Effects of a Single Application of ScenarTM, a Low-Frequency Modulated Electric Current Therapy, for Pain Relief in Patients with Low Back and Neck Pain: A Randomized Single Blinded Trial.
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SUBMITTER: Michel-Cherqui M
PROVIDER: S-EPMC8658569 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Objective: Recent advances in brain imaging have deepened our knowledge of the neural activity in distinct brain areas associated with acupuncture analgesia. However, there has not been conclusive research into the frequency-specific resting-state functional changes associated with acupuncture analgesia in patients with chronic pain. Here, we aimed to characterize changes across multiple frequencies of resting-state cortical activity associated with ankle acupuncture stimulation (AAS) in patients with chronic low back pain (CLBP) and healthy controls. Methods: Twenty seven patients with CLBP and Twenty five age- and gender-matched healthy volunteers were enrolled in the study. Participants received tactile sham acupuncture (TSA) and AAS, respectively. The whole-brain amplitude of low-frequency fluctuation (ALFF) in the range 0.01-0.25 Hz was assessed for changes associated with each intervention. Further, a visual analog scale (VAS) was used to collect subjective measures of pain intensity in patients. Linear mixed-effect modeling (LME) was used to examine the mean ALFF values of AAS and TSA between patients and healthy controls. Results: The ALFF was modulated in the default mode network (an increase in the medial prefrontal cortex, and a decrease in the cerebellum/posterior ingulate/parahippocampus, P < 0.01, corrected) in both patients and controls. Decreased ALFF in the bilateral insular was frequency-dependent. Modulations in the cerebellum and right insular were significantly correlated with VAS pain score after AAS (P < 0.01). Conclusion: Hence, frequency-specific resting-state activity in the cerebellum and insular was correlated to AAS analgesia. Our frequency-specific analysis of ALFF may provide novel insights related to pain relief from acupuncture.
| S-EPMC8688988 | biostudies-literature
Project description:BackgroundThe therapeutic approach to chronic aspecific low back pain (CALBP) has to consider the multifactorial aetiology of the disorder. International guidelines do not agree on unequivocal treatment indications. Recommendations for fascial therapy are few and of low level evidence but several studies indicate strong correlations between fascial thickness and low back pain. This study aims at comparing the effectiveness of Fascial Manipulation® associated with a physiotherapy program following guidelines for CALBP compared to a physiotherapy program alone.Methods24 subjects were randomized into two groups, both received eight treatments over 4 weeks. Outcomes were measured at baseline, at the end of therapy and at a 1 month and a 3 months follow-up. Pain was measured with the visual analogue scale (VAS) and the brief pain inventory (BPI), function with the Rolland-Morris disability questionnaire (RMDQ), state of well-being with the short-form 36 health-survey (SF-36). The mean clinical important difference (MCID) was also measured.ResultsPatients receiving Fascial Manipulation® showed statistically and clinically significant improvements at the end of care for all outcomes, in the short (RMDQ, VAS, BPI) and medium term for VAS and BPI compared to manual therapy. The MCID show significant improvements in the means and percentage of subjects in groups in all outcomes post-treatment, in the short and medium term.ConclusionFascial tissues were implicated in the aetiology of CALBP and treatment led to decreased symptomatic, improved functional and perceived well-being outcomes that were of greater amplitude compared to manual therapy alone.
