Meaningful Improvements In Pain Research Articles

Effectiveness and cost-effectiveness of radiofrequency denervation versus placebo for chronic and moderate to severe low back pain: study protocol for the RADICAL randomised controlled trial

IntroductionLow back pain (LBP) is the leading global cause of disability. Patients with moderate to severe LBP who respond positively to a diagnostic medial nerve branch block can be offered...

Assessment of health-related quality of life (HRQoL) in triple-class–exposed patients with relapsed or refractory multiple myeloma (RRMM) treated with linvoseltamab in the LINKER-MM1 trial.

e23185 Background: Linvoseltamab, a B-cell maturation antigen × CD3 bispecific antibody, is being evaluated in LINKER-MM1, a Phase 1/2 study in patients with RRMM (NCT03761108). Early results over 36 weeks of treatment showed promising efficacy and a generally manageable safety profile (Jagannath et al., ASH 2023), and improvement or stability in patient-reported outcomes (PROs) including pain and fatigue (Hoffman et al., ASH 2023). We now report PRO data over a treatment period of 76 weeks. Methods: We evaluated patients in LINKER-MM1 who received the 5-25-200 mg dosing regimen in Phases 1 and 2 (n = 117). Patients ≥18 years old with triple-class exposed RRMM were administered linvoseltamab at Weeks 1 (5 mg), 2 (25 mg), and 3 (200 mg), followed by 200 mg once weekly through Weeks 14 (Phase 2) or 16 (Phase 1), then every 2 weeks until progression. Patients with a very good partial response by Week 24 in Phase 2 transitioned to dosing every 4 weeks. The EORTC QLQ-C30 was administered at baseline, Week 4, and then every 4 weeks. Least squares (LS) mean change from baseline and 95% confidence interval (CI) were estimated at each timepoint and overall on all scales using a mixed effects model for repeated measures. A 10-point change from baseline was considered clinically meaningful. Results were stratified by objective response status (at least partial response). No adjustment for multiplicity was performed; statistical significance is nominal, with LS mean change from baseline considered statistically significant if 95% CI did not cross 0. Results: PRO completion rates were generally ≥80% through Week 44 and dropped slightly after Week 44. LS mean change showed improvement in Global Health Status/QoL at Week 12, reaching the clinically meaningful threshold at Week 44; clinically meaningful improvements were observed on role and social functioning scales at Weeks 24 and 28, respectively. Pain and fatigue significantly improved and reached the clinically meaningful threshold at Weeks 20 and 44, respectively; the clinically meaningful improvement in pain was generally maintained through Week 76. Overall LS mean change in pain was clinically meaningful (-10.2; 95% CI -13.7, -6.7). Among treatment responders, statistically significant improvements were observed on all scales, including clinically meaningful improvement in pain (-11.2; 95% CI -14.7, -7.6). Non-responders had statistically significant worsening in fatigue (9.9; 95% CI 0.8, 19.1); overall change from baseline was not significant on other scales. Conclusions: Over 76 weeks of treatment, improvements in measures of HRQoL including pain and fatigue were reported in patients with triple-class exposed RRMM receiving linvoseltamab; responders showed significant improvements on all scales. These PRO results support a favorable benefit–risk profile of linvoseltamab. Clinical trial information: NCT03761108 .

The effects of the addition of Mulligan mobilization with movement to exercise on elbow pain and function associated with lateral elbow tendinopathy

BackgroundMulligan mobilization with movement (MWM) and eccentric exercise (EE) have been shown to be effective for the treatment of chronic lateral elbow tendinopathy (LET). However, the addition of MWM to EE effects on LET remained unknown. The objective of the study was to determine the effects of adding of Mulligan mobilization with movement to eccentric exercise for the treatment of LET. MethodsIn this quasi-experimental study, thirty participants with unilateral LET were assigned into two groups: 15 in MWM (received MWM + EE) (7 M and 8 F, mean age 36.8 ± 8.3 years) and 15 in EE (9 M and 6 F, mean age 46 ± 8.1 years). Both groups received education about painful activities and eccentric exercise, while the MWM group received MWM with the same eccentric exercise as the EE group. The visual analog scale (VAS) and the patient-rated tennis elbow evaluation (PRTEE) were used to assess pain and upper limb function, respectively, at baseline and at the end of 4 weeks. The data was analyzed using an independent t-test and a paired t-test. ResultsThere was no significant difference (p > 0.05) between groups at baseline. At the end of 4 weeks, significant and clinically meaningful improvements in pain and function were observed for both groups (p < 0.001); however, MWM group showed much better results in VAS (p < 0.001, d = 1.3) and PRTEE (p < 0.001, d = 5.2) ConclusionThis study showed that adding MWM to eccentric exercise resulted in enhanced pain reduction and improved function of the upper limb.

