Evidence for the improvement of fatigue in fibromyalgia: A 4‐week left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation randomized‐controlled trial

Background

Fibromyalgia is a complex chronic disorder with few effective treatments currently available. One promising treatment option is repetitive transcranial magnetic stimulation (rTMS), a non‐invasive brain stimulation technique that has shown promise in disorders effecting the central nervous system.

Methods

We assessed the efficacy of a course of high‐frequency (10 Hz) left‐hemisphere dorsolateral prefrontal cortex (DLPFC) rTMS in 26 patients (14 active; 12 sham) with a diagnosis of fibromyalgia. Participants underwent a double‐blind stimulation protocol of daily (Monday–Friday) rTMS sessions over four consecutive weeks (total of 20 sessions; 75 × 4‐s 10 Hz trains at 120% resting motor threshold). Assessments were conducted at baseline, 4 weeks and at 1‐month follow‐up.

Results

Using mixed‐model analysis we did not identify a group difference for our primary outcome measures. However, we found that patients in the active group compared to sham treatment group had significantly greater improvement in the Physical Fatigue (p = 0.045) and General Fatigue (p = 0.023) scales of the Multidimensional Fatigue Inventory‐20 at the 1 month follow‐up. In a responder analysis, we also found the active group was significantly more likely (2.84 times) to achieve a minimum 30% improvement in pain intensity ratings. (p = 0.024).

Conclusions

High‐frequency rTMS applied daily for 4 weeks to the left DLPFC induces significant relief from fatigue and a greater chance of clinically meaningful improvement in pain intensity in patients with fibromyalgia. These results suggest DLPFC rTMS may be a relevant therapy for fibromyalgia.

Significance

This study provides evidence that 4‐weeks of daily rTMS to the left DLPFC is able to improve fatigue in fibromyalgia. This novel finding provides impetus for the further investigation of the utility of TMS approaches for the relief of fatigue, an otherwise difficult‐to‐treat symptom, in fibromyalgia and related disorders.     

Impact of Bifrontal Home-Based Transcranial Direct Current Stimulation in Pain Catastrophizing and Disability due to Pain in Fibromyalgia: A Randomized,Double-Blind Sham-Controlled Study

This randomized, double-blind trial tested the hypothesis that 20 sessions of home-based anodal(a)-transcranial direct current stimulation (tDCS) (2mA for 20 minutes) bifrontal, with anodal on the left dorsolateral prefrontal cortex (l-DLPFC) would be better than sham-(s)-tDCS to reduce scores on Pain Catastrophizing Scale and disability-related to pain assessed by the Profile of Chronic Pain: Screen (primary outcomes). Secondary outcomes were depressive symptoms, sleep quality, heat pain threshold , heat pain tolerance , and serum brain-derived-neurotrophic-factor (BDNF). Forty-eight women with fibromyalgia, 30 to 65 years-old were randomized into 2:1 groups [a-tDCS (n = 32) or s-tDCS (n = 16)]. Post hoc analysis revealed that a-tDCS reduced the Pain Catastrophizing Scale total scores by 51.38% compared to 26.96% in s-tDCS, and a-tDCS reduced Profile of Chronic Pain: Screen total scores by 31.43% compared to 19.15% in s-tDCS. The a-tDCS improved depressive symptoms, sleep quality and increased the heat pain tolerance. The delta-value in the serum BDNF (mean post treatment end minus pretreatment) was conversely correlated with the a-tDCS effect in pain catastrophizing. In contrast, the a-tDCS impact on reducing the disability-related to pain at the treatment end was positively associated with a reduction in the serum BDNF and improvement of depressive symptoms, sleep quality and pain catastrophizing symptoms.PerspectiveHome-based bifrontal tDCS with a-tDCS on the l-DLPFC are associated with a moderate effect size (ES) in the following outcomes: 1) Decreased rumination and magnification of pain catastrophizing. 2) Improved the disability for daily activities due to fibromyalgia symptoms. Overall, these findings support the feasibility of self-applied home-based tDCS on DLPFC to improve fibromyalgia symptoms.     

