scholarly journals Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3348 ◽  
Author(s):  
Mayte Serrat ◽  
Míriam Almirall ◽  
Marta Musté ◽  
Juan P. Sanabria-Mazo ◽  
Albert Feliu-Soler ◽  
...  

A recent study (FIBROWALK) has supported the effectiveness of a multicomponent treatment based on pain neuroscience education (PNE), exercise therapy (TE), cognitive behavioral therapy (CBT), and mindfulness in patients with fibromyalgia. The aim of the present RCT was: (a) to analyze the effectiveness of a 12-week multicomponent treatment (nature activity therapy for fibromyalgia, NAT-FM) based on the same therapeutic components described above plus nature exposure to maximize improvements in functional impairment (primary outcome), as well as pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables) compared with treatment as usual (TAU); (b) to preliminarily assess the effects of the nature-based activities included (yoga, Nordic walking, nature photography, and Shinrin Yoku); and (c) to examine whether the positive effects of TAU + NAT-FM on primary and secondary outcomes at post-treatment were mediated through baseline to six-week changes in process variables. A total of 169 FM patients were randomized into two study arms: TAU + NAT-FM vs. TAU alone. Data were collected at baseline, at six-week of treatment, at post-treatment, and throughout treatment by ecological momentary assessment (EMA). Using an intention to treat (ITT) approach, linear mixed-effects models and mediational models through path analyses were computed. Overall, TAU + NAT-FM was significantly more effective than TAU at posttreatment for the primary and secondary outcomes evaluated, as well as for the process variables. Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal. The number needed to treat (NNT) was 3 (95%CI = 1.6–3.2). The nature activities yielded an improvement in affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy. Kinesiophobia and perceived competence were the mediators that could explain a significant part of the improvements obtained with TAU + NAT-FM treatment. TAU + NAT-FM is an effective co-adjuvant multicomponent treatment for improving FM-related symptoms.

2021 ◽  
Author(s):  
Maisa Ziadni ◽  
Lluvia Gonzalez-Castro ◽  
Steven Anderson ◽  
Parthasarathy Krishnamurthy ◽  
Beth D Darnall

BACKGROUND Pain-cognitive behavioral therapy is an evidence-based treatment for chronic pain, with significant patient burden including healthcare cost, travel, multiple sessions, and lack of access in remote areas. A previously developed and efficacious single-session intervention “Empowered Relief” (ER) based on CBT principles has particular salience and fills an urgent clinical need during COVID-19. However, key questions remain about the efficacy of online-delivered ER. OBJECTIVE The primary goal is to pilot test the comparative efficacy of a single-session videoconference-delivered ER group to a waitlist control (WLC) among individuals with chronic pain. We hypothesized that ER would be superior to WLC for reductions in pain catastrophizing, pain intensity, and other pain-related outcomes at 1-3 months post-treatment. METHODS We conducted a randomized controlled trial involving an online sample of adults (N=104) aged 18-80 years with self-reported chronic pain. Participants were randomized (1:1) to one of the two unblinded study groups: ER (n=50) or a WLC (n=54). Participants allocated to ER completed a Zoom-delivered class, and all participants completed follow-up surveys at 2 weeks, 1, 2, and 3 months post-treatment. All study procedures occurred remotely and electronically. The primary outcome was pain catastrophizing one-month post-treatment, with pain intensity, pain bothersomeness, and sleep disruption as secondary outcomes. We also report a more rigorous test of the durability of treatment effects at 3 months post-treatment. Data were collected from September 2020 - February 2021 and analyzed using intention-to-treat analysis. The analytic dataset included participants (18% clinic patients, 82% community) who completed at least one study surveys: ER (n=50) and WLC (n=51). RESULTS Participants (N=101) were 69.3% (70/101) female, with mean age of 49.76 years (SD 13.90; range 24.00-78.00); 32.7% (33/101) had an undergraduate degree, with self-reported chronic pain >= 3 months. Participants reported high engagement (94%), high satisfaction with ER (mean 8.26, SD 1.57; range 0-10), and Zoom-platform (92%). For the between-groups factor, ER was superior to WLC for all primary and secondary outcomes at 3 -months post-treatment (highest P=.0001), and between-groups Cohen d effect sizes ranged from 0.45 to 0.79, indicating superiority was of moderate to substantial clinical importance. At 3 months, clinically meaningful PCS reductions were found for ER but not for WLC (ER: PCS, -8.72, 42.25% reduction; WLC: PCS -2.25, 11.13% reduction). ER resulted in significant improvements in pain intensity, sleep disturbance, and clinical improvements in pain bothersomeness. CONCLUSIONS Zoom-delivered ER had high participant satisfaction and very high engagement. Among adults with chronic pain, this single-session, Zoom-delivered, skills-based pain class resulted in clinically significant improvement across a range of pain-related outcomes and sustained at 3 months. Online delivery of ER could allow greater accessibility of home-based pain treatment and could address the inconveniences and barriers faced by patients when attempting to receive in-person care. CLINICALTRIAL ClinicalTrials.gov Identifier NCT 04546685, Registered on 04 September 2020.


