Therapeutic Patient Education for Fibromyalgia during Spa Therapy: The FiETT Randomized Controlled Trial.
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ABSTRACT:
SUBMITTER: Ducamp P
PROVIDER: S-EPMC9030628 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Patients with fibromyalgia (FM) experience increased lifetime levels of psychosocial adversity, trauma, and emotional conflict. To address these risk factors, we developed emotion awareness and expression therapy (EAET) and tested its benefits against an active control condition, FM education, and the field's gold standard intervention for FM, cognitive behavioral therapy (CBT) for symptom management. Adults with FM (N = 230) formed 40 treatment groups, which were randomized to EAET, CBT, or education and given 8, 90-minute sessions. Patient-reported outcomes were assessed at baseline, posttreatment, and 6-month follow-up (primary end point). Retention of patients to follow-up was excellent (90.4%). Intent-to-treat analyses indicated that although EAET did not differ from FM education on pain severity (primary outcome), EAET had significantly better outcomes than FM education on overall symptoms, widespread pain, physical functioning, cognitive dysfunction, anxiety, depression, positive affect, and life satisfaction (between-condition d's ranging from 0.29-0.45 SD) and the percentage of patients reporting being "very much/much" improved (34.8% vs 15.4%). Emotional awareness and expression therapy did not differ from CBT on the primary or most secondary outcomes, but compared to CBT, EAET led to significantly lower FM symptoms (d = 0.35) and widespread pain (d = 0.37) and a higher percentage of patients achieving 50% pain reduction (22.5% vs 8.3%). In summary, an intervention targeting emotional awareness and expression related to psychosocial adversity and conflict was well received, more effective than a basic educational intervention, and had some advantages over CBT on pain. We conclude that EAET should be considered as an additional treatment option for FM.
| S-EPMC5680092 | biostudies-literature
Project description:Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality. The aim of this study is to investigate the feasibility of applying a partially randomized patient preference (PRPP) trial model in evaluating the efficacy of two types of traditional Chinese medicine therapies, acupuncture and cupping, for fibromyalgia while accounting for patients' preference of either therapeutic modality.This protocol was approved by the Institutional Ethics Committee of affiliated Dongfang Hospital, Beijing University of Chinese Medicine (approval number: 2013052104-2). One hundred participants with fibromyalgia will be included in this study. Diagnosis of fibromyalgia will be based on the American College of Rheumatology criteria. Before treatment, participants will be interviewed for their preference toward acupuncture or cupping therapy. Fifty participants with no preference will be randomly assigned to one of the two groups and another 50 participants with strong preference to either acupuncture or cupping will receive what they choose. For acupuncture and cupping therapy, the main acupoints used will be tender points (Ashi). Treatment will be three times a week for 5 consecutive weeks with a follow-up period of 12 weeks. Outcome measures will be qualitative (patient expectation and satisfaction) and quantitative (pain intensity, quality of life, depression assessment).NCT01869712 (in clinicaltrials.gov, on 22nd May 2013).
| S-EPMC4226966 | biostudies-literature
Project description:BACKGROUND: Patient education materials can assist patient decision making on prostate cancer screening. OBJECTIVE: To explore the effectiveness of presenting health information on prostate cancer screening using video, internet, and written interventions on patient decision making, attitudes, knowledge, and screening interest. DESIGN: Randomized controlled trial. PARTICIPANTS: A total of 161 men aged over 45, who had never been screened for prostate cancer, were randomized to receive information on prostate cancer screening. MEASUREMENTS: Participants were assessed at baseline and 1-week postintervention for decisional conflict, screening interest, knowledge, anxiety, and decision-making preference. RESULTS: A total of 156 men were followed-up at 1-week postintervention. There was no statistical, or clinical, difference in mean change in decisional conflict scores between the 3 intervention groups (video vs internet -0.06 [95% CI -0.24 to 0.12]; video vs pamphlet 0.04 [95%CI -0.15 to 0.22]; internet vs pamphlet 0.10 [95%CI -0.09 to 0.28]). There was also no statistically significant difference in mean knowledge, anxiety, decision-making preference, and screening interest between the 3 intervention groups. CONCLUSION: Results from this study indicate that there are no clinically significant differences in decisional conflict when men are presented health information on prostate cancer screening via video, written materials, or the internet. Given the equivalence of the 3 methods, other factors need to be considered in deciding which method to use. Health professionals should provide patient health education materials via a method that is most convenient to the patient and their preferred learning style.
