FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic.

Objective: To describe protocol adaptations to the Fibromyalgia Integrative Training for Teens (FIT Teens) randomized controlled trial in response to the COVID-19 pandemic. The overarching aims of the FIT Teens multi-site 3-arm comparative effectiveness trial are to assess whether a specialized neuromuscular exercise training intervention combined with cognitive-behavioral therapy (CBT) is superior to CBT alone or graded aerobic exercise alone. Design/methods: The trial was originally designed as an in-person, group-based treatment with assessments at baseline, mid- and post-treatment, and four follow-up time points. The original study design and methodology was maintained with specific modifications to screening, consenting, assessments, and group-based treatments to be delivered in remote (telehealth) format in response to COVID-19 restrictions. Results: Study enrollment was paused in March 2020 for five months to revise operations manuals, pilot remote treatment sessions for accuracy and fidelity, complete programming of REDCap assent/consent and assessment materials, train study staff for new procedures and obtain regulatory approvals. The trial was relaunched and has been successfully implemented in remote format since July 2020. Trial metrics thus far demonstrate a consistent rate of enrollment, strong attendance at remote treatment sessions, high retention rates and high treatment fidelity after protocol adaptations were implemented. Conclusions: Preliminary findings indicate that FIT Teens protocol adaptations from in-person to remote are feasible and allowed for sustained enrollment, retention, and treatment fidelity comparable to the in-person format. Methodologic and statistical considerations resulting from the adaptations are discussed as well as implications for interpretation of results upon completion of the trial.

Pressure Pain Threshold and Anxiety in Adolescent Females With and Without Juvenile Fibromyalgia: A Pilot Study.

OBJECTIVES: Reduced pain thresholds have been documented in adult fibromyalgia, but there are no quantitative studies of altered pain sensitivity in adolescents with juvenile fibromyalgia (JFM). The current study examined differences in pressure pain sensitivity between adolescent females with JFM and healthy controls. The relationship between levels of anxiety and pain were also examined. METHODS: A total of 34 JFM (15.4±1.4 y old) and 31 controls (14.5±1.3 y old) completed self-report measures of pain and anxiety. Pressure pain threshold was assessed (palm and forehead sites) with a hand-held algometer. Participants indicated the first sensation of pain and then rated the intensity of pain on a Numerical Rating Scale. RESULTS: Adolescents with JFM exhibited greater sensitivity to pressure pain compared with controls. While the difference between JFM and controls was only observed at the forehead, the intensity of pain produced by the pressure algometry at both sites was significantly higher in the JFM participants compared with controls. Correlations between clinical pain and anxiety were significant for the JFM group only. No relationships were observed between anxiety and pressure pain for either group. DISCUSSION: This study is a first step toward investigating mechanisms of altered pain processing in adolescents with JFM. Adolescents with JFM were found be more sensitive to pressure pain than their healthy peers, which suggests a propensity for sensitization of peripheral and/or central nociceptive information often reported in adult fibromyalgia, and which does not appear to be affected by anxiety.

Quality of life and emotional functioning in youth with chronic migraine and juvenile fibromyalgia.

SUMMARY: Chronic pain in children is associated with significant negative impact on social, emotional, and school functioning. Previous studies on the impact of pain on children's functioning have primarily used mixed samples of pain conditions or single pain conditions (eg, headache and abdominal pain) with relatively small sample sizes. As a result, the similarities and differences in the impact of pain in subgroups of children with chronic pain have not been closely examined. OBJECTIVE: To compare pain characteristics, quality of life, and emotional functioning among youth with pediatric chronic migraine (CM) and juvenile fibromyalgia (JFM). METHODS: We combined data obtained during screening of patients for 2 relatively large intervention studies of youth (age range, 10 to 18 y) with CM (N=153) and JFM (N=151). Measures of pain intensity, quality of life (Pediatric Quality of Life; PedsQL, child and parent-proxy), depressive symptoms (Children's Depression Inventory), and anxiety symptoms (Adolescent Symptom Inventory-4-Anxiety subscale) were completed by youth and their parent. A multivariate analysis of covariance controlling for effects of age and sex was performed to examine differences in quality of life and emotional functioning between the CM and JFM groups. RESULTS: Youth with JFM had significantly higher anxiety and depressive symptoms, and lower quality of life in all domains. Among children with CM, overall functioning was higher but school functioning was a specific area of concern. DISCUSSION: Results indicate important differences in subgroups of pediatric pain patients and point to the need for more intensive multidisciplinary intervention for JFM patients.

Qualitative analysis of parent experiences with achieving cystic fibrosis nutrition recommendations.

BACKGROUND: A combined behavior-nutrition approach is recommended for children with CF with growth deficits. The present study aimed to use a qualitative approach to 1) understand families' experiences using behavior-nutrition intervention strategies and 2) identify the challenges with CF management families experienced during the developmental transition between toddlerhood and early school-age. METHODS: Eight families (mean age of children=8.2 years) participated in a semistructured interview. Themes were independently identified by three coders, confirmed via consensus, and compared to a reliability coder. RESULTS: Parents discussed behavior and nutrition strategies, ongoing challenges with nutrition and behavior, new challenges, and protective factors. Challenges included transition to school, transfer of treatment responsibility, picky eating, and parental stress. CONCLUSIONS: Ongoing assessment and recommendations to address parent stress and child behavior are warranted. Providing families with anticipatory guidance can better prepare families for challenging developmental transitions including starting school and the transfer of treatment responsibility.