Optimizing Chronic Pain Treatment with Enhanced Neuroplastic Responsiveness: A Pilot Randomized Controlled Trial.
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ABSTRACT:
SUBMITTER: Pratscher S
PROVIDER: S-EPMC8147927 | biostudies-literature | 2021 May
REPOSITORIES: biostudies-literature
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Optimizing Chronic Pain Treatment with Enhanced Neuroplastic Responsiveness: A Pilot Randomized Controlled Trial.
Pratscher Steven S Mickle Angela M AM Marks John G JG Rocha Harold H Bartsch Felix F Schmidt Jeffrey J Tejera Lazaro L Garcia Steven S Custodero Carlo C Jean Federlin F Garvan Cynthia C Johnson Alisa J AJ Pop Ralisa R Greene Anthony A Woods Adam J AJ Staud Roland R Fillingim Roger B RB Keil Andreas A Sibille Kimberly T KT
Nutrients 20210505 5
Chronic pain affects mental and physical health and alters brain structure and function. Interventions that reduce chronic pain are also associated with changes in the brain. A number of non-invasive strategies can promote improved learning and memory and increase neuroplasticity in older adults. Intermittent fasting and glucose administration represent two such strategies with the potential to optimize the neurobiological environment to increase responsiveness to recognized pain treatments. The ...[more]
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Project description:IntroductionChronic back pain is the leading cause of disability in the United States. Based on the hypothesis that nonspecific back pain may be rooted in a psychophysiologic etiology, we propose a new approach to chronic back pain.ObjectivesA pilot study was conducted to assess whether psychophysiologic symptom relief therapy (PSRT) can reduce disability and back pain bothersomeness for patients with chronic back pain.MethodsThis was a three-armed, randomized trial for adults with nonspecific chronic back pain that compared PSRT with usual care and an active comparator (mindfulness-based stress reduction [MBSR]). Psychophysiologic symptom relief therapy-randomized participants received a 12-week (36 hours) course based on the psychophysiological model of pain. All groups were administered validated questionnaires at baseline and at 4, 8, 13, and 26 weeks. The primary outcome was the reduction in pain disability measured by the Roland-Morris Disability Questionnaire.ResultsThe mean Roland-Morris Disability Questionnaire score for the PSRT group (n = 11) decreased from 9.5 (±4.3 SDs) to 3.3 (±5.1) after 26 weeks which was statistically significant compared with both MBSR (n = 12) (P = 0.04) and usual care (n = 12) (P = 0.03). Pain bothersomeness scores and pain-related anxiety decreased significantly over 26 weeks in PSRT compared with MBSR and usual care (data in manuscript). At 26 weeks, 63.6% of the PSRT arm reported being pain free (0/10 pain) compared with 25.0% and 16.7% in MBSR and usual care arms, respectively. Psychophysiologic symptom relief therapy attendance was 76%, and there was 100% follow-up of all groups.ConclusionPsychophysiologic symptom relief therapy is a feasible and potentially highly beneficial treatment for patients with nonspecific back pain.
| S-EPMC8476063 | biostudies-literature
Project description:PurposeTo determine the feasibility of implementing a yoga intervention for cancer survivors with chronic CIPN pain, as well as the impact of the intervention on patient-reported outcomes.MethodsCancer survivors with chronic CIPN pain were recruited from the breast, gastrointestinal, and gynecological oncology centers at Dana-Farber Cancer Institute. Participants were randomized (2:1) to receive an 8-week yoga intervention or usual care. After 21/50 of participants were enrolled, the COVID-19 pandemic required the yoga intervention to be delivered virtually (i.e., Zoom). Pre- and post-intervention, participants self-reported CIPN and co-occurring symptom severity. Adherence to the intervention was defined as practicing ≥ 12 yoga sessions over the 8-week intervention period. Changes in patient-reported outcomes between groups were compared using Wilcoxon's rank-sum tests.ResultsParticipants (n = 28 yoga, n = 16 control) were mainly female (96%) and diagnosed with stage III/IV disease (66%). Overall, 19/28 (67.8%) of yoga group participants were adherent to the yoga protocol. Yoga group participants experienced significant within-group improvements in all patient-reported outcomes, including worst CIPN pain (median change = - 1.7, p < 0.0001) and sensory CIPN (median change = - 14.8, p < 0.0001), but only improvements in fatigue (p = 0.05) and depression (p = 0.04) were significant compared to the control. There were no differences (p > 0.05) in changes in patient-reported outcomes between in-person (n = 6) or virtual (n = 15) yoga group participants.ConclusionsYoga is a feasible non-pharmacological modality for cancer survivors with CIPN, but more information is needed regarding its impact on CIPN and other symptoms.Trial registrationClinicalTrials.gov Identifier: NCT03824860 IMPLICATIONS FOR CANCER SURVIVORS: Oncology clinicians may consider referring cancer survivors to yoga for chronic CIPN pain, but yoga cannot be currently recommended as an efficacious treatment.
| S-EPMC8442518 | biostudies-literature
Project description:BACKGROUND: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. METHODS: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. RESULTS: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). CONCLUSION: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain.