Effect of Music as Nursing Intervention for People Diagnosed with Fibromyalgia

Primary fibromyalgia, a poorly understood chronic pain syndrome, is a disorder of uncertain etiology. The ultimate goal of fibromyalgia treatment is to develop a multimodal therapy. In recent years, the use of music as an intervention for the pain management and other symptoms has increased. The purpose of this study was to investigate the effects of music on pain and depression for people diagnosed with fibromyalgia using Rogers’ theory of the unitary human being as the theoretical framework. An experimental 4-week longitudinal trial design was undertaken. Sixty patients diagnosed with fibromyalgia were randomly assigned to either a music intervention group or a control group. Music interventions consisted of listening to music once a day for 4 consecutive weeks using two types of CDs. Pain was measured with the McGill Pain Questionnaire Long Form and depression with the Beck inventory; a100-mm visual analog scale was used to measure pain and depression. The treatment group reported a significant reduction in pain and depression at week 4 compared with the control group. Members of the control group reported no differences in pain. The findings of this pilot study suggest the importance of music therapy as a nursing intervention and justify further investigation into music as a self-management intervention to reduce pain and depression.     

The Effect of Fibromyalgia and Widespread Pain on the Clinically Significant Temporomandibular Muscle and Joint Pain Disorders—A Prospective 18-Month Cohort Study

Although most cases of temporomandibular muscle and joint disorders (TMJD) are mild and self-limiting, about 10% of TMJD patients develop severe disorders associated with chronic pain and disability. It has been suggested that fibromyalgia and widespread pain play a significant role in TMJD chronicity. This paper assessed the effects of fibromyalgia and widespread pain on clinically significant TMJD pain (GCPS II-IV). Four hundred eighty-five participants recruited from the Minneapolis/St. Paul area through media advertisements and local dentists received examinations and completed the Graded Chronic Pain Scale (GCPS) at baseline and at 18 months. Baseline widespread pain (OR: 2.53, P = .04) and depression (OR: 5.30, P = .005) were associated with onset of clinically significant pain (GCPS II-IV) within 18 months after baseline. The risk associated with baseline fibromyalgia was moderate, but not significant (OR: 2.74, P = .09). Persistence of clinically significant pain was related to fibromyalgia (OR: 2.48, P = .02) and depression (OR: 2.48, P = .02). These results indicate that these centrally generated pain conditions play a role in the onset and persistence of clinically significant TMJD.     

Effects of Naltrexone on Pain Sensitivity and Mood in Fibromyalgia: No Evidence for Endogenous Opioid Pathophysiology

The pathophysiological mechanisms underlying fibromyalgia are still unknown, although some evidence points to endogenous opioid dysfunction. We examined how endogenous opioid antagonism affects pain and mood for women with and without fibromyalgia. Ten women with fibromyalgia and ten age- and gender-matched, healthy controls each attended two laboratory sessions. Each participant received naltrexone (50mg) at one session, and placebo at the other session, in a randomized and double-blind fashion. Participants were tested for changes in sensitivity to heat, cold, and mechanical pain. Additionally, we collected measures of mood and opioid withdrawal symptoms during the laboratory sessions and at home the night following each session. At baseline, the fibromyalgia group exhibited more somatic complaints, greater sensory sensitivity, more opioid withdrawal somatic symptoms, and lower mechanical and cold pain-tolerance than did the healthy control group. Neither group experienced changes in pain sensitivity due to naltrexone administration. Naltrexone did not differentially affect self-reported withdrawal symptoms, or mood, in the fibromyalgia and control groups. Consistent with prior research, there was no evidence found for abnormal endogenous opioid activity in women with fibromyalgia.     

Decreased Pain and Improved Quality of Life in Fibromyalgia Patients Treated with Olanzapine, an Atypical Neuroleptic

