Osteopathic manipulative treatment, pain neuroscience education and clinical hypnosis as pain management interventions in chronic low back pain: a randomized sham-controlled feasibility pilot trial.

Chronic non-specific low back pain (CNLBP) affects millions worldwide and is a major contributor to disability and healthcare costs. Pain neuroscience education (PNE) aims to improve understanding of pain mechanisms, reduce maladaptive beliefs, and promote active coping strategies. To evaluate the effectiveness of pain neuroscience education (PNE) on pain intensity, frequency, disability, and quality of life in adults with chronic non-specific low back pain (CNLBP). Umbrella review (UR) (PROSPERO, CRD42023382825). A comprehensive search was conducted in 8 databases, covering April 2014 to April 2024. Inclusion: adults with CNLBP, PNE interventions provided by healthcare professionals, and systematic reviews (SRs) of randomized controlled trials (RCTs). studies focusing solely on psychological or physical aspects. Data on pain intensity, pain frequency, disability, and quality of life measured using validated scales were extracted. The results were shown according to the type of intervention and the period evaluated (short or long-term). Nineteen SRs with 5200 participants were included. Five studies (1120 participants) showed significant short-term pain reductions with PNE alone but inconsistent long-term effects. Four studies (860 participants) showed enhanced pain reduction with PNE combined with physiotherapy or exercise. Ten studies (3220 participants) indicated that combining PNE with other educational and biopsychosocial interventions led to more sustained pain reductions. Six studies were included in a quantitative review assessing PNE combined with exercise, with MD (mean difference) for pain, -1.11 (95 % CI, -1.57 to -0.66). For disability, SMD (standardized mean difference) was -0.42 (95 % CI, -1.09 to 0.24). PNE decreases pain intensity in CNLBP, with improved outcomes when combined with physiotherapy, exercise, or additional educational and biopsychosocial strategies. A multidisciplinary approach, including PNE, is recommended. Further research using standardized tools and diverse populations is needed to enhance the efficacy and generalizability of PNE interventions. This umbrella review (UR) demonstrates that PNE can effectively reduce pain intensity and disability in CNLBP, especially when combined with physiotherapy, exercise, or biopsychosocial approaches, and it launches new hypotheses about how PNE may work. Adding PNE to different interventions may enhance participant outcomes and support more sustained pain relief. PROSPERO, CRD42023382825.

BackgroundPatients with chronic low back pain (CLBP) suffer with functional, social, and psychological aspects. There is a growing number of studies with multimodal approaches in the management of these patients, combining physical and behavioral therapies such as osteopathic manipulative treatment, associating pain education and clinical hypnosis. The aim of the present study will be to evaluate the effects of osteopathic manipulative treatment (OMT) associated with pain neuroscience education (PNE) and clinical hypnosis (CH) on pain and disability in participants with CLBP compared to PNE, CH, and sham therapy.MethodsA randomized controlled clinical trial will be conducted in participants aged 20–60 years with CLBP who will be divided into two groups. Group 1 will receive PNE and CH associated with OMT, and G2 will receive PNE, CH, and sham therapy. In both groups, 4 interventions of a maximum of 50 min and with an interval of 7 days will be performed. As primary outcomes, pain (numerical pain scale), pressure pain threshold (pressure algometer), and disability (Oswestry Disability Questionnaire) will be evaluated and, as a secondary outcome, global impression of improvement (Percent of Improvement Scale), central sensitization (Central Sensitization Questionnaire), biopsychosocial aspects (Start Beck Toll Questionnaire), and behavior of the autonomic nervous system (heart rate variability) will be assessed. Participants will be evaluated in the pre-intervention moments, immediately after the end of the protocol and 4 weeks after the procedures. Randomization will be created through a simple randomized sequence and the evaluator will be blinded to the allocation of intervention groups.DiscussionThe guidelines have been encouraging multimodal, biopsychosocial approaches for patients with CLBP; in this sense, the results of this study can help clinicians and researchers in the implementation of a model of treatment strategy for these patients. In addition, patients may benefit from approaches with minimal risk of deleterious effects and low cost. In addition, it will enable the addition of relevant elements to the literature, with approaches that interact and do not segment the body and brain of patients with CLBP, allowing new studies in this scenario.Trials registrationDate: September 4, 2021/Number: NCT05042115.

