Kelleher, Eoin

Abstract Background/Aims The aim of this prospective cohort study was to evaluate the extent that kinesiophobia at baseline contributed to pain intensity at follow-up after starting first line treatments in patients with a range of musculoskeletal conditions, including rheumatoid arthritis (RA), fibromyalgia (FM) and knee osteoarthritis (OA). Methods 469 patients (RA n = 156, FM n = 149, OA n = 164) recruited from the Nuffield Orthopaedic Centre, Oxford University Hospitals, participated in this study. Pain was assessed with the pain detect questionnaire, with the item average pain severity over the last 4 weeks used for the primary analysis. The Tampa Scale for Kinesiophobia (TSK) was administered to assess fear of movement. The association between TSK and pain at baseline was investigated by analysing their correlation using Pearson’s Product-Moment Correlation. RA, FM and OA groups were treated with standard care, which consisted of DMARDs, pain rehabilitation therapy, and total knee arthroplasty, respectively. The correlation between baseline TSK and change from baseline in 4-week average pain severity was calculated at 3-, 6- and 12-month follow-up using Pearson’s Product-Moment Correlation. A simple linear regression model was used for each cohort to evaluate the extent TSK contributed to change in pain from baseline. Results At baseline, mean TSK was 38.8±7.0 and mean 4-week average pain severity was 6.6±2.0 (all conditions pooled), with a Pearson’s Product-Moment Correlation of 0.28 [95% CI: 0.18-0.37], representing a small positive correlation (p < 0.01) between baseline TSK and baseline pain. The results were similar for all 3 conditions independently (RA correlation 0.30 [95% CI: 0.14-0.44], FM correlation 0.31 [95% CI: 0.15-0.46], OA correlation 0.25 [95% CI: 0.06-0.41], all ps < 0.01). No correlation was found between TSK and change from baseline in pain severity for the RA or FM cohorts at any follow-up. A weak negative correlation between TSK and change in pain severity was found in the knee OA group at 3 months (correlation: -0.18 [95% CI: -0.39-0.04]) and 12 months (correlation: -0.16 [95% CI: -0.39-0.08]); however, these results were not statistically significant (p = 0.12 and 0.19 respectively). The linear regression analysis showed that TSK was not associated with change in pain from baseline for any condition at any timepoint. Mean pain decreased in the RA and OA groups irrespective of TSK, with no improvement in pain seen in the FM group (RA mean pain at baseline: 6.5±2.1, at 12 months: 4.3±2.6; FM mean pain at baseline: 6.6±1.6, at 12 months: 6.6±1.8; OA mean pain at baseline: 6.5±2.2, at 12 months: 1.9±2.6). Conclusion Whilst kinesiophobia and pain severity were correlated at baseline, kinesiophobia did not negatively influence change in pain with treatment in any of the cohorts studied. Disclosure R.C. Murphy: None. A. Irani: None. E. Kelleher: None. A.J. Wall: None.

Abstract Background/Aims Sleep disturbance is a defining feature of fibromyalgia (FM), contributing to pain, fatigue, cognitive dysfunction, and reduced quality of life. Effective management options remain limited. Cognitive behavioural therapy for insomnia (CBT-I) is effective in primary insomnia, but evidence in FM is sparse and access to face-to-face therapy is limited. Digital CBT-I (dCBT-I) offers a scalable, self-directed solution that may overcome these barriers. We conducted the first randomised controlled trial of dCBT-I in FM to evaluate its impact on quality of life and associated symptoms. Methods This single-blind randomised controlled trial evaluated Sleepio, a validated dCBT-I programme of six self-directed 20-minute sessions delivered over 12 weeks. Participants with a clinical diagnosis of FM, self-reported sleep disturbance, and cognitive complaints were recruited in Oxford, UK. After baseline assessment, participants were randomized to dCBT-I or a control group. All participants also received standardised sleep hygiene advice. The primary outcome was disease-specific quality of life measured by the revised Fibromyalgia Impact Questionnaire (FIQR). Secondary outcomes included insomnia severity (Insomnia Severity Index), actigraphy-derived sleep parameters, pain (SF36 Bodily Pain Scale), cognitive complaints (British Columbia Cognitive Complaints Inventory), sustained attention, and fear of movement (Tampa Scale of Kinesiophobia). Outcomes were collected online at baseline, 3 months, and 6 months. Analyses followed the intention-to-treat principle using constrained longitudinal data analysis. Ethical approval was obtained from South Central - Oxford B Research Ethics Committee (19/SC/0168). The study was pre-registered with clinicaltrials.gov (NCT05962138). Results Of 514 individuals contacted, 241 were screened, 132 were eligible, and 80 were randomised (42 dCBT-I, 38 control). The mean age was 46.6 (SD 14.5) years; 93.8% were female. Retention was high: 97.5% of participants provided outcomes at 3 months, and 83.8% at 6 months. In the dCBT-I group, 90.5% initiated the programme, and 54.8% reached the core session on sleep restriction therapy. At 3 months, there was no significant difference between groups in FIQR (mean difference −2.79; p = 0.3). At 6 months, however, dCBT-I participants demonstrated greater improvement in FIQR compared with controls (mean difference −5.45; 95% CI − 10.5 to − 0.4; p = 0.035), corresponding to a small-to-moderate effect size (Cohen’s d = −0.31). No significant between-group differences were observed for secondary outcomes. Conclusion In adults with FM, dCBT-I produced a sustained, clinically meaningful improvement in disease-related quality of life at 6 months compared with a sleep hygiene control. Although benefits were not observed across secondary outcomes, this trial provides the first controlled evidence that dCBT-I can address an important unmet need in FM. Digital behavioural therapies represent scalable, accessible, non-pharmacological interventions with potential for rapid integration into clinical care. Disclosure E. Kelleher: Grants/research support; National Institute for Health Research (NIHR) Pfizer Doctoral Fellowship (NIHR301808). A.J. Wall: Grants/research support; Grant is funded by UKRI and Versus Arthritis as part of the UKRI Strategic Priorities Fund (SPF) Advanced Pain Discovery Platform (APDP), a co-funded initiative by UKRI (MRC, BBSRC, ESRC), VA. V. Wanigasekera: None. R. Sharman: None. S. Kyle: None. I. Tracey: None. B. Seymour: Grants/research support; Grant is funded by UKRI and Versus Arthritis as part of the UKRI Strategic Priorities Fund (SPF) Advanced Pain Discovery Platform (APDP), a co-funded initiative by UKRI (MRC, BBSRC, ESRC), VA. A. Irani: Grants/research support; Grant is funded by UKRI and Versus Arthritis as part of the UKRI Strategic Priorities Fund (SPF) Advanced Pain Discovery Platform (APDP), a co-funded initiative by UKRI (MRC, BBSRC, ESRC), VA.