Smallest Clinically Meaningful Improvement in Amputation-Related Pain and Brief Pain Inventory Scores as Defined by Patient Reports of Global Improvement After Cryoneurolysis: a Retrospective Analysis of a Randomized, Controlled Clinical Trial.

The smallest meaningful improvement in pain scores (minimal clinically important difference [MCID]) after an analgesic intervention is essential information when both interpreting published data and designing a clinical trial. However, limited information is available for patients with chronic pain conditions, and what is published is derived from studies involving pharmacologic and psychological interventions. We here calculate these values based on data collected from 144 participants of a previously published multicenter clinical trial investigating the effects of a single treatment with percutaneous cryoneurolysis. In the original trial, we enrolled patients with a lower-limb amputation and established phantom pain. Each received a single-injection femoral and sciatic nerve block with lidocaine and was subsequently randomized to receive either ultrasound-guided percutaneous cryoneurolysis or sham treatment at these same locations. Investigators, participants, and clinical staff were masked to treatment group assignment with the exception of the treating physician performing the cryoneurolysis, who had no subsequent participant interaction. At both baseline and 4 months (primary end point), participants rated their phantom limb pain based on a numeric rating scale (NRS) and their interference of pain on physical and emotional functioning as measured with the Brief Pain Inventory's interference subscale. They subsequently qualitatively defined the change using the 7-point ordinal Patient Global Impression of Change (PGIC). The smallest clinically meaningful improvements in phantom limb pain and Brief Pain Inventory scores were calculated using an anchor-based method based on the PGIC. The median (interquartile range [IQR]) phantom pain NRS (0-10) improvements at 4 months considered small, medium, and large were 1 [1-1], 3 [3-4], and 4 [3-6], respectively. The median improvements in the Brief Pain Inventory interference subscale (0-70) associated with a small, medium, and large analgesic changes were 16 [6-18], 24 [22-31], and 34 [22-46]. The proportions of patients that experienced PGIC ≥5 were 33% and 36% in the active and placebo groups, respectively. The relative risk of a patient experiencing PGIC ≥5 in the active group compared to the sham group with 95% confidence interval was 0.9 (0.6-1.4), P = .667. Amputees with phantom limb pain treated with percutaneous cryoneurolysis rate analgesic improvements as clinically meaningful similar to pharmacologic treatments, although their MCID for the Brief Pain Inventory was somewhat larger than previously published values. This information on patient-defined clinically meaningful improvements will facilitate interpretation of available studies and guide future trial design.

The Best Exercise Modality and Dose for Reducing Pain in Adults With Low Back Pain: A Systematic Review With Model-Based Bayesian Network Meta-analysis.

OBJECTIVE: To quantify the dose-response relationship between overall and specific exercise modalities and pain, in patients with nonspecific chronic low back pain (LBP). DESIGN: Systematic review with Bayesian network meta-analysis. LITERATURE SEARCH: We searched the Medline, Embase, Web of Science, Cochrane Library, Scopus, and SPORTDiscus databases from inception to June 2023. STUDY SELECTION CRITERIA: We included randomized controlled trials of exercise interventions in adults with nonspecific chronic LBP and at least 1 pain outcome reported at the main trial end point. DATA SYNTHESIS: A random-effects network meta-analysis was conducted. We assessed risk of bias using the Cochrane Risk of Bias Tool 2.0, and used the GRADE approach to judge the certainty of evidence for each outcome. RESULTS: Eighty-two trials were included (n = 5033 participants). We found a nonlinear dose-response relationship between total exercise and pain in patients with nonspecific chronic LBP. The maximum significant response was observed at 920 MET minutes (standardized mean difference = -1.74; 95% credible intervals: -2.43, -1.04). The minimal clinically important difference for achieving meaningful pain improvement was 520 MET minutes per week. The dose to achieve minimal clinically important difference varied by type of exercise; Pilates was the most effective. The certainty of the evidence was very low to moderate for all outcomes. CONCLUSION: The dose-response relationship of different exercise modalities to improve pain in patients with nonspecific chronic LBP had a U-shaped trajectory and low- to moderate-certainty evidence. The clinical effect was most pronounced with Pilates exercise. J Orthop Sports Phys Ther 2024;54(5):1-13. Epub 8 March 2024. doi:10.2519/jospt.2024.12153.

Gastrocnemius Release in the Treatment of Achilles Tendinopathy: A Systematic Review.

