Acceptance-Commitment Therapy for Women with Episodic Migraine: A Pilot Randomized Trial.

Objective: The aim of this study was to conduct a pilot, randomized controlled trial (RCT) of acceptance-commitment therapy (ACT) among women with episodic migraine, aged 18-65 years, and living in the United States. Background: Biobehavioral treatments have recently been proposed as possible preventive therapies for migraine management. ACT is a third wave biobehavioral therapy focused on acceptance and development of psychological flexibility and is evidence based for use in other chronic pain conditions. However, its use for reducing migraine frequency and disability has been understudied to date. Methods: The authors performed a pilot RCT evaluating ACT versus enhanced usual care (EUC) among adult women with episodic migraine. ACT consisted of eight virtual weekly sessions (for 8 weeks). Primary aims evaluated feasibility, retention, and protocol adherence. Secondary clinical outcomes included changes in migraine days and Migraine Disability Assessment (MIDAS). Results: We were able to successfully recruit 54 women in 15 months, which surpassed our recruitment goal. However, the completion rates of migraine logs and questionnaires at both outcome assessments were lower than anticipated. Among the 17 individuals randomized to EUC, 12 (71%) completed migraine logs and 12 (71%) completed questionnaires at the end of the intervention. In the postintervention follow-up, 11 (65%) individuals completed logs and 11 (65%) completed questionnaires. We observed slightly larger decreases in migraine days for those assigned to ACT from baseline to the end of the intervention, but these differences did not persist during postintervention follow-up. Both groups reported similar decreases in MIDAS over time. Conclusions: Recruitment for a large-scale trial of ACT is feasible. Challenges with remote data collection as well as participant burden during the COVID-19 pandemic resulted in lower than anticipated completion rates. Future studies should focus on decreasing participant burden and streamlining study procedures. Clinical Trials Registration: NCT05003362.

Biofeedback EMG alternative therapy for chronic low back pain (the BEAT-pain study).

Objective: The aim of this study was to assess the feasibility and potential effectiveness of an 8-week virtual EMG biofeedback intervention for patients with CLBP. Methods: Patients with CLBP completed validated baseline and post-intervention assessments of pain intensity and interference (Brief Pain Inventory), back pain-related disability (Oswestry Disability Index), anxiety and depression (Hospital Anxiety and Depression Scale). Participants underwent a series of Quantitative Sensory Testing (QST) procedures assessing responses to mechanical stimuli during two separate visits (baseline and post-intervention). In addition, we assessed, using surface EMG, the muscle tension in the trapezius, latissimus, and low back muscles at each session. Patients were randomized into the EMG biofeedback intervention or usual care group. Factorial analysis of variance including the interaction between treatment group and time was used to analyze the changes in pain intensity (primary outcome), pain interference, disability (secondary outcomes), anxiety, and depression (secondary outcomes). Results: Compared to the treatment as usual comparison group, patients in the EMG biofeedback group reported lower pain intensity after completing the intervention (mean group difference 0.9, 95% CI -1.07, -0.32; p≤0.01). Compared to baseline, participants in the EMG biofeedback group demonstrated statistically significant reductions in pain interference (mean difference 1.3, 95% CI 0.42, 2.1; p≤0.01), disability (mean difference 4.32, 95% CI 1.2, 7.3; p≤0.01), and significant increases in low back pain thresholds (mean difference 0.5, 95% CI -0.87, -0.05; p≤0.01), assessed by QST. However, no significant group by time effects were observed for secondary outcomes: pain interference, disability, and low back pain thresholds. In addition, significant changes were observed in muscle tension for the trapezius, latissimus, and low back muscles in the EMG biofeedback group (p<0.001). Conclusions: Virtual EMG biofeedback shows promise as a potential therapy for reducing pain and disability in individuals with chronic nonspecific low back pain.

Acceptance and commitment therapy for episodic migraine: Rationale and design of a pilot randomized controlled trial.