| S-EPMC2359522 | biostudies-other
Project description:Statistical analysis plans increase the transparency of decisions made in the analysis of clinical trial results. The purpose of this paper is to detail the planned analyses for the PREVENT trial, a randomized, placebo-controlled trial of patient education for acute low back pain.We report the pre-specified principles, methods, and procedures to be adhered to in the main analysis of the PREVENT trial data. The primary outcome analysis will be based on Mixed Models for Repeated Measures (MMRM), which can test treatment effects at specific time points, and the assumptions of this analysis are outlined. We also outline the treatment of secondary outcomes and planned sensitivity analyses. We provide decisions regarding the treatment of missing data, handling of descriptive and process measure data, and blinded review procedures.Making public the pre-specified statistical analysis plan for the PREVENT trial minimizes the potential for bias in the analysis of trial data, and in the interpretation and reporting of trial results.ACTRN12612001180808 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808).
| S-EPMC5537460 | biostudies-other
Project description:Fibromyalgia is a chronic pain disease with few effective therapeutic options. We evaluated the efficacy of a 12-weeks therapy program that involves the use of whole body vibration in patients with fibromyalgia. The experimental group (N = 20 patients) participated in a neuromuscular training with a rotational whole body vibration platform for 12 weeks. The control group (N = 20 patients) received no physiotherapy treatment. The following variables were assessed before, after and 3 months after the therapy program: Fibromyalgia impact questionnaire, pain intensity, quality of life, sensitivity measurements (pressure pain thresholds, vibration thresholds), motor function tasks (Berg scale, 6-min walk test, isometric back muscle strength), and static and dynamic balance. We found improvements in the indexes of functional disability, static equilibrium and vibration sensitivity and a reduction of pain sensitivity. Our results showed that the intervention group improved almost all parameters immediately after the therapy program, in contrast to the control group that showed no changes. These improvements were not maintained in the follow-up. The whole body vibration therapy can be an effective therapy in patients with fibromyalgia and it can improve symptomatology and quality of life in these patients.
| S-EPMC8208732 | biostudies-literature
Project description:Fibromyalgia is difficult to treat and requires the use of multiple approaches. This study is a randomized controlled trial of qigong compared with a wait-list control group in fibromyalgia.One hundred participants were randomly assigned to immediate or delayed practice groups, with the delayed group receiving training at the end of the control period. Qigong training (level 1 Chaoyi Fanhuan Qigong, CFQ), given over three half-days, was followed by weekly review/practice sessions for eight weeks; participants were also asked to practice at home for 45 to 60 minutes per day for this interval. Outcomes were pain, impact, sleep, physical function and mental function, and these were recorded at baseline, eight weeks, four months and six months. Immediate and delayed practice groups were analyzed individually compared to the control group, and as a combination group.In both the immediate and delayed treatment groups, CFQ demonstrated significant improvements in pain, impact, sleep, physical function and mental function when compared to the wait-list/usual care control group at eight weeks, with benefits extending beyond this time. Analysis of combined data indicated significant changes for all measures at all times for six months, with only one exception. Post-hoc analysis based on self-reported practice times indicated greater benefit with the per protocol group compared to minimal practice.This study demonstrates that CFQ, a particular form of qigong, provides long-term benefits in several core domains in fibromyalgia. CFQ may be a useful adjuvant self-care treatment for fibromyalgia.clinicaltrials.gov NCT00938834.