The aim of this study is to evaluate the use of isolated gastrocnemius release in the treatment of Achilles tendinopathy. The primary outcome is the change in patient-reported pain outcomes. Secondary outcomes include the change in patient-reported foot and ankle function, ankle range of motion and strength, patient satisfaction and rate of surgical complications. A systematic review was undertaken of studies involving patients treated with an isolated gastrocnemius release for Achilles tendinopathy. Randomised controlled trials, cohort studies, case-control studies and case series were eligible and identified from the following databases: MEDLINE and EMBASE. Isolated gastrocnemius release results in improved patient-reported outcome scores for pain and foot and ankle function. There is an increase in ankle range of motion but a reduction in ankle strength. Patients report a high rate of overall satisfaction. The most common surgical complications are sural nerve injury and wound infection. Isolated gastrocnemius release may offer maintained and clinically meaningful improvements in pain and foot and ankle function with an associated reduction in ankle strength.

Improvements in Patient-Reported Outcomes Through Six Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real-World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.

Evaluate patient-reported outcomes after 6 months of on-label guselkumab use in patients with rheumatologist-diagnosed active psoriatic arthritis (PsA) enrolled in the CorEvitas PsA/Spondyloarthritis Registry. This analysis includes registry participants who initiated and persisted with on-label guselkumab (after US Food and Drug Administration approval for PsA; 100 mg at weeks 0, 4, and every 8 weeks) at their 6-month follow-up visit (On-Label Persisters). Among patients not meeting response criteria at baseline, responses at 6 months were determined for patient-reported outcomes, including patient-reported pain (0-100 mm visual analog scale), patient global assessment of arthritis + psoriasis (PtGA; 0-100 visual analog scale), and Health Assessment Questionnaire-Disability Index (HAQ-DI; 0-3). Unadjusted, nominal P values were calculated via single-proportion, one-sided test (H0 = 0%; α=0.05). Of 90 On-Label Persisters, most had treatment-resistant PsA (92.2% and 73.3% previously received ≥1 and ≥2 biologic/targeted synthetic disease-modifying antirheumatic drugs, respectively), with mean (SD) baseline patient-reported pain, PtGA, and HAQ-DI scores of 57.0 (24.6), 50.3 (24.4), and 0.9(0.6), respectively. Among those with patient-reported pain and PtGA scores of at least 15 at baseline, 40.2% (33/82) and 46.8% (36/77), respectively, achieved at least 15-mm reductions at 6 months; among those with HAQ-DI scoresof at least 0.35 and more than 0.5 at baseline, respectively, 30.4% (21/69) achieved improvements of at least 0.35 and 10.3% (6/58) achieved scores of 0.5 or lower at 6 months (all nominal P < 0.001). Pain and physical function are important contributors to health-related quality of life. In this real-world population of patients with treatment-resistant PsA and 6 months of persistent guselkumab treatment, clinically meaningful improvements in pain and physical function were achieved by approximately 40% and 30% of patients, respectively.

The effectiveness of cervical transforaminal epidural steroid injections for the treatment of cervical radicular pain: A prospective cohort study reporting 12-month outcomes

ObjectivesTo evaluate the effectiveness of cervical transforaminal epidural steroid injection (CTFESI) for the treatment of unilateral cervical radicular pain. DesignSingle-group prospective cohort study. MethodsOutcomes included ≥50% reductions in Numeric Rating Scale (NRS) for arm pain, ≥30% Neck Disability Index (NDI-5) improvement, health-related quality of life (EQ-5D), global improvement (PGIC), personal goal achievement (COMBI), Chronic Pain Sleep Index (CPSI), and healthcare utilization at one, three, six, and 12 months. Data analysis included descriptive statistics with the calculations of 95% confidence intervals (CIs), contingency table analysis, and multilevel logistic regression (LR) analysis, including a worst-case (WC) sensitivity analysis in which missing data were treated as treatment failure. Participants who were treated surgically were considered failures in the categorical analyses. Results33 consecutively enrolled participants (63.6% females, 51.2 ± 12.2 years of age, BMI 28.3 ± 4.5 kg/m2) were analyzed. Success rates for ≥50% reduction in NRS for arm pain at one, three, six and 12 months were 57.6% (95% CI 40.8–72.8%), 71.9% (95% CI 54.6–84.4%), 64.5% (95% CI 46.9–78.9%), and 64.5% (95% CI 46.9–78.9%). Success rates for ≥30% improvement in NDI-5 were 60.6% (95% CI 43.7–75.3%), 68.8% (95% CI 51.4–82.0%), 61.3% (95% CI 43.8–76.3%), and 71.0% (95% CI 53.4–83.9%). In WC analysis, success rates for ≥50% arm NRS and NDI-5 were 0–4.3% lower between 1 and 12 months. PGIC scores were at least “much improved” or “very much improved,” in 48.4–65.6% of participants between 1 and 12 months. 6.1%, 6.1%, and 3.0% had one, two, or three repeat injections, respectively. 18.2% of participants underwent surgery by 12 months. Participants showed significant improvements in arm NRS and NDI-5 after treatment (p < 0.05), multilevel logistic regression models showed no significant decline in improvements across the follow-up time points (p > 0.05). ConclusionStatistically significant and clinically meaningful improvements in pain and disability were observed after CTFESI for up to 12 months in individuals with unilateral cervical radicular pain.

