SF-36 Bodily Pain Research Articles

Abstract 4143239: Extracorporeal Shockwave Therapy Improves Physical Outcomes and Quality of Life In Patients With Symptomatic Peripheral Arterial Disease: Results from a Meta-analysis of Randomized Controlled Trials

Introduction: Extracorporeal shockwave therapy (ESWT) is a non-invasive procedure that may be useful to treat symptomatic peripheral arterial disease (PAD). Trials comparing ESWT with control groups have shown promising results. Methods: PubMed, Cochrane, EMBASE, and Google Scholar were searched for randomized controlled trials reporting the efficacy of extracorporeal shockwave therapy versus control in patients with symptomatic PAD. Data from eligible studies was analyzed using the Review Manager 5.4 software. Mean difference (MD) and 95% Confidence intervals (CI) were calculated for continuous outcomes. Inverse variance method and a random effects model were used for pooled estimates. A p-value < 0.05 (Z-test) was considered significant. Results: 5 randomized controlled trials with 264 patients were included in our analysis. A significant increase in the mean walking distance (MD: 54.13, 95% CI 9.34 to 98.92, p=0.02), pain-free walking distance (MD: 54.13, 95% CI 14.19, 57.88, p= 0.001), SF-36 physical component summary (MD: 11.97, 95% CI 0.26 to 23.69, p=0.05), EQ-5D-3L index score (MD; 0.08, 95% CI: 0.00 to 0.15, p=0.05) and VascuQoL index ((MD: 0.48, 95% CI 0.03 to 0.92, p= 0.04) was seen with ESWT. A slightly higher ankle brachial pressure index was seen in the control group (MD: -0.01, 95% CI: -0.02 to -0.00, p=0.04). There was no difference in SF-36 physical functioning domain score (MD: 18.58, 95% CI: -0.29 to 37.45, p=0.05) and SF-36 bodily pain score (MD: 9.17, 95% CI: -2.885 to 21.19, p=0.13). Conclusions: There was significant improvement in walking distances, exertional symptoms, and quality of life with ESWT. However, ESWT did not translate to an increase in post-treatment ankle-brachial index which was slightly higher in the control group. There is a need for larger randomized controlled trials to substantiate the efficacy of ESWT in treating symptomatic PAD.

Efficacy of Combination Therapy (Hydrodilatation and Subdeltoid Bursa Injection With Corticosteroid, Mobilization, and Physical Therapy) vs Physical Therapy Alone for Treating Frozen Shoulder: A Randomized Single-Blind Controlled Trial, Phase I

ObjectiveTo compare the efficacy of combination therapy (hydrodilatation and subdeltoid bursa injection with corticosteroid, mobilization, and physical therapy [PT]) with that of PT alone for treating frozen shoulder. DesignA prospective, 2-arm parallel, single-blinded, randomized controlled trial. SettingRehabilitation clinic of a private academic hospital. ParticipantsPatients (n=70) with frozen shoulder (freezing stage). InterventionsParticipants (n=35) in the combination group underwent hydrodilatation and subdeltoid bursa injection with corticosteroid twice, mobilization, and usual-care PT for 8 weeks; participants (n=35) in the PT group received only the usual-care PT for 8 weeks. Main Outcome MeasuresThe Shoulder Pain and Disability Index (SPADI) was the primary outcome measure. The secondary outcome measures were pain scores on a visual analog scale, range of motion (ROM), the Shoulder Disability Questionnaire (SDQ), quality of life (evaluated using the 36-item Short-Form Health Survey [SF-36]), and self-assessment of the treatment effect. ResultsCompared with the PT group, the combination group had significantly better pain (during activity), SPADI, SDQ, active and passive ROM, and self-assessment scores (all P<.001) as well as scores on some parts of the SF-36 (physical function and bodily pain, P<.05). Between-group differences were significant at the 1-, 2-, 4-, and 6-month follow-ups. ConclusionsA combination of hydrodilatation (with corticosteroid), bursal corticosteroid injection, and joint mobilization with PT was superior to PT alone for treating frozen shoulder, and the effects persisted for at least 6 months.

Effects of Inpatient Rehabilitation in Leg Lymphedema: A Naturalistic Prospective Cohort Study With Intra-individual Control of Effects

ObjectiveTo quantify therapy-attributable effects of a comprehensive inpatient rehabilitation program for lower limb lymphedema (LLL) and to compare the levels of health-related quality of life (HRQL) to population-based norms. DesignNaturalistic prospective cohort study with intra-individual control of effects. SettingRehabilitation hospital. ParticipantsPatients with LLL (N=67; 46 women). InterventionsComprehensive, multidisciplinary inpatient rehabilitation with 45-60 hours of therapy. Main Outcome MeasuresShort Form 36 (SF-36) for HRQL, lymphedema-specific Freiburg Quality of Life Assessment for lymphatic disorders, Short Version (FLQA-lk), knee-specific Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), and Symptom Checklist-90Standard (SCL-90S). Observed pre/post rehabilitation effects were individually corrected by subtracting the home waiting-time effects and expressed as standardized effect sizes (ESs) and standardized response means (SRMs). Score differences to norms were quantified by standardized mean differences (SMDs). ResultsParticipants were on average aged 60.5 years, not yet obese, and had 3 comorbidities (n=67). The greatest improvement was in HRQL on the FLQA-lk with ES=0.767/SRM=0.718, followed by improvements in pain and function with ES/SRM=0.430-0.495 on the SF-36, FLQA-lk, and KOS-ADL (all P<.001). Vitality, mental health, emotional well-being, and interpersonal sensitivity improved most by ES/SRM=0.341-0.456 on all 4 measures (all P≤.003). Post rehabilitation scores were significantly higher than population norms on SF-36 bodily pain (SMD=1.140), vitality (SMD=0.886), mental health (SMD=0.815), and general health (SMD=0.444) (all P<.001), and comparable on the other scales. ConclusionsThose affected by LLL stages II and III benefited substantially from the intervention, attaining equal or higher levels of HRQL than expected compared with the general population norms. Multidisciplinary, inpatient rehabilitation should be recommended for LLL management.