| S-EPMC3580572 | biostudies-literature
Project description:Objective:There is a growing interest in evaluating the effectiveness of compassion interventions for treating psychological disorders. The present study evaluated the effectiveness of "attachment-based compassion therapy" (ABCT) in the treatment of fibromyalgia (FM), and the role of psychological flexibility as a mediator of improvements. Methods:A total of 42 patients with FM were randomly assigned to ABCT or relaxation (active control group). Both the intervention and control condition were combined with treatment as usual (TAU). The primary outcome was functional status (FIQ), and the secondary outcomes were clinical severity (CGI-S), pain catastrophizing (PCS), anxiety (HADS-A), depression (HADS-D), quality of life (EQ-5D), and psychological flexibility (AAQ-II). Differences between the groups were estimated using mixed-effects models, and mediation assessments were conducted using path analyses. Results:The ABCT group demonstrated superior outcomes compared to the relaxation group, including better FIQ values after treatment (B?=?-3.01; p?=?0.003). Differences in FIQ were maintained at 3-month follow-up (B?=?-3.33; p?=?0.001). The absolute risk reduction in ABCT compared to relaxation increased by 40.0%, with an NNT?=?3 based on criteria of ?50% FIQ reduction after treatment. Psychological flexibility had a significant mediating effect on improvements. Conclusion:These results suggest that ABCT combined with TAU appears to be effective in the treatment of FM symptoms. Clinical Trial Registration:http://ClinicalTrials.gov, identifier NCT02454244.
| S-EPMC5775966 | biostudies-literature
Project description:BACKGROUND AND AIMS: Patient's posture change is commonly employed by a colonoscopist to achieve complete examination. We studied whether patient's posture (left-lateral decubitus vs supine) influenced the success rate of ileal intubation. PATIENTS AND METHODS: In this prospective open-label randomized study performed in the Endoscopy Suite of a tertiary-care center, all adult outpatients referred for colonoscopy, in whom cecal intubation was achieved and who satisfied predefined inclusion criteria, were randomized to undergo ileal intubation in either of the above two postures. Colonoscopy (EC-201 WL, Fujinon) was performed after overnight poly-ethylene-glycol preparation, under conscious sedation and continuous pulse-oxymetry monitoring. After confirming cecal intubation, patients were randomized for ileal intubation. Success was defined by visualization of ileal mucosa or villi (confirmed by digital photography) and was attempted until limited by pain and/or time of ≥ 6 min. RESULTS: Of 320 eligible patients, 217 patients (150 males) were randomized, 106 to left-lateral decubitus and 111 to supine posture. At baseline, the two groups were evenly matched. Successful ileal intubation was achieved in 145 (66.8 %) patients overall, significantly higher in the supine posture (74.8 % versus 58.5 %; P = 0.014). On multivariate analysis, supine posture (P = 0.02), average/good right-colon preparation (P < 0.01), non-thin-lipped ileocecal (IC) valve (P < 0.001) and younger age (P = 0.02) were independent predictors of success. Positive ileal findings were recorded in 13 (9 %) patients. CONCLUSION: Ileoscopy is more successful in supine than in left-lateral decubitus posture. Age, bowel preparation and type of IC valve also determine success.
| S-EPMC4423309 | biostudies-other
Project description:Therapeutic exercise (TE) is one of the most investigated approaches for the management of FMS. Pain neurophysiology education (PNE) helps toward understanding the pain condition, leading to maladaptive pain cognitions and coping strategies in patients with chronic pain. Our study aimed to assess the effects of therapeutic exercise and pain neurophysiology education versus TE in isolation on fatigue, sleep disturbances, and physical function in the short term and at three months of follow-up in women with fibromyalgia syndrome (FMS). A single-blind randomized controlled trial was carried out. A total of 32 women with FMS referred from medical doctors and fibromyalgia association were randomized in 2 groups: PNE + TE group or TE group. Fatigue and sleep disturbances (Visual Analog Score) and physical function (Senior Fitness Test) were assessed before, after intervention, and at three months of follow-up. Significant improvements were achieved in the Timed Up and Go test (p = 0.042) and Arm Curl test (p = 0.043) after intervention and on handgrip in the non-dominant side at three months of follow-up (p = 0.036) on the PNE + TE group. No between-groups differences were found for fatigue, sleep disturbances, and the rest of test included in the Senior Fitness Test. In conclusion, these results suggest that PNE + TE appears to be more effective than TE in isolation for the improvement of physical function (Timed Up and Go test and Arm Curl test) in women with FMS in the short term.
| S-EPMC8201111 | biostudies-literature
Project description: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.
| S-EPMC7603188 | biostudies-literature