Assessing the feasibility of a clinical trial to evaluate an advanced practice physiotherapy model of care in chronic pain management: a feasibility study.

BACKGROUND: Chronic pain management is challenging for health systems worldwide. Clinical practice guidelines recommend interprofessional chronic pain management, but chronic pain clinics often have lengthy wait-lists. Advanced practice physiotherapists (APP) in orthopedic clinics and emergency departments have provided effective care and reduced wait times. The purpose of this study is to determine the feasibility of a clinical trial to evaluate the effects of integrating an APP into a chronic pain clinic setting. The primary objectives are as follows: (1) determine the feasibility of implementing trial methods by evaluating participant recruitment rates, retention, and assessment completion; (2) determine the feasibility of implementing the APP model of care by monitoring care provided and treatment fidelity; and (3) assess contextual factors that may influence implementation of the APP model of care by exploring the perspectives of patient participants and healthcare providers related to the model of care. METHODS: This will be a single-arm feasibility study with embedded qualitative interviews to assess contextual factors influencing implementation by exploring participant and provider perspectives. Approximately 40 adults with chronic musculoskeletal pain referred for care at an interprofessional chronic pain clinic will be invited to participate in the feasibility study. Approximately 10-12 patient participants and 5-10 health professionals from the interprofessional team will be interviewed using an interpretive description approach. The APP model of care will involve participants seeing a physiotherapist as the first point of contact within the interprofessional team. The APP will complete an initial assessment and make care recommendations. Outcome measures planned for the full trial will be reported descriptively, including pain severity, pain interference, health-related quality of life, psychosocial risk factors for chronic pain, treatment satisfaction, perceived change, healthcare utilization, and healthcare costs over one year. DISCUSSION: This study will inform plans to implement a full-scale study to evaluate the impact of an APP model of care in an interprofessional chronic pain management program. The results of the full study are intended to inform stakeholders considering this model to improve patient-centered and health system outcomes in interprofessional pain management program settings. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05336903 (Registered April 5, 2022).

One in four women with stress urinary incontinence who are taught "the knack" maneuver adopt this motor pattern while coughing: A prospective interventional cohort study.

QUESTIONS: Do women with stress urinary incontinence (SUI) who receive instruction to perform the knack maneuver as part of a 12-week pelvic floor muscle training (PFMT) program perform it during voluntary coughing without specific instruction to do so, and are subjective and objective outcomes better among those who do than among those who do not demonstrate the knack during voluntary coughing? DESIGN: Secondary analysis of a prospective interventional cohort. PARTICIPANTS: Women with SUI. INTERVENTION: 12-week PFMT intervention including instruction to perform the knack. OUTCOME MEASURES: Performance of the knack before a voluntary cough as confirmed through ultrasound imaging. SUI severity determined subjectively (International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms [ICIQ-FLUTS] overall score, ICIQ-FLUTS UI subscale score, 3-day bladder diary) and objectively (30-min pad test). RESULTS: Outcome data were available from 69 participants. At baseline, no participants performed the knack when asked to cough. At follow-up, more participants performed the knack during a voluntary cough [18/69 (26%), 95% confidence interval [CI] 15%-35%] than at baseline. The extent of improvement in SUI symptoms was not different between participants who did and did not demonstrate the knack during a voluntary cough [FLUTS-UI subscale score (d = 0.31, 95% CI -0.78 to 2.77, n = 69), FLUTS overall score (d = 0.26, 95% CI -1.52-4.23, n = 69), 30-min pad test (d = 0.03, 95% CI -9.35 to 10.32, n = 69), 3-day bladder diary (d = 0.03, 95% CI -4.07 to 3.60, n = 51)]. CONCLUSION: Approximately one in four women appear to adopt the knack as a motor response to a cough command, however, adopting the knack was not independently associated with greater improvements in SUI.

What improvements in levator ani motor function lead to improvement in stress urinary incontinence signs and symptoms in females?