Abstract:   Fibromyalgia is a significant clinical problem associated with generalized pain and significant interference with daily activities. Although a variety of treatment modalities have been utilized, clinicians have struggled to find an effective means of treatment. Therefore, this study assessed the efficacy of the atypical neuroleptic olanzapine for the treatment of fibromyalgia symptoms. To examine the efficacy of olanzapine for the treatment of fibromyalgia symptoms, the charts of 51 patients treated with olanzapine were evaluated for improvements in pain and daily life functioning. At the time of initial assessment, patients had been diagnosed with a variety of medical and psychiatric disorders and a history of neuroleptic treatment. Pain was widespread and characteristic of pain associated with fibromyalgia. Pretreatment ratings on pain and the interference scales averaged 6.54–8.69 on a 0–10 scale. Post-treatment ratings on the same scales revealed significant improvement on virtually all scales. The benefits of olanzapine to improve fibromyalgia symptoms must, however, be carefully considered because there were a variety of side effects (i.e., weight gain, somnolence/sedation) that were of sufficient strength to cause a number of patients to discontinue treatment. In general, the data provide strong support that olanzapine can, in certain patients, improve symptoms associated with fibromyalgia in patients who have had limited success with other treatment modalities.     

A Meta‐Analysis of Pain Response in the Treatment of Fibromyalgia

Objective: This meta‐analysis compared efficacy (pain response) of drugs that are licensed or commonly used in the treatment of fibromyalgia. A meta‐analysis of safety measured via discontinuation because of adverse events was also performed. Methods: We conducted a meta‐analysis of 21 clinical trials to estimate treatment differences vs. placebo, separately, for duloxetine, fluoxetine, gabapentin, milnacipran, pramipexole, pregabalin, either of two tricyclic antidepressants, and tramadol plus paracetamol. Indirect treatment comparisons using mixed treatment comparisons methodology were conducted for all pairwise comparisons. Pain response was analyzed as improvement of at least 30%, and separately of 50%, from baseline. Results: When compared with placebo, statistically significant pain responses (improvement of 30% and 50%) were observed for patients treated with duloxetine, milnacipran 200 mg/day, pregabalin 300 or 450 mg/day, and tramadol plus paracetamol. Treatment with fluoxetine, gabapentin, or milnacipran 100 mg/day resulted in significant findings for the 30% improvement in pain response. The meta‐analysis showed a statistically increased risk of discontinuation because of adverse events for milnacipran 100 and 200 mg/day (both P < 0.001), and pregabalin 300 and 450 mg/day (P = 0.009 and P < 0.001, respectively). All other treatments, except fluoxetine, showed numerically increased risk over placebo for discontinuation because of adverse events. In the indirect comparisons, no pairwise comparison of active treatments reached statistical significance for either pain response end point. Conclusion: All eight active treatments displayed evidence suggesting improvement over placebo in the treatment of pain in patients suffering from fibromyalgia. Indirect comparison of active treatments found no strong differences.     

Venlafaxine treatment of fibromyalgia

BACKGROUND: Although the pathophysiology of fibromyalgia is unknown, central monoaminergic transmission may play a role. Antidepressants have proved to be successful in alleviating symptoms of fibromyalgia. Medications that act on multiple neurotransmitters may be more effective in symptom management. OBJECTIVE: To assess the efficacy of venlafaxine, a potent inhibitor of both norepinephrine and serotonin reuptake, in the treatment of patients with fibromyalgia. METHODS: Fifteen patients with fibromyalgia were assessed prior to and after treatment with fixed-dose venlafaxine 75 mg/d. Before initiation of pharmacotherapy, patients were interviewed with the Structured Clinical Interview for Axis I disorders in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition. The study lasted for 12 weeks, and patients were evaluated in weeks 6 and 12. The primary outcome measures were the Fibromyalgia Impact Questionnaire (FIQ) total score and pain score. The anxiety and depression levels of the patients were measured with the Beck Depression, the Beck Anxiety, the Hamilton Anxiety, and the Hamilton Depression scales. RESULTS: There was a significant improvement in the mean intensity of pain (F = 14.3; p = 0.0001) and in the disability caused by fibromyalgia (F = 42.7; p = 0.0001) from baseline to week 12 of treatment. The depression and anxiety scores also decreased significantly from baseline to week 12. The improvement in the FIQ scores did not correlate with the decrease of scores in both patient- and physician-rated depression and anxiety inventories. Change in pain scores also was not correlated with the change in depression and anxiety scores. CONCLUSIONS: Venlafaxine was quite promising in alleviating the pain and disability associated with fibromyalgia. This effect seems to be independent of its anxiolytic and antidepressant properties. Blockade of both norepinephrine and serotonin reuptake might be more effective than blockade of either neurotransmitter alone in the treatment of fibromyalgia.     