2020 ◽  
Author(s):  
Mayte Serrat ◽  
Juan P. Sanabria-Mazo ◽  
Míriam Almirall ◽  
Marta Musté ◽  
Albert Feliu Soler ◽  
...  

Methods. A randomised controlled trial (RCT) was carried out to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioural therapy and mindfulness, in addition to treatment as usual (TAU), compared to TAU only in patients with fibromyalgia (FM). The multicomponent treatment (2h weekly sessions) was delivered in groups of 20 participants. TAU was mainly based on pharmacotherapy. We collected data on functional impairment (the Revised Fibromyalgia Impact Questionnaire [FIQR], as primary outcome), pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, at 12 weeks and, for the multicomponent group only, at 6 and 9 months. An intention to treat approach was used to analyse between-group differences. We also analysed baseline differences between responders (> 20% FIQR reduction) and non-responders and computed the number needed to treat (NNT). Results. A total of 272 patients with FM were randomly assigned to either the multicomponent treatment (n = 135) or TAU (n = 137). Significant between-group differences (p < .001) with a large effect size (Cohen’s d > .80) were found for functional impairment, pain, kinesiophobia, and physical function, whilst differences with a moderate size effect (Cohen’s d > 0.50 and < 0.80) were found for fatigue, anxiety, and depressive symptoms. Non-responders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI 1.7 - 2.3).Conclusions. Our results indicate that, when compared to TAU, the multicomponent treatment was effective for improving FM-related symptoms. Nevertheless, we must temper our findings in light of some methodological limitations in the study design.Impact statement●This is the first RCT showing positive effects on a wide range of clinical outcomes of a multicomponent treatment that integrates pain neuroscience education for patients with fibromyalgia.●This work reports promising results and it might be the first step towards a paradigm shift in the management of fibromyalgia.


Author(s):  
Heidrun Lioba Wunram ◽  
Max Oberste ◽  
Stefanie Hamacher ◽  
Susanne Neufang ◽  
Nils Grote ◽  
...  

Background: Pro-inflammatory cytokines (PICs) have gained attention in the pathophysiology and treatment of depressive disorders. At the same time, the therapeutic effect of physical activity seems to work via immunomodulatory pathways. The interventional study “Mood Vibes” analyzed the influence of exercise on depression severity (primary endpoint) in depressive adolescents; the influence of PICs on the clinical outcome was analyzed as a secondary endpoint. Methods: Clinically diagnosed depressed adolescents (N = 64; 28.1% male; mean age = 15.9; mean BMI = 24.6) were included and participated either in Whole Body Vibration (WBV) (n = 21) or bicycle ergometer training (n = 20) in addition to treatment-as-usual (TAU). Patients in the control treatment group received TAU only (n = 23). The PICs (interleukin-6—IL-6 and tumor necrosis factor-α—TNF-α) were analyzed before intervention, after 6 weeks of training (t1), and 8 weeks post-intervention (t2). The effects of the treatment on depression severity were rated by self-rating “Depression Inventory for Children and Adolescents” (DIKJ). Results: Basal IL-6 decreased in all groups from t0 to t1, but it increased again in WBV and controls at t2. TNF-α diminished in ergometer and controls from baseline to t1. PIC levels showed no correlation with depression severity at baseline. The influence on DIKJ scores over time was significant for IL-6 in the WBV group (p = 0.008). Sex had an impact on TNF-α (p < 0.001), with higher concentrations in male patients. Higher body mass index was associated with higher IL-6 concentrations over all measurement points (p < 0.001). Conclusions: The positive effects of an intensive add-on exercise therapy on adolescent depression seem to be partly influenced by immunomodulation. A small sample size and non-randomized controls are limitations of this study.


