Tactile acuity training for patients with chronic low back pain: a pilot randomised controlled trial.
ABSTRACT: BACKGROUND: Chronic pain can disrupt the cortical representation of a painful body part. This disruption may play a role in maintaining the individual's pain. Tactile acuity training has been used to normalise cortical representation and reduce pain in certain pain conditions. However, there is little evidence for the effectiveness of this intervention for chronic low back pain (CLBP). The primary aim of this study was to inform the development of a fully powered randomised controlled trial (RCT) by providing preliminary data on the effect of tactile acuity training on pain and function in individuals with CLBP. The secondary aim was to obtain qualitative feedback about the intervention. METHODS: In this mixed-methods pilot RCT 15 individuals were randomised to either an intervention (tactile acuity training) or a placebo group (sham tactile acuity training). All participants received 3 sessions of acuity training (intervention or sham) from a physiotherapist and were requested to undertake daily acuity home training facilitated by an informal carer (friend/relative). All participants also received usual care physiotherapy. The primary outcome measures were pain (0-100visual analogue scale (VAS)) and function (Roland Morris Disability Questionnaire (RMDQ)). Participants and their informal carers were invited to a focus group to provide feedback on the intervention. RESULTS: The placebo group improved by the greatest magnitude for both outcome measures, but there was no statistically significant difference (Mean difference (95%CI), p-value) between groups for change in pain (25.6 (-0.7 to 51.9), p = 0.056) or function (2.2 (-1.6 to 6.0), p = 0.237). Comparing the number of individuals achieving a minimally clinically significant improvement, the placebo group had better outcomes for pain with all participants achieving ?30% improvement compared to only a third of the intervention group (6/6 vs. 3/9, p = 0.036). Qualitatively, participants reported that needing an informal carer was a considerable barrier to the home training component of the study. CONCLUSIONS: This pilot RCT found tactile acuity training to be no more effective than sham tactile acuity training for function and less effective for pain in individuals with CLBP. That the intervention could not be self-applied was a considerable barrier to its use. TRIAL REGISTRATION ISRCTN: ISRCTN98118082.
Project description:Prior studies have shown that patients suffering from chronic Low Back Pain (cLBP) have impaired somatosensory processing including reduced tactile acuity, i.e. reduced ability to resolve fine spatial details with the perception of touch. The central mechanism(s) underlying reduced tactile acuity are unknown but may include changes in specific brain circuitries (e.g. neuroplasticity in the primary somatosensory cortex, S1). Furthermore, little is known about the linkage between changes in tactile acuity and the amelioration of cLBP by somatically-directed therapeutic interventions, such as acupuncture. In this longitudinal neuroimaging study, we evaluated healthy control adults (HC, N ?= ?50) and a large sample of cLBP patients (N ?= ?102) with structural brain imaging (T1-weighted MRI for Voxel-Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT) over the lower back (site of pain) and finger (control) locations. Patients were evaluated at baseline and following a 4-week course of acupuncture, with patients randomized to either verum acupuncture, two different forms of sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control. At baseline, cLBP patients demonstrated reduced acuity (greater 2PDT, P ?= ?0.01) over the low back, but not finger (P ?= ?0.29) locations compared to HC, suggesting that chronic pain affects tactile acuity specifically at body regions encoding the experience of clinical pain. At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P ?< ?0.05). GMV in cLBP correlated with greater 2PDT-back scores (? ?= ?0.27, P ?= ?0.02). Following verum acupuncture, tactile acuity over the back was improved (reduced 2PDT) and greater improvements were associated with reduced S1-back GMV (? ?= ?0.52, P ?= ?0.03) and increased S1-back adjacent white matter FA (? ?= ?-0.56, P ?= ?0.01). These associations were not seen for non-verum control interventions. Thus, S1 neuroplasticity in cLBP is linked with deficits in tactile acuity and, following acupuncture therapy, may represent early mechanistic changes in somatosensory processing that track with improved tactile acuity.
