QUESTION: What is the effect of an expanded warm-up program including pelvic floor muscle training (PFMT) compared with usual warm-up on bother and prevalence of urinary incontinence (UI) among rhythmic gymnasts? What is...QUESTION: What is the effect of an expanded warm-up program including pelvic floor muscle training (PFMT) compared with usual warm-up on bother and prevalence of urinary incontinence (UI) among rhythmic gymnasts? What is the self-perceived effect of PFMT, including its progression over time, assessed via the global rating of change? DESIGN: A cluster-randomised controlled trial with concealed allocation and intention-to-treat analysis. PARTICIPANTS: Gymnasts had to be ≥ 12 years of age and training in rhythmic gymnastics ≥ 3 days/week. Twenty-three rhythmic gymnastics clubs were randomised to an experimental group (12 clubs, 119 gymnasts) or a control group (11 clubs, 86 gymnasts). INTERVENTION: The experimental group performed one set of 8 to 12 near-maximum pelvic floor muscle contractions and exercises for the knees, lower back and hip/groin as warm-up before each training session for 8 months. The control group continued rhythmic gymnastics training as usual without PFMT or additional lower back and lower limb exercises. OUTCOME MEASURES: Primary outcomes were bother from UI (score 0 to 21) and prevalence of UI, each measured by the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI-SF). The secondary outcome measure was the self-perceived effect and its progress over time, assessed using the global rating of change (-5 to 5). RESULTS: The difference between the groups in the ICIQ-UI-SF total score (ie, UI bother) was clearly negligible (MD -0.48, 95% CI -1.27 to 0.31). The prevalence of UI reduced from 46 to 41% in the experimental group and increased from 32 to 34% in the control group; despite this, the risk difference at 8 months was negligible (RD 0.07) and the confidence interval spanned mainly negligible effects (95% CI -0.08 to 0.21). Experimental group participants rated their global change at a mean of 2.1 (SD 1.7). CONCLUSION: Eight months of warm-up before rhythmic gymnastics training sessions that included one set of 8 to 12 near-maximum PFM contractions did not reduce UI bother. The effect on UI prevalence was also likely to be negligible, despite experimental group participants perceiving benefit from the intervention. REGISTRATION: ClinicalTrials.gov NCT05506579.
QUESTION: In people with chronic non-specific low back pain, what is the effect of high-intensity Pilates exercise compared with low-intensity Pilates exercise on pain, disability, patient-specific function, kinesiophobi...QUESTION: In people with chronic non-specific low back pain, what is the effect of high-intensity Pilates exercise compared with low-intensity Pilates exercise on pain, disability, patient-specific function, kinesiophobia and isometric hip strength? DESIGN: Randomised trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: One hundred and sixty-eight people with chronic non-specific low back pain and aged between 18 and 60 years. INTERVENTIONS: Participants were allocated to undertake 1-hour sessions of clinical Pilates at either high-intensity or low-intensity, twice per week for 6 weeks. OUTCOME MEASURES: The primary outcomes were the numerical pain scale and the Roland Morris Disability Questionnaire at the end of the 6-week intervention period. The secondary outcomes were the Patient-Specific Functional Scale, the Tampa Scale for Kinesiophobia and isometric hip strength at 6 weeks. Pain and disability were also re-measured 6 and 12 months after the intervention. RESULTS: The two Pilates regimens had negligible differences in effects on all outcomes at the end of the intervention period. At 6 and 12 months, the between-group differences in pain intensity were still negligible but the confidence intervals around those estimates spanned from around no effect to a worthwhile benefit (≥ 1.4) from low-intensity Pilates compared with high-intensity Pilates: 6-month MD 0.6 (95% CI -0.2 to 1.4) and 12-month MD 0.8 (95% CI 0.0 to 1.6). The effect on disability remained negligible at 6 and 12 months. Adverse events were less common in the low-intensity group: absolute risk reduction 0.20 (95% CI 0.10 to 0.31). CONCLUSION: High-intensity and low-intensity Pilates had very similar effects on pain, disability and other outcomes in people with chronic non-specific low back pain. Physiotherapists should endorse low-intensity Pilates exercises for managing chronic non-specific low back pain because the effects on most outcomes are very similar to high-intensity Pilates exercise but there are fewer side effects. REGISTRATION: RBR-2d2vb9.
QUESTION: What is the smallest worthwhile (SWE) effect of discectomy compared with non-surgical treatments amongst people with sciatica? DESIGN: Benefit-harm trade-off study. PARTICIPANTS: People with sciatica of any dur...QUESTION: What is the smallest worthwhile (SWE) effect of discectomy compared with non-surgical treatments amongst people with sciatica? DESIGN: Benefit-harm trade-off study. PARTICIPANTS: People with sciatica of any duration living in Australia and recruited through social media. OUTCOME: The outcome of interest was leg pain intensity. Participants were asked to nominate the additional percentage reduction in leg pain from discectomy--above the reduction anticipated from non-surgical treatments--that would make discectomy worthwhile for them. The SWE was estimated as the median (IQR) of the smallest percentage reduction in leg pain with discectomy (compared with non-surgical treatment) that participants considered worthwhile. The SWE was estimated for the overall sample and those with acute (≤ 6 weeks), subacute (> 6 to 12 weeks) and chronic (> 12 weeks) sciatica, and investigated factors associated with the SWE. RESULTS: Two hundred participants with a mean age of 59 years (SD 12) were included. The SWE was estimated to be an additional 15% (IQR 10 to 40) reduction in leg pain with discectomy, beyond any reduction in leg pain achieved by non-surgical treatments. Dissatisfaction with previous non-surgical treatments and low pain self-efficacy were associated with smaller SWE estimates. CONCLUSION: People with sciatica would require discectomy to provide an additional 15% reduction in their leg pain beyond the expected 50% improvement in leg pain from non-surgical treatments in the short term to consider discectomy worthwhile. These results can inform the interpretation of the effects of discectomy in randomised trials and meta-analysis from the perspective of consumers.