2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Bruno Chrcanovic ◽  
Johan Larsson ◽  
Eva-Maj Malmström ◽  
Hans Westergren ◽  
Birgitta Häggman-Henrikson

Abstract Objectives Acute as well as chronic pain syndromes are common after whiplash trauma and exercise therapy is proposed as one possible intervention strategy. The aim of the present systematic review was to evaluate the effect of exercise therapy in patients with Whiplash-Associated Disorders for the improvement of neck pain and neck disability, compared with other therapeutic interventions, placebo interventions, no treatment, or waiting list. Content The review was registered in Prospero (CRD42017060356) and conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A literature search in PubMed, Scopus and Cochrane from inception until January 13, 2020 was combined with a hand search to identify eligible randomized controlled studies. Abstract screening, full text assessment and risk of bias assessment (Cochrane RoB 2.0) were conducted by two independent reviewers. Summary The search identified 4,103 articles. After removal of duplicates, screening of 2,921 abstracts and full text assessment of 100 articles, 27 articles that reported data for 2,127 patients were included. The included articles evaluated the effect of exercise therapy on neck pain, neck disability or other outcome measures and indicated some positive effects from exercise, but many studies lacked control groups not receiving active treatment. Studies on exercise that could be included in the random-effect meta-analysis showed significant short-term effects on neck pain and medium-term effects on neck disability. Outlook Despite a large number of articles published in the area of exercise therapy and Whiplash-Associated Disorders, the current evidence base is weak. The results from the present review with meta-analysis suggests that exercise therapy may provide additional effect for improvement of neck pain and disability in patients with Whiplash-Associated Disorders.


2018 ◽  
Vol 08 (03) ◽  
pp. 163-167
Author(s):  
Abida Arif ◽  
Ghousia Shahid ◽  
Muhammad Arif Siddique ◽  
Khalid Aziz ◽  
Muhammad Faisal Fahim

Objective: To evaluate the effect of therapeutic exercises on pregnancy related low back pain in a tertiary care hospital of Karachi. Material & Methods: This was a quasi-experimental study with non-probability convenience sampling technique. Study was carried out at Liaquat National Hospital Karachi. Patients were divided into two groups (Experimental and Control). Inclusion criteria were age <30 years, 2nd and 3rd trimester, stable medical status and those who gave the informed consent. Exclusion were pregnancy induced hypertension (>140/90mmHg), Cardiac disease, diabetes mellitus, persistent vaginal bleeding, history of miscarriages, decreased foetal movement. Data was collected through assessment Modified Oswestry Low back pain disability questionnaire. SPSS version 23.0 was used to analyze the data. Results: A total of 30 samples were selected for the study. There were 15 respondents in experimental while 15 in control group. Disability levels were found to be significantly decreased after post treatment in experimental group with P-value= 0.002. It was seen that number of patients was increased from 1(6.7%) to 6(40%) in minimal disability group whereas crippled back pain group in pre-treatment group was totally shifted towards minimal or moderate pain 3(20.0%) and no case was seen in post-treatment. Conclusion: Low back pain in pregnancy can disturb daily life routine but exercise therapy and proper counselling will lead stress free life to female in gestation. After post treatment in experimental group showed decrease in pain as compare to control group who were not provided any exercise therapy. Working women in experimental group also showed decrease by crippled back pain to moderate pain after exercise. So in the end researcher suggest that physiotherapy exercises play a vital role in reducing Low Back Pelvic Pain (LBPP) during pregnancy.


Pain Medicine ◽  
2020 ◽  
Vol 21 (11) ◽  
pp. 2811-2822
Author(s):  
Brandon C Yarns ◽  
Mark A Lumley ◽  
Justina T Cassidy ◽  
W Neil Steers ◽  
Sheryl Osato ◽  
...  

Abstract Objective Emotional awareness and expression therapy (EAET) emphasizes the importance of the central nervous system and emotional processing in the etiology and treatment of chronic pain. Prior trials suggest EAET can substantially reduce pain; however, only one has compared EAET with an established alternative, demonstrating some small advantages over cognitive behavioral therapy (CBT) for fibromyalgia. The current trial compared EAET with CBT in older, predominately male, ethnically diverse veterans with chronic musculoskeletal pain. Design Randomized comparison trial. Setting Outpatient clinics at the West Los Angeles VA Medical Center. Subjects Fifty-three veterans (mean age = 73.5 years, 92.4% male) with chronic musculoskeletal pain. Methods Patients were randomized to EAET or CBT, each delivered as one 90-minute individual session and eight 90-minute group sessions. Pain severity (primary outcome), pain interference, anxiety, and other secondary outcomes were assessed at baseline, post-treatment, and three-month follow-up. Results EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively). At post-treatment, 41.7% of EAET patients had &gt;30% pain reduction, one-third had &gt;50%, and 12.5% had &gt;70%. Only one CBT patient achieved at least 30% pain reduction. Secondary outcomes demonstrated small to medium effect size advantages of EAET over CBT, although only post-treatment anxiety reached statistical significance. Conclusions This trial, although preliminary, supports prior research suggesting that EAET may be a treatment of choice for many patients with chronic musculoskeletal pain. Psychotherapy may achieve substantial pain reduction if pain neuroscience principles are emphasized and avoided emotions are processed.