Migraine is a debilitating disorder with limited pharmacological options. Many migraine medications can have intolerable side effects leading patients to seek complementary and integrative health (CIM) approaches for treatment. One option that is growing in popularity and evidence is Acceptance and Commitment Therapy (ACT), a mindfulness-based therapy. The purpose of this paper is to describe how ACT may be an effective modality integrated into the treatment of migraine and to describe the design of a pilot study of ACT for migraine. First, we review the research and the promise of mindfulness therapies for the treatment of migraine. Then, we describe how ACT differs from other mindfulness therapies for migraine and why it can be a promising option for these patients. Finally, we summarize the design of a pilot study designed to determine the feasibility of performing a future fully powered study to determine the effectiveness of ACT on migraine frequency and disability. This pilot study includes unique features, including a remotely-delivered ACT intervention and the measurement of cortisol levels before and after the intervention.

Biofeedback EMG alternative therapy for chronic low back pain: Study protocol of a pilot randomized controlled trial.

BACKGROUND: Chronic pain affects about 100 million U.S. adults, with chronic low back pain (CLBP) cited as the most prevalent type. Although there is evidence that non-pharmacological therapies seem to be effective for treating low back pain, there is limited evidence of the effectiveness of EMG biofeedback with non-specific chronic low back pain (NCLBP). The purpose of this study is, therefore, to determine the efficacy of a portable EMG biofeedback device on pain in individuals with CLBP. METHODS/DESIGN: This study is a prospective, single-center, assessor-blind, two-arm, parallel randomized controlled trial to be conducted at Brigham and Women's Hospital, Boston, MA. Eighty patients with CLBP will be randomized in a 2:1 ratio to receive sEMG-BF (surface EMG biofeedback) or continued care (no intervention). All participants will receive treatment virtually weekly for 8 weeks. The primary outcome will be pain intensity (Brief Pain Inventory). The secondary outcomes will include pain interference (Brief Pain Inventory), disability (The Oswestry Disability Index (ODI)), anxiety and depression (Hospital Anxiety and Depression Scale). All outcomes will be assessed at baseline, immediately post-intervention, and 3 months follow-up. CONCLUSION: To our knowledge, this study will be the first powered randomized controlled trial to compare the effectiveness of a virtual sEMG-BF protocol specifically designed for CLBP. The outcome of the study may provide evidence for the effectiveness of biofeedback using digital therapeutics to relieve pain in individuals with CLBP. TRIAL REGISTRATION: Clinical Trials Registry (http://ClinicalTrials.gov Identifier: NCT04607460). Registered on October 29, 2020.

The impact of COVID-19 pandemic on mental and physical wellbeing in women with fibromyalgia: a longitudinal mixed-methods study.

OBJECTIVE: The COVID-19 pandemic has strongly influenced psychological and physical health worldwide. The aim of this study was to examine the impact of the pandemic on women with fibromyalgia. METHODS: This mixed methods pilot study explored measures of pain severity and interference, as well as pain catastrophizing and level of fibromyalgia impact among women with fibromyalgia before and during the COVID-19 pandemic in the USA. Fibromyalgia patients completed demographic, pain-related, and other validated psychosocial questionnaires prior to the onset of the COVID-19 pandemic, and then were re-assessed with those questionnaires, as well as a pandemic-related questionnaire assessing the impact of the pandemic on the patients' life, during the pandemic. RESULTS: When comparing data reported before the pandemic to data collected 3-6 months into the pandemic, women with fibromyalgia reported a general worsening of their pain and pain-related symptoms. During the pandemic, pain catastrophizing (p ≤ 0.05) and fibromyalgia impact (p ≤ 0.05) increased significantly compared to before the pandemic. The increase in pain catastrophizing scores was highly correlated with the impact of the pandemic on the participants' ability to cope with pain and on their mental health. Qualitative analysis corroborated the significant impact of the pandemic on patients' mental health, with the vast majority reporting a worsening of their mood. Other impacted domains included anxiety, level of activity and sleep. CONCLUSIONS: Collectively, the pandemic appears to have produced a substantive worsening of pain-related symptomatology among women with fibromyalgia, which should be addressed by targeted interventions.