Long-term maintenance of the analgesic effects of transcranial magnetic stimulation in fibromyalgia

We assessed for the first time the long-term maintenance of repetitive transcranial magnetic stimulation (rTMS)-induced analgesia in patients with chronic widespread pain due to fibromyalgia. Forty consecutive patients were randomly assigned, in a double-blind fashion, to 2 groups: one receiving active rTMS (n = 20) and the other, sham stimulation (n = 20), applied to the left primary motor cortex. The stimulation protocol consisted of 14 sessions: an “induction phase” of 5 daily sessions followed by a “maintenance phase” of 3 sessions a week apart, 3 sessions a fortnight apart, and 3 sessions a month apart. The primary outcome was average pain intensity over the last 24 hours, measured before each stimulation from day 1 to week 21 and at week 25 (1 month after the last stimulation). Other outcomes measured included quality of life, mood and anxiety, and several parameters of motor cortical excitability. Thirty patients completed the study (14 in the sham stimulation group and 16 in the active stimulation group). Active rTMS significantly reduced pain intensity from day 5 to week 25. These analgesic effects were associated with a long-term improvement in items related to quality of life (including fatigue, morning tiredness, general activity, walking, and sleep) and were directly correlated with changes in intracortical inhibition. In conclusion, these results suggest that TMS may be a valuable and safe new therapeutic option in patients with fibromyalgia.     

Results of a multidisciplinary program for patients with fibromyalgia implemented in the primary care

Purpose. Fibromyalgia is a syndrome of unknown origin with a high prevalence. Multimodal approaches seem to be the treatment of choice in fibromyalgia. A multidisciplinary program was developed and implemented for patients with fibromyalgia in the primary care setting. The program included education (seven sessions) and physical therapy (25 sessions).

Method. Patients were referred to the program by their general practitioner or by a medical specialist. A prospective non-controlled treatment study was performed, patients were evaluated before, after and three months after the program (single group time series design). The following measurements were performed: The Fibromyalgia Impact Questionnaire, RAND 36, the Pain Coping and Cognition List, the Tampa scale for kinesiophobia, two physical tests and a qualitative evaluation. Data of 65 patients with fibromyalgia were analysed, of whom 97% were female. The mean age was 44 and the mean duration of pain was nine years.

Results. Data of 65 patients with fibromyalgia were analysed, patients significantly improved on the domains feeling good, pain, fatigue, stiffness, quality of life, catastrophizing and on the physical tests.

Conclusion. The multidisciplinary program fibromyalgia implemented in primary care seems feasible and the results are promising.     

Fibromyalgia: Moderate and substantial pain intensity reduction predicts improvement in other outcomes and substantial quality of life gain

Chronic pain is associated with a range of other problems, including disturbed sleep, depression, anxiety, fatigue, reduced quality of life, and an inability to work or socialise. We investigated whether good symptom control of pain (using definitions of moderate and substantial benefit) is associated with improvement in other symptoms. Individual patient data from four randomised trials in fibromyalgia (2575 patients) lasting 8–14 weeks were used to calculate percentage pain reduction for each completing patient (1858), divided into one of five groups according to pain reduction, irrespective of treatment: substantial benefit – ?50% pain reduction; moderate – 30% to <50%; minimal – 15% to <30%; marginal – 0% to <15%; worse – <0% (increased pain intensity). We then calculated change from baseline to end of trial for measures of fatigue, function, sleep, depression, anxiety, ability to work, general health status, and quality-adjusted life year (QALY) gain over a 12-month period. Substantial and moderate pain intensity reductions were associated with statistically significant reduction from baseline by end of trial in all measures, with values by trial end at or approaching normative values. Substantial pain intensity reduction resulted in 0.11 QALYs gained, and moderate pain intensity reduction in 0.07 QALYs gained over a 12-month period. Substantial and moderate pain intensity reduction predicts broad beneficial outcomes and improved quality of life that do not occur without pain relief. Pain intensity reduction is a simple and effective predictor of which patients should continue treatment, and which should discontinue and try an alternative therapy.     

