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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 35 - 35
7 Aug 2024
Alotibi FS Hendrick P Moffatt F
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Background. Immersive virtual reality (VR) demonstrates potential benefits in patients with chronic low back pain (CLBP). However, few studies have investigated the feasibility and the acceptability of introducing immersive VR for use with patients with CLBP and in the Kingdom of Saudi Arabia (KSA). Aim. To investigate immersive VR's feasibility, tolerability, and acceptability as a rehabilitation intervention for adult patients with CLBP and explore the views of relevant Health Care Practitioners (HCPs) in the KSA. Methodology and Methods. A multi-centre, mixed-methods, explanatory sequential design was adopted to test immersive VR's feasibility, tolerability, and acceptability. An uncontrolled feasibility trial was conducted. The immersive VR intervention involved a training session followed by three sessions over one week using commercially available hardware and software. Feasibility outcomes were collected from patients immediately post-intervention. Patients and HCPs were recruited for semi-structured interviews. Results. Thirty-three patients and three HCPs were recruited. The feasibility a priori criteria were met for recruitment, retention, dropout, completeness of questionnaire data, treatment compliance and fidelity. Adverse events included one who reported aggravation of tinnitus, whereas two experienced dizziness. Qualitative data suggested that entertainment and motivation were key enablers. Barriers included technological capability and HCPs’ perceptions that immersive VR was time-consuming. Conclusion. The results suggested that immersive VR was feasible, acceptable, and tolerable among patients with CLBP and HCPs in clinical settings in the KSA. Further research focusing on the effectiveness is warranted in this field. Conflicts of Interest. None. Sources of Funding. None. Trial registration number. ISRCTN14434517


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 19 - 19
1 Oct 2019
Hill J Tooth S Cooper V Chen Y Lewis M Wathall S Saunders B Bartlam B Protheroe J Chudyk A Dunn K Foster N
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Background and aims. The Keele STarT Back approach is effective for stratifying patients with low back pain in primary care, but a similar approach has not been tested with a broader range of patients with musculoskeletal (MSK) pain. We report a feasibility and pilot trial examining the feasibility of a future main trial of a primary care based, risk-stratification (STarT MSK) approach for patients with back, neck, knee, shoulder or multi-site pain. Methods. A pragmatic, two-parallel arm, cluster randomised controlled trial (RCT) in 8 GP practices (4 stratified care involving use of the Keele STarT MSK tool and matched treatment options: 4 usual care). Following screening, adults with one of the five most common MSK pain presentations were invited to take part in data collection over 6 months. Feasibility outcomes included exploration of selection bias, recruitment and follow-up rates, clinician engagement with using the Keele STarT MSK tool and matching patients to treatments. Results. 524 participants (231-stratified care, 293-usual care) were recruited (target n=500) over 7 months (target 3 months), with 15-withdrawals (5-intervention, 10-controls). Minimal selection bias was identified between participants/non-participants, or trial arms. The pain-intensity follow-up rate was 88%. Clinicians used the STarT MSK tool in 41% of relevant consultations (judged as ‘partial success’) and adhered to recommended matched treatments in 69% of cases (judged as ‘success’). Conclusions. A future main RCT is feasible, with some amendments in the wording of the tool and the matched treatment options, to determine the clinical and cost-effectiveness of stratified care versus usual care for patients with MSK pain. Conflicts of interest: ‘No conflicts of interest’. Sources of Funding: This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (grant number: RP-PG-1211-20010). Nadine Foster is a NIHR Senior Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 20 - 20
1 Oct 2022
Newton C Singh G O'Neill S Diver C Booth V Logan P O'Sullivan K O'Sullivan P
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Purposes of the study and background

Cognitive Functional Therapy (CFT) is a psychologically informed, physiotherapist-led intervention that targets the biopsychosocial complexity of persistent low back pain (LBP). CFT has demonstrated positive outcomes in two randomised controlled trials (RCT) but has not previously been evaluated in the United Kingdom National Health Service (NHS).

This study aimed to determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care (UPC) for people with persistent LBP in the NHS.

Methods and results

A two-arm parallel feasibility RCT compared CFT with UPC in participants with persistent LBP. Data concerning study processes, resources, management and patient reported outcome measures (disability, pain intensity, quality of life and psychosocial function) were collected at baseline, three and six-month follow-up, analysed and evaluated in order to establish feasibility.