INTRODUCTION AND HYPOTHESIS: The objectives were to determine whether levator ani muscle (LAM) motor function is associated with female stress urinary incontinence (SUI) severity, and whether changes in LAM motor function induced through pelvic floor muscle training (PFMT) are associated with improvements in SUI signs and symptoms. METHODS: Pelvic morphology and LAM function were evaluated using ultrasound imaging and manual palpation using the elements of the PERFECT Scheme (Power, Endurance, Repetitions, Fast contractions, Elevation, Co-contraction and Timing) before and after women with SUI underwent a 12-week PFMT intervention. SUI severity was determined subjectively (ICIQ-FLUTS-UI) and objectively (30-min pad test [30MPT]). RESULTS: At baseline (n = 97), less leakage on the 30MPT was weakly associated with higher bladder neck position (ρs = -0.209,p = 0.044), yet with lower LAM function based on the PERFECT Scheme (overall score: ρs = 0.206, p = 0.043; repeated maximum voluntary contractions (MVCs): ρs = 0.203, p = 0.046; power/motor control: ρs = 0.214, p = 0.035). Lower symptom severity (ICIQ-FLUTS-UI) was associated with observed perineal lift during coughing (U = 34.000; p = 0.042). All measures of SUI severity and LAM function were significantly improved after PFMT intervention. Greater improvements in bladder neck elevation during MVC (ρs = -0.261, p = 0.027) and greater reductions in levator plate length during MVC (ρs = 0.292, p = 0.016) were weakly associated with greater reductions in leakage (30MPT), the latter also being associated with more improvement symptoms (ICIQ-FLUTS-UI; ρs = 0.238, p = 0.041). Greater improvement in the ability to repeat MVCs (ρs = 0.303, p = 0.009) was weakly associated with smaller improvements in symptoms (ICIQ-FLUTS-UI). CONCLUSION: Improvements in bladder neck support and elevation show weak associations with improvement in SUI signs and symptoms. LAM function as measured by the PERFECT Scheme is not associated with SUI severity in women, and improvements in LAM function when measured by the PERFECT Scheme are not associated with improvements in SUI signs and symptoms.

Pelvic floor muscle training as an adjunct to a midurethral sling: a single-blind randomised controlled trial.

INTRODUCTION AND HYPOTHESIS: This single-blind, randomised controlled trial was aimed at determining whether peri-operative physiotherapist-supervised pelvic floor muscle (PFM) training was superior to standard care (handout) in terms of improvements in stress urinary incontinence (SUI) symptoms, cure rate, and/or post-operative filling or voiding symptoms among women undergoing surgical mid-urethral sling (MUS) insertion for SUI. METHODS: Women with SUI were recruited from surgical wait lists at four participating urogynecology clinics. Participants were assessed at baseline (V1) then randomised (1:1 allocation) to receive supervised PFM training or a handout. Immediately following the 12-week intervention period (V2) and at 12 weeks following surgery (V3) the groups were compared based on the Female Lower Urinary Tract Symptoms (FLUTS) questionnaire total score and urinary incontinence, filling, and voiding subscale scores as well as on a standardised 30-min pad test administered by a blinded assessor. Intention-to-treat analyses were performed. RESULTS: A total of 52 participants were randomised to physiotherapy and 51 to the control group between December 2012 and August 2016. The groups were not different on any outcomes at V1 and all were improved at V3 compared with V1 (p < 0.001). At V3 the physiotherapy group reported significantly fewer UI symptoms (FLUTS UI subscale score) than the control group; yet, there were no group differences in FLUTS overall score or the pad test (p > 0.05). Based on a FLUTS UI subscale score <4, the cure rate at V3 was higher in the intervention group (73%) than in the control group (47%); (2.36 < OR < 3.47, p = 0.012). There were no group differences in cure rate at V3 based on a pad test (p = 0.27). No group differences were found in the filling or voiding symptoms at V3 (p > 0.05). No adverse events were reported. CONCLUSION: Physiotherapist-supervised PFM training improves SUI cure rates associated with surgical MUS insertion when considering symptoms of SUI, but does not improve post-operative continence function as measured by a pad test, nor does it lead to fewer post-operative voiding or filling symptoms.

