scholarly journals Independent prescribing by advanced physiotherapists for patients with low back pain in primary care: protocol for a feasibility trial with an embedded qualitative component

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e027745 ◽  
Author(s):  
Timothy David Noblet ◽  
John F Marriott ◽  
Alison B Rushton

IntroductionLow back pain (LBP) is the most prevalent musculoskeletal condition in the UK. Guidelines advocate a multimodal approach, including prescription of medications. Advanced physiotherapy practitioners (APPs) are well placed to provide this care in primary care. Physiotherapist independent prescribing remains novel, with the first prescribers qualifying in 2014. This feasibility trial aims to evaluate the feasibility, suitability and acceptability of assessing the effectiveness of independent prescribing by APPs for patients with LBP in primary care, to inform the design of a future definitive stepped-wedged cluster trial.Method and analysis(1) Trial component. An APP (registered prescriber) will complete the initial participant consultation. If prescription drugs are required within the multimodal physiotherapeutic context, these will be prescribed. Patient-reported outcome measures will be completed prior to initial assessment and at 6 and 12 weeks to assess feasibility of follow-up and data collection procedures. Accelerometers will be fitted for 7 days to assess physical activity, sedentary behaviour and feasibility of use. (2) Embedded qualitative component. A focus group and semistructured interviews will be used to evaluate the views and experiences of the participants and APPs respectively, about the feasibility, suitability and acceptability of the proposed full trial. A Consolidated Standards of Reporting Trials diagram will be used to analyse feasible eligibility, recruitment and follow-up rates. Descriptive analysis of the data will be completed to evaluate procedures. Thematic analysis will be used to analyse and synthesise the qualitative data.Ethics and disseminationThis feasibility trial is approved by the Health Research Authority (HRA). Ethical approval was sought and granted via the Integrated Research Application System (IRAS) ID 250734.Data will be disseminated via publication in peer reviewed journal and conference presentation. It is anticipated that the results of this study will be used in conjunction with ethical evaluation, economic and risk analyses, as well as consultation with key stakeholders including the British health consumer when contemplating change, enhancement or redesign of the essential full randomised controlled trial.Trial registration numberISRCTN15516596, Pre-results.

PLoS ONE ◽  
2020 ◽  
Vol 15 (3) ◽  
pp. e0229792 ◽  
Author(s):  
Tim Noblet ◽  
John Marriott ◽  
Amanda Hensman-Crook ◽  
Simon O’Shea ◽  
Sarah Friel ◽  
...  

2013 ◽  
Vol 93 (12) ◽  
pp. 1603-1614 ◽  
Author(s):  
Karin Verkerk ◽  
Pim A.J. Luijsterburg ◽  
Martijn W. Heymans ◽  
Inge Ronchetti ◽  
Annelies L. Pool-Goudzwaard ◽  
...  

Background Few data are available on the course of and predictors for disability in patients with chronic nonspecific low back pain (CNSLBP). Objective The purpose of this study was to describe the course of disability and identify clinically important prognostic factors of low-back-pain–specific disability in patients with CNSLBP receiving multidisciplinary therapy. Design A prospective cohort study was conducted. Methods A total of 1,760 patients with CNSLBP who received multidisciplinary therapy were evaluated for their course of disability and prognostic factors at baseline and at 2-, 5-, and 12-month follow-ups. Recovery was defined as 30% reduction in low back pain–specific disability at follow-up compared with baseline and as absolute recovery if the score on the Quebec Back Pain Disability Scale (QBPDS) was ≤20 points at follow-up. Potential prognostic factors were identified using multivariable logistic regression analysis. Results Mean patient-reported disability scores on the QBPDS ranged from 51.7 (SD=15.6) at baseline to 31.7 (SD=15.2), 31.1 (SD=18.2), and 29.1 (SD=20.0) at 2, 5, and 12 months, respectively. The prognostic factors identified for recovery at 5 and 12 months were younger age and high scores on disability and on the 36-Item Short-Form Health Survey (SF-36) (Physical and Mental Component Summaries) at baseline. In addition, at 5-month follow-up, a shorter duration of complaints was a positive predictor, and having no comorbidity and less pain at baseline were additional predictors at 12-month follow-up. Limitations Missing values at 5- and 12-month follow-ups were 11.1% and 45.2%, respectively. Conclusion After multidisciplinary treatment, the course of disability in patients with CNSLBP continued to decline over a 12-month period. At 5- and 12-month follow-ups, prognostic factors were identified for a clinically relevant decrease in disability scores on the QBPDS.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
A. M. Garratt ◽  
H. Furunes ◽  
C. Hellum ◽  
T. Solberg ◽  
J. I. Brox ◽  
...  