Addition of preoperative transversus abdominis plane block to multimodal analgesia in open gynecological surgery: a randomized controlled trial

BackgroundTransversus abdominis plane (TAP) block can provide effective analgesia for abdominal surgery. However, it was questionable whether TAP had additional effect in the context of multimodal analgesia (MMA). Therefore, this study aimed to assess the additional analgesic effect of preoperative TAP block when added to MMA protocol in open gynecological surgery.MethodsIn this prospective, randomized-controlled trial, 64 patients scheduled for open gynecological surgery were randomized to receive preoperative TAP block (Study group, n = 32) or placebo (Control group, n = 32) in addition to MMA protocol comprising dexamethasone, acetaminophen, flurbiprofen and celecoxib, and rescued morphine analgesia. The primary outcome was rescued morphine within 24 h after surgery. Secondary outcomes included pain scores, adverse effects, quality of recovery measured by 40-item quality of recovery questionnaire score (QoR-40) at 24 h, and quality of life measured with short-form health survey (SF − 36) on postoperative day (POD) 30.ResultsThe Study group had less rescued morphine than the control group within 24 h [5 (2–9) vs. 8.5 (5–12.8) mg, P = 0.013]. The Study group had lower pain scores at 1 h [3 (2–4) vs. 4 (3–5), P = 0.007], 2 h [3 (2–4) vs. 3.5 (3–5), P = 0.010] and 6 h [3 (2–3) vs. 3 (2.3–4), P = 0.028], lower incidence of nausea at 48 h (25.8% vs. 50%, P = 0.039), and higher satisfaction score [10 (10–10) vs. 10 (8–10), P = 0.041]. The SF-36 bodily pain score on POD 30 was higher in the Study group (59 ± 13 vs. 49 ± 16, P = 0.023).ConclusionsPreoperative TAP block had additional analgesic effect for open gynecological surgery when used as part of multimodal analgesia. Rescued morphine within 24 h was significantly reduced and the SF-36 bodily pain dimension at 30 days after surgery was significantly improved.Trial registrationwww.chictr.org.cn (ChiCTR2000040343, on Nov 28 2020).

Translation, cultural adaptation, and validation of the Manchester-Oxford Foot Questionnaire into Brazilian Portuguese

Objective: Translate, culturally adapt and validate the Manchester-Oxford Foot Questionnaire (MOXFQ) into Brazilian Portuguese. Methods: The translation followed the guidelines standardized in the literature, including initial translation, back-translation, committee review, pre-test phase, and application of the final questionnaire in 50 patients. Intraobserver reproducibility was evaluated by reapplying the final version of the questionnaire 14 days after the first application. The validation of the final MOXFQ translation was assessed by conjoint application with the SF-36 Quality of Life questionnaire; similar domain scores of the two questionnaires were compared and analyzed. Results: Excellent reproducibility was observed for three domains with statistical significance, the intra-class correlation coefficient (ICC) values were: pain 0.98, walking/standing 0.99, and social interaction 0.98. Internal consistency/reliability obtained excellent values: pain 0.992, walking/standing 0.997, and social interaction 0.992, all with statistical significance (p&lt;0.001). In the MOXFQ validation compared to the SF-36, the highest correlations of the study were found between the SF36 physical functioning domain and the MOXFQ walking/standing (-0.72) and social interaction domains (-0.73). Comparing the MOXFQ walking/standing domain, a good correlation was obtained with the SF-36 physical functioning (-0.41), bodily pain (-0.42), vitality (-0.45), and mental health (-0.40) domains. Also a good correlation was obtained on MOXFQ pain domain with the SF-36 physical functioning (-0.45) and social functioning (-0.43). Conclusion: The MOXFQ Brazilian version proved reliable, valid, and reproducible in measuring the symptoms and functional limitations of patients affected by foot and ankle diseases. Level of Evidence IV; Therapeutic Studies; Case Series.