A model identifying characteristics predictive of successful pelvic floor muscle training outcomes among women with stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to prospectively identify aspects of baseline demographic, clinical, and pelvic morphology of women with stress urinary incontinence (SUI) that are predictive of cure with physiotherapist-supervised pelvic floor muscle training (PFMT). METHODS: Women ≥18 years old with SUI were recruited from urogynecology and pelvic health physiotherapy clinics. Participants completed a 3-day bladder diary, the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), a standardized pad test, manual assessment of pelvic floor muscle (PFM) strength and tone, and transperineal ultrasound (TPUS) assessment of their urogenital structures at rest while in a supine position and standing, and during contraction, straining, and coughing. Participants attended six physiotherapy sessions over 12 weeks and performed a home PFMT program. The assessment was repeated after the intervention; cure was defined as a dry (≤2 g) pad test. RESULTS: Seventy-seven women aged 50 (±10) years completed the protocol; 38 (49%) were deemed cured. Based on univariate testing, four predictors were entered into a binary logistic regression model: ICIQ-UI-SF, PFM tone, bladder neck (BN) height in a quiet standing position, and BN height during a cough in a standing position. The model was significant (p < 0.001), accurately classifying outcome in 74% of participants. The model, validated through bootstrapping, performed moderately, with the area under the receiver operating characteristic curve = 0.80 (95% CI: 0.69-0.90; p = 0.00), and with 70% sensitivity and 75% specificity. CONCLUSIONS: Women with better bladder support in a standing position and less severe symptoms were most likely to be cured with PFMT. CLINICAL TRIAL REGISTRATION: #NCT01602107.

Determining the feasibility of a trial to evaluate the effectiveness of phototherapy versus placebo at reducing pain during physical activity for people with knee osteoarthritis: a pilot randomized controlled trial.

BACKGROUND: Although practice guidelines recommend physical activity and exercise for the management of knee osteoarthritis, pain is a common barrier to participation. Phototherapy has been shown to reduce pain intensity for people with knee osteoarthritis, but it is unclear if it reduces pain during physical activity or contributes to improved rehabilitation outcomes. OBJECTIVE: The aim of this study is to assess the feasibility of performing a fully powered randomized controlled trial (RCT) comparing an active phototherapy intervention versus placebo on pain during physical activity for people with knee osteoarthritis. METHODS: A pilot RCT was conducted to test the feasibility of a trial comparing 8-sessions (4 weeks) of active phototherapy versus placebo. People were able to participate if they (1) were an English speaking adult (> 18 years of age), (2) had received a diagnosis of knee osteoarthritis from a physician, and (3) self-reported experiencing pain and disability related to their knee osteoarthritis for > 3 months. Primary outcomes were the feasibility of participant recruitment, retention, assessment procedures, and maintaining high treatment fidelity. Secondary outcomes piloted for a full trial included pain during physical activity (primary outcome of full trial); self-reported pain severity, physical function, stiffness, adherence to prescribed exercise, global rating of change, patient satisfaction, and adverse events; 6-min walk test; and pressure pain threshold. RESULTS: Twenty participants (4 men; 16 women) with knee osteoarthritis and a mean age of 63.95 (SD: 9.27) years were recruited over a 3-week period (6.7 participants per week). Fifteen out of 20 (75%) of participants completed the primary outcome assessment at 4 weeks and 19/20 (95%) of participants were retained and completed the final 16-week assessment. Overall, 89% of all assessment items were completed by participants across all time-points. Fifteen out of 20 participants (75%) completed all 8 treatment sessions. Treatment fidelity was 100% for all completed treatment sessions. No adverse events were reported by participants in either group. CONCLUSIONS: Results suggest that the trial methodology and intervention are feasible for implementation in a fully powered randomized controlled trial to determine the effectiveness of phototherapy at reducing pain during physical activity for people with knee osteoarthritis. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04234685 , January 21, 2020-Retrospectively registered.

Reliability and validity of a mobile home pelvic floor muscle trainer: The Elvie Trainer.