Attributes of response in depressed patients switched to treatment with duloxetine

Background: This study was designed to assess clinical and functional outcomes associated with switching to duloxetine treatment in patients with major depressive disorder (MDD) experiencing emotional and painful physical symptoms in their current episode. Methods: In this 8‐week, multinational, multicentre, single‐arm, open‐label clinical trial, 242 MDD patients were switched to duloxetine 60 mg/day after selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) treatment. The primary analysis compared mean change from baseline in Brief Pain Inventory – Modified Short Form (BPI‐SF) interference score between initial responders [≥ 50% reduction from baseline on the 17‐item Hamilton Depression Rating Scale (HAMD₁₇) Maier subscale] and initial non‐responders after 4 weeks. Initial responders continued with duloxetine 60 mg/day. Initial non‐responders received duloxetine 120 mg/day for the remaining 4 weeks. Depression, pain, anxiety and functional outcomes were also compared after 8 weeks. Results: BPI‐SF interference decreased from baseline in initial responders (n = 108) and initial non‐responders (n = 85) after 4 weeks of duloxetine treatment, with greater reductions in initial responders [BPI‐SF mean difference in reduction: 1.01 (95% CI 0.42–1.61); p < 0.001]. Reductions in pain interference favouring initial responders were also apparent after 8 weeks [0.68 (95% CI: 0.03–1.33); p = 0.042]. Depression, pain, anxiety and function improved over 8 weeks across patient groups. Conclusions: Elements of core mood and pain are important residual symptoms following poor treatment response in MDD. Early improvement in these symptoms after switching to duloxetine indicated an increased chance of functional recovery.     

Changes in Pain Coping,Catastrophizing, and Coping Efficacy After Cognitive-Behavioral Therapy in Children and Adolescents With Juvenile Fibromyalgia

A recent randomized multisite clinical trial found that cognitive-behavioral therapy (CBT) was significantly more effective than fibromyalgia education (FE) in reducing functional disability in adolescents with juvenile fibromyalgia (JFM). The primary objective of this study was to examine the psychological processes of CBT effectiveness by evaluating changes in pain coping, catastrophizing, and coping efficacy and to test these changes as mediators of continued improvements in functional disability and depressive symptoms at 6-month follow-up. One hundred adolescents (11–18 years old) with JFM completed the clinical trial. Coping, catastrophizing, and coping efficacy (Pain Coping Questionnaire) and the outcomes of functional disability (Functional Disability Inventory) and depressive symptoms (Children's Depression Inventory) were measured at baseline, posttreatment, and 6-month follow-up. Participants in both conditions showed significant improvement in coping, catastrophizing, and efficacy by the end of the study, but significantly greater improvements were found immediately following treatment for those who received CBT. Treatment gains were maintained at follow-up. Baseline to posttreatment changes in coping, catastrophizing, and efficacy were not found to mediate improvements in functional disability or depressive symptoms from posttreatment to follow-up. Future directions for understanding mechanisms of CBT effectiveness in adolescents with chronic pain are discussed.PerspectiveCBT led to significant improvements in pain coping, catastrophizing, and efficacy that were sustained over time in adolescents with juvenile fibromyalgia. Clinicians treating adolescents with JFM should focus on teaching a variety of adaptive coping strategies to help patients simultaneously regain functioning and improve mood.     

Biogenic amine depletion causes chronic muscular pain and tactile allodynia accompanied by depression: A putative animal model of fibromyalgia

Fibromyalgia is a prevalent and burdensome disorder characterized by chronic widespread pain and complex comorbid symptoms. To develop better treatments for pain-centered fibromyalgia symptoms, there is still a need for animal models which mimic the features of fibromyalgia patients. In the present study, we have established a fibromyalgia animal model by utilizing a never-before-published pharmacological effect of reserpine. Repeated administration of reserpine (1 mg/kg s.c., once daily, for three consecutive days) causes a significant decrease in the muscle pressure threshold and tactile allodynia, which are sustained for 1 week or more in both male and female rats. This treatment regimen decreases the amount of biogenic amines (dopamine, norepinephrine, and 5-hydroxytryptamine) in the spinal cord, thalamus, and prefrontal cortex, which are deeply involved in pain signal processing. It also significantly increases immobility time in the forced swim test, which is indicative of depression, a common comorbid symptom of fibromyalgia. Pregabalin, duloxetine, and pramipexole significantly attenuated the reserpine-induced decrease in muscle pressure threshold, but diclofenac did not. The validity of the use of this reserpinized animal as a fibromyalgia model is demonstrated from three different aspects, i.e., face validity (manifestation of chronic pain and comorbid symptoms), construct validity (dysfunction of biogenic amine-mediated central nervous system pain control is involved), and predictive validity (similar responses to treatments used in fibromyalgia patients). This animal model is expected to contribute to the better understanding of fibromyalgia pathophysiology and the evaluation of drugs, especially those which would activate biogenic amine system.     

