Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial

Background: Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks’ immobilisation in a below-knee cast. Method/design: We have designed a pragmatic randomised controlled trial (p-RCT) to compare the EMADE intervention against usual care. We will recruit 144 independently living adult participants, absent of tissue-healing comorbidities, who have undergone surgical stabilisation of isolated Weber B ankle fractures. The EMADE intervention consists of a non-weight-bearing progressive home exercise programme, complemented with manual therapy and education. Usual care consists of immobilisation in a non-weight-bearing below-knee cast. The intervention period is between week 2 and week 6 post surgery. The primary outcome is the Olerud and Molander Ankle Score (OMAS) patient-reported outcome measure (PROM) at 12 weeks post surgery. Secondary PROMs include the EQ-5D-5 L questionnaire, return to work and return to driving, with objective outcomes including ankle range of motion. Analysis will be on an intention-to-treat basis. An economic evaluation will be included. Discussion: The EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external validity. Accordingly, if significant clinical benefits and cost-effectiveness are demonstrated, EMADE should become a worthwhile treatment option. A larger-scale, multicentre trial may be required to influence national guidelines. Trial registration: ISRCTN, ID: ISRCTN11212729. Registered retrospectively on 20 March 2017

Association of lumbar spine radiographic changes with severity of back pain-related disability among middle-aged, community-dwelling women

Importance Previous studies, using mostly cross-sectional data, provide conflicting evidence of an association between lumbar spine radiographic changes and the severity of back pain–related disability. Such conflicting evidence may be associated with widely unnecessary diagnostic imaging of the lumbar spine. Objective To examine both cross-sectional and longitudinal associations between lumbar spine radiographic changes and the severity of back pain–related disability among middle-aged, community-dwelling women. Design, Setting, and Participants This population-based prospective cohort study used data from the Chingford 1000 Women Study. Analyses included data collected from year 6 (1994-1996; physical activity was measured), year 9 (1997-1999; treated as baseline), and year 15 (2003-2005), with a total length of follow-up for longitudinal analyses of 6 years. Data were analyzed from April 17 to November 3, 2020. Exposures Primary exposure was lumbar spine radiographic changes, defined using the Kellgren-Lawrence (K-L) grade. Secondary exposures were defined using presence of osteophytes and disc space narrowing. The composite score combined the number of lumbar spine segments with definite changes detected on radiographic images (ie, radiographic changes) (K-L grade ≥2, which means at least definite osteophyte and possible narrowing of disc space are present; osteophyte and disc space narrowing grade ≥1, which means at least mild or definite changes are present). Main Outcomes and Measures Self-reported back pain–related disability measured in years 9 and 15 assessed by the St Thomas disability questionnaire. Results Among 650 women (mean [SD] age, 61.3 [5.9] years) in cross-sectional analyses and 443 women (mean [SD] age, 60.6 [6.0] years) in longitudinal analyses, there was no evidence to support an association between higher number of lumbar segments with radiographic changes (K-L grade, osteophytes, and disc space narrowing) and more severe back pain–related disability (eg, cross-sectional analyses using the K-L grade; 1 segment vs 0 segment: adjusted odds ratio, 1.22 [95% CI, 0.76-1.96]). No interactions were found of an association between lumbar spine radiographic changes and the severity of back pain–specific disability with age, body mass index, or smoking status. Conclusions and Relevance In this cohort of middle-aged, community-dwelling women, there was no evidence to support an association between a higher number of lumbar segments with radiographic changes (K-L grade, osteophytes, and disc space narrowing) and more severe back pain–related disability cross-sectionally or over time. These findings provide further evidence against routinely using diagnostic imaging of the lumbar spine

Preliminary evidence for physical activity following pelvic exenteration: A pilot longitudinal cohort study

Background: The physical activity (PA) level of patients undergoing major cancer surgery remains unclear. This pilot study aimed to: (i) Compare preoperative PA level between patients undergoing major cancer surgery and the general population; (ii) describe PA trajectories following major cancer surgery; (iii) Compare objective versus subjective PA measures in patients undergoing major cancer surgery; and (iv) Investigate the association between preoperative PA level and postoperative outcomes. Methods: Patients undergoing pelvic exenteration between September/2016 and September/2017 were included and followed at preoperative, 6-weeks and 6-months postoperative. PA was measured using the International Physical Activity Questionnaire Short-Form and McRoberts activity monitor. Analyses were performed using SPSS. Results: This pilot study included 16 patients. When compared to the general population, patients undergoing major cancer surgery presented a reduced preoperative PA level. PA levels decreased at 6 weeks but returned to preoperative levels at 6 months postoperative. Objective and subjective measures of PA were comparable, with some variables presenting strong correlations. A higher preoperative level PA was associated with an absence of postoperative complications and better quality of life outcomes. Conclusions: Patients undergoing major cancer surgery demonstrated lower PA levels when compared to the general population. PA trajectories decreased at 6 weeks postoperative, returning to preoperative levels within 6-months. In this cohort, it seems that higher preoperative PA level may improve postoperative surgical outcomes; however, this preliminary evidence should be confirmed in a larger cohort

Rehabilitation after immobilization for ankle fracture: The EXACT randomized clinical trial

IMPORTANCE: The benefits of rehabilitation after immobilization for ankle fracture are unclear. OBJECTIVES: To determine the effectiveness of a supervised exercise program and advice (rehabilitation) compared with advice alone and to determine if effects are moderated by fracture severity or age and sex. DESIGN, SETTING, AND PARTICIPANTS: The EXACT trialwas a pragmatic, randomized clinical trial conducted from December 2010 to June 2014. Patients with isolated ankle fracture presenting to fracture clinics in 7 Australian hospitals were randomized on the day of removal of immobilization. Of 571 eligible patients, 357 chose not to participate and 214 were allocated to rehabilitation (n = 106) or advice alone (n = 108), with 194 (91%) followed up at 1 month, 173 (81%) at 3 months, and 170 (79%) at 6 months. There were no withdrawals attributed to adverse effects. Recruitment terminated early on December 31, 2013 (planned enrollment, 342; actual, 214), because funding was exhausted. INTERVENTIONS :Supervised exercise program and advice about self-management (rehabilitation) (individually tailored, prescribed, monitored, and progressed) or advice alone, both delivered by a physical therapist. MAIN OUTCOMES AND MEASURES: Primary outcomeswere activity limitation assessed using the Lower Extremity Functional Scale (score range, 0-80; higher scores indicate better activity), and quality of life assessed using the Assessment of Quality of Life (score range, 0-1; higher scores indicate better quality of life), measured at baseline and at 1, 3 (primary time point), and 6 months. RESULTS :Mean activity limitation and quality of life at baseline were 30.1 (SD, 12.5) and 0.51 (SD, 0.24), respectively, for advice and 30.2 (SD, 13.2) and 0.54 (SD, 0.24) for rehabilitation, increasing to 64.3 (SD, 13.5) and 0.85 (SD, 0.17) for advice vs 64.3 (SD, 15.1) and 0.85 (SD, 0.20) for rehabilitation at 3 months. Rehabilitation was not more effective than advice for activity limitation (mean effect at 3 months, 0.4 [95%CI, -3.3 to 4.1]) or quality of life (-0.01 [95%CI, -0.06 to 0.04]). Treatment effects were not moderated by fracture severity or age and sex. CONCLUSIONS AND RELEVANCE :A supervised exercise program and advice did not confer additional benefits in activity limitation or quality of life compared with advice alone for patients with isolated and uncomplicated ankle fracture. These findings do not support the routine use of supervised exercise programs after removal of immobilization for patients with isolated and uncomplicated ankle fracture