Project description:Although mindfulness meditation (MM) is increasingly used for chronic pain treatment, limited evidence supports its clinical application for opioid-treated chronic low back pain (CLBP). The goal of this study was to determine feasibility, acceptability, and safety of an MM-based intervention in patients with CLBP requiring daily opioid therapy.26-week pilot randomized controlled trial comparing MM-based intervention, combined with usual care, to usual care alone.Outpatient.Adults with CLBP treated with ≥30 mg of morphine-equivalent dose (MED) per day for 3 months or longer.Targeted MM-based intervention consisted of eight weekly 2-hour group sessions and home practice (30 minutes/d, 6 days/wk) during the study. "Usual care" for opioid-treated CLBP was provided to participants by their regular clinicians.Feasibility and acceptability of the MM intervention were assessed by adherence to intervention protocol and treatment satisfaction among experimental participants. Safety was evaluated by inquiry about side effects/adverse events and opioid dose among all study participants.Thirty-five participants enrolled during the 10-week recruitment period. The mean age (±standard deviation) was 51.8 ± 9.7 years; the patients were predominantly female, with substantial CLBP-related pain and disability, and treated with 148.3 ± 129.2 mg of MED per day. All participants completed baseline assessments; none missed both follow-up assessments or withdrew. Among experimental participants (n = 21), 19 attended 1 or more intervention sessions and 14 attended 4 or more. They reported, on average, 164.0 ± 122.1 minutes of formal practice per week during the 26-week study and 103.5 ± 111.5 minutes of brief, informal practice per week. Seventeen patients evaluated the intervention, indicating satisfaction; their qualitative responses described the course as useful for pain management (n = 10) and for improving pain coping skills (n = 8). No serious adverse events or safety concerns occurred among the study participants.MM-based intervention is feasible, acceptable, and safe in opioid-treated CLBP.
Project description:Changes in central pain processing have been shown in patients with chronic low-back pain (cLBP). We used quantitative sensory testing methods to identify differences in pain sensitization between patients with cLBP (N = 167) and healthy controls (N = 33). Results indicated that, compared with healthy pain-free controls, cLBP patients showed increased sensitivity and greater painful aftersensations for mechanical pressure and pin-prick stimuli and lower tactile spatial acuity in the 2-point discrimination task (ps < 0.05). Then, we examined the role of pain catastrophizing as a mediator of the group differences in pain sensitization. We found that catastrophizing partially accounted for group differences in pressure required to produce moderate pain. Finally, we examined the relationship between pain sensitization, catastrophizing, and clinical pain among patients with cLBP. We found that catastrophizing and deep-tissue pressure pain were associated with greater pain intensity in the past month, week, and at the visit as well as low-back pain bothersomeness. Furthermore, deep-tissue pressure pain mediated the associations between catastrophizing and both pain in the past month and low-back pain severity. Taken together, these results indicate that not only do patients with cLBP demonstrate increased pain sensitization and decreased sensitivity to innocuous stimuli, but these changes are also linked with increased catastrophizing. Furthermore, both catastrophizing and sensitization are associated with increased clinical pain among cLBP patients.
Project description:BACKGROUND:One-size-fits-all interventions reduce chronic low back pain (CLBP) a small amount. An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT). However, systematic reviews show group interventions are as effective as one-to-one interventions for musculoskeletal pain. This RCT investigated whether a physiotherapist-delivered individualised intervention (CFT) was more effective than physiotherapist-delivered group-based exercise and education for individuals with CLBP. METHODS:206 adults with CLBP were randomised to either CFT (n=106) or group-based exercise and education (n=100). The length of the CFT intervention varied according to the clinical progression of participants (mean=5 treatments). The group intervention consisted of up to 6 classes (mean=4 classes) over 6-8?weeks. Primary outcomes were disability and pain intensity in the past week at 6 months and 12months postrandomisation. Analysis was by intention-to-treat using linear mixed models. RESULTS:CFT reduced disability more than the group intervention at 6?months (mean difference, 8.65; 95%?CI 3.66 to 13.64; p=0.001), and at 12 months (mean difference, 7.02; 95%?CI 2.24 to 11.80; p=0.004). There were no between-group differences observed in pain intensity at 6 months (mean difference, 0.76; 95% CI -0.02 to 1.54; p=0.056)?or 12 months (mean difference, 0.65; 95% CI -0.20 to 1.50; p=0.134). CONCLUSION:CFT reduced disability, but not pain, at 6 and 12 months compared with the group-based exercise and education intervention. Future research should examine whether the greater reduction in disability achieved by CFT renders worthwhile differences for health systems and patients. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov registry (NCT02145728).