| S-EPMC1713236 | biostudies-other
Project description:Veterans seeking care in VA medical facilities have high rates of chronic pain, which often co-occur with mental health and substance use disorders, including prescription opioid misuse. The overall goal of the Optimizing Pain Treatment Interventions (OPTI) study was to pilot a 12-week Collaborative Care intervention to improve opioid safety, chronic pain disability, and use of non-pharmacological pain management strategies in veterans in VA primary care. Between November 2014 and January 2017, 100 veteran patients with chronic pain and high-risk prescription opioid use (e.g., high-dose therapy, early refills, etc.) were enrolled and completed an initial one-hour study visit with a primary care provider (PCP) within 4 weeks of enrollment. Study PCPs were guided by a web-based opioid management decision support program and templated notes in the VA electronic medical record. After assessment and education, study PCPs used Shared Decision-Making to formulate a Pain Care Plan aligned with a participant's personal values and goals. After the initial visit, patients randomized to Collaborative Care received one Motivational Interviewing (MI) session with a Care Manager followed by 3 Care Manager-delivered brief telephone MI sessions at 6, 8, and 12 weeks to reinforce Pain Care Plans; patients randomized to an Attention Control condition met with a Care Manager briefly, followed by 3 brief scripted telephone psychoeducation sessions at 6, 8, and 12 weeks. Masked evaluators assessed outcomes at baseline, end of intervention (12 weeks), and after eight weeks of no contact (20 weeks). We present study rationale, detailed methods, preliminary results and lessons learned.
| S-EPMC6392081 | biostudies-literature
Project description:IntroductionOver recent years, there has been growing interest in the role of positive, psychological resources that promote resilience and optimal functioning in chronic pain. Although multiple factors comprise resilience, hope is a strength-based motivational state known to contribute to positive psychosocial adjustment and adaptive pain coping. Emerging evidence supports the viability of therapeutic approaches that foster resilience; however, interventions designed to target hope in the context of pain have been remarkably understudied.ObjectivesThe objectives of this pilot study were to test the feasibility and preliminary efficacy of a resilience-oriented hope intervention for clinical pain, as well as psychosocial outcomes and experimental pain sensitivity in individuals with orofacial pain.MethodsTwenty-nine participants with temporomandibular disorder were randomized to a 3-session intervention intended to increase hope or a control intervention (EDU) involving education about pain and stress. Before and after the intervention, participants attended 2 laboratory sessions whereby they completed psychosocial questionnaires and sensitivity to heat, cold, and pressure pain was assessed. Hope was measured using the Adult State Hope Scale.ResultsCompared with EDU, the Hope group exhibited an increase in state hope, lower heat pain sensitivity, higher pressure pain thresholds at the temporomandibular joint, and reductions in pain catastrophizing.ConclusionAlthough preliminary, results suggest that a resilience-based hope intervention may be beneficial in reducing pain sensitivity and catastrophizing and could serve as a target for pain management.
| S-EPMC6455683 | biostudies-literature
Project description:BackgroundThe therapy of chronic musculoskeletal pain (CMSP) is complex and the treatment results are often insufficient despite numerous therapeutic options. While individual patients respond very well to specific interventions, other patients show no improvement. Personalized treatment assignment offers a promising approach to improve response rates; however, there are no validated cross-disease allocation algorithms available for the treatment of chronic pain in validated personalized pain interventions. This trial aims to test the feasibility and safety of a personalized pain psychotherapy allocation with three different treatment modules and estimate initial signals of efficacy and utility of such an approach compared to non-personalized allocation.MethodsThis is a randomized, controlled assessor-blinded pilot trial with a multifactorial parallel arm design. CMSP patients (n = 105) will be randomly assigned 1:1 to personalized or non-personalized treatment based on a cluster assignment of the West Haven-Yale Multidimensional Pain Inventory (MPI). In the personalized assignment condition, patients with high levels of distress receive an emotional distress-tailored intervention, patients with pain-related interference receive an exposure/extinction-tailored treatment intervention and patients who adapt relatively well to the pain receive a low-level smartphone-based activity diary intervention. In the control arm, patients receive one of the two non-matching interventions. Effect sizes will be calculated for change in core pain outcome domains (pain intensity, physical and emotional functioning, stress experience, participant ratings of improvement and satisfaction) after intervention and at follow-up. Feasibility and safety outcomes will assess rates of recruitment, retention, adherence and adverse events. Additional data on neurobiological and psychological characteristics of the patients are collected to improve treatment allocation in future studies.ConclusionAlthough the call for personalized treatment approaches is widely discussed, randomized controlled trials are lacking. As the personalization of treatment approaches is challenging, both allocation and intervention need to be dynamically coordinated. This study will test the feasibility and safety of a novel study design in order to provide a methodological framework for future multicentre RCTs for personalized pain psychotherapy.Trial registrationGerman Clinical Trials Register, DRKS00022792 ( https://www.drks.de ). Prospectively registered on 04/06/2021.
