensity on a visual analog scale at week 8; secondary outcomes included pain on movement, pressure pain sensitivity, functional disability, health-related quality of life, well-being, anxiety, depression, stress perception, pain acceptance, body awareness, patients' global impression of improvement, and safety.In comparison with sham, CST patients reported significant and clinically relevant effects on pain intensity at week 8 (-21 mm group difference; 95% confidence interval, -32.6 to -9.4; P=0.001; d=1.02) and at week 20 (-16.8 mm group difference; 95% confidence interval, -27.5 to -6.1; P=0.003; d=0.88). Minimal clinically important differences in pain intensity at week 20 were reported by 78% within the CST group, whereas 48% even had substantial clinical benefit. Significant between-group differences at week 20 were also found for pain on movement, functional disability, physical quality of life, anxiety and patients' global improvement. Pressure pain sensitivity and body awareness were significantly improved only at week 8. No serious adverse events were reported.CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and the quality of life up to 3 months after intervention.

SUBMITTER: Haller H

PROVIDER: S-EPMC4894825 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial.

Haller Heidemarie H Lauche Romy R Cramer Holger H Rampp Thomas T Saha Felix J FJ Ostermann Thomas T Dobos Gustav G

The Clinical journal of pain 20160501 5

<h4>Objectives</h4>With growing evidence for the effectiveness of craniosacral therapy (CST) for pain management, the efficacy of CST remains unclear. This study therefore aimed at investigating CST in comparison with sham treatment in chronic nonspecific neck pain patients.<h4>Materials and methods</h4>A total of 54 blinded patients were randomized into either 8 weekly units of CST or light-touch sham treatment. Outcomes were assessed before and after treatment (week 8) and again 3 months later ...[more]

PMID: 26340656

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Project description:OBJECTIVES:To systematically assess the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. METHODS:PubMed, Central, Scopus, PsycInfo and Cinahl were searched up to August 2018. Randomized controlled trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for pain intensity and functional disability (primary outcomes) using Hedges' correction for small samples. Secondary outcomes included physical/mental quality of life, global improvement, and safety. Risk of bias was assessed using the Cochrane tool. RESULTS:Ten RCTs of 681 patients with neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included. CST showed greater post intervention effects on: pain intensity (SMD = -0.32, 95%CI = [- 0.61,-0.02]) and disability (SMD = -0.58, 95%CI = [- 0.92,-0.24]) compared to treatment as usual; on pain intensity (SMD = -0.63, 95%CI = [- 0.90,-0.37]) and disability (SMD = -0.54, 95%CI = [- 0.81,-0.28]) compared to manual/non-manual sham; and on pain intensity (SMD = -0.53, 95%CI = [- 0.89,-0.16]) and disability (SMD = -0.58, 95%CI = [- 0.95,-0.21]) compared to active manual treatments. At six months, CST showed greater effects on pain intensity (SMD = -0.59, 95%CI = [- 0.99,-0.19]) and disability (SMD = -0.53, 95%CI = [- 0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups. DISCUSSION:In patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain. PROTOCOL REGISTRATION AT PROSPERO:CRD42018111975.

Project description:BackgroundChronic neck pain is a prevalent condition adversely impacting patients' wellbeing in both life and work experience. Electro-thumbtack needle (ETN) therapy, combining acupuncture with transcutaneous stimulation, might be one of the effective complementary and alternative medicine (CAM) therapies in treating chronic neck pain, although the evidence is scarce. This study aims to estimate the efficacy and safety of ETN therapy for chronic neck pain.Methods and analysisThis is a sham-controlled, randomized clinical trial. A total of 180 subjects will be randomly allocated to either the ETN group or the sham ETN group. Treatment will be administrated three times a week for four consecutive weeks, with a 6-month follow-up. The primary outcome measure will be the Numerical Rating Scale for neck pain (NRS-NP) over a period of the 4 weeks. Secondary outcome measures include the Northwick Park Neck Pain Questionnaire (NPQ), Neck Disability Index (NDI), Patient Global Impression of Change (PGIC), patient expectation, and preference assessment. The chi-square test or Fisher's exact test will be used for proportions of participants having clinically meaningful improvement. Analysis of covariance or repeated-measures analysis of variance will be applied to examine changes in the outcome measures from baseline.DiscussionsThis prospective trial will contribute to evaluating the efficacy and safety of ETN in the treatment of chronic neck pain, with an intermediate-term follow-up. This study will provide further evidence for clinical neck pain management.Ethics and disseminationThis trial has been approved by the Research Ethical Committee of Guang'anmen Hospital (ethical approval number: 2021-039-KY-01). Recruitment began in March 2022 and will continue until December 2023. Dissemination plans include posters, WeChat, websites, and bulletin boards in hospital and communities.Clinical trial registrationThis trial is registered at ClinicalTrials.gov (identifier: NCT04981171).