Pain and Fatigue Variability Patterns Distinguish Subgroups of Fibromyalgia Patients

The current study examined between- and within-subject variability in pain-related symptoms as predictors of pain and fatigue, and identified patient subgroups on the basis of symptom variability characteristics. Two hundred fifty-six fibromyalgia (FM) patients completed daily diaries up to a period of 154 days and reported on symptoms of pain intensity, pain unpleasantness, fatigue, anxiety, and depressed mood. Measures of health status, quality of life, and somatic symptoms were obtained at baseline, and hierarchical linear modeling and cluster analyses were used. Significant intra- and interindividual variability in daily FM symptoms was observed. Higher levels of pain were associated with greater fluctuations in pain unpleasantness, fatigue, and depressed mood. Similar effects were observed for fatigue and individual variability in anxiety also emerged as a robust predictor. Three FM subgroups were revealed: low variability in symptoms (cluster 1), high symptom variability (cluster 2), and a mixed variability group characterized by low fluctuation in pain unpleasantness; moderate pain, fatigue, and depressed mood variability; and high anxiety variability (cluster 3). Cluster 3 exhibited lower social functioning and higher levels of pain, compared with cluster 1. These findings support the dynamic nature of FM pain and suggest the presence of FM subgroups on the basis of variation in mood and pain symptomatology.

Site-specific Effects of Transcranial Direct Current Stimulation on Sleep and Pain in Fibromyalgia: A Randomized, Sham-controlled Study

Objective: To investigate whether active anodal transcranial direct current stimulation (tDCS) (of dorsolateral prefrontal cortex [DLPFC] and primary motor cortex [M1]) as compared to sham treatment is associated with changes in sleep structure in fibromyalgia. Methods: Thirty‐two patients were randomized to receive sham stimulation or active tDCS with the anode centered over M1 or DLPFC (2 mA, 20 minutes for five consecutive days). A blinded evaluator rated the clinical symptoms of fibromyalgia. All‐night polysomnography was performed before and after five consecutive sessions of tDCS. Results: Anodal tDCS had an effect on sleep and pain that was specific to the site of stimulation: such as that M1 and DLPFC treatments induced opposite effects on sleep and pain, whereas sham stimulation induced no significant sleep or pain changes. Specifically, whereas M1 treatment increased sleep efficiency (by 11.8%, P = 0.004) and decreased arousals (by 35.0%, P = 0.001), DLPFC stimulation was associated with a decrease in sleep efficiency (by 7.5%, P = 0.02), an increase in rapid eye movement (REM) and sleep latency (by 47.7%, P = 0.0002, and 133.4%, P = 0.02, respectively). In addition, a decrease in REM latency and increase in sleep efficiency were associated with an improvement in fibromyalgia symptoms (as indexed by the Fibromyalgia Impact Questionnaire). Finally, patients with higher body mass index had the worse sleep outcome as indexed by sleep efficiency changes after M1 stimulation. Interpretation: Our findings suggest that one possible mechanism to explain the therapeutic effects of tDCS in fibromyalgia is via sleep modulation that is specific to modulation of primary M1 activity. ?     