Sixty participants (n=30 CFT and n=30 UPC) were recruited with 71.6% (n=43) retained at six-month follow-up. CFT was delivered to fidelity, relevant and clinically important outcome data were rigorously collected and CFT was tolerated by participants with no safety concerns. The Roland-Morris disability questionnaire was the most suitable primary outcome measure and sample size calculations were completed for a definitive RCT. Intention to treat analysis indicated a signal of effect in favour of CFT with moderate and large between group effect sizes observed across outcome measures at six-month follow-up.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_10 | Pages 8 - 8
1 May 2017
Draper-Rodi J Vogel S Bishop A
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A statement of the purposes of the study and background

The biopsychosocial (BPS) model is recommended for managing non-specific low back pain (NSLBP) but the best method for teaching the BPS model is unclear. E-learning is a promising alternative to face-to-face methods.

This study was a pilot randomised controlled trial (RCT) with embedded interview study to investigate the feasibility of conducting a main RCT and to explore the impact of an BPS for NSLBP e-learning programme on experienced practitioners' attitudes to back pain.

A summary of the methods used and the results

Mixed methods evaluated the impact of an evidence-based e-learning programme on participants' attitudes to back pain. A pilot RCT assessed 45 experienced osteopaths' attitudes before and after the intervention, using the Pain Attitudes and Beliefs Scale (PABS) and the Attitudes to Back Pain Scale (ABS). The qualitative study explored 9 participants' views on the e-learning programme and possible impact on their clinical practice.

91% of participants completed the course and the overall satisfaction was very high. Participants' views on the BPS model ranged between not being structural enough, already done and transformative. The e-learning programme was well accepted. It would be feasible to run a main study using the same recruitment procedures, eligibility criteria, randomisation procedure, consent process, data collection and outcome measures.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 49 - 49
1 Sep 2019
Beemster T van Velzen J van Bennekom C Reneman M Frings-Dresen M
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Purpose

The aim of this study was to explore the usefulness and feasibility of comprehensive vocational rehabilitation (C-VR) and less comprehensive vocational rehabilitation (LC-VR) for workers on sick leave due to CMP, from the perspective of patients, professionals, and managers.

Methods

Semi-structured interviews were held with patients, professionals, and managers. Using topic lists, interviewees were questioned about barriers to and facilitators of the usefulness and feasibility of C-VR and LC-VR. All interviews were transcribed verbatim. Data were analyzed by systematic text condensation using thematic analysis.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 49 - 49
1 Jun 2012
Rout R Mills RJ
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Introduction

It is becoming increasingly more accepted that Patient Reported Outcome Measures (PROMs) should be used to assess surgical interventions. We report on a pilot study of a generic database with complete pre and post-operative data sets in a UK hospital.

Method

19 cases undergoing lumbar surgery in our institution were prospectively reviewed between January and August 2010. Pre and post–operative data assessing pain, back pain specific function, generic health, work disability and patient satisfaction were collected using a core outcome measures index, EuroQol EQ-5D and Oswestry Disability Index (ODI). Details of surgery and assessment of treatment outcome by the operating surgeon was also assessed.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 25 - 25
1 Oct 2019
Saunders B Hill J Foster N Cooper V Protheroe J Chudyk A Chew-Graham C Campbell P Bartlam B
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Background

Improving primary care management of musculoskeletal (MSK) pain is a priority. A pilot cluster RCT tested prognostic stratified care for patients with common MSK pain presentations, including low back pain, in 8 UK general practices (4 stratified care; 4 usual care) with 524 patients. GPs in stratified care practices were asked to use i) the Keele STarT MSK tool for risk-stratification and ii) matched treatment options for patients at low-, medium- and high-risk of persistent pain. A linked qualitative process evaluation explored patients' and GPs' views and experiences of stratified care.

Methods

Individual ‘stimulated-recall’ interviews with patients and GPs in the stratified care arm (n=10 patients; 10 GPs), prompted by consultation-recordings. Data were analysed thematically and mapped onto the COM-B behaviour change model; exploring the Opportunity, Capability and Motivation GPs and patients had to engage with stratified care.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 8 - 8
1 Jan 2012
Hurley D Eadie J Tully M van Mechelen W Boreham C McDonough S Lonsdale C Daly L
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Background and purpose

Sleep disturbance is a prevalent symptom in people with chronic low back pain (CLBP >12 weeks), but there is currently no knowledge of the effectiveness of physiotherapy for this problem. This study evaluated the feasibility of a randomised controlled trial (RCT) exploring the effects of physiotherapy on sleep disturbance in CLBP [Current controlled trial ISRCTN 54009836].