Osteopathic manipulative treatment (OMT) is frequently offered to people with nonspecific low back pain (LBP) but never compared with sham OMT for reducing LBP-specific activity limitations. To compare the efficacy of standard OMT vs sham OMT for reducing LBP-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP. This prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial recruited participants with nonspecific subacute or chronic LBP from a tertiary care center in France starting February 17, 2014, with follow-up completed on October 23, 2017. Participants were randomly allocated to interventions in a 1:1 ratio. Data were analyzed from March 22, 2018, to December 5, 2018. Six sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by nonphysician, nonphysiotherapist osteopathic practitioners. The primary end point was mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index (score range, 0-100). Secondary outcomes were mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leaves, as well as number of LBP episodes at 12 months; and consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months. Overall, 200 participants were randomly allocated to standard OMT and 200 to sham OMT, with 197 analyzed in each group; the median (range) age at inclusion was 49.8 (40.7-55.8) years, 235 of 394 (59.6%) participants were women, and 359 of 393 (91.3%) were currently working. The mean (SD) duration of the current LBP episode was 7.5 (14.2) months. Overall, 164 (83.2%) patients in the standard OMT group and 159 (80.7%) patients in the sham OMT group had the primary outcome data available at 3 months. The mean (SD) Quebec Back Pain Disability Index scores for the standard OMT group were 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months, and in the sham OMT group were 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months. The mean reduction in LBP-specific activity limitations at 3 months was -4.7 (95% CI, -6.6 to -2.8) and -1.3 (95% CI, -3.3 to 0.6) for the standard OMT and sham OMT groups, respectively (mean difference, -3.4; 95% CI, -6.0 to -0.7; P = .01). At 12 months, the mean difference in mean reduction in LBP-specific activity limitations was -4.3 (95% CI, -7.6 to -1.0; P = .01), and at 3 and 12 months, the mean difference in mean reduction in pain was -1.0 (95% CI, -5.5 to 3.5; P = .66) and -2.0 (95% CI, -7.2 to 3.3; P = .47), respectively. There were no statistically significant differences in other secondary outcomes. Four and 8 serious adverse events were self-reported in the standard OMT and sham OMT groups, respectively, though none was considered related to OMT. In this randomized clinical trial of patients with nonspecific subacute or chronic LBP, standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable. ClinicalTrials.gov Identifier: NCT02034864.

Context: The United States opioid epidemic has been an ongoing public health crisis. Nationally, maternal opioid use resulted in 82% increase in Neonatal Abstinence Syndrome (NAS), from 2010 to 2017. The opioid withdrawal process of NAS can lead to somatic dysfunctions. Osteopathic Manipulative Treatment (OMT) may decrease muscular and fascial strain in the body and provide relaxation to the NAS neonate. Objectives: The objectives of this study were to compare the length of hospital stay (LOS) of NAS neonates who received OMT, and neonates given standard medical care without OMT and to evaluate the change in weight of the two groups. Methods: This was a retrospective cohort study of NAS neonates who received either OMT added to standard medical care or standard medical care alone at Berkshire Medical Center (BMC) in Pittsfield, Massachusetts from January 1, 2013, to December 31, 2018. IRB exemption was obtained. Information was obtained from the electronic medical records. Inclusion criteria were neonates delivered at BMC and diagnosed with NAS. Exclusion criteria were neonates transferred to a tertiary care facility. Data was separated into two groups, OMT and standard medical care only. Records were reviewed for LOS and change in weight. The de-identified data was analyzed and compared via T-tests. Results: A total of 175 neonates coded for NAS during the study period, with 2 neonates excluded for transfer, leaving 173 (98.86%) neonates meeting the inclusion criteria. Of the 173 neonates 40 (23.12%) received OMT and 133 (76.88%) received standard medical care only. The LOS for all subjects ranged from 2 to 62 days (M=17.06, SD=10.48). In the OMT group, the LOS ranged from 3 to 45 days (M=17.40, SD=14.8). In the standard medical care-only group the LOS ranged from 2 to 62 days (M=16.61, SD=13.1). There was no significant difference in LOS between the OMT and standard medical care-only groups, t (173) = 0.73, p= 0.649. The change in weight for all subjects ranged from a loss of 15.7 ounces to a gain of 54.1 ounces (M=+7.00, SD=14.12) with an average daily weight gain of 0.4 ounces. In the OMT group the change in weight ranged from a loss of 13.9 ounces to a gain of 51.4 ounces (M=+7.00, SD=11.4) with an average daily weight gain of 0.4 ounces. In the standard medicalcare-only group the change in weight ranged from a loss of 15.7 ounces to a gain of 54.1 ounces (M=+6.40, SD=9.19) with an average daily weight gain of 0.4 ounces. There was no significant difference in weight change between the OMT and standard medical care-only groups, t(170) = 0.03, p= 0.791. Seven providers provided osteopathic consultation and treatment in the OMT group. We reject our hypotheses that there is an association between LOS or weight change in NAS neonates treated with OMT compared to standard medical care only. Conclusion: OMT has previously been shown to have similar or beneficial outcomes to standard medical care. In this study, a direct relationship between LOS or change in weight between NAS neonates treated with OMT compared to standard medical care alone was not found. The findings showed similar low and high ranges in the OMT group compared to the standard medical care only group, suggesting that OMT is a safe option for NAS neonates.

