Osteopathic Manual Treatment and Ultrasound Therapy for Chronic Low Back Pain: A Randomized Controlled Trial
ABSTRACT PURPOSE We studied the efficacy of osteopathic manual treatment (OMT) and ultrasound therapy (UST) for chronic low back pain. METHODS A randomized, double-blind, sham-controlled, 2 × 2 factorial design was used to study OMT and UST for short-term relief of nonspecific chronic low back pain. The 455 patients were randomized to OMT (n = 230) or sham OMT (n = 225) main effects groups, and to UST (n = 233) or sham UST (n = 222) main effects groups. Six treatment sessions were provided over 8 weeks. Intention-to-treat analysis was performed to measure moderate and substantial improvements in low back pain at week 12 (30% or greater and 50% or greater pain reductions from baseline, respectively). Five secondary outcomes, safety, and treatment adherence were also assessed. RESULTS There was no statistical interaction between OMT and UST. Patients receiving OMT were more likely than patients receiving sham OMT to achieve moderate (response ratio [RR] = 1.38; 95% CI, 1.16-1.64; P <.001) and substantial (RR = 1.41, 95% CI, 1.13-1.76; P = .002) improvements in low back pain at week 12. These improvements met the Cochrane Back Review Group criterion for a medium effect size. Back-specific functioning, general health, work disability specific to low back pain, safety outcomes, and treatment adherence did not differ between patients receiving OMT and sham OMT. Nevertheless, patients in the OMT group were more likely to be very satisfied with their back care throughout the study (P <.001). Patients receiving OMT used prescription drugs for low back pain less frequently during the 12 weeks than did patients in the sham OMT group (use ratio = 0.66, 95% CI, 0.43-1.00; P = .048). Ultrasound therapy was not efficacious. CONCLUSIONS The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.
SourceAvailable from: Francesco Cerritelli[Show abstract] [Hide abstract]
ABSTRACT: Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy of a specific technique or a pre-determined protocol. The protocol has been registered on ClinicalTrials.gov ( NCT02146677 ) on 20 May 2014.Trials 12/2015; 16(1):615. DOI:10.1186/s13063-015-0615-3 · 2.12 Impact Factor
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ABSTRACT: Nonspecific back pain is common, disabling, and costly. Therefore, we assessed effectiveness of osteopathic manipulative treatment (OMT) in the management of nonspecific low back pain (LBP) regarding pain and functional status.BMC Musculoskeletal Disorders 08/2014; 15(1):286. DOI:10.1186/1471-2474-15-286 · 1.90 Impact Factor
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ABSTRACT: Skeletal muscle functionality is governed by multiple stimuli including cytokines and biomechanical strain. Fibroblasts embedded within muscle connective tissue respond to biomechanical strain by secreting cytokines that induce myoblast differentiation and we hypothesize regulate myotube function. A coculture was established to allow crosstalk between fibroblasts in Bioflex wells, and myoblasts on non-deformable coverslips situated above Bioflex wells. Cyclic-short duration strain (CSDS) modeling repetitive stress/injury, acyclic long-duration strain (ALDS) modeling manipulative therapy, and combined strain paradigms (CSDS+ALDS) were applied to fibroblasts. Non-strained myoblasts in uniculture and coculture served as controls. After fibroblasts had induced myoblast differentiation, myotube contraction was assessed by perfusion of ACh[10(-11)-10(-3M)] and KCl[10(-2M)]. CSDS-fibroblasts increased myotube contractile sensitivity versus uniculture (P<0.05). As contraction is dependent upon ACh binding, expression and clustering of nicotinic receptors (nAChRs) were measured. CSDS-fibroblasts increased nAChR expression (P<0.05) which correlated with myotube contraction. ALDS-fibroblast did not significantly affect contraction nor nAChR expression. Agrin-treated myotubes were then used to design a computer algorithm to identify αBGT-stained nAChR clusters. ALDS-fibroblasts increased nAChR clustering (P<0.05); while CSDS-fibroblasts disrupted clusters from forming. CSDS-fibroblasts produced nAChRs preferentially located in non-clustered regions (P<0.05). Strain-activated fibroblasts mediate myotube differentiation with multiple functional phenotypes. Similar to muscle injury, CSDS-fibroblasts disrupted nAChR clusters and hypersensitized myotube contraction, while ALDS-fibroblasts aggregated nAChRs in large clusters which may have important clinical implications. Cellular strategies aimed at improving muscle functionality, such as through biomechanical strain vehicles that activate fibroblasts to stabilize neuromuscular junctions on nearby skeletal muscle may serve as novel targets in neuromuscular disorders.AJP Cell Physiology 08/2014; 307(8). DOI:10.1152/ajpcell.00335.2013 · 3.67 Impact Factor