Project description:BACKGROUND AND OBJECTIVE:Chronic low back pain (CLBP) is highly prevalent, with a substantial psychosocial burden. Pain has both sensory and affective components. The latter component is a significant driver of disability and psychiatric comorbidity but is often inadequately treated. Previously we reported that noninvasive transcranial direct current stimulation (tDCS) may modulate pain-associated affective distress. Here we tested whether 10 daily tDCS sessions aimed to inhibit the left dorsal anterior cingulate cortex (dACC), a region strongly implicated in the affective component of pain, would produce selective reduction in pain-related symptoms. METHODS:In this multisite, double-blinded, randomized placebo-controlled trial (RCT), 21 CLBP patients received 10 weekday sessions of 2-mA active tDCS or sham (20 minutes/session). A cathodal electrode was placed over FC1 (10-20 electroencephalography coordinates), and an identical anodal return electrode was placed over the contralateral mastoid. Participants rated pain intensity, acceptance, interference, disability, and anxiety, plus general anxiety and depression. RESULTS:Regression analysis noted significantly less pain interference (P =0.002), pain disability (P =0.001), and depression symptoms (P =0.003) at six-week follow-up for active tDCS vs sham. Omnibus tests suggested that these improvements were not merely due to baseline (day 1) group differences. CONCLUSIONS:To our knowledge, this is the first double-blinded RCT of multiple tDCS sessions targeting the left dACC to modulate CLBP's affective symptoms. Results are encouraging, including several possible tDCS-associated improvements. Better-powered RCTs are needed to confirm these effects. Future studies should also consider different stimulation schedules, additional cortical targets, high-density multi-electrode tDCS arrays, and multimodal approaches.
Project description:BACKGROUND AND OBJECTIVE:Recent systematic reviews show promising effects for multidisciplinary biopsychosocial (BPS) interventions in patients with chronic low back pain (CLBP). Nowadays, BPS interventions have also been developed for primary care physiotherapy settings. Our aim was to systematically review the evidence on the effectiveness of primary care BPS interventions in improving functional disability, pain, and work status for patients with CLBP. Secondly, we aimed to provide an elaborated overview of BPS intervention designs, physiotherapist training programs, and process-related factors (practical implementation). METHODS:We searched in scientific databases and reference lists. Randomized controlled trials (RCTs) evaluating primary care physiotherapist-led BPS interventions in adults (?18 years) with nonspecific CLBP (?12 weeks) were included. RESULTS:Our search resulted in 943 references; 7 RCTs were included (1,426 participants). Results show moderate-quality evidence (3 trials; 991 participants) that a BPS intervention is more effective than education/advice for reducing disability and pain in the short, medium, and long term. Low-quality evidence (4 trials; 435 participants) was found for no difference with physical activity treatments. CONCLUSIONS:BPS interventions seem more effective than education/advice and were found to be as effective as physical activity interventions in patients with CLBP. BPS interventions with a clear focus on psychosocial factors (understanding pain, unhelpful thoughts, coping styles, and goal setting) seem most promising. Sufficient delivery of BPS elements is expected when physiotherapists participate in training programs with extensive support prior and during delivery (manual, supervision, and informative resources).
Project description:<b>Aim: </b>To determine the feasibility of conducting a definitive randomised control trial (RCT) to answer the following questions: (1) Is early physiotherapy treatment acceptable and feasible for patients and direct healthcare providers? and (2) Is early physiotherapy intervention associated with better disability and psychosocial outcomes compared with the practice of routine MRIs?<br><br><b>Methods: </b>In a feasibility RCT in Riyadh City from 01 March 2018 until 29 July 2018, chronic low back pain (CLBP) patients presenting to spine clinics were randomised to receive an MRI (intervention) plus physiotherapy rehabilitation or physiotherapy alone (control group). The acceptability of randomisation to the control group (non-MRI) was tested during the recruitment by qualitatively interviewing study participants and referring physicians. Moreover, interviews with study participants explored the broader social, political, economic, and environmental (context) aspects that may influence trial delivery and intervention implementation.<br><br><b>Results: </b>The recruitment target was not met: 16/24 (66%) participants were recruited in 4 months (12.4% of those screened); 33% declined. The process evaluation identified numerous factors that may affect the success of a definitive RCT in Saudi Arabia. These were research resources, the lack of research infrastructure to support recruitment to trials, limited research capacity in terms of knowledge and skills of the healthcare team, and limited funding.<br><br><b>Conclusion: </b>A definitive RCT to test the influence of MRI diagnosis on the psychosocial and disability outcomes in people with CLBP treated with physiotherapy in Saudi Arabia is feasible. However, the lack of research infrastructure, research capacity, the impact of MRI on patient outcomes, and a lack of clinical equipoise in the treatment and management of CLBP in Saudi Arabia pose major barriers to clinical trials.