Total knee arthroplasty (TKA) is widely regarded as one of the most common and successful orthopaedic procedures in the United States, specifically in regard to the treatment of end-stage osteoarthritis of the knee. However, pain and range of motion (ROM) restrictions continue to burden patients in the acute postoperative period following TKA. Osteopathic manipulative treatment (OMT) is a safe and non-invasive therapy utilized by osteopathic physicians to treat and heal dysfunctions of the musculoskeletal system. The effectiveness of OMT in enhancing postoperative recovery remains a subject of ongoing debate. This meta-analysis investigates the efficacy of OMT in creating a difference in pain, measured on the numeric rating scale, and ROM in flexion in the acute postoperative period following TKA. Three randomized controlled trials (RCTs) with a total of 153 patients, 74 of them receiving OMT and 79 not receiving OMT, were identified and included in this meta-analysis. In regard to postoperative pain, the mean difference between OMT and non-OMT groups, using the random-effects model, was -0.59 (-1.96; 0.78). This mean difference favors a slightly lower postoperative pain level in the OMT group; however, this fails to reach statistical significance. Moderate to high heterogeneity was appreciated between studies (I²=50.8%), but this failed to reach statistical significance (p=0.1309). In regard to postoperative ROM in flexion, the mean difference between OMT and non-OMT groups, using the random-effects model, was 5.57 (-15.57; 26.70). This mean difference favors a slightly greater postoperative ROM in the OMT group; however, this fails to reach statistical significance. High heterogeneity was appreciated between studies (I²=89.9%), which proved to be statistically significant (p<0.0001). Given the overall similarity in patient recovery metrics, the effectiveness of OMT in improving postoperative pain and ROM following TKA cannot be proven at this time. However, the potential for clinical significance and minor improvements should be considered. Additional high-quality RCTs and comprehensive meta-analyses are needed to further define the role of OMT in the postoperative period following orthopaedic procedures.

Rehabilitation with osteopathic manipulative treatment after lumbar disc surgery: A randomised, controlled pilot study

Reply to "Pain neuroscience education for fibromyalgia syndrome".

The evidence for the efficacy of osteopathic manipulative treatment (OMT) in the management of low back pain (LBP) is considered weak by systematic reviews, because it is generally based on low-quality studies. Consequently, there is a need for more randomized controlled trials (RCTs) with a low risk of bias. The objective of this study is to evaluate the efficacy of an OMT intervention for reducing pain and disability in patients with chronic LBP. A single-blinded, crossover, RCT was conducted at a university-based health system. Participants were adults, 21-65 years old, with nonspecific LBP. Eligible participants (n=80) were randomized to two trial arms: an immediate OMT intervention group and a delayed OMT (waiting period) group. The intervention consisted of three to four OMT sessions over 4-6weeks, after which the participants switched (crossed-over) groups. The primary clinical outcomes were average pain, current pain, Patient-Reported Outcomes Measurement Information System (PROMIS)29 v1.0 pain interference and physical function, and modified Oswestry Disability Index (ODI). Secondary outcomes included the remaining PROMIS health domains and the Fear Avoidance Beliefs Questionnaire (FABQ). These measures were taken at baseline (T0), after one OMT session (T1), at the crossover point (T2), and at the end of the trial (T3). Due to the carryover effects of OMT intervention, only the outcomes obtained prior to T2 were evaluated utilizing mixed-effects models and after adjusting for baseline values. Totals of 35 and 36 participants with chronic LBP were available for the analysis at T1 in the immediate OMT and waiting period groups, respectively, whereas 31 and 33 participants were available for the analysis at T2 in the immediate OMT and waiting period groups, respectively. After one session of OMT (T1), the analysis showed a significant reduction in the secondary outcomes of sleep disturbance and anxiety compared to the waiting period group. Following the entire intervention period (T2), the immediate OMT group demonstrated a significantly better average pain outcome. The effect size was a 0.8 standard deviation (SD), rendering the reduction in pain clinically significant. Further, the improvement in anxiety remained statistically significant. No study-related serious adverse events (AEs) were reported. OMT intervention is safe and effective in reducing pain along with improving sleep and anxiety profiles in patients with chronic LBP.