Effects of concurrent exercise on health-related quality of life in middle-aged women

Objective This study aimed to evaluate the influence of a 16-week concurrent exercise program on health-related quality of life in middle-aged women. Methods A total of 150 middle-aged women from the FLAMENCO project (age range 45–60 years) were randomized into a counseling (n = 75) or an exercise (n = 75) group. The exercise group followed a 16-week (3 days/week, 60 min/session) concurrent exercise program (aerobic + resistance training). The counseling group attended conferences on a healthy lifestyle. Participants’ health-related quality of life was assessed with the EuroQol plus, a visual analog scale and the 36-item Short Form Health Survey (SF-36), where greater values indicate a better health-related quality of life. Results The visual analog scale increased by 9.0% in the exercise group, whereas it only increased by 3.5% in the counseling group (p = 0.040). The SF-36 physical function, physical role, bodily pain, vitality and emotional role increased by 5.5%, 11.3%, 10.8%, 9.6% and 8.9%, respectively, in the exercise group, whereas these only increased by 0.6%, decreased by 0.7% and increased by 1.4%, 3.8% and 0.6% in the counseling group (all p < 0.05). Conclusions Our results suggest that a 16-week concurrent exercise program adapted for midlife women improved their health-related quality of life. ClinicalTrials.gov Identifier NCT02358109. Date of registration: 05/02/2015

Longitudinal association of sedentary time and physical activity with pain and quality of life in fibromyalgia.

To analyze changes over time and the predictive value of baseline and changes of sedentary time (ST) and physical activity (PA) on pain, disease impact, and health-related quality of life (HRQoL) at 2- and 5-year follow-up in women with fibromyalgia. This is a longitudinal and exploratory study with three time points. A total of 427 women with fibromyalgia (51.4 ± 7.6 years) were followed after 2 (n= 172) and 5 years (n=185). ST and PA (light and moderate-to-vigorous [MVPA]) were assessed using triaxial accelerometers. Pain, disease impact, and HRQoL were measured using: pressure pain threshold, the pain subscale of the revised fibromyalgia impact questionnaire (FIQR), the bodily pain subscale of the 36-item short-form health survey (SF-36), a visual analog scale (VAS), the FIQR, and the SF-36 physical and mental components. Over 5 years, pressure pain threshold, ST, light PA, and MVPA variables were worsened, while FIQR and SF-36 variables were improved (Cohen's d <0.1-0.3). Baseline ST or light PA were not associated with future outcomes, whereas greater MVPA at baseline was associated with better SF-36 bodily pain at 5-year follow-up (β=0.13). Reducing ST and increasing light PA were associated with better bodily pain (β=-0.16 and 0.17, respectively) and SF-36 physical component (β=-0.20 and 0.17, respectively) at 5-year follow-up. Increasing MVPA was associated with less pain (pressure pain threshold, VAS, and FIQR-pain) and better SF-36 physical component at 2- and 5-year follow-up (β's from -0.20 to 0.21). Objectively measured variables slightly worsened over years, while for self-reported outcomes there was a trend for improvement. Reductions in ST and increases in light PA and MVPA were associated with better HRQoL at 5-year follow-up, and increases in MVPA were additionally associated with better pain and HRQoL at 2-year follow-up.

OR13-1 Long-Term Burosumab Therapy Provides Sustained Benefit in Patients with Tumor-Induced Osteomalacia: End of Study Findings From the Pivotal Phase 2 Study

Abstract Tumor-induced osteomalacia (TIO) is a rare paraneoplastic syndrome wherein small tumors secrete excess fibroblast growth factor 23 (FGF23) leading to hypophosphatemia, osteomalacia, bone pain, fractures, and muscle weakness. Burosumab is an anti-FGF23 monoclonal antibody approved for treatment of TIO. We report end of study (EOS) data from the open-label phase 2 UX023T-CL201 trial (NCT02304367) of burosumab in adults with TIO. In UX023T-CL201, participants received burosumab (0.3–2.0 mg/kg) by subcutaneous injection every 4 weeks for 48 weeks with an extension up to 300 weeks (∼6 years). Co-primary endpoints were change in serum phosphorus at Week 24 and change in excess osteoid by trans-iliac crest bone biopsy at Week 48. Additional endpoints included changes in bone biomarkers, activity on radionucleotide bone scan representing fractures/pseudofractures, patient-reported outcomes, and safety measures. This analysis included 14/17 UX023T-CL201 participants; excluding those with other diagnoses (n=3). Mean (SD) serum phosphorus improved from 1.6 (0.5) mg/dL at baseline to 2.3 (0.5) mg/dL when averaged across the mid-point of the dose interval through Week 24 (co-primary endpoint). Levels further improved (2.6 [0.4] mg/dL; n=7) to within the normal range (2.5–3.6 mg/dL) at Week 240. Most measures of osteomalacia improved at Week 48 (co-primary endpoint), including osteoid/bone volume, osteoid thickness, and mineralization lag time. However, osteoid surface/bone surface showed no change. Bone biomarkers (P1NP, CTx, BALP) followed similar trends. Upon initiation of burosumab, markers briefly increased by Week 24 as bone healing began, then gradually decreased with further treatment, reaching normal (P1NP, CTx) or near-normal (BALP) ranges by Week 240. At baseline, 249 areas of increased radionucleotide uptake indicating fracture activity were detected across 14 participants. By Week 144, 36% (72/201) and 13% (26/201) regions of abnormal uptake were fully or partially restored, respectively. By EOS, further reduction of active fractures and fewer new areas of uptake were observed. New fractures at Week 144 were observed in a single participant (considered a burosumab partial responder) and between Week 144 and EOS in another participant unrelated to burosumab (car accident). Participants reported sustained mean reduction from baseline pain at Week 240 per Brief Pain Inventory and significantly per SF-36 Bodily Pain score. Significant reductions in baseline fatigue at Week 240 were reported per Brief Fatigue Inventory and SF-36 Vitality scores. SF-36 physical health (Role Physical, Bodily Pain, Component Score) and mental health (Social Function, Vitality) significantly improved from baseline at Week 240. The observed safety profile of long-term burosumab in participants with TIO was consistent with the known safety profile of burosumab and similar to patients with XLH. Long-term burosumab therapy was associated with improved serum phosphorus, osteomalacia, bone turnover, fracture incidence and healing, health-related quality of life, and reductions in pain and fatigue in adults with TIO. Presentation: Sunday, June 12, 2022 11:00 a.m. - 11:15 a.m.