Teclistamab Improves Patient-Reported Symptoms and Health-Related Quality of Life in Relapsed or Refractory Multiple Myeloma: Results From the Phase II MajesTEC-1 Study

IntroductionPatients with relapsed or refractory multiple myeloma (RRMM) report significantly lower HRQoL compared with patients with newly diagnosed MM and experience further deterioration in HRQoL with each relapse and subsequent treatment. Therefore, consideration of the impact of treatment on HRQoL in addition to clinical outcomes is vital. Patients and MethodsIn the phase I/II MajesTEC-1 (NCT03145181, NCT04557098) study, patients with RRMM who received teclistamab, an off-the-shelf, T-cell redirecting BCMA × CD3 bispecific antibody, had deep and durable responses with manageable safety. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30-item and the EuroQol 5 Dimension 5 Level descriptive questionnaire. Changes over time from baseline were measured with a repeated measures mixed-effects model. Proportions of patients with clinically meaningful improvement after starting treatment and time to clinically meaningful worsening were assessed. ResultsCompliance was maintained throughout the study. Compared with baseline, positive changes were observed for pain, global health status, and emotional functioning with treatment; other assessments were largely unchanged from baseline. Post hoc analysis showed patients with deeper clinical response generally reported improved HRQoL outcomes. Following an initial decline in HRQoL in some scales, the proportion of patients reporting clinically meaningful improvements increased, while the proportion reporting clinically meaningful worsening decreased over time. Clinically meaningful improvements in pain were reported in ≥40% of patients at most assessment time points. ConclusionsThese results complement previously reported clinical benefits and support teclistamab as a promising therapeutic option for patients with RRMM.

Combined Digital Interventions for Pain Reduction in Patients Undergoing Knee Replacement

Digital technology represents an opportunity to improve outcomes following total knee replacement (TKR). Digitally delivered interventions have been shown to be similar to face-to-face interventions and to increase participation levels in people with osteoarthritis. To assess the effect of a digital technology package in reducing pain compared with usual care following TKR. This randomized clinical trial recruited 102 adults after they received TKR in 3 rehabilitation hospitals in Sydney, Australia, between June 2020 and July 2021. All participants underwent usual care. In addition to usual care, 51 participants received a digital technology package consisting of an exercise app, fitness tracker, and online health coaching. In the usual care group, 51 participants received a fitness tracker but with all notifications turned off and goals for step count, sleep, and active hours removed. Participants were followed up for 12 months (June 2021 to July 2022). The primary outcome was mean knee pain during the past week assessed using a numerical rating scale (range, 0-10, with 10 indicating worst possible pain) at 3 months. In unadjusted analyses, considered primary and based on multiple imputations, independent t tests were used to compare means between groups. Secondary outcomes, including measures of function, activity participation, and quality of life, were analyzed using a generalized estimating equation model that accounted for repeated measurements. Of 102 participants (mean [SD] age, 67.9 [7.2] years; 68 [67%] female; and 92 [90%] White) randomly assigned to intervention or usual care groups, 47 (92%) in each group completed the 3-month follow up. At 3 months, participants in the intervention group demonstrated small but not clinically meaningful improvements in pain compared with the usual care group in the unadjusted intention-to-treat analysis (mean difference, -0.84; 95% CI, -1.59 to -0.10; P = .03). Secondary outcomes indicated a statistically significant reduction in pain intensity, (mean difference, -0.94; 95% CI, -1.82 to -0.06), pain disability (mean difference, -5.42; 95% CI, -10.00 to -0.83), and sedentary behavior (mean difference, -9.76; 95% CI, -19.17 to -0.34) favoring the intervention from baseline to 3, 6, and 12 months. In this randomized clinical trial, a combined digital technology program provided small but not clinically meaningful improvements in pain at 3 months and other longer-term favorable outcomes following TKR compared with usual care. Future studies should tailor digital interventions based on participants' abilities and preferences to ensure that the intervention is appropriate and fosters long-term self-management. Anzctr.org.au Identifier: ACTRN12618001448235.