Background The evidence supporting the application of pain neuroscience education (PNE) in patients with chronic low back pain (LBP) remains some arguments. Objective This review aims to investigate the effect of PNE alone and combined with physical therapy or exercise for chronic LBP. Methods PubMed, Embase, Web of Science, and the Cochrane databases were searched from establishment to June 3, 2023. Randomized controlled trials (RCT) evaluating the effect of PNE in patients with chronic LBP were considered eligible. Data were analyzed using a random-effects model (I2 >50%) or a fixed-effects model (I2 <50%) and trials were appraised using the Cochrane ROB tool. Meta-regression was conducted to assess the moderator factors. Results Seventeen studies (1078 participants) were included in this review. PNE plus exercise and PNE plus physiotherapy both showed a reduction of short-term pain (mean differences [MD] −1.14 [−1.55, −0.72]; MD −1.15 [−1.67, −0.64]) and disability (standardized mean difference [SMD] −0.80 [−1.13, −0.47]; SMD −0.85 [−1.29, −0.40]) than physiotherapy or exercise alone. Meta-regression showed that only single PNE session duration was associated with a greater reduction in pain (P < .05). Subgroup results showed that a single PNE session exceeding 60 minutes (MD −2.04), 4 to 8 sessions (MD −1.34), intervention for 7 to 12 weeks (MD −1.32), and a group-based approach (MD −1.76) may be more beneficial. Conclusion This review indicates that adding PNE to treatment programs would lead to more efficacious effects for chronic LBP. Additionally, we preliminarily extracted dose-effect relationships for PNE intervention, providing guidance for clinicians to design effective PNE sessions.

Effects of Adding Respiratory Training to Osteopathic Manipulative Treatment on Exhaled Nitric Oxide Level and Cardiopulmonary Function in Patients With Pulmonary Arterial Hypertension

Standard pulmonary rehabilitation (SPR) does not use osteopathic manipulative treatment (OMT), but OMT has potential to improve lung function and patient perception of breathing. To analyze the immediate effects of OMT and SPR techniques on pulmonary function using spirometry and subjective ratings in young, healthy persons. Participants were healthy students recruited from the Lake Erie College of Osteopathic Medicine-Bradenton and were randomly assigned to either the OMT or SPR group. During the first 4 weeks, each participant in the OMT group received 1 OMT technique (rib raising, doming of the diaphragm, thoracic lymphatic pump, and thoracic high velocity, low amplitude), and each participant in the SPR group received 1 SPR treatment (tapotement, pursed lip breathing, saline nebulizer, and rest) per week. Treatments were then ranked based on positive change in pulmonary function as measured by forced expiratory volume in the first second of expiration (FEV1) and forced vital capacity (FVC). During the fifth week, the OMT group received the 2 highest-ranked OMT techniques, and the SPR group received the 2 highest-ranked SPR treatments. During the sixth week, the OMT group received the highest-ranked OMT and SPR treatment, while the SPR group received the same treatment combination but in the reverse order. Pulmonary function, as measured through FEV1, FVC, and FEV1/FVC, were collected before and after each treatment or treatment combination. Participants subjectively rated change in breathing after each treatment. A total of 53 students participated in the study, with 28 in the OMT group and 25 in the SPR group. In the OMT group, rib raising yielded the highest positive mean (SD) change of 0.001 (0.136) L in FEV1 and 0.052 (0.183) L in FVC, followed by lymphatic pump, with a change of 0.080 (0.169) L in FEV1 and -0.031 (0.229) L in FVC. In the SPR group, pursed lip breathing yielded the highest positive mean (SD) change of 0.101 (0.278) L in FEV1 and 0.031 (0.179) L in FVC, followed by tapotement, with a change of 0.045 (0.229) L in FEV1 and 0.061 (0.239) L in FVC. Saline treatment significantly decreased lung function. All other treatments did not result in any significant changes in lung function. Overall, SPR subjective ratings were significantly lower than ratings for both OMT and combination (OMT+SPR) treatments. Saline significantly reduced lung function and had low subjective posttreatment ratings in young healthy adults. Additionally, OMT and combination OMT and SPR significantly improved subjective breathing more than SPR alone. Future applications of this study include evaluating OMT and SPR effects on lung function in patients with various pulmonary conditions.