| S-EPMC4706049 | biostudies-literature
Project description:BackgroundLow-back pain, including facet joint pain, accounts for up to 20 % of all sick leaves in DenmarkA proposed treatment option is cryoneurolysis. This study aims to investigate the effect of cryoneurolysis in lumbar facet joint pain syndrome.MethodsA single-center randomized controlled trial (RCT) is performed including 120 participants with chronic facet joint pain syndrome, referred to the Department of Neurosurgery, Aarhus University Hospital. Eligible patients receive a diagnostic anesthetic block, where a reduction of pain intensity ≥ 50 % on a numerical rating scale (NRS) is required to be enrolled. Participants are randomized into three groups to undergo either one treatment of cryoneurolysis, radiofrequency ablation or placebo. Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments. All groups receive physiotherapy for 6 weeks, starting 4 weeks after treatment. The primary outcome is the patients' impression of change in pain after intervention (Patient Global Impression of Change (PGIC)) at 4 weeks follow-up, prior to physiotherapy. Secondary outcomes are a reduction in low-back pain intensity (numeric rating scale) and quality of life (EQ-5D, SF-36) and level of function (Oswestry Disability Index), psychological perception of pain (Pain Catastrophizing Scale) and depression status (Major Depression Inventory). Data will be assessed at baseline (T0), randomization (T1), day one (T2), 4 weeks (T3), 3 (T4), 6 (T5) and 12 months (T6).DiscussionThis study will provide information on the effectiveness of cryoneurolysis vs. the effectiveness of radiofrequency ablation or placebo for patients with facet joint pain, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population.Trial registrationThe trial is approved by the ethical committee of Central Jutland Denmark with registration number 1-10-72-27-19 and the Danish Data Protection Agency with registration number 666,852. The study is registered at Clinicaltrial.gov with the ID number NCT04786145 .
| S-EPMC8135178 | biostudies-literature
Project description:Dry needling (DN) is a standard procedure for treating musculoskeletal disorders. However, there are no clear recommendations for using DN in low back pain (LBP). Therefore, this study aimed to assess the effectiveness of the novel DN program for reducing pain intensity and improving functional efficiency in patients with chronic LBP. A group of 40 patients with chronic LBP due to the L5-S1 discopathy were eligible and randomized into experimental (n = 20) and control (n = 20) groups. The DN program was performed for the experimental group according to the Five Regulatory Systems (FRS) concept. The control group received sham therapy using placebo needles. DN sessions were performed twice a week for 4 weeks. A single needling application lasted 60 min. Both groups received standard treatment and physical exercise of LBP for 1 month. Subjective pain was measured by a visual analog scale (VAS), functional efficiency was assessed with the Oswestry Disability Index (ODI), and the lower spine range of motion was measured with the Schober test. There were significant differences in pain reduction (VAS) in both groups (p < 0.001). The strongest analgesic effect in the DN group yielded 6.45 points immediately after the therapy, 6.2 points after 1 month, and 6 points after 3 months. The DN group scored higher VAS reduction than the control group (p < 0.001). There were significant differences in the functional state (ODI) in the experimental group (p < 0.001). There was a significant ODI decrease by 18.1 points, after 1 month by 18.9 points, and after 3 months by 17.6 points. No significant differences were found in the control group (p > 0.05). Intergroup differences were observed in the functional efficiency in ODI in all measurement time-points (p < 0.001). There were significant differences in the range of motion (Schober test) in the DN group (main effect: p < 0.001). For all measurements, differences (p < 0.001) were observed in favor of DN compared to the control. In conclusion, DN program according to the FRS concept stands for the novel treatment method supplemented by an exercise program, effectively reducing pain and improving functional efficiency in LBP patients.
| S-EPMC9500077 | biostudies-literature
Project description:Non-specific low back pain (NSLBP) affects many people and represents a high cost for health care. Manual pressure release of myofascial trigger points is used to treat NSLBP and is very effective but difficult to standardize since it is provided by different therapists, which also suffer musculoskeletal complications from this highly repetitive activity. A robot designed for this purpose may help in reducing these problems. Here, we present data from a two-arm, single-blinded, randomized controlled clinical trial evaluating the efficiency of a therapeutic massage robot (ADAMO) in reducing NSLBP (clinicaltrials.gov, registration number: NCT04882748). Forty-four patients were randomly distributed into the two arms of the study (robot vs. control). A physician filled the Oswestry disability index (ODI) before starting the treatment and at the end of it, in a blind fashion. In addition, patients filled a visual analogue scale (VAS) after each of the 10 treatment sessions. The ODI and the VAS were analyzed as the primary and secondary outcome measures. Both treatments (robot and control) resulted in a significantly lower ODI (p < 0.05). On the other hand, robot-treated patients significantly reduced their VAS levels (p = 0.0001) whereas control treatment did not reach statistical significance. Patients of both sexes obtained similar benefits from either treatment. Overweight patients (body mass index ≥ 25kg/m2) in the robot arm benefited more from the treatment (p = 0.008) than patients with normal weight. In conclusion, the ADAMO robot is, at least, as efficient as regular treatment in reducing low back pain, and may be more beneficial for specific patients, such as those with excessive weight.