Patellofemoral Arthroplasty Results in Better Time-weighted Patient-reported Outcomes After 6 Years than TKA: A Randomized Controlled Trial.

Patellofemoral Arthroplasty Results in Better Time-weighted Patient-reported Outcomes After 6 Years than TKA: A Randomized Controlled Trial.

P25. A rough road to recovery: the impact of complications after adult spinal deformity surgery on specific health-related quality of life domains

BACKGROUND CONTEXT Previous reports indicate postoperative complications have minimal impact on long-term outcomes after ASD surgery. Little data has evaluated the impact of complications on specific heath domains during postoperative period. PURPOSE To evaluate the impact of specific complications on patient reported health domains compared to patients with no complications. STUDY DESIGN/SETTING Prospective, multicenter, propensity score matched analysis. PATIENT SAMPLE ASD patients enrolled into a prospective multi-center study. OUTCOME MEASURES Oswestry Disability Index, Scoliosis Research Society-22r questionnaire (SRS-22r), Short Form-36v2 questionnaire (SF-36), postoperative complications. METHODS Surgically treated ASD patients enrolled into a multicenter study were assessed for postoperative complications requiring surgery including wound (WOUND), pseudoarthrosis (PSEUDO), neurologic (NEURO) and malalignment (MAL) and matched to patients with no complications (NOCOMP) using inverse probability weighting for demographic, radiographic and surgical variables. Health domains for SRS-22r, and SF-36 were evaluated at regular time intervals, domain scores normalized to the date of revision surgery, and compared to patients with no complications at minimum 2-year follow-up. RESULTS A total of 566 of 1130 were analyzed, average 3.6 yrs (range: 1.9 to 9). WOUND (n=12) compared to NOCOMP (n=390) had worse SF-36 physical function(21.7 vs 27.4), social function(19.6 vs 28.9), general health (-7.3 vs 8.9) and vitality (-0.9 vs 26.6,p < 0.05). PSEUDO (n=64) was worse than NOCOMP for SRS-22r function, 1.4 vs 2.1, and SF-36 social function, (17.1 vs 28.9) (p < 0.05). NEURO (n=28) was worse than NOCOMP for SRS-22r (0.9 vs 2.1), SF-36 bodily pain (14.7 vs 35.7) and social function (13.4 vs 28.9) (p < 0.05). MAL (n=72) was worse than NOCOMP for SRS-22r pain, (2.7 vs 3.4), function (1.2 vs 2.1), self-image (3.0 vs 3.9), SF-36 bodily pain (27.6 vs 35.7), physical function (18.7 vs 27.4), and social function (11.6 vs 28.9) (p < 0.05). CONCLUSIONS Counter to previous reports, specific postoperative complications requiring surgery uniquely impact specific health domains, resulting in worse patient reported quality of life compared to ASD patients with no complications. Social function was negatively impacted for all complications, while wound complications negatively impacted patient perceived general health and vitality and patients with malalignment requiring surgery reported worse self-image. These data highlight new findings that postoperative complications have a negative impact on specific aspects of ASD quality of life that can undermine the potential benefits of ASD surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs. Previous reports indicate postoperative complications have minimal impact on long-term outcomes after ASD surgery. Little data has evaluated the impact of complications on specific heath domains during postoperative period. To evaluate the impact of specific complications on patient reported health domains compared to patients with no complications. Prospective, multicenter, propensity score matched analysis. ASD patients enrolled into a prospective multi-center study. Oswestry Disability Index, Scoliosis Research Society-22r questionnaire (SRS-22r), Short Form-36v2 questionnaire (SF-36), postoperative complications. Surgically treated ASD patients enrolled into a multicenter study were assessed for postoperative complications requiring surgery including wound (WOUND), pseudoarthrosis (PSEUDO), neurologic (NEURO) and malalignment (MAL) and matched to patients with no complications (NOCOMP) using inverse probability weighting for demographic, radiographic and surgical variables. Health domains for SRS-22r, and SF-36 were evaluated at regular time intervals, domain scores normalized to the date of revision surgery, and compared to patients with no complications at minimum 2-year follow-up. A total of 566 of 1130 were analyzed, average 3.6 yrs (range: 1.9 to 9). WOUND (n=12) compared to NOCOMP (n=390) had worse SF-36 physical function(21.7 vs 27.4), social function(19.6 vs 28.9), general health (-7.3 vs 8.9) and vitality (-0.9 vs 26.6,p < 0.05). PSEUDO (n=64) was worse than NOCOMP for SRS-22r function, 1.4 vs 2.1, and SF-36 social function, (17.1 vs 28.9) (p < 0.05). NEURO (n=28) was worse than NOCOMP for SRS-22r (0.9 vs 2.1), SF-36 bodily pain (14.7 vs 35.7) and social function (13.4 vs 28.9) (p < 0.05). MAL (n=72) was worse than NOCOMP for SRS-22r pain, (2.7 vs 3.4), function (1.2 vs 2.1), self-image (3.0 vs 3.9), SF-36 bodily pain (27.6 vs 35.7), physical function (18.7 vs 27.4), and social function (11.6 vs 28.9) (p < 0.05). Counter to previous reports, specific postoperative complications requiring surgery uniquely impact specific health domains, resulting in worse patient reported quality of life compared to ASD patients with no complications. Social function was negatively impacted for all complications, while wound complications negatively impacted patient perceived general health and vitality and patients with malalignment requiring surgery reported worse self-image. These data highlight new findings that postoperative complications have a negative impact on specific aspects of ASD quality of life that can undermine the potential benefits of ASD surgery.