Effectiveness of Pulsed Radiofrequency Based on the Minimum Clinically Important Differences in Lumbar Spine-Related Pain in Patients without Recent Lumbar Surgery

Pulsed radiofrequency (PRF) has been used for treatment of chronic pain in several body regions, including axial and radicular pain. However, a limited number of reports have specifically demonstrated the effectiveness of PRF for spine-related pain among nonsurgical patients. Therefore, we evaluated the effectiveness of PRF for lumbar spine-associated pain in patients without recent spine surgery, and identified the factors associated with clinically meaningful improvement in pain and quality of life. Records of patients who underwent PRF for lumbar spine-related pain and were followed up over 6months between 2019 and 2022 were retrospectively reviewed. Data on patient demographics, interventional factors, and patient-reported outcomes, such as the numerical rating scale (NRS) and EuroQol Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), were collected. Patients were divided into 2 groups (responsive and nonresponsive) based on the NRS and EQ-5D-5L scores using the previously reported minimal clinically important difference values of the NRS and EQ-5D-5L as cutoffs, and baseline parameters were compared to identify contributing factors. Forty-three patients were included in the final analysis. The NRS and EQ-5D-5L scores improved significantly at 3 and 6months after PRF compared to baseline. The groups with NRS and EQ-5D-5L improvement over the minimal clinically important difference had significantly higher baseline NRS and EQ-5D-5L scores. Our results demonstrated that PRF improved pain and patient-reported outcomes for spine-related pain for at least 6months in our patient cohort. PRF may be a good option for treating lumbar spine-related issues, even with severe pain and/or dysfunction.

Functional outcomes after open reconstruction or nonoperative management of 81 pathologic acetabular fractures from metastatic bone disease

BackgroundPathologic acetabular fracture secondary to skeletal metastasis may result in debilitating pain, inability to ambulate, and impaired quality of life, which may mark the first period of dependent care in cancer patients. Acetabular reconstruction may involve morbid procedures with increased complication rates. This study aimed to evaluate the evolution of pain, performance status, and ambulation following nonoperative management or open reconstruction of pathologic acetabular fractures. MethodsA retrospective cohort of 2630 adult patients with osseous metastatic disease treated at a high-volume cancer center between 2005 and 2021 was screened for pathologic fractures of the acetabulum. The study outcomes were pain, performance status, and the ability to ambulate. We identified 78 patients (median age, 60 years; 37 female patients [46%]) with 81 fractures. Of these, treatment consisted of open reconstruction (n = 34) or nonoperative management alone (n = 47). The mean follow-up in surviving patients was 3.4 years. ResultsOpen reconstruction was performed more frequently for displaced fractures (P < 0.01), Harrington class III or IV acetabula (P < 0.01), and patients with a performance status ≥3 at hospitalization (P = 0.00). Open reconstruction was associated with clinically meaningful improvements in pain (adjusted odds ratio [aOR], 8.3; 95% CI, 1.4–50.6; P = 0.02) and performance status (aOR, 10.9; 95% CI, 1.7–71.0; P = 0.01) at discharge and a restoration of ambulation (aOR, 7.5; 95% CI, 1.9–29.8; P < 0.01) at final follow-up. ConclusionsIn patients with pathologic acetabular fracture due to osseous metastatic disease, functional improvements in pain, performance status, and ambulation were observed following open acetabular reconstruction in carefully selected patients, with no impact on survival, while noninferior improvements were observed in patients receiving nonoperative management when considering their larger clinical context. Level of evidenceLevel III, therapeutic study.

Poster 365: Initial outcomes after unicompartmental tibiofemoral bipolar osteochondral and meniscus allograft transplantation in the knee using high-viability tissues