Project description:Low back pain is highly prevalent and a significant public health burden in Western society. Feasibility studies suggest personalised pedometer-driven walking is an acceptable and effective motivating tool in the management of chronic low back pain (CLBP???12 weeks). The proposed study will investigate pedometer-driven walking as a low cost, easily accessible, and sustainable means of physical activity to improve disability and clinical outcomes for people with CLBP in Saskatchewan, Canada.A fully-powered single-blinded randomised controlled trial will compare back care advice and education with back care advice and education followed by a 12-week pedometer-driven walking programme in adults with CLBP. Adults with self-reported CLBP will be recruited from the community and screened for elibility. Two-hundred participants will be randomly allocated to one of two intervention groups. All participants will receive a single back care advice and education session with a physiotherapist. Participants in the walking group will also receive a physiotherapist-facilitated pedometer based walking programme. The physiotherapist will facilitate the participant to monitor and progress the walking programme, by phone, on a weekly basis over 10 weeks following two face-to-face sessions. Outcome measures of self-reported disability, physical activity, participants' low back pain beliefs/perceptions, quality of life and direct/indirect cost estimates will be gathered at baseline, three months, six months, and 12 months by a different physiotherapist blinded to group allocation. Following intervention, focus groups will be used to explore participants' thoughts and experiences of pedometer-driven walking as a management tool for CLBP.This paper describes the design of a community-based RCT to determine the effectiveness of a pedometer-driven walking programme in the management of CLBP.United States National Institutes of Health Clinical Trails registry (http://ClinicalTrials.gov/) No. NCT02284958 . Registered on 27(th) October 2014).
Project description:INTRODUCTION:Chronic lower back pain (CLBP) is problematic in older veterans. Spinal manipulative therapy (SMT) is commonly utilized for CLBP in older adults, yet there are few randomized placebo-controlled trials evaluating SMT. METHODS:The purpose of the study was to compare the effectiveness of SMT to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics. RESULTS:Older veterans (? 65 years of age) who were naive to chiropractic were recruited. A total of 136 were included in the study with 69 being randomly assigned to SMT and 67 to sham intervention. Patients were treated 2 times per week for 4 weeks assessing outcomes at baseline, 5, and 12 weeks postbaseline. Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the SMT group when compared to the sham intervention group. There were no significant differences in adverse events between the groups. CONCLUSIONS:The SMT did not result in greater improvement in pain when compared to our sham intervention; however, SMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.
Project description:Purpose:The present study evaluated the modulation effect of a painless acupuncture technique, ankle acupuncture (AA), on resting-state functional change in patients with chronic low back pain (CLBP). Patients and methods:Fourteen participants diagnosed with CLBP received AA and underwent one brain functional image scan after tactile stimulation and another one following the insertion of the needle. The needling sensations and clinical pain intensities were evaluated after the end of each functional image scan. The significance levels of Visual Analog Scales/Scores (VASs) before and after acupuncture were determined using paired t-test. The brain areas showing differences in the amplitude of low-frequency fluctuation (ALFF) and fractional ALFF (fALFF) between the two scans were identified. We also explored the relationship between mean ALFF values in brain areas identified and VAS scores based on Pearson correlation coefficient. Results:A complete-case analysis was performed on 12 participants. Neither different needling sensations nor any local sensations during the two scans was found. The clinical findings indicated that the scores of VAS scores were significantly lower after AA intervention (P<0.001). Compared with those after tactile stimulation, ALFF decreased in the left insular and increased in the left precuneus and right precentral gyrus, and fALFF decreased in the left insular, during retaining of AA (corrected). Moreover, there was a positive correlation found between mean ALFF change in the left insular and that of VAS values (P<0.05). Conclusion:The present study demonstrated the low-frequency BOLD signal oscillation response in the left insular in brain activity was associated with an immediate analgesia of AA in patients with CLBP, which provides new insights into intrinsic connections between low-frequency brain signals and analgesic effects of acupuncture.