Supervised physical therapy versus surgery for patients with lumbar spinal stenosis: a propensity score-matched analysis

BackgroundPrevious studies comparing surgical with nonsurgical treatment for lumbar spinal stenosis (LSS) reported that surgery is superior to nonsurgical treatments, but intensive and adequate volume of physical therapy were rarely performed. The purpose of this study was to compare the 1-year follow-up outcomes of patients with LSS treated with supervised physical therapy or surgery using propensity score-matched analysis.MethodsA total of 224 patients with LSS who received supervised physical therapy (n = 38) or surgery (n = 186) were included, of which 66 were matched on baseline demographics, radiological findings, and patient-reported outcomes. The physical therapy group received supervised physical therapy twice weekly for 6 weeks. The physical therapy sessions included manual therapy, individually tailored exercises, cycling, and body-weight supported treadmill walking. The surgery group underwent decompression surgery with or without spinal fusion. A propensity score analysis was performed using a one-to-one nearest neighbor approach.ResultsThe surgery group showed greater improvements in Zurich claudication questionnaire symptom severity and physical function, SF-36 physical functioning, bodily pain, and mental health, but had more severe stenosis and symptoms and mental health problems than the physical therapy group at baseline (P < 0.05). After propensity score matching, there were no significant differences in baseline characteristics, and all clinical outcomes at 1 year, except for a higher percentage of responders achieving minimum clinically important difference in the role-emotional subscale of SF-36 in the surgery group (P < 0.05).ConclusionsWhen baseline characteristics were considered, supervised physical therapy yielded similar effects to lumbar surgery. These results suggest that supervised physical therapy is preferred over surgery as first-choice treatment, to prevent complications and to minimize health care costs, especially in mild to moderate cases of LSS.

Numerical rating scale for dysmenorrhea-related pain: a clinimetric study

Objective: To evaluate the numerical rating scale (NRS) measurement properties in women with dysmenorrhea. Methods: This was an online clinimetric study. Brazilian women aged over 18 years old with internet access to respond to online instruments were included in the study. We evaluated criterion validity (comparing women with and without dysmenorrhea), construct validity between the NRS and the bodily pain domain of the SF-36, test-retest reliability, and measurement errors (in women with dysmenorrhea). Results: Two hundred thirty-eight women with and 192 without dysmenorrhea participated in the study. For criterion validity, the area under the receiver operating characteristic curve was 0.902 (95%CI, 0.873–0.931), and a cutoff point of 3 was considered to have the best sensitivity (83%) and specificity (86%). For construct validity, the NRS showed a moderate negative correlation with the SF-36 bodily pain domain (r=-0.46; p < 0.001). For test-retest reliability and measurement errors, 105 women whose symptoms did not change between 7 and 10 days of retest, with intraclass correlation coefficient = 0.90, standard error of measurement = 0.97, and smallest detectable change = 2.76 points. Conclusions: The NRS can be considered a valid and reliable patient-reported outcome measure for assessing dysmenorrhea-related pain intensity.

A Simple New Cost-Effective Retractor System for Exposure in Lumbar Microdiscectomy: 1-Year Outcome Analysis

To introduce a new technique for retraction in lumbar microdiscectomy, the rubber band technique (RT), and compare 1-year clinical outcomes of the technique with standard microdiscectomy (SM). In this retrospective analysis, 81 consecutive patients with single-level lumbar disc herniation underwent lumbar microdiscectomy by either RT or SM. The primary outcome was Oswestry Disability Index score 1 year after surgery. Secondary outcomes included Short-Form Health Survey (SF-36) physical functioning subscale score, SF-36 bodily pain subscale score, and visual analog scale back pain and leg pain scores. Other parameters were operative time, hospital stay, skin incision, complications, and redo surgery. Of 81 patients, 93% (76 patients) had complete data up to 1-year follow up. The RT group comprised 39 patients (20 males, 19 females), and the SM group comprised 37 patients (19 males 18 females). Primary and secondary outcomes Oswestry Disability Index score, SF-36 physical functioning score, SF-36 bodily pain score, VAS back and leg pain scores, complications, and redo surgery did not differ significantly between the treatment groups at follow-up points (P > 0.05). Skin incision was smaller in the RT group compared with the SM group (P= 0.0001). Over the 1-year follow-up period, clinical outcomes of patients treated with RT were comparable to patients treated with SM. RT appears to be an alternative safe, effective, and economical approach for lumbar microdiscectomy.