Escitalopram is associated with reductions in pain severity and pain interference in opioid dependent patients with depressive symptoms

Pain is common among opioid-dependent patients, yet pharmacologic strategies are limited. The aim of this study was to explore whether escitalopram, a selective serotonin reuptake inhibitor, was associated with reductions in pain. The study used longitudinal data from a randomized, controlled trial that evaluated the effects of escitalopram on treatment retention in patients with depressive symptoms who were initiating buprenorphine/naloxone for treatment of opioid dependence. Participants were randomized to receive escitalopram 10 mg or placebo daily. Changes in pain severity, pain interference, and depression were assessed at 1-, 2-, and 3-month visits with the visual analog scale, Brief Pain Inventory, and the Beck Depression Inventory II, respectively. Fixed-effects estimators for panel regression models were used to assess the effects of intervention on changes in outcomes over time. Additional models were estimated to explore whether the intervention effect was mediated by within-person changes in depression. In this sample of 147 adults, we found that participants randomized to escitalopram had significantly larger reductions on both pain severity (b = −14.34, t = −2.66, P < .01) and pain interference (b = −1.20, t = −2.23, P < .05) between baseline and follow-up. After adjusting for within-subject changes in depression, the estimated effects of escitalopram on pain severity and pain interference were virtually identical to the unadjusted effects. This study of opioid-dependent patients with depressive symptoms found that treatment with escitalopram was associated with clinically meaningful reductions in pain severity and pain interference during the first 3 months of therapy.     

Effect moderators in Internet-based exposure therapy for fibromyalgia: The role of pain intensity

Background

A recent randomized controlled trial (N = 140) was indicative of large and sustained average improvements of Internet-based exposure for fibromyalgia, as compared to a waitlist. However, little is known about who benefits the most from this treatment.

Objectives

To test for potential moderating effects of age, educational attainment, the duration of fibromyalgia, baseline overall fibromyalgia severity, pain intensity, fibromyalgia-related avoidance behaviour and symptom preoccupation on the waitlist-controlled effect of 10 weeks of Internet-based exposure for fibromyalgia.

Methods

Secondary analysis of a randomized controlled trial ( ClinicalTrials.gov NCT02638636). We used linear mixed effects models to determine whether the waitlist-controlled effect of exposure therapy on overall fibromyalgia severity (Fibromyalgia Impact Questionnaire) differed as a function of the potential moderators.

Results

Only pain intensity (0–10) was found to be a significant moderator, where a higher baseline pain intensity predicted a more limited waitlist-controlled effect of Internet-based exposure (B = 3.48, 95% CI: 0.84–6.13). Standardized point estimates of effects were small for the sociodemographic variables, and in the moderate range for some clinical variables that did not reach statistical significance such as behavioural avoidance and time with the fibromyalgia diagnosis.

Conclusions

Results suggest that Internet-based exposure treatment was more useful for participants with lower baseline levels of pain, and less so for participants with higher baseline levels of pain. The treatment had relatively similar effects across the other tested moderators.

Significance

This study evaluated potential effect moderators in exposure-based treatment for fibromyalgia. Results indicated that a higher level of pain intensity at baseline was predictive of a less favourable outcome. It may be extra important to monitor progression for these patients and to provide additional therapeutic support when needed.     

The effect of electroacupuncture on opioid‐like medication consumption by chronic pain patients: A pilot randomized controlled clinical trial

Opioid‐like medications (OLM) are commonly used by patients with various types of chronic pain, but their long‐term benefit is questionable. Electroacupuncture (EA) has been previously shown beneficial in reducing post‐operative acute OLM consumption. In this pilot randomized controlled trial, the effect of EA on OLM usage and associated side effects in chronic pain patients was evaluated. After a two‐week baseline assessment, participants using OLM for their non‐malignant chronic pain were randomly assigned to receive either real EA (REA, n=17) or sham EA (SEA, n=18) treatment twice weekly for 6 weeks before entering a 12‐week follow‐up. Pain, OLM consumption and their side effects were recorded daily. Participants also completed the McGill Pain Questionnaire (MPQ), SF‐36 and Beck Depression Inventory (BDI) at baseline, and at the 5th, 8th, 12th, 16th and 20th week. Nine participants withdrew during the treatment period with another three during the follow‐up period. Intention to treat analysis was applied. At the end of treatment period, reductions of OLM consumption in REA and SEA were 39% and 25%, respectively (p=0.056), but this effect did not last more than 8 weeks after treatment. There was no difference between the two groups with respect to reduction of side effects and pain and the improvement of depression and quality of life. In conclusion, REA demonstrates promising short‐term reduction of OLM for participants with chronic non‐malignant pain, but such effect needs to be confirmed by trials with adequate sample sizes.