| S-EPMC8478348 | biostudies-literature
Project description:BackgroundMusculoskeletal disorders are the second leading cause of disability worldwide.ObjectiveExamine experiences of chiropractic patients in the United States with chronic low back or neck pain.MethodObservational study of 1853 chronic low back pain and neck pain patients (74% female) who completed an online questionnaire at the 3-month follow-up that included Consumer Assessment of Healthcare Providers and Systems (CAHPS) items assessing their experiences with care.ResultsWe found similar reports of communication for the chiropractic sample and patients in the 2016 CAHPS National Database, but 85% in the database versus 79% in the chiropractic sample gave the most positive response to the time spent with provider item. More patients in the CAHPS database rated their provider at the top of the scale (8 percentage points). More chiropractic patients reported always getting answers to questions the same day (16 percentage points) and always being seen within 15 minutes of their appointment time (29 percentage points).ConclusionsThe positive experiences of patients with chronic back and neck pain are supportive of their use of chiropractic care.
| S-EPMC7410126 | biostudies-literature
Project description:BackgroundChronic spinal pain is prevalent and long-lasting. Although provider-based nonpharmacologic therapies, such as chiropractic care, have been recommended, healthcare and coverage policies provide little guidance or evidence regarding long-term use of this care.ObjectiveTo determine the relationships between visit frequency and outcomes for patients using ongoing chiropractic care for chronic spinal pain.Study designObservational 3-month longitudinal study.SettingData collected from patients of 124 chiropractic clinics in 6 United States regions.MethodsWe examined the impact of visit frequency and patient characteristics on pain (pain 0-10 numeric rating scale) and functional outcomes (Oswestry Disability Index [ODI] for low-back pain and Neck Disability Index [NDI] for neck pain, both 0-100 scale) using hierarchical linear modeling (HLM) in a large national sample of chiropractic patients with chronic low back pain (CLBP) and/or chronic neck pain (CNP). This study was approved by the RAND Human Subjects Protection Committee and registered under ClinicalTrials.gov Identifier: NCT03162952.ResultsOne thousand, three hundred, sixty-two patients with CLBP and 1,214 with CNP were included in a series of HLM models. Unconditional (time-only) models showed patients on average had mild pain and function, and significant, but slight improvements in these over the 3-month observation period: back and neck pain decreased by 0.40 and 0.44 points, respectively; function improved by 2.7 (ODI) and 3.0 points (NDI) (all P < 0.001). Adding chiropractic visit frequency to the models revealed that those with worse baseline pain and function used more visits, but only visits more than once per week for those with CLBP were associated with significantly better improvement. These relationships remained when other types of visits and baseline patient characteristics were included.LimitationsThis is an observational study based on self-reported data from a sample representative of chiropractic patients, but not all patients with CLBP or CNP.ConclusionsThis 3-month window on chiropractic patients with CLBP and/or CNP revealed that they were improving, although slowly; may have reached maximum therapeutic improvement; and are possibly successfully managing their chronic pain using a variety of chiropractic visit frequencies. These results may inform payers when building coverage policies for ongoing chiropractic care for patients with chronic pain.
| S-EPMC8667562 | biostudies-literature
Project description:BACKGROUND:There is some evidence and anecdotal reports that high-velocity low-amplitude (HVLA) spinal manipulation therapy (SMT) for non-specific low back pain (NSLBP) may immediately reduce pain in some patients. The mechanism for such a change remains unclear and the evidence is conflicting. The aim of this study was to seek consensus among a sample of expert manual therapists as to the possible clinical predictors that could help identify patients who are most likely to receive instant relief from NSLBP with SMT intervention. METHODS:Thirty-seven expert chiropractors and manipulative physiotherapists from around the world were invited to participate in a three round online Delphi questionnaire during the second half of 2018. Participants were provided with a list of 55 potential signs and symptoms as well as offering them the option of suggesting other factors in the first round. The variables were rated using a 4-point Likert likelihood scale and a threshold of 75% agreement was required for any item to progress to the next round. RESULTS:Of these 37 experts, 19 agreed to participate. Agreement as to the proportion of patients who receive instantaneous relief was minimal (range 10-80%). A total of 62 items were ranked over the 3 rounds, with 18 of these retained following the third round. The highest rated of the 18 was 'A history including a good response to previous spinal manipulation'. DISCUSSION/CONCLUSION:Five categories; patient factors, practitioner factors, signs and symptoms of NSLBP presentation, an instrument of measurement (FABQ), and the presence of cavitation following SMT best describe the overall characteristics of the factors. The 18 factors identified in this study can potentially be used to create an instrument of measurement for further study to predict those patients with NSLBP who will receive instantaneous relief post-SMT.