Trajectories of depressive symptoms in systemic lupus erythematosus over time.

The objectives of this study were to determine the trajectories of depressive symptoms in patients with SLE and to identify baseline characteristics that are associated with a patient's trajectory of depression. Data from the Lupus Outcomes Study at the University of California, San Francisco were analysed. Depressive symptomatology was assessed in years two through seven using the Center for Epidemiologic Studies Depression Scale (CES-D), with higher scores representing more severe depressive symptoms. Group-based trajectory modelling was used to determine latent classes of CES-D scores over time. Ordinal logistic regression analyses were performed to identify baseline characteristics associated with worse classes of depressive symptoms. CES-D scores for 763 individuals with SLE over 6years were mapped into four distinct classes. Class 1 (36%) and class 2 (32%) comprised the largest proportion of the cohort and were defined by the lowest and low CES-D scores (no depression), respectively. Class 3 (22%) and class 4 (10%) had high and the highest scores (depression), respectively. Greater age [odds ratio (OR): 0.97, 95% CI: 0.96, 0.99] and higher education level (OR: 0.79, 95% CI: 0.70, 0.89) at baseline were associated with lower odds of membership in worse classes of depressive symptoms. Conversely, lower income (OR: 1.73, 95% CI: 1.03, 2.92), worse SF-36 physical functioning scores (OR: 1.12, 95% CI: 1.12, 1.13) and worse SF-36 bodily pain scores (OR: 1.58, 95% CI: 1.55, 1.61) were positively associated with membership in worse classes of depressive symptoms. Four classes of depressive symptoms were identified in patients with SLE. Understanding the trajectories of depressive symptoms and the associated risk factors can aid in the management of these symptoms in individuals living with SLE.

Self-Reported Injury History and Health-Related Quality of Life in Competitive, Collegiate Baton Twirlers.

Injury epidemiology and health-related quality of life (HRQOL) have not been researched in baton twirlers. This cross-sectional study described time-loss injuries sustained by competitive collegiate baton twirlers, identified the relationship between training volume and injuries, and established injury impact on HRQOL. An online survey was used to collect activity volume, number and characteristics of time-loss injuries experienced within a 12-month window, and HRQOL via the Short Form-36. Current injury status was addressed to place participants into categories: no injury history (No Injury), history of injury but no symptoms (Injury Hx, No Sx), and currently injured (Current Injury). One hundred forty-two participants met the inclusion criteria. One hundred twenty-eight (90%) participants experienced a time-loss injury with 295 total reported injuries (2.1±1.4; range 1-9 injuries). Sixty-two percent of all reported injuries were still producing symptoms. There was a high average reported injury severity score (6.3±2.3). The most commonly affected area was the hip/thigh (30%), followed by the knee (15%) and ankle (14%). The Current Injury group had worse SF-36 bodily pain (p=0.003), vitality domains (p=0.001), and physical composite score (p=0.015) compared to the No Injury group. Both the No Injury and Injury Hx, No Sx groups performed better than the Current Injury group on physical function (p=0.007 and 0.02, respectively). Competitive collegiate baton twirlers experience the majority of injuries in the lower extremity which cause prolonged physical and non-physical symptoms.

P277 Ixekizumab shows a distinct pattern of pain improvement beyond measurable inflammation as assessed by MRI, CRP or BASDAI questions 5 and 6 in patients with ankylosing spondylitis