Objectives: To report initial outcomes for unicompartmental tibiofemoral bipolar osteochondral allograft transplantation (OCAT) with meniscus allograft transplantation (MAT) using fresh high-cell- viability tissues for treatment of knee articular cartilage defects with meniscus deficiency. The study was designed to test the hypothesis that primary OCAT and MAT using high-viability tissues will be associated with successful short-term (2 to 6 years) outcomes based on statistically significant and clinically meaningful improvements in pain and function in the majority of patients. Methods: With IRB approval and documented informed consent, patients who underwent primary OCAT and MAT for large articular cartilage defects with meniscus deficiency involving at least one femoral condyle, tibial plateau, and meniscus, all of which were opposing (bipolar). Surgeries were defined as Uni when patients underwent OCAT and MAT involving one femoral condyle, tibial plateau, and meniscus in the same compartment or Uni-Plus when patients underwent Uni OCAT and MAT with at least one other OCA transplant to treat a large (&gt;2.5cm2) grade III or IV focal articular cartilage defect of the patella, trochlea, femoral condyle, or tibial plateau. Patients who had at least 2-year follow up data regarding complications, failures, adherence, and patient reported outcome measures (PROMs) were analyzed. Patients who required OCA and/or MAT revision or artificial arthroplasty were defined as treatment failures. Patient reported outcome measures (PROMs) including VAS pain, IKDC, SANE, PROMIS Global Health and Physical Function, were collected at 3 and 6 months and then yearly after transplantation. Outcomes were compared based on patient sex, age, and BMI, tobacco use, previous and concurrent procedures, differences in number of surfaces transplanted (Uni vs Uni-Plus), and adherence. Significance was set at P &lt; 0.05. Differences in PROMs were also assessed for minimum clinically important differences. Results: Seventy-six patients (n=52 males; 68%) met inclusion criteria (mean followup = 52 months; median = 56 months; range, 24-70 months). Mean age was 41.1 years (range, 15-69 years) and mean body mass index (BMI) was 28.9 kg/m2 (range, 17-46). Forty-eight patients underwent OCAT(s) in addition to Uni (Uni-Plus). Eight patients (10.5%) underwent concurrent ACL reconstruction, and 28 patients (36.8%) underwent ipsilateral lower extremity osteotomy in order to address co-morbidities. Twenty-three patients (30.3%) were documented to be non-adherent during the first year after transplantation. Initial (&gt;2-year) success rate was 77.6% with 8 patients (10.5%) undergoing OCA and/or MAT revision and 9 patients (11.8%) converted to arthroplasty. Variables associated with increased risk for treatment failure (revision or arthroplasty) included ipsilateral osteotomy (p = .046; OR = 3.3), ipsilateral concurrent procedure (p = .0057; OR = 5.5), and non-adherence (p = .0009; OR = 7.2). None of the patients undergoing OCA and/or MAT revision surgery in the present study required arthroplasty at the time of data analysis such that overall success rate for primary and revision unicompartmental bipolar OCA plus MAT was 88.2%. There were statistically significant (p &lt; .0001) and clinically important improvements from preoperative levels for all patient reported outcomes at each annual follow-up time point. Conclusions: Unicompartmental tibiofemoral bipolar osteochondral and meniscus allograft transplantation can result in successful short-term (2 to 6 years) outcomes and satisfaction in the majority (78%) of patients. Primary MOPS-preserved OCAT and MAT for treatment of femoral condyle and tibial plateau articular cartilage defects with concurrent meniscus deficiency was associated with statistically significant and clinically meaningful improvements in patient-reported measures of pain and function.

An impairment-based physical therapy program for runners with femoroacetabular impingement (FAI).

Purpose. Running is a common sport and recreational activity in the United States. Due to its dysfunctional implication in runners, femoroacetabular impingement (FAI) is increasingly recognized as a problematic source of anterior hip pain. The purpose of this case series was to describe an impairment-based physical therapy intervention in non-professional runners with FAI.&#x0D; Materials and methods. Two males, non-professional runners with a mean age of 28.5± 2.1 years, both with a diagnosis of femoroacetabular impingement (FAI), were treated with manual therapy, dynamic neuromuscular stabilization (DNS), and functional training. At initial evaluation, subjects were examined and completed self-reported outcome measures including the visual analog scale (VAS), and the patient-specific functional scale (PSFS). At discharge, they completed the same outcome measures along with the global rating of change (GROC) questionnaire.&#x0D; Results. Both subjects showed clinically meaningful improvement in pain and function above the minimal clinically important difference (MCID). Upon discharge, subject 1 had a 86% reduction in VAS score, a 75% improvement in PSFS score, and a GROC score of 6; subject 2 had a 88% reduction in VAS, a 64% improvement in PSFS, and a GROC score of 5.&#x0D; Conclusion. The overall improvement observed in this study was clinically meaningful to subjects who participated, however, because a cause and effect cannot be inferred from case series studies, follow-up randomized clinical/controlled trials are recommended to further investigate the studied intervention on runners with FAI.

Acupuncture versus massage for pain in patients living with advanced cancer: The IMPACT randomized clinical trial.