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Project description:BackgroundChronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities.ObjectiveThe aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial.MethodsAn unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting.ResultsOnly 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up-characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=-2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=-2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=-3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001).ConclusionsThis study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible.Trial registrationClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762.
| S-EPMC7592067 | biostudies-literature
Project description:BackgroundVeterans are disproportionately affected by chronic pain, with high rates of pain diagnoses (47%-56%) and a 40% higher rate of prevalence of severe pain than nonveterans. This is often accompanied by negative functional outcomes and higher mortality. Combined with research suggesting medical treatments for chronic pain are often insufficient, there is an urgent need for nonmedical pain self-management programs. An interactive online platform to deliver an efficacious treatment for chronic pain such as acceptance and commitment therapy (ACT) could be a valuable option to assist veterans with pain care at home.ObjectiveThis study aims to evaluate the virtual coach-guided Veteran ACT for Chronic Pain (VACT-CP) online program compared to a waitlist and treatment as usual (WL+TAU) control group through a small pilot feasibility randomized controlled trial. The primary aim was to evaluate the feasibility and acceptability of VACT-CP and study procedures, such as ease of recruitment, treatment receptivity, attrition and retention, sustained participation, system usability, and assessment of trial procedures. Secondary aims explored differences in the VACT-CP and WL+TAU groups on pre- and posttest (week 7) outcome measures for pain, mental health, functioning, and ACT processes.MethodsVeterans with chronic pain were recruited and randomized to either the VACT-CP (n=20) or the WL+TAU (n=22) group in a parallel group trial design. Self-report surveys were administered to participants at baseline (week 0), at the intervention midpoint (week 3), immediately after the intervention (week 7), and at the 1-month follow-up (week 11). We used Wilcoxon signed rank tests with the intention-to-treat sample to describe changes in secondary outcomes from pre- to postintervention within each group.ResultsStudy procedures showed good feasibility related to recruitment, enrollment, randomization, and study completion rates. Participants reported that VACT-CP was easy to use (System Usability Scale: mean 79.6, SD 12.8; median 82.5, IQR 70-87.5); they completed an average of 5 of the 7 total VACT-CP modules with high postintervention satisfaction rates. Qualitative feedback suggested a positive response to program usability, content tailoring, veteran centeredness, and perceived impact on pain management. Although the pilot feasibility trial was not powered to detect differences in clinical outcomes and significant findings should be interpreted with caution, the VACT-CP group experienced significant increases in chronic pain acceptance (P<.001) and decreases in depressive symptoms (P=.03).ConclusionsVACT-CP showed encouraging evidence of feasibility, usability, and acceptance, while also providing promising initial results in improving a key process in ACT for chronic pain-chronic pain acceptance-after online program use. A full-scale efficacy trial is needed to assess changes in clinical outcomes.Trial registrationClinicalTrials.gov NCT03655132; http://clinicaltrials.gov/ct2/show/NCT03655132.International registered report identifier (irrid)RR2-10.2196/45887.
| S-EPMC11584538 | biostudies-literature
Project description:BackgroundHypnosis treatment in general practice is a rather new concept. This pilot study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP).MethodsThe study was designed as a randomized control group-controlled study. Sixteen patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering. Data were analyzed by means of T-tests.ResultsThe treatment group improved from their symptoms, (change from 62.5 to 55.4), while the control group deteriorated, (change from 37.2 to 45.1), (p = 0,045). The 12 patients who completed the treatment showed a mean improvement from 51.5 to 41.6. (p = 0,046). One year later the corresponding result was 41.3, indicating a persisting improvement.ConclusionThe study indicates that hypnosis treatment may have a positive effect on pain and quality of life for patients with chronic muscular pain. Considering the limited number of patients, more studies should be conducted to confirm the results.Trial registrationThe study was registered in ClinicalTrials.gov and released 27.08.07 Reg nr NCT00521807 Approval Number: 05032001.
| S-EPMC2553788 | biostudies-literature
Project description:Current evidence suggests it may be difficult for patients with chronic pain to quit smoking and, based on previous formative work, a 7-session individual and group-based cognitive behavioral (CB) intervention was developed. The primary aim of this randomized controlled pilot trial was to test the hypothesis that abstinence at month 6 would be greater among patients with chronic pain who received the CB intervention compared to a control condition. Upon admission to a 3-week interdisciplinary pain treatment (IPT) program, patients were randomized to receive the CB intervention (n=30) or the control condition (n=30). The 7-day point prevalence of self-reported smoking status was assessed at week 3 (upon completion of the 3-week IPT program) and at month 6 in an intent-to-treat analysis. At week 3, 30% (n=9) of patients in the CB condition were abstinent from smoking compared to 10% (n=3) in the control group (P=.104). At month 6, 20% (n=6) of patients who received the CB intervention were abstinent compared to none in the control group (P=.024). At week 3, a significant group by time interaction effect was found where the CB patients experienced greater improvements in self-efficacy from baseline compared to the control group (P=.002). A greater proportion of patients randomized to the CB group completed the IPT program (P=.052). The findings of this pilot trial suggest that integration of a CB-based smoking abstinence intervention into ongoing pain therapy may be an effective treatment for smokers with chronic pain.
| S-EPMC4412145 | biostudies-literature