Abstract Background/Aims Efficacy of ixekizumab (IXE) in patients (pts) with ankylosing spondylitis (AS) at week (W) 16 in the absence of elevated inflammation as measured by CRP and MRI Spondyloarthritis Research Consortium of Canada (SPARCC) has been previously reported. In this analysis, we evaluated the improvement in pain with IXE based on longitudinal status of objective measures of inflammation by MRI, CRP value, and BASDAI 5/6 over 16W. Methods The Phase III COAST-V (NCT02696785) 52W, multi-center, randomized, double-blind, placebo (PBO)-controlled study examined the efficacy of IXE in pts with active AS. Adalimumab (ADA) was used as an active reference arm for the first 16W. Pts assigned to ADA went through a wash-out period of 6W prior to getting their first dose of IXE. Change in spinal pain at night (SP-N) and Short Form 36 Health Survey Questionnaire (SF-36) Bodily Pain were measured during study visits and analyzed while controlling for inflammation status using MRI, CRP levels and mean of BASDAI 5/6 (Q5: Duration, Q6: Intensity of morning stiffness). Observed data analyses are presented for each group stratified by treatment arm. Initial analysis: ‘controlled inflammation’ is defined as MRI SPARCC SI joint &amp;lt;4 and MRI SPARCC Spine &amp;lt;3 at W16, CRP &amp;lt;5mg/L at every visit W4-16, or BASDAI 5/6 improvement of ≥ 2 points W12 and W16. Second analysis: control is defined as CRP &amp;lt;5 mg/L at every week between W4-16 and MRI SPARCC SI joint &amp;lt;4 at W16 and MRI SPARCC Spine &amp;lt;3 at W16. Results When inflammation is controlled per MRI, pts treated (tx) with IXEQ4W (-3.9 p&amp;lt;0.001) and ADA (-2.8 p=0.02) experienced significant reduction in SP-N vs PBO (-1.6) at W16; further improvements were experienced in pts rerandomized to IXE by W52. When inflammation was not controlled per MRI, IXEQ4W (-3.5 p&amp;lt;0.01) and ADA (-3.1 p=0.02) experienced significant reduction in SP-N at W16; all IXE tx pts had further reductions at W52. When inflammation was controlled per MRI+CRP, IXEQ4W (-3.8 p=0.2) and ADA (-3.1 p=0.4) had reduction in SP-N at W16 vs PBO (-2.4); all IXE groups had further improvements at W52. When inflammation was not controlled as measured by MRI+CRP, IXEQ4W (-3.7 p&amp;lt;0.001) had significant reduction in SP-N vs PBO (-1.7), whereas improvement with ADA (-2.6 p=0.06) was not significant; all IXE tx pts had further reduction by W52. For SF-36 bodily pain, improvements were observed with IXE and ADA at W16 and W52, whether inflammation was controlled or not controlled per MRI, CRP, MRI+CRP, or BASDAI 5/6. Conclusion This analysis adds support to the hypothesis that IXE improves pain in pts with and without measurable inflammation. Disclosure N. Maney: None. K. de Vlam: Consultancies; Celgene, Eli Lilly and Company, Galapagos NV, Novartis, Pfizer, and UCB Pharma. Grants/research support; Celgene. P.G. Conaghan: Consultancies; Amgen, Bristol Myers Squibb, Eli Lilly and Company, Galapagos NV, Gilead Sciences, Novartis, Pfizer, and UCB Pharma. P.J. Mease: Member of speakers’ bureau; AbbVie, Amgen, Bristol Myers Squibb, Celgene, Genentech, Janssen, Pfizer, and UCB Pharma. Grants/research support; AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos NV, Gilead Sciences, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB Pharma. P. Rahman: Grants/research support; AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB Pharma. V. Krishnan: Shareholder/stock ownership; Eli Lilly and Company. R. Bolce: Shareholder/stock ownership; Eli Lilly and Company. D. Marcelino Sandoval Calderon: Shareholder/stock ownership; Eli Lilly and Company. S. Park: Shareholder/stock ownership; Eli Lilly and Company. G. Gallo: Shareholder/stock ownership; Eli Lilly and Company. W. Maksymowych: Grants/research support; AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Galapagos NV, Janssen, Novartis, Pfizer, and UCB Pharma; and is the Chief Medical Officer of CARE Arthritis Ltd.

Trajectories of Pain in Very Old Age: The Role of Eudaimonic Wellbeing and Personality.

Pain is common in very old age and in the last years prior to death. However, little is known regarding longitudinal trajectories of pain in very old age and at the end of life. Moreover, whereas medical and morbidity-related factors contributing to pain are established, the role of psychosocial factors, such as eudaimonic wellbeing or personality as potential determinants of late-life pain trajectories has so far not been sufficiently investigated. We used data from the LateLine project. The sample consisted of n = 118 very old adults (M = 90.5 years, SD = 2.8 years) who were living alone at baseline and who had died between 2009 and 2021. They took part in up to 16 measurement occasions (M = 5.2, SD = 4.7, range 1–16) within an observational interval of 7 years. Assessment of pain was based on the SF-36 bodily pain subscale. Key indicators of eudaimonic wellbeing (autonomy, environmental mastery, and purpose in life) as well two of the Big Five personality traits (neuroticism and extraversion) were included as predictors. We controlled in all analyses for gender, education, subjective health, and depressive symptoms. Contrasting pain trajectories over chronological age (time since birth) vs. time to death, a time-to-death-related model resulted in a better model fit and accounted for a larger amount of pain variability than the age-related model. Mean-level change in pain, both over age and time to death, was not significant, but there was substantial interindividual variability in intraindividual trajectories. Age-related change in pain was significantly predicted by autonomy and neuroticism, with increasing pain among those who had lower initial autonomy scores and higher initial neuroticism scores. With regard to time-to-death-related trajectories of pain, higher purpose in life as well as lower extraversion at baseline predicted less increase or even steeper decrease in pain with approaching death. Our findings suggest that, despite overall mean-level stability in pain both over age and time to death, there is a substantial proportion of individuals who reveal deterioration in pain over time. Regarding the role of psychosocial predictors, personality traits and eudaimonic wellbeing are related with late-life pain trajectories both over age and time-to-death.