Project description:BackgroundIn 2020, 203 million people experienced neck pain, with a higher prevalence in women. By 2050, it is predicted that neck pain will affect 269 million people, representing a 32.5% increase. Physical rehabilitation is often employed for the treatment of chronic non-specific neck pain (CNSNP) and the associated functional loss. Taping is frequently used as an adjunct treatment alongside primary physical rehabilitation. Unlike kinesio tape (KT), the therapeutic benefits of dynamic tape (DT) have not been thoroughly explored and documented in non-athletic conditions. Therefore, the aim of this trial was to determine the effects of DT on pain, disability, and overall well-being in individuals experiencing CNSNP.MethodsA prospective parallel-group active controlled trial was conducted at a single center, involving 136 patients with CNSNP, randomly allocated in a 1:1 ratio. The sham taping group (STC) received standard physiotherapy care (n = 67) alongside DT without tension, while the dynamic taping group (DTC) (n = 69) underwent standard cervical offloading technique with appropriate tension in addition to standard physiotherapy care. Demographic information and three patient-reported outcome measures (PROMs), namely the Neck Disability Index (NDI), Visual Analogue Scale (VAS), and the World Health Organization-Five Well-Being Index (WHO-5), were collected for each participant at three time points (baseline, four weeks post-taping, and four weeks follow-up).ResultsAt baseline, no significant differences were observed between the STC and DTC for any outcome measure. Notably, all three PROMs exhibited a significant improvement from baseline to four weeks post-intervention, with moderate to small effect sizes (NDI ηp2 = 0.21, VAS ηp2 = 0.23, and WHO-55 ηp2 = 0.05). The WHO-5 scores for both groups demonstrated improvement from baseline through follow-up (p < 0.001). The NDI and VAS scores ameliorated from baseline to the four weeks post-taping period, with marginal improvements observed during the four weeks follow-up.ConclusionThe incorporation of DT as an adjunct to standard physiotherapy care yielded enhancements in pain levels, functional disability, and well-being among patients with CNSNP when compared to the sham group. However, the sustainability of these improvements beyond the taping period lacks statistical significance and warrants further validation.

Project description:BackgroundPain is the primary symptom of chronic pancreatitis (CP) and remains a considerable therapeutic challenge. In patients with obstruction of the pancreatic duct, including stones and strictures, endoscopic treatment with or without preceding extracorporeal shock wave lithotripsy (ESWL) has been used for pancreatic duct decompression. The rationale for these procedures is based on the assumption that obstruction of the pancreatic duct leads to ductal hypertension and pain. However, clinical pain symptoms correlate poorly with pancreatic duct morphology, and the evidence for pancreatic duct decompression as an effective treatment for pain is based on case series and comparison between different procedures. No randomized, prospective, sham-controlled trials are currently available. The SCHOKE (Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis) trial is a randomized, sham-controlled trial designed to determine if pancreatic duct decompression is an effective treatment for pain in patients with CP.MethodsThe SCHOKE trial is a randomized, single-blind, parallel-group, sham-controlled trial designed to evaluate the effect of combined ESWL and endoscopic treatment for pain in patients with CP. In total, 106 adult patients with painful CP and pancreatic duct obstruction will be randomized to combined ESWL and subsequent endoscopic treatment or corresponding sham procedures. The primary outcome is pain relief during the 3-month postrandomization period as documented in a pain diary. Secondary outcomes include quality of life and functional scores, patient global impression of change, change in use of analgesics, frequency of hospitalization, and complications. Standard follow-up is at 3 and 6 months after randomization. In an experimental substudy, quantitative sensory testing obtained before and after intervention will be used to obtain information on central pain processing and to develop models for prediction of treatment outcome.DiscussionThe SCHOKE trial investigates if pancreatic duct decompression, obtained by combined ESWL and endoscopic treatment, is effective for pain treatment in patients with CP.Trial registrationClinicalTrials.gov, NCT03966781. Registered on May 25, 2019. Protocol date and version identifier: March 1, 2020; version 3.0.SponsorRupjyoti Talukdar, Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.

Project description:BackgroundChronic 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.Methods/designThis 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.DiscussionThe 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.Trial registrationThis study is registered with the United States National Institutes of Health Clinical Trials Registry: NCT01491321.

Dataset Information

Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial.

Publications

Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial.

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