Methods

A sample of 60 consenting patients with CLBP [23 M, 37 F; mean (SD) age = 44.93 (13.41) years] were recruited in Beaumont Hospital, Dublin and randomly allocated to one of three groups [supervised exercise class (SEC), walking programme (WP) and usual physiotherapy (UP)] in a concealed manner. The main outcomes were sleep quality, functional disability, pain, and quality of life at baseline, 3 and 6 months.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 31 - 31
1 Feb 2018
Snidvongs S Taylor R Ahmad A Thomson S Sharma M Fitzsimmons D Poulton S Mehta V Langford R
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Purposes of the study and background

Pain of lumbar facet-joint origin is a common cause of low back pain in adults, and may lead to chronic pain and disability. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain.

The study's objective was to assess the feasibility of carrying out a definitive study to evaluate the clinical- and cost-effectiveness of lumbar facet-joint injections compared to a sham procedure.

Summary of methods and results

This was a blinded parallel two-arm pilot randomised controlled trial. Adult patients referred to the pain and orthopaedic clinics at Barts Health NHS Trust with non-specific low back pain of at least three months' duration were considered for inclusion.

Participants who had a positive result following diagnostic single medial branch nerve blocks were randomised to receive either intra-articular lumbar facet-joint injections with steroid or a sham procedure. All participants were invited to attend a combined physical and psychological programme.

Questionnaires were used to assess a range of pain and disability-related issues. Healthcare utilisation and cost data were also assessed.

Of 628 participants screened for eligibility, 9 were randomised to receive the study intervention and 8 participants completed the study.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 4 - 4
1 Jun 2012
Kanna R Shetty A Rajasekaran S
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Study Design

Prospective analysis of computerised tomogram images of 376 normal pediatric cervical pedicles

Objectives and Summary of Background Data

Although the usage of cervical pedicle screws (CPS) in adults has become established, the feasibility of its application in children has not been studied. There are no in-vivo studies that define the normal pediatric cervical pedicle morphometrics and its changes with growth and development of the child.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 85 - 85
1 Jun 2012
Rajasekaran S Kanna R Shetty A
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Study design. Prospective clinical and radiological analysis of children with complex cervical deformities for the safety of cervical pedicle screw insertion. Objectives. To analyse the possibility, safety and efficacy of cervical pedicle screw insertion in complex pediatric cervical deformities, where conventional stabilisation techniques would not have provided rigid fixation. Summary of Background Data. Although the usage of cervical pedicle screws (CPS) in adults has become established, the feasibility and safety of its application in children has not been described previously in the literature. Methods. Sixteen children of mean age 9.7 ± 2.6 years (range: 3 - 13) requiring spinal stabilization for cranio-vertebral junction anomalies (n=10), cervico-thoracic kyphosis/ kyphoscoliosis (n=5) and cervical tumor excision (n=1) formed the study group. Feasibility of CPS insertion was assessed by computerised tomography images. Standard 3.0 mm titanium pedicle screws were inserted using intraoperative Iso-C C arm based 3 D computer navigation and the containment was post operatively evaluated with CT scan. Results. Based on preoperative CT imaging, 55 pedicles were selected for screw fixation. Intra operatively CPS was successfully inserted at 51 levels and at four sclerosed pedicles (7.3%), screws could not be inserted. At 42 levels, the screws were inserted in the classical description of pedicle screw application and in nine deformed vertebra, the screws were inserted in a non-classical fashion, taking purchase in the three columns of the cervical vertebra. Forty five (88.3%) screws were fully contained, six (11.7 %) had a non-critical breach and none had a critical breach. No perioperative complications related to pedicle screw insertion were noted. Conclusion. Safe insertion of cervical pedicle screws is possible in children. Iso-C navigation provides real time virtual imaging and improves the safety and accuracy of successful pedicle fixation even in altered vertebral anatomy. Pedicle width morphometrics do not restrict screw insertion