Self-management advice, exercise and foot orthoses for plantar heel pain: the TREADON pilot and feasibility randomised trial.

BACKGROUND: Plantar heel pain (PHP) is common and impacts negatively on physical function and quality of life. Initial treatment usually comprises analgesia and self-management advice (SMA), with referral to a physiotherapist or podiatrist recommended only when symptoms persist. Systematic reviews highlight limitations of existing evidence for the effectiveness of exercises and orthoses. The objective of the TREADON pilot and feasibility trial was to inform the design of a future main trial to compare the clinical and cost-effectiveness of self-management advice (SMA), individualised exercises and foot orthoses for PHP. METHODS: This was a four-arm randomised feasibility and pilot trial with 12-week follow-up. Adults aged ≥ 18 years with PHP were identified from primary care by general practice consultation, retrospective general practice medical record review or a population survey. Participants were randomised to either (i) SMA, (ii) SMA plus individualised exercises (SMA-exercises), (iii) SMA plus prefabricated foot orthoses (SMA-orthoses) or (iv) SMA plus combined individualised exercises and prefabricated foot orthoses (SMA-combined). Feasibility outcomes were recruitment; retention; intervention adherence, credibility and satisfaction; performance of three potential primary outcome measures (pain numeric rating scale (NRS), Foot Function Index-pain subscale (FFI-pain), Manchester Foot Pain and Disability Index-pain subscale (MFPDI-pain)); and parameters for informing the main trial sample size calculation. RESULTS: Eighty-two participants were recruited. All three identification methods met the target number of participants. Retention at 12 weeks was 67%. All interventions were successfully delivered as per protocol. Adherence (range over 12 weeks 64-100%) and credibility (93%) were highest in the SMA-combined arm. Satisfaction with treatment was higher for the three clinician-supported interventions (SMA 29%, SMA-exercises 72%, SMA-orthoses 71%, SMA-combined 73%). Responsiveness (baseline to 12 weeks) was higher for FFI-pain (standardised response mean 0.96) and pain NRS (1.04) than MFPDI-pain (0.57). Conservative sample size parameter estimates for standard deviation were pain NRS 2.5, FFI-pain 25 and MFPDI-pain 4, and baseline-outcome correlations were 0.5-0.6, 0.4 and < 0.3, respectively. CONCLUSIONS: We demonstrated the feasibility of conducting a future main randomised clinical trial comparing the clinical and cost-effectiveness of SMA, exercises and/or foot orthoses for PHP. TRIAL REGISTRATION NUMBER: ISRCTN 12160508 . Prospectively registered 5th July 2016.

Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial.

BACKGROUND: Brace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients' clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists. METHODS AND ANALYSIS: A multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions. ETHICS AND DISSEMINATION: North West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN28555470.

How Do Physical Therapists in the United Kingdom Manage Patients With Hip Osteoarthritis? Results of a Cross-Sectional Survey.

Background: Hip osteoarthritis (OA) is common, painful, and disabling. Physical therapists have an important role in managing patients with hip OA; however, little is known about their current management approach and whether it aligns with clinical guideline recommendations. Objective: The objective of this study is to describe United Kingdom (UK) physical therapists' current management of patients with hip OA and to determine whether it aligns with clinical guidelines. Design: The design is a cross-section questionnaire. Methods: A questionnaire was mailed to 3126 physical therapists in the UK that explored physical therapists' self-reported management of a patient with hip OA using a case vignette and clinical management questions. Results: The response rate was 52.7% (n = 1646). In total, 1148 (69.7%) physical therapists had treated a patient with hip OA in the last 6 months and were included in the analyses. A treatment package was commonly provided incorporating advice, exercise (strength training 95.9%; general physical activity 85.4%), and other nonpharmacological modalities, predominantly manual therapy (69.6%), and gait retraining (66.4%). There were some differences in reported management between physical therapists based in the National Health Service (NHS) and non-NHS-based physical therapists, including fewer treatment sessions being provided by NHS-based therapists. Limitations: Limitations include the potential for nonresponder bias and, in clinical practice, physical therapists may manage patients with hip OA differently. Conclusion: UK-based physical therapists commonly provide a package of care for patients with hip OA that is broadly in line with current clinical guidelines, including advice, exercise, and other nonpharmacological treatments. There were some differences in clinical practice between NHS and non-NHS-based physical therapists, but whether these differences impact on clinical outcomes remains unknown.

High-resolution MRI assessment of dactylitis in psoriatic arthritis shows flexor tendon pulley and sheath-related enthesitis.

OBJECTIVE: Dactylitis is a hallmark of psoriatic arthritis (PsA) where flexor tenosynovitis is common. This study explored the microanatomical basis of dactylitis using high-resolution MRI (hrMRI) to visualise the small entheses around the digits. METHODS: Twelve patients with psoriatic dactylitis (4 fingers, 8 toes), and 10 healthy volunteers (6 fingers, 4 toes) had hrMRI of the digits using a 'microscopy' coil and contrast enhancement. All structures were evaluated including the tendons and ligaments, related enthesis organs, pulleys, volar/plantar plates and tendon sheaths. RESULTS: In dactylitis, collateral ligament enthesitis was seen in nine digits (75%), extensor tendon enthesitis in six digits (50%), functional enthesitis (5 digits, 42%), abnormal enhancement at the volar plates (2/5 joints, 40%) and the plantar plate (1/5 joints, 20%). Nine cases (75%) demonstrated flexor tenosynovitis, with flexor tendon pulley/flexor sheath microenthesopathy observed in 50% of all cases. Less abnormalities which were milder was observed in the normal controls, none of whom had any signal changes in the tendon pulleys or fibrous sheaths. CONCLUSIONS: This study provides proof of concept for a link between dactylitis and 'digital polyenthesitis' including disease of the miniature enthesis pulleys of the flexor tendons, further affirming the concept of enthesitis in PsA.

The microanatomic basis of finger clubbing - a high-resolution magnetic resonance imaging study.

OBJECTIVE: Hypervascularization in finger clubbing is recognized, but its microanatomical basis remains unclear. This pilot descriptive study used magnetic resonance imaging (MRI) to explore this further. METHODS: High-resolution MRI acquired with contrast agent was carried out in 4 patients with finger clubbing and 4 healthy volunteers. The anatomy of the nail bed, capsular structures, and bony changes were described. RESULTS: Marked nail bed thickening and contrast enhancement was noted in all clubbed fingers, with bone edema in 3 of the 4 patients. None of the healthy subjects had similar abnormalities. CONCLUSION: This confirms that hypervascularization of the nail bed observed in the microanatomy on high-resolution MRI is associated with clubbed appearances of the nails.

Detection of pH in microemulsions, without a probe molecule, using magnetic resonance.

Proton NMR relaxation times have been used to probe the pH of water inside reverse micelles of a cetyltrimethylammonium bromide (CTAB)-hexanol-aq microemulsion. T(2) relaxation times were found to change with pH; however, T(1) relaxation times remained unaffected. This behavior was attributed to acid-catalyzed exchange between protons of water and hydroxyl protons of the cosurfactant hexanol. The rate of exchange and its influence on the T(2) relaxation time of water, inside the reverse micelle, were investigated as a function of water-to-surfactant ratio (ω(0)) and ionic strength. This exchange behavior and pH-dependent T(2) relaxation time were also observed for two other microemulsions--CTAB-hexane-pentanol-aq and Triton X-100-cyclohexane-hexanol-aq. Using this pH-dependent T(2) relaxation time, it was possible to monitor pH changes in the bromate-sulfite reaction inside a CTAB-hexanol-aq microemulsion.