Abstract Background The EuroQol EQ-5D is one of the most widely researched and applied patient-reported outcome measures worldwide. The original EQ-5D-3L and more recent EQ-5D-5L include three and five response categories respectively. Evidence from healthy and sick populations shows that the additional two response categories improve measurement properties but there has not been a concurrent comparison of the two versions in patients with low back pain (LBP). Methods LBP patients taking part in a multicenter randomized controlled trial of lumbar total disc replacement and conservative treatment completed the EQ-5D-3L and 5L in an eight-year follow-up questionnaire. The 3L and 5L were assessed for aspects of data quality including missing data, floor and ceiling effects, response consistency, and based on a priori hypotheses, associations with the Oswestry Disability Index (ODI), Pain-Visual Analogue Scales and Hopkins Symptom Checklist (HSCL-25). Results At the eight-year follow-up, 151 (87%) patients were available and 146 completed both the 3L and 5L. Levels of missing data were the same for the two versions. Compared to the EQ-5D-5L, the 3L had significantly higher floor (pain discomfort) and ceiling effects (mobility, self-care, pain/discomfort, anxiety/depression). For these patients the EQ-5D-5L described 73 health states compared to 28 for the 3L. Shannon’s indices showed the 5L outperformed the 3L in tests of classification efficiency. Correlations with the ODI, Pain-VAS and HSCL-25 were largely as hypothesized, the 5L having slightly higher correlations than the 3L. Conclusion The EQ-5D assesses important aspect of health in LBP patients and the 5L improves upon the 3L in this respect. The EQ-5D-5L is recommended in preference to the 3L version, however, further testing in other back pain populations together with additional measurement properties, including responsiveness to change, is recommended. Trial registration: retrospectively registered: https://clinicaltrials.gov/ct2/show/NCT01704677.


2016 ◽  
Vol 25 (4) ◽  
pp. 1234-1241 ◽  
Author(s):  
Evelien I. T. de Schepper ◽  
Bart W. Koes ◽  
Edwin H. G. Oei ◽  
Sita M. A. Bierma-Zeinstra ◽  
Pim A. J. Luijsterburg

Pain Medicine ◽  
2020 ◽  
Vol 21 (10) ◽  
pp. 2061-2070
Author(s):  
Kasper Ussing ◽  
Per Kjaer ◽  
Anne Smith ◽  
Peter Kent ◽  
Rikke K Jensen ◽  
...  

Abstract Background Effective, inexpensive, and low-risk interventions are needed for patients with nonspecific persistent low back pain (NS-PLBP) who are unresponsive to primary care interventions. Cognitive functional therapy (CFT) is a multidimensional behavioral self-management approach that has demonstrated promising results in primary care and has not been tested in secondary care. Objective To investigate the effect of CFT and compare it with usual care for patients with NS-PLBP. Design Case–control study. Setting A secondary care spine center. Subjects Thirty-nine patients received a CFT intervention and were matched using propensity scoring to 185 control patients receiving usual care. Methods The primary outcome was Roland Morris Disability Questionnaire (0–100 scale) score. Group-level differences at six- and 12-month follow-up were estimated using mixed-effects linear regression. Results At six-month follow-up, a statistically significant and clinically relevant difference in disability favored the CFT group (–20.7, 95% confidence interval [CI] = –27.2 to –14.2, P < 0.001). Significant differences also occurred for LBP and leg pain, fear, anxiety, and catastrophizing in favor of CFT. At 12-month follow-up, the difference in disability was smaller and no longer statistically significant (–8.1, 95% CI = –17.4 to 1.2, P = 0.086). Differences in leg pain intensity and fear remained significantly in favor of CFT. Treatment satisfaction was significantly higher in the CFT group at six- (93% vs 66%) and 12-month (84% vs 52%) follow-up. Conclusions These findings support that CFT is beneficial for patients with NS-PLBP who are unresponsive to primary care interventions. Subsequent randomized controlled trials could incorporate booster sessions, which may result in larger effects at 12-month follow-up.


2021 ◽  
Author(s):  
AM Garratt ◽  
Håvard Furunes ◽  
Christian Hellum ◽  
Tore Solberg ◽  
Jens Ivar Brox ◽  
...  

Abstract Background: The EuroQol EQ-5D is the most widely researched and applied patient-reported outcome measure worldwide. The original EQ-5D-3L and more recent EQ-5D-5L include three and five response categories respectively. Evidence from healthy and sick populations shows that the additional two response categories improve measurement properties but there has not been a concurrent comparison of the two versions in patients with low back pain (LBP). Methods: LBP patients taking part in a multicenter randomized controlled trial of lumbar total disc replacement and conservative treatment completed the EQ-5D-3L and 5L in an eight-year follow-up questionnaire. The 3L and 5L were assessed for aspects of data quality including missing data, floor and ceiling effects, response consistency, and based on a priori hypotheses, associations with the Oswestry Disability Index (ODI), Pain-Visual Analogue Scales and Hopkins Symptom Checklist (HSCL-25). Results: At the eight-year follow-up, 151 (87%) patients were available and 146 completed both the 3L and 5L. Levels of missing data were the same for the two versions. Compared to the EQ-5D-5L, the 3L had significantly higher floor (pain discomfort) and ceiling effects (mobility, self-care, pain/discomfort, anxiety/depression). For these patients the EQ-5D-5L described 73 health states compared to 28 for the 3L. Shannon’s indices also showed the 5L outperformed the 3L in tests of classification efficiency. Correlations with the ODI, Pain-VAS and HSCL-25 were largely as hypothesized, the 5L having slightly higher correlations than the 3L. In a multivariate regression analysis, ODI, Pain-VAS and HSCL-25 scores explained 13% more variation in EQ-5D-5L scores compared to 3L scores. Conclusion: The EQ-5D assesses important aspect of health in LBP patients and the 5L improves upon the 3L in this respect. The EQ-5D-5L is recommended in preference to the 3L version, however, further testing in other back pain populations together with additional measurement properties, including responsiveness to change, is recommended. Trial Registration: retrospectively registered: https://clinicaltrials.gov/ct2/show/NCT01704677.


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