CJEM ◽  
2016 ◽  
Vol 18 (S1) ◽  
pp. S53-S53
Author(s):  
T. Kawano ◽  
B.E. Grunau ◽  
K. Gibo ◽  
F.X. Scheuermeyer ◽  
R. Stenstrom

Introduction: H1-antihistamines are often used to treat allergic reactions, however, the influence of H1-antihistamines on progression to anaphylaxis remains unclear. Among patients initially presenting with allergic reactions, we investigated whether H1-antihistamines were associated with a lower proportion of patients progressing to anaphylaxis during observation. Methods: This was a retrospective cohort study conducted at two urban EDs from 2007 to 2012. We included adult patients with allergy and excluded those who met criteria of anaphylaxis at first evaluation by medical professionals and/or received antihistamines before the evaluation. Primary outcomes of interest were the number of patients who developed anaphylaxis during observation at ED and/or transportation by EMS. Secondary outcomes were the number of biphasic reactions and severe anaphylaxis (defined as sBP<90; SpO2<92%; and/or confusion, collapse, loss of conscious, or incontinence). Logistic regression was performed comparing primary and secondary outcomes between H1-antihistamine treated and non-treated groups with propensity score adjustment of the baseline covariates. Number needed to treat (NNT) was calculated by adjusted absolute risk reduction of H1-antihistamine compared to non H1-antihistamine use on primary outcome. Results: This study included 1717 patients with allergic reactions, of whom 1228 were treated with H1-antihistamines. In the H1-antihistamine group 1.0% and 0.2% developed anaphylaxis and severe anaphylaxis, respectively; in the non-H1-antihistamine group 2.6% and 0.6% developed anaphylaxis and severe anaphylaxis, respectively. There were no biphasic reactions (0%, 95% confidence interval [CI] 0 to 0.17%). Administration of H1-antihistamines was associated with a lower incidence of subsequent anaphylaxis (adjusted odds ratio [OR] 0.23, 95% CI 0.10 to 0.53; NNT to benefit 49.1, 95% CI 41.6 to 83.3). There were no significant associations between H1-histamines administration and secondary outcomes. Conclusion: Among ED patient with allergic reactions, H1-antihistamine administration was associated with a lower likelihood of progression to anaphylaxis. These findings suggest that H1-antihistamines should be administered early in the care of patients with allergic reactions.


BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e034735
Author(s):  
Luke Sheridan Rains ◽  
Thomas Steare ◽  
Oliver Mason ◽  
Sonia Johnson

ObjectivesContingency management (CM) is a treatment for substance misuse that involves the provision of incentives. This review examines the hypothesis that adding another formal psychotherapy, such as cognitive–behavioural therapy (CBT) or motivational enhancement therapy (MET), to CM improves substance use outcomes at both treatment end and at post-treatment follow-up compared with CM only.Data sourcesSearches were performed in December 2017 and July 2019 of seven electronic bibliographic databases (MEDLINE, PsycINFO, EMBASE, Scopus, Web of Science, CINAHL, PsycEXTRA), as well as online trial registries and EThoS, and were followed by reference list screening.Eligibility criteriaIncluded studies were randomised controlled trials of adults (18–65) who were using illicit substances, alcohol or tobacco. Studies featured an experimental arm delivering CM combined with a structured evidence-based psychotherapeutic intervention and a CM-only arm. Studies published up to July 2019 were included.Data extraction and synthesisThe primary outcome was biometrically verified point prevalent abstinence (PPA) at treatment end. Secondary outcomes included biometrically verified PPA at post-treatment follow-up and self-reported days of use at treatment end and post-treatment follow-up. Pooled risk ratios for PPA outcomes and standardised mean differences for days of use were calculated using random effects models. Risk of bias was assessed using the Grading of Recommendations Assessment, Development and Evaluation.Results12 studies (n=1654) were included. The primary analysis found no evidence of a synergistic effect in PPA at treatment end (relative risk (RR) 0.97, 95% CI 0.85 to 1.09; p=0.57). Sensitivity analysis of studies featuring CBT/MET also found no evidence of an effect (RR 0.92; 95% CI 0.79 to 1.08; p=0.32). None of the secondary outcomes showed any evidence of benefit.ConclusionThe results of the meta-analyses found no evidence that combining CM with another intervention improves the short-term or long-term effects of CM treatment.


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