Extended Follow-up of Local Steroid Injection for Carpal Tunnel Syndrome

Local steroid injection is commonly used in treating patients with idiopathic carpal tunnel syndrome, but evidence regarding long-term efficacy is lacking. To assess the long-term treatment effects of local steroid injection for carpal tunnel syndrome. This exploratory 5-year extended follow-up of a double-blind, placebo-controlled randomized clinical trial was conducted from November 2008 to March 2012 at a university hospital orthopedic department. Participants included patients aged 22 to 69 years with primary idiopathic carpal tunnel syndrome and no prior treatment with local steroid injections. Data were analyzed from May 2018 to August 2018. Patients were randomized to injection of 80 mg methylprednisolone, 40 mg methylprednisolone, or saline. The coprimary outcomes were the symptom severity score and rate of subsequent carpal tunnel release surgery on the study hand at 5 years. Secondary outcomes were time from injection to surgical treatment, SF-36 bodily pain score, and score on the 11-item disabilities of the arm, shoulder, and hand scale. A total of 111 participants (mean [SD] age at follow-up, 52.9 [11.6] years; 81 [73.0%] women and 30 [27.0%] men) were randomized, with 37 in the 80 mg methylprednisolone group, 37 in the 40 mg methylprednisolone group, and 37 in the saline placebo group. Complete 5-year follow-up data were obtained from all 111 participants with no dropouts (100% follow-up). At baseline, mean (SD) symptom severity scores were 2.93 (0.85) in the 80 mg methylprednisolone group, 3.13 (0.70) in the 40 mg methylprednisolone group, and 3.18 (0.75) in the placebo group, and at the 5-year follow up, mean (SD) symptom severity scores were 1.51 (0.66) in the 80 mg methylprednisolone group, 1.59 (0.63) in the 40 mg methylprednisolone group, and 1.67 (0.74) in the placebo group. Compared with placebo, there was no significant difference in mean change in symptom severity score from baseline to 5 years for the 80 mg methylprednisolone group (0.14 [95%CI, -0.17 to 0.45]) or the 40 mg methylprednisolone group (0.12 [95%CI, -0.19 to 0.43]). After injection, subsequent surgical treatment on the study hand was performed in 31 participants (83.8%) in the 80 mg methylprednisolone group, 34 participants (91.9%) in the 40 mg methylprednisolone group, and 36 participants (97.3%) in the placebo group; the number of participants who underwent surgical treatment between the 1-year and 5-year follow-ups was 4 participants (10.8%) in the 80 mg methylprednisolone group, 4 participants (10.8%) in the 40 mg methylprednisolone group, and 2 participants (5.4%) in the placebo group. All surgical procedures were conducted while participants and investigators were blinded to type of injection received. The mean (SD) time from injection to surgery was 180 (121) days in the 80 mg methylprednisolone group, 185 (125) days in the 40 mg methylprednisolone group, and 121 (88) days in the placebo group. Kaplan-Meier survival curves showed statistically significant difference in time to surgical treatment (log-rank test: 80 mg methylprednisolone vs placebo, P = .002 ; 40 mg methylprednisolone vs placebo, P = .02; methylprednisolone 80 mg vs 40 mg, P = .37). These findings suggest that in idiopathic carpal tunnel syndrome, local methylprednisolone injection resulted in statistically significant reduction in surgery rates and delay in need for surgery. ClinicalTrials.gov Identifiers: NCT00806871 and NCT02652390.

Comparison of Two Multidisciplinary Occupational Rehabilitation Programs Based on Multimodal Cognitive Behavior Therapy on Self-Rated Health and Work Ability.

Objective: Musculoskeletal pain and common mental disorders constitute the largest proportion of people who are on sick leave. This study investigated the efficacy of two multidisciplinary occupational rehabilitation programs on self-rated health and work-related outcomes. The interventions were identical in content but differed in length. It was hypothesized that a longer inpatient program would yield greater improvements than a shorter outpatient program.Methods: Patients were sick-listed workers referred to occupational rehabilitation by the Norwegian Labor and Welfare Administration. A non-randomized 2 Condition (20 days, n = 64 versus 12 days, n = 62) × 4 repeated measures (start, end, 3 months, 12 months) between-subject design was used. Both programs were based on multimodal cognitive behavior therapy with a return-to-work focus. Health-related questionnaires were the Subjective Health Complaints inventory, Hospital Anxiety and Depression Scale, and SF-36 Bodily Pain. Work-related questionnaires were the Work Ability Index, the Fear-Avoidance Beliefs Questionnaire, Return To Work Self-Efficacy, and Return To Work expectations. Intervention effects were estimated using linear mixed models and Cohen’s d.Results: The results revealed that both groups improved on the selected outcomes. Within-group contrasts and effect sizes showed that the inpatient group showed larger effect sizes at the end of rehabilitation and 12 months post-intervention for work-related outcomes than the outpatient group.Conclusion: Both programs were efficacious in improving health- and work-related outcomes during and after rehabilitation, but the inpatient group generally displayed stronger and more rapid improvements and was more stable at one-year postintervention.

Functional outcome of lumbar spine disorders treated with laminectomy

Patients with multiple levels of stenosis had somewhat less severe pain at baseline on the SF-36 bodily pain scale compared to one and two levels. Patients with single level stenosis were less likely to present with neurogenic claudication (p