The "self" in pain: high levels of schema-enmeshment worsen fibromyalgia impact.

OBJECTIVE: Chronic pain can have detrimental effects on quality of life and a profound impact on one's identity. The Pictorial Representation of Illness- and Self-Measure (PRISM), is a visual tool designed to measure the self-illness separation (SIS) that represents the degree of schema-enmeshment (i.e., the degree to which the self-schema and the illness-schema come to overlap). Our aim was to investigate the relationship between schema-enmeshment and pain-related outcomes in patients with fibromyalgia. METHODS: In this cross-sectional study, 114 patients with fibromyalgia completed self-report assessments of pain catastrophizing, pain severity and interference, impact of symptoms, anxiety, and depression. SIS was assessed using an iPad version of PRISM. Mediation analyses evaluated the mediating role of schema-enmeshment on the association between pain catastrophizing and fibromyalgia impact. RESULTS: A higher degree of schema-enmeshment was associated with greater pain catastrophizing, pain severity and interference, impact of symptoms, and depression. Moreover, a mediation analysis revealed that schema-enmeshment significantly mediated the association between pain catastrophizing and fibromyalgia impact (p < 0.001). CONCLUSIONS: Our results indicate that schema-enmeshment is associated with greater intrusiveness of chronic pain on everyday life, thereby posing significant limitations on the emotional and physical well-being of fibromyalgia patients. Schema-enmeshment also appears to partly account for the deleterious effect of pain catastrophizing on disease impact. The PRISM is a simple tool that may uniquely capture the extent to which chronic pain and illness infiltrates and affects one's self-concept.

Individual variation in diurnal cortisol in patients with knee osteoarthritis: Clinical correlates.

BACKGROUND: The cortisol awakening response (CAR) is a core biomarker of hypothalamic-pituitary-adrenal (HPA) axis regulation. To date, however, studies of HPA-axis function among patients with chronic pain are scarce and show equivocal results. The objectives of this study were to investigate the association between CAR and pain-related outcomes and to investigate potential sex differences in patients with knee osteoarthritis (KOA). METHODS: In this cross-sectional study, KOA patients (N = 96) completed self-report questionnaires assessing pain and psychosocial factors and underwent Quantitative Sensory Testing (QST) to assess pressure pain threshold (PPT). Additionally, salivary cortisol samples (N = 60) were collected to assess HPA-axis function at 6 time points (awakening, 15- and 30-minute post-awakening, 4 PM, 9 PM and bedtime). The CAR was calculated by examining increases in salivary cortisol from awakening to 30 min post awakening and the total post-awakening cortisol concentration by calculating the lower areas under the curve of cortisol with respect to ground (AUCG). RESULTS: Patients with a relatively blunted CAR had significantly higher anxiety levels and lower PPT than patients with relatively normal CAR. Similarly, patients with a relatively reduced AUCG had significantly higher pain interference and anxiety levels compared to patients with relatively normal AUCG. PPT was positively correlated with CAR and AUCG and negatively correlated with pain severity and anxiety. Men with KOA had significantly lower anxiety, higher PPT and higher CAR and AUCG than women with KOA. Mediation analysis results revealed a significant indirect effect of PPT on the relationship between sex and AUCG. CONCLUSIONS: The findings of this study suggest that neuroendocrine factors such as CAR and AUCG may contribute to individual differences in pain-related outcomes in patients with KOA. Additionally, our results show sex differences in the magnitude of morning HPA activation and pain-related outcomes. Finally, our findings are suggestive of a sex-dependent relationship between post-awakening cortisol concentrations and pain perception. Future research should examine these associations across various pain populations.