QUESTION: Is electrical stimulation (ES) combined with strength training and usual care more effective than usual care alone in increasing the strength of very weak muscles in people with recent spinal cord injury (SCI)?...QUESTION: Is electrical stimulation (ES) combined with strength training and usual care more effective than usual care alone in increasing the strength of very weak muscles in people with recent spinal cord injury (SCI)? DESIGN: A randomised controlled trial with concealed allocation, intention-to-treat analysis and blinded outcome assessors. PARTICIPANTS: Sixty participants with recent SCI were recruited from three SCI units in Australia and Bangladesh. INTERVENTIONS: Participants were randomised to either a treatment or control group. A major muscle group of the upper or lower limb with Grade 1 or Grade 2 strength on a standard 6-point manual muscle test was selected. Participants in the experimental group received strength training combined with ES and usual care for the target muscle group over 8 weeks. Participants in the control group received only usual care. OUTCOME MEASURES: Assessments were undertaken by a blinded assessor at baseline and 8 weeks. The primary outcome was voluntary muscle strength on a modified 13-point manual muscle test. The three secondary outcomes were participants' perceptions of strength, function and ability to perform self-selected goals. RESULTS: The mean between-group difference for voluntary strength at 8 weeks was 0.7 out of 13 points (95% CI -0.7 to 2.1), where the clinically worthwhile treatment effect was deemed a priori as 1 point. None of the secondary outcomes demonstrated a clinically important effect. CONCLUSION: Strength training combined with ES over 8 weeks has a negligible effect on the strength of very weak muscles in people with SCI. REGISTRATION: ACTRN12621000197831.
QUESTION: How effective is an e-learning program based on international clinical guidelines in promoting beliefs more aligned with the current evidence for the management of low back pain among physiotherapists? DESIGN:...QUESTION: How effective is an e-learning program based on international clinical guidelines in promoting beliefs more aligned with the current evidence for the management of low back pain among physiotherapists? DESIGN: Randomised controlled trial with concealed allocation and intention-to-treat analysis. PARTICIPANTS: 106 physiotherapists who treat patients with low back pain. INTERVENTIONS: The experimental group received access to an e-learning program, based on recommendations of clinical practice guidelines for the management of low back pain, over a 6-week period. The program consisted of six units, totalling 15 hours, and was offered in a self-instructional and self-paced format. The control group was instructed to continue their activities as usual. OUTCOME MEASURES: The primary outcome was beliefs about low back pain measured using the Modified Back Beliefs Questionnaire (MBBQ, -50 worst to 50 best). Secondary outcomes included the Back Pain Attitudes Questionnaire (Back-PAQ, -20 worst to 20 best) and agreement with two statements (1: X-rays or scans are necessary to get the best medical care for low back pain; 2: Everyone with low back pain should have spine imaging). Participants were evaluated at baseline and 6 weeks. RESULTS: Out of 53 participants allocated to the e-learning program, two completed only the first unit and one did not complete any units, resulting in an overall adherence rate of 94%. Compared with control, the e-learning program improved the MBBQ (MD 8 points, 95% CI 5 to 10) and the Back-PAQ score (MD 3.1 points, 95% CI 1.8 to 4.3). For the imaging beliefs statements, the e-learning program was able to increase the proportion of participants with beliefs aligned with the current evidence (statement 1: RD 38%, 95% CI 21 to 52; statement 2: RD 17%, 95% CI 7 to 29) compared with the control group. CONCLUSION: The e-learning program based on recommendations of clinical practice guidelines for the management of low back pain improved physiotherapists' beliefs about the management of low back pain. REGISTRATION: NCT05661968.
QUESTION: What is the effect of 3 days of preoperative inspiratory muscle training (IMT) on lung function prior to heart valve surgery and on postoperative lung function and pulmonary complications compared with sham and...QUESTION: What is the effect of 3 days of preoperative inspiratory muscle training (IMT) on lung function prior to heart valve surgery and on postoperative lung function and pulmonary complications compared with sham and no IMT? DESIGN: A three-arm, multicentre, randomised controlled trial with concealed allocation, intention-to-treat analysis and blinded assessment of some outcomes. PARTICIPANTS: This study included 228 adults scheduled for heart valve surgery. INTERVENTIONS: The IMT group received 3 days of IMT at 30% maximal inspiratory pressure, the sham IMT group received the same but at 10% maximal inspiratory pressure and the control group received no IMT. OUTCOME MEASURES: Spirometric measures, maximal inspiratory pressure and maximum voluntary ventilation were measured at hospital admission, the day before surgery and at discharge. The incidence of postoperative pulmonary complications (primary outcome) and adverse events were recorded. RESULTS: A total of 215 participants completed surgery as planned and all participants were followed up until discharge. Spirometric measures, maximal inspiratory pressure and maximum voluntary ventilation improved in all groups between admission and the day before surgery, but more so in the IMT group. At discharge, these measures had deteriorated in all groups, but less so in the IMT group. Preoperative IMT reduced the total number of participants experiencing a pulmonary complication in the IMT group compared with the sham IMT group (ARR -0.18, 95% CI -0.33 to -0.03) and compared with the control group (ARR -0.21, 95% CI -0.35 to -0.05). Very few adverse events occurred in all three groups. CONCLUSIONS: Preoperative IMT improved lung function prior to surgery and at hospital discharge and reduced postoperative pulmonary complications in adults undergoing elective heart valve surgery. REGISTRATION: ChiCTR2100054869.