AIMS: Reliability and validity of force measurement and task detection by the Elvie Trainer were evaluated against an intravaginal dynamometer (IVD) and ultrasound (US) imaging. METHODS: Women were recruited from local physiotherapy clinics. At the first visit, pelvic floor muscle (PFM) strength and tone were assessed manually. Women performed two sets of three repetitions of rest, PFM maximal voluntary contraction (MVC), and maximal Valsalva maneuver (MVM) tasks in supine and standing, with the Elvie Trainer in situ. Women performed another set of rest and MVC repetitions with a custom IVD in situ. At the second visit, PFM strength and tone were reassessed manually. Women performed two sets of three repetitions of the rest, PFM MVC, and MVM tasks in supine and standing, with the Elvie Trainer in situ. Concurrent US imaging was then acquired during a final set of PFM MVC and MVM repetitions in supine and standing, while the Elvie Trainer remained in situ. Reliability was evaluated using intraclass correlation coefficients. Validity was evaluated using Spearman's/Pearson's correlations and receiver operator characteristic curves. RESULTS: Thirty women participated in the study. The Elvie Trainer MVC force outcomes exhibited excellent within-day and good between-day reliability, but were significantly lower than IVD measures, and exhibited poor relationships with IVD force outcomes. The Elvie Trainer was able to specify correct/incorrect performance of a PFM MVC. CONCLUSIONS: The Elvie Trainer exhibits acceptable within-day and between-day reliability and can detect the correct performance of PFM MVCs; however, force measurements are not valid indicators of PFM strength and should not be used to measure outcomes.

The impact of a familiarization session on the magnitude and stability of active and passive pelvic floor muscle forces measured through intravaginal dynamometry.

AIMS: The aim of this study was to investigate the impact of task familiarization on (1) the magnitude and (2) the repeatability of active and passive properties of the female pelvic floor muscles (PFMs) measured using automated intra-vaginal dynamometry. METHODS: Women attended three laboratory sessions at one-week intervals. After receiving initial task instruction and feedback at the start of the first session, standardized instructions were given while women performed maximal effort voluntary contractions of their PFMs with the dynamometer arms open at two different diameters and kept their PFMs relaxed while the dynamometer arms opened to 40 mm at two speeds. Outcomes included baseline force, peak force, relative peak forces (N), rate of force development (N/s) and stiffness. Between session effects were tested for all outcomes using one-way ANOVAs. Intra-class correlation coefficients (ICCs) and minimal detectable change values were computed within each session and between sessions 1 and 2 and sessions 2 and 3. RESULTS: Twenty nulliparous women (mean age = 35 ± 15 years) participated. No differences in the mean values were found across the three visits for any outcomes. Within sessions, neither ICC nor minimal detectable change differed among sessions and between-session ICC values were not different between visits 1 and 2 and visits 2 and 3. CONCLUSIONS: There is no evidence of a familiarization effect over a two-week period on the amplitude nor repeatability of dynamometric measures of active or passive PFM properties recorded from nulliparous women.

Pelvic floor muscle training in women with stress urinary incontinence causes hypertrophy of the urethral sphincters and reduces bladder neck mobility during coughing.

AIMS: The purpose of this study was to determine the effect of a 12-week pelvic floor muscle (PFM) training program on urethral morphology and mobility in women with stress urinary incontinence (SUI). METHODS: Forty women with SUI were randomly assigned to one of two groups: the treatment group received 12 weekly physiotherapy sessions during which they learned how to properly contract their pelvic floor muscles (PFMs) and a home exercise program was prescribed, reviewed, and progressed; the control group received no treatment. Before and after the 12-week study period, ultrasound imaging was used to evaluate bladder neck position and mobility during coughing and Valsalva maneuver in supine and in standing, as well as urethral morphology. Secondary outcome measures included a 3-day bladder diary, 30-min pad test, the Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6). RESULTS: The women in the treatment group demonstrated reduced bladder neck mobility during coughing and increased cross-sectional area of their urethra after as compared to before the training. These changes were not evident in the control group. No differences in the resting position of the bladder neck or in bladder neck excursion during Valsalva maneuver were noted in either group. Concomitantly the women in the treatment group demonstrated significant improvements in the 3-day bladder diary and IIQ-7 after the PFM training and improved significantly more than the control group. CONCLUSION: Physiotherapist-supervised PFM training reduces bladder neck motion during coughing, and results in hypertrophy of the urethral sphincter in women who present with SUI.