| S-EPMC7331174 | biostudies-literature
Project description:Acupuncture has pain-relief effects, but no data were available on the use of transcutaneous electric acupoint stimulation (TEAS) in pain relief during oocyte retrieval. This study was designed to examine the effect of TEAS for pain relief in women undergoing transvaginal ultrasound-guided oocyte aspiration. This single-blinded, multicenter, randomized controlled trial was performed in China between May 2013 and May 2015. The subjects were randomized to mock TEAS and TEAS. TEAS or mock TEAS was administered 30 min before oocyte retrieval until the end of the operation. The primary and secondary endpoints were the pain measured using the visual analog scale (VAS) within 1 min and 1 hour after oocyte retrieval, respectively. Serum β-endorphin levels were tested in the first 50 patients/group. 390 women were undergoing oocyte retrieval. Pain levels evaluated using VAS within 1 min (18.6 ± 1.3 vs. 24.4 ± 1.7, P < 0.01) and 1 h after oocyte aspiration (4.6 ± 0.7 vs. 6.8 ± 0.8, P < 0.05) were lower in the TEAS group than in the mock TEAS group. Nausea assessment revealed a significantly lower VAS score in the TEAS group within 1 min (1.2 ± 0.4 vs. 2.9 ± 0.7, P < 0.033). Serum β-endorphin levels were significantly higher in the TEAS group than in the mock TEAS group (11.4 ± 0.5 vs. 9.1 ± 0.4, P < 0.001) after retrieval. Serum β-endorphin levels were higher in the TEAS group after the procedure than baseline (11.4 ± 0.5 vs. 9.1 ± 0.3, P < 0.001). Oocyte retrieval causes pain and discomfort, but TEAS is effective and safe for suppressing the pain and alleviating nausea associated with the operation.
| S-EPMC7530499 | biostudies-literature
Project description:BACKGROUND:Chronic spinal pain is prevalent, expensive and long-lasting. Several provider-based nonpharmacologic therapies have now been recommended for chronic low-back pain (CLBP) and chronic neck pain (CNP). However, healthcare and coverage policies provide little guidance or evidence regarding the long-term use of this care. To provide one glimpse into the long-term use of nonpharmacologic provider-based care, this study examines the predictors of visit frequency in a large sample of patients with CLBP and CNP using ongoing chiropractic care. METHODS:Observational data were collected from a large national sample of chiropractic patients in the US with non-specific CLBP and CNP. Visit frequency was defined as average number of chiropractic visits per month over the 3-month study period. Potential baseline predictor variables were entered into two sets of multi-level models according to a defined causal theory-in this case, Anderson's Behavioral Model of Health Services Use. RESULTS:Our sample included 852 patients with CLBP and 705 with CNP. Visit frequency varied significantly by chiropractor/clinic, so our models controlled for this clustering. Patients with either condition used an average of 2.3 visits per month. In the final models visit frequency increased (0.44 visits per month, p =?.008) for those with CLBP and some coverage for chiropractic, but coverage had little effect on visits for patients with CNP. Patients with worse function or just starting care also had more visits and those near to ending care had fewer visits. However, visit frequency was also determined by the chiropractor/clinic where treatment was received. Chiropractors who reported seeing more patients per day also had patients with higher visit frequency, and the patients of chiropractors with 20 to 30?years of experience had fewer visits per month. In addition, after controlling for both patient and chiropractor characteristics, the state in which care was received made a difference, likely through state-level policies and regulations. CONCLUSIONS:Chiropractic patients with CLBP and CNP use a range of visit frequencies for their ongoing care. The predictors of these frequencies could be useful for understanding and developing policies for ongoing provider-based care.
| S-EPMC7222295 | biostudies-literature