Elderly nursing home residents are generally in poor health. Many residents report pain on a daily basis, few are independent in their activities of daily living, and most take a large number of medications. To investigate the benefits elderly nursing home residents may receive from preventative osteopathic manipulative treatment (OMT) designed to optimize structure and function and enhance their bodies' homeostatic mechanisms. Volunteer nursing home residents were randomly assigned to 1 of 3 groups: (1) OMT, (2) light touch (LT), or (3) treatment as usual (TAU). The OMT group received an OMT protocol twice per month for 5 months, for a total of 10 visits. The LT group received a light-touch protocol meant to simulate OMT at the same frequency as the OMT group. The TAU group received no intervention. Participant health information from Minimum Data Set assessments was monitored during the study, along with hospitalizations, emergency room visits, and outpatient procedures. The nursing home personnel and the participants' attending physicians were blinded to treatment group assignment. Twenty-one participants completed the study: 8 in the OMT group, 6 in the LT group, and 7 in the TAU group. The OMT and LT groups had fewer hospitalizations (P=.04) and decreased medication usage (P=.001) compared with the TAU group. Twice monthly OMT and LT protocols reduced the number of hospitalizations and decreased medication usage in elderly nursing home residents.

Patients with low back pain (LBP) may receive osteopathic manipulative treatment (OMT) to resolve or manage their pain. The indication for OMT for patients with LBP is the presence of somatic dysfunction, diagnosed using palpatory examination. Because palpatory findings commonly have poor interexaminer reliability, the current study used ultrasonography (US) to establish pre-OMT and post-OMT musculoskeletal measurements of relative asymmetry between pelvic and sacral bony landmarks. To document objective musculoskeletal changes that occur in response to OMT using US and to compare palpatory assessment of landmark asymmetry with US assessment. Sixty men and women aged 20 to 55 years with at least 1 episode of LBP in the past 2 weeks were assigned to a seated control, walking control, or OMT group (20 participants per group). Participants received an initial, bilateral US measurement of the skin to posterior superior iliac spine (SPSIS), skin to sacral base position (SBP), and sacral sulcus depth (SSD). Participants in seated control and OMT groups received a palpatory assessment of SBP and SSD prior to initial US assessment. After assessment, the seated control group sat in a waiting room for 30 minutes, the walking control group walked for 5 minutes, and the OMT group received OMT to address sacral base asymmetry using predominantly direct techniques for a maximum of 20 minutes. Participants then received a second US assessment of the same structures. Body mass index (BMI) was correlated with SPSIS (r=0.5, P=.001) and SBP (r=0.6, P<.001). More participants in seated control (75%) and OMT (65%) groups had an increase in asymmetry from first to second US assessment for SPSIS compared with participants in the walking control group (35%, P=.05). No significant differences were found between groups for absolute asymmetry or total change in asymmetry (all P>.10). The κ was -0.1 (95% CI, -0.2 to 0.03) for SBP and -0.01 (95% CI, -0.1 to 0.1) for SSD. Musculoskeletal changes in SPSIS and SBP measurements related to OMT could not be readily identified using US. The SPSIS and SBP measurements were dependent on BMI, which may have affected the accuracy of US to detect small changes in asymmetry. Qualitative palpatory assessments did not correlate with US measurements. Further study is needed to identify US measurements that demonstrate change with OMT. (ClinicalTrials.gov number NCT02820701).

BackgroundOsteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain.MethodsComputerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature.Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses.ResultsOverall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 – -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up.ConclusionOMT significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.

Purpose: To compare the effectiveness of culture-sensitive and standard pain neuroscience education (PNE) on pain knowledge, pain intensity, disability, and pain cognitions in first-generation Turkish migrants with chronic low back pain (CLBP). Methods: Twenty-nine Turkish first-generation migrants with CLBP were randomly assigned to the culture-sensitive (n = 15) or standard PNE (n = 14) groups. Primary (pain knowledge, pain intensity, and disability) and secondary outcomes (pain beliefs, catastrophization, and fear of movement) were evaluated at baseline, immediately after the second session of PNE (week 1), and after 4 weeks. Results: There was a significant main effect of time in pain knowledge (p < .001), pain intensity (p = .03), disability (p = .002), organic and psychological pain beliefs (p = .002, p = .01), catastrophization (p = .002), and fear of movement (p = .02). However, no significant difference was found between groups in terms of all outcome measures (p > .05). Conclusions: Both PNE programs resulted in improvements in knowledge of pain, pain intensity, perceived disability, and pain cognitions. Nevertheless, the superiority of the culture-sensitive PNE approach could not be proved. Therefore, maybe migrants who are living in the host country for longer length of time do not need culturally adapted therapies due to cultural integration, while these adaptations might be essential for the recent migrants or the autochthonous population in Turkey. Further research is required to investigate the effects of culture-sensitive PNE alone or in combination with physiotherapy interventions in recent migrants or Turkish natives with CLBP.