12101 Background: Pain represents a challenging symptom for patients living with advanced cancer and is often associated with fatigue and insomnia. While American Society for Clinical Oncology clinical guidelines recommend acupuncture and massage for oncological pain management, the long-term comparative effectiveness between these two therapies is unknown, particularly among those living with advanced cancer. Methods: We conducted a pragmatic randomized clinical trial to compare acupuncture and massage for musculoskeletal pain among patients living with advanced cancer who experienced at least moderate pain and had a life expectancy of at least six months. Patients received weekly acupuncture or massage treatments for ten weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint was the change in worst pain intensity score measured by the Brief Pain Inventory (BPI) from baseline to 26 weeks. The secondary outcomes included pain-related interference (BPI), pain medication usage, patient-reported fatigue, insomnia, and quality of life. Analyses were performed using linear mixed models adhering to intent to treat. Results: Among 298 participants (mean age [SD] 58.7 [14.1] years, baseline worst pain 6.6 [1.5], 67.1% women, 25.9% non-white, 15.4% Hispanic, cancer types [21.5% hematologic, 19.8% breast, 14.4% gynecological, and 11.7% gastrointestinal, 9.7% lung, and 9.7% prostate]), 242 (81.2%) completed the primary endpoint. From baseline to week 26, acupuncture reduced worst pain by 2.53 points (95% CI 2.15-2.92) while massage reduced worst pain by 3.01 points (95% CI 2.63-3.38); the between-group difference was not significant (0.48, 95% CI -0.03-0.98, p = 0.066). Both treatments reduced pain-related interference and pain medication usage and improved comorbid fatigue, insomnia, and quality of life to a similar degree without between-group differences. Adverse events were mild: bruising was reported by 9 (6.5%) acupuncture patients, and transient soreness was reported by 21(15.1%) massage patients and 8 (5.8%) acupuncture patients. Despite receiving close in-person treatment, no known COVID-19 transmission was reported between patients and providers. Conclusions: Among patients living with advanced cancer, acupuncture and massage produced similar clinically meaningful improvements in pain and comorbid fatigue and insomnia, decreased use of pain medications, and improved quality of life. Integrating these non-pharmacological therapies into comprehensive cancer care can improve symptom management and quality of life for the ever-growing number of patients living with advanced cancer as a chronic illness. Clinical trial information: NCT04095234 .

Endoscopic iliopsoas lengthening for treatment of recalcitrant iliopsoas tendinitis after total hip arthroplasty.

Iliopsoas (IP) tendinitis from impingement upon the acetabular component after total hip arthroplasty (THA) has been treated with open and endoscopic IP tenotomy or acetabular component revision. This study describes the results of a consecutive series of patients treated with endoscopic IP tenotomy as a less invasive alternative. Twenty-eight patients with IP impingement after THA underwent endoscopic IP lengthening from 2012 to 2021 at a single-center academic institution. The follow-up of 24 of these patients was achieved with a mean follow-up of 7.6 months (range 1-28). Outcomes included the modified Harris Hip Score (mHHS), visual analog pain scale (VAS), satisfaction, component positioning and complications. Seventy-one percent of patients were satisfied or very satisfied after their operation. The median mHHS preoperatively was 57 (Interquartile range [IQR] 43-60) and postoperatively was 75 (IQR 66-92, P < 0.001). Clinically meaningful improvements in mHHS were seen in patients with VAS pain scores <5, cup prominence >8 mm, body mass index >30, and less than 2 years from their index THA. Two patients developed a deep infection 7 and 10 months postoperatively (neither related to the release), and one patient underwent open psoas release for persistent impingement. Endoscopic IP tenotomy is a safe and effective treatment for impingement after THA. Patients with cup prominence >8 mm, body mass index >30 and less than 2 years since their index THA may have more clinically meaningful improvements in pain and function.

Patient-reported outcomes (PROs) in cisplatin-ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC) treated with enfortumab vedotin (EV) alone or in combination with pembrolizumab (P) in the phase 1b/2 EV-103 Cohort K study.

439 Background: The EV-103 Cohort K trial evaluated 1L EV+P or EV alone (NCT03288545) in pts with la/mUC who were cisplatin-ineligible. EV+P showed a clinically meaningful objective response rate (64.5%; 95% CI, 52.7–75.1) with a manageable safety profile. Because la/mUC is associated with symptoms with a frequent impact on quality of life (QOL) and functioning (Mamtani et al. JCO 2021), we describe the impact of EV+P or EV alone on QOL and symptoms. Methods: In this open-label, Phase 1b/2 trial, cisplatin-ineligible pts with la/mUC were randomized 1:1 to EV+P or EV alone. For exploratory PRO endpoints, pts completed EORTC QLQ-C30 and the BPI-SF at baseline, weekly for cycles 1–3, and once every cycle for the remainder of treatment period. The PRO analysis set included only pts who were treated and completed the questionnaire at baseline. Mixed effect models for repeated measures (MMRM; least squares [LS] mean, standard error [SE]) not adjusted for multiplicity, estimated change vs baseline until Week 24; established thresholds (EORTC QLQ-C30: 10-point change; BPI-SF: 2-point change) were applied to determine clinically meaningful change. Results: Of the 76 pts treated with EV+P, 65 were included in the PRO analysis set. EORTC QLQ-C30 and BPI-SF were completed by 100% and 95%, respectively, at baseline; compliance rates were ≥84% for both instruments through Week 24. In the EORTC QLQ-C30 MMRM analyses, QOL was maintained through Week 24 for EV+P; functioning and symptom scores remained stable over time, with improvements in emotional functioning, pain and sleep disturbance vs observed baseline. In the EV+P arm, clinically meaningful reductions in pain were seen at Week 12 (-12.64 [3.208]) vs baseline and persisted through Week 24 (-13.20 [3.406]). In the BPI-SF MMRM analyses, worst and average pain, pain interference and severity consistently showed improved scores from Week 4–24 for EV+P; clinically meaningful change in worst pain was seen at Week 21 (-2.08 [0.361]). Similar completion and compliance rates were seen for the EV alone PRO analysis set (n=63). EV alone demonstrated clinically meaningful improvements in pain at Week 24 in the EORTC QLQ-C30 (-10.63 [4.110]) and consistent small-to-moderate improvements in the BPI worst and average pain, and pain severity (0.5–1.0 points). Sleep disturbances demonstrated improvement, and other symptom scales, QOL and functional domains remained stable. Conclusions: PRO data showed that EV+P in cisplatin-ineligible pts with la/mUC was associated with preservation or improvement of QOL, functioning, and symptoms. Improvement in pain was demonstrated consistently in both PRO instruments and treatment arms. These PRO data complement the clinical outcomes of EV+P in 1L cisplatin-ineligible pts with la/mUC. Clinical trial information: NCT03288545 .

