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Using a Robot to Treat Non-specific Low Back Pain: Results From a Two-Arm, Single-Blinded, Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Marin-Mendez H

PROVIDER: S-EPMC8478348 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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 .

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.

Project description:BACKGROUND:Registered healthcare workers worldwide have a high prevalence of work-related musculoskeletal disorders, particularly of the back. Multidisciplinary interventions among these workers have improved fear avoidance beliefs, but not low back pain (LBP) and related sickness absences, cost-effectiveness studies are scarce. Our purpose was to investigate the effectiveness and cost-effectiveness of three intervention-arms (combined neuromuscular exercise and back care counselling or either alone) compared with non-treatment. METHODS:We randomly assigned female healthcare workers with recurrent non-specific LBP to one of four study-arms: Combined neuromuscular exercise and back care counseling; Exercise; Counseling; and no intervention Control. We assessed the effectiveness of the interventions on intensity of LBP, pain interfering with work and fear avoidance beliefs against the Control, and calculated the incremental cost-effectiveness ratios for sickness absence and QALY. RESULTS:We conducted three sub-studies in consecutive years of 2011, 2012, and 2013 to reach an adequate sample size. All together 219 women were randomized within each sub-study, of whom 74 and 68% had adequate questionnaire data at 6 and 12?months, respectively. No adverse events occurred. Compliance rates varied between intervention-arms. After 12?months, the Combined-arm showed reduced intensity of LBP (p?=?0.006; effect size 0.70, confidence interval 0.23 to 1.17) and pain interfering with work (p?=?0.011) compared with the Control-arm. Work-related fear of pain was reduced in both the Combined- (p?=?0.003) and Exercise-arm (p?=?0.002). Physical activity-related fear was reduced only in the Exercise-arm (p?=?0.008). During the study period (0-12?months) mean total costs were lowest in the Combined-arm (€476 vs. €1062-€1992, p?<?0.001) as were the mean number of sickness absence days (0.15 vs. 2.29-4.17, p?=?0.025). None of the intervention-arms was cost-effective for sickness absence. There was 85% probability of exercise-arm being cost-effective if willing to pay €3550 for QALY gained. CONCLUSIONS:Exercise once a week for 6?months combined with five sessions of back care counseling after working hours in real-life settings effectively reduced the intensity of LBP, work interference due to LBP, and fear of pain, but was not cost-effective. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01465698 November 7, 2011 (prospective).

Project description:BACKGROUND:Chronic low back pain is a common problem and is associated with high costs, including those related to health care and indirect costs due to absence at work or reduced productivity. Previous studies have demonstrated that acupuncture or electroacupuncture can relieve low back pain. Electronic acupuncture shoes (EAS) are a novel device designed in this study. This device combines the properties of acupuncture and transcutaneous electrical nerve stimulation for clinical use. OBJECTIVE:The aim of this study was to evaluate the efficacy of EAS in patients with chronic low back pain. METHODS:In this prospective double-blinded randomized controlled study, the data of 83 patients who experienced chronic low back pain were analyzed. Patients came to our clinic for 20 visits and underwent assessment and treatment. Patients were randomly allocated to receive either EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (EAS group, n=42) or sham EAS plus NSAIDs (NSAID group, n=41). The visual analog scale (VAS) score and range of motion were assessed at baseline, before and after each EAS treatment, and 2 weeks after the last treatment. The time for achieving pain remission was recorded. Quality of life was assessed at the 2nd, 14th, and 20th visits. RESULTS:After 6 weeks of treatment, the treatment success rate in each visit in the EAS group was higher than that in the NSAID group, as revealed by the intention-to-treat (ITT) and per-protocol (PP) analyses, but significant differences were observed only during the 16th visit in the ITT analysis (EAS group: 31/37, 84% and NSAID group: 21/34, 62%; P=.04). The change in the VAS score from baseline in each visit in the EAS group was greater than that in the NSAID group, as revealed by the ITT and PP analyses, and significant differences were observed in the 5th visit and 9th visit in the ITT analysis (P=.048 and P=.048, respectively). Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively). No significant differences were observed in the VAS score before and after treatment in each visit and in the quality of life in both groups. CONCLUSIONS:EAS might serve as a reliable alternative therapeutic tool for patients with chronic low back pain who are contraindicated for oral NSAIDs. TRIAL REGISTRATION:ClinicalTrials.gov NCT02468297 https://clinicaltrials.gov/ct2/show/NCT02468297.

Project description:OBJECTIVES:The aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal. DESIGN:A two-arm, parallel, assessor-blinded, feasibility RCT. SETTING:A rehabilitation hospital in Kathmandu, Nepal. PARTICIPANTS:Forty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women). INTERVENTIONS:Eligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session. PRIMARY OUTCOME MEASURES:The primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment. SECONDARY OUTCOME MEASURES:Pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation. RESULTS:Forty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported. CONCLUSION:We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted. TRIAL REGISTRATION NUMBER:NCT03387228; Results.

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Using a Robot to Treat Non-specific Low Back Pain: Results From a Two-Arm, Single-Blinded, Randomized Controlled Trial.

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