Initial Outcomes After Unicompartmental Tibiofemoral Bipolar Osteochondral and Meniscal Allograft Transplantation in the Knee Using MOPS-Preserved Fresh (Viable) Tissues

Background: Unicompartmental tibiofemoral bipolar osteochondral allograft transplantation (OCAT) with meniscal allograft transplantation (MAT) has not historically been associated with consistently successful outcomes for treatment of knee articular cartilage defects with meniscal deficiency. Hypothesis: Primary OCAT and MAT using fresh tissues will be associated with successful short-term outcomes based on statistically significant and clinically meaningful improvements in pain and function in the majority of patients. Study Design: Case series; Level of evidence, 4. Methods: Patients were prospectively enrolled into a registry for outcomes after OCAT and MAT. Patients included those who underwent primary OCAT and MAT using Missouri Osteochondral Preservation System (MOPS)–preserved allografts for treatment of large bipolar tibiofemoral articular cartilage defects with meniscal deficiency and had a minimum of 2-year follow-up data. Results: A total of 76 patients (n = 52 male; 68%) met inclusion criteria (mean follow-up, 52 months). The mean age was 41.1 years (range, 15-69 years), and the mean body mass index was 28.9 (range, 17-46); 48 patients underwent another OCAT in addition to the unicompartmental bipolar tibiofemoral OCAT and MAT; 23 patients (30.3%) were documented to be nonadherent to the prescribed postoperative restriction and rehabilitation protocol. The initial success rate (>2 years) was 77.6%, with 8 patients (10.5%) undergoing revision and 9 (11.8%) converting to arthroplasty. Variables associated with an increased risk for treatment failure (revision or arthroplasty) included ipsilateral osteotomy (P = .046; odds ratio [OR] = 3.3), ipsilateral concurrent procedure (P = .0057; OR = 5.5), and nonadherence (P = .0009; OR = 7.2). None of the patients undergoing revision surgery required arthroplasty at the time of data analysis such that the overall success rate for primary and revision unicompartmental bipolar OCA plus MAT was 88.2%. There were statistically significant (P < .0001) and clinically important improvements for all patient-reported outcomes at each annual follow-up time point. Conclusion: Unicompartmental tibiofemoral bipolar OCAT and MAT can result in successful short-term outcomes (2-6 years) and satisfaction in the majority of patients (78%). Primary MOPS-preserved OCAT with MAT for treatment of femoral condyle and tibial plateau articular cartilage defects with concurrent meniscal deficiency was associated with statistically significant and clinically meaningful improvements in patient-reported measures of pain and function.

What's New in Hand and Wrist Surgery.

What's New in Hand and Wrist Surgery.

Use of Aerobic Exercise as an Adjunct to Conventional Therapy in the Management of an Older Adult with Chronic Low Back Pain in Nigeria: A Case Report

Treatment preferences utilized by most physical therapists on adults with LBP in Nigeria often do not adhere to global clinical practice guidelines, which include aerobic exercise. This case report describes the utilization of aerobic exercise within a conventional multimodal treatment approach in the management of chronic LBP for an older adult living in Nigeria. Baseline measures of NPRS, ODI, RPE, and lumbar range of movement were taken at the initial visit. Subsequently, the intervention combined a walking aerobic exercise both overground and, on the treadmill, with other therapies (e.g., directional preference exercises, strengthening exercises) for 16 sessions over four weeks. Following 16 sessions, clinically meaningful improvements in pain, disability, lumbar range of motion, and rate of perceived exertion were observed. The patient complied, reported no side effects, and had positive feedback regarding the intervention. The utilization of aerobic exercises within a conventional multimodal treatment approach is safe and could be useful for the management of chronic LBP in older adults. Keywords: Aerobic exercise, Conventional management, Clinical practice guidelines, Low back pain, Physical therapy, Walking exercise.