scholarly journals Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

2019 ◽  
Author(s):  
Deirdre Hurley ◽  
Isabelle Jeffares ◽  
Amanda M Hall ◽  
Alison Keogh ◽  
Elaine Toomey ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Complex Intervention ◽  
Qualitative Interviews ◽  
Self Management ◽  
Low Back ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background The Self-management of Osteoarthritis (OA) and Low back pain (LBP) through Activity and Skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. Results 14 clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (Intervention: mean (SD) =4.92 (1.31), range 2-7; UP: mean (SD) =5.08 (2.43), range 1-9). 120 participants (83.3% of n=144 expected) were recruited (Intervention n=59; UP n=61), with follow up data obtained from 80.8% (n=97) at 6 weeks, 84.2% (n=101) at 2 months and 71.7% (n=86) at 6 months. Most participants received treatment as allocated (Intervention n=49; UP n=54). The qualitative interviews (12 participants; 10 PTs) found the Intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between group effects. Conclusions While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. Trial Registration: ISRCTN Registry, ISRCTN49875385, Registered 26 March 2014. https://doi.org/10.1186/ISRCTN49875385

scholarly journals Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Deirdre A. Hurley ◽  
Isabelle Jeffares ◽  
Amanda M. Hall ◽  
Alison Keogh ◽  
Elaine Toomey ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Complex Intervention ◽  
Qualitative Interviews ◽  
Self Management ◽  
Low Back ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background The self-management of osteoarthritis (OA) and low back pain (LBP) through activity and skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland, between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. Results Fourteen clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (intervention: mean (SD) = 4.92 (1.31), range 2–7; UP: mean (SD) = 5.08 (2.43), range 1–9). One hundred twenty participants (83.3% of n = 144 expected) were recruited (intervention n = 59; UP n = 61), with follow-up data obtained from 80.8% (n = 97) at 6 weeks, 84.2% (n = 101) at 2 months and 71.7% (n = 86) at 6 months. Most participants received treatment as allocated (intervention n = 49; UP n = 54). The qualitative interviews (12 participants; 10 physiotherapists (PTs) found the intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between-group effects. Conclusions While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. Trial registration ISRCTN ISRCTN49875385. Registered on 26 March 2014.

scholarly journals Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

2020 ◽  
Author(s):  
Deirdre Hurley ◽  
Isabelle Jeffares ◽  
Amanda M Hall ◽  
Alison Keogh ◽  
Elaine Toomey ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Complex Intervention ◽  
Qualitative Interviews ◽  
Self Management ◽  
Low Back ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background The Self-management of Osteoarthritis (OA) and Low back pain (LBP) through Activity and Skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. Results 14 clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (Intervention: mean (SD) =4.92 (1.31), range 2-7; UP: mean (SD) =5.08 (2.43), range 1-9). 120 participants (83.3% of n=144 expected) were recruited (Intervention n=59; UP n=61), with follow up data obtained from 80.8% (n=97) at 6 weeks, 84.2% (n=101) at 2 months and 71.7% (n=86) at 6 months. Most participants received treatment as allocated (Intervention n=49; UP n=54). The qualitative interviews (12 participants; 10 PTs) found the Intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between group effects. Conclusions While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. Trial Registration: ISRCTN Registry, ISRCTN49875385, Registered 26 March 2014. https://doi.org/10.1186/ISRCTN49875385

scholarly journals Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

2020 ◽  
Author(s):  
Deirdre Hurley ◽  
Isabelle Jeffares ◽  
Amanda M Hall ◽  
Alison Keogh ◽  
Elaine Toomey ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Complex Intervention ◽  
Qualitative Interviews ◽  
Self Management ◽  
Low Back ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background The Self-management of Osteoarthritis (OA) and Low back pain (LBP) through Activity and Skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. Results 14 clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (Intervention: mean (SD) =4.92 (1.31), range 2-7; UP: mean (SD) =5.08 (2.43), range 1-9). 120 participants (83.3% of n=144 expected) were recruited (Intervention n=59; UP n=61), with follow up data obtained from 80.8% (n=97) at 6 weeks, 84.2% (n=101) at 2 months and 71.7% (n=86) at 6 months. Most participants received treatment as allocated (Intervention n=49; UP n=54). The qualitative interviews (12 participants; 10 PTs) found the Intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between group effects. Conclusions While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. Trial Registration: ISRCTN Registry, ISRCTN49875385, Registered 26 March 2014. https://doi.org/10.1186/ISRCTN49875385

scholarly journals Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

2019 ◽  
Author(s):  
Deirdre Hurley ◽  
Isabelle Jeffares ◽  
Amanda M Hall ◽  
Alison Keogh ◽  
Elaine Toomey ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Complex Intervention ◽  
Qualitative Interviews ◽  
Self Management ◽  
Low Back ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background The Self-management of Osteoarthritis (OA) and Low back pain (LBP) through Activity and Skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. Results 14 clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (Intervention: mean (SD) =4.92 (1.31), range 2-7; UP: mean (SD) =5.08 (2.43), range 1-9). 120 participants (83.3% of n=144 expected) were recruited (Intervention n=59; UP n=61), with follow up data obtained from 80.8% (n=97) at 6 weeks, 84.2% (n=101) at 2 months and 71.7% (n=86) at 6 months. Most participants received treatment as allocated (Intervention n=49; UP n=54). The qualitative interviews (12 participants; 10 PTs) found the Intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between group effects. Conclusions While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. Trial Registration: ISRCTN Registry, ISRCTN49875385, Registered 26 March 2014. https://doi.org/10.1186/ISRCTN49875385

scholarly journals Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

2020 ◽  
Author(s):  
Deirdre Hurley ◽  
Isabelle Jeffares ◽  
Amanda M Hall ◽  
Alison Keogh ◽  
Elaine Toomey ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Complex Intervention ◽  
Qualitative Interviews ◽  
Self Management ◽  
Low Back ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background: The Self-management of Osteoarthritis (OA) and Low back pain (LBP) through Activity and Skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods: This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. Results: 14 clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (Intervention: mean (SD) =4.92 (1.31), range 2-7; UP: mean (SD) =5.08 (2.43), range 1-9). 120 participants (83.3% of n=144 expected) were recruited (Intervention n=59; UP n=61), with follow up data obtained from 80.8% (n=97) at 6 weeks, 84.2% (n=101) at 2 months and 71.7% (n=86) at 6 months. Most participants received treatment as allocated (Intervention n=49; UP n=54). The qualitative interviews (12 participants; 10 PTs) found the Intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between group effects.Conclusions: While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial.Trial Registration: ISRCTN Registry, ISRCTN49875385, Registered 26 March 2014. https://doi.org/10.1186/ISRCTN49875385

scholarly journals Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

2020 ◽  
Author(s):  
Deirdre Hurley ◽  
Isabelle Jeffares ◽  
Amanda M Hall ◽  
Alison Keogh ◽  
Elaine Toomey ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Complex Intervention ◽  
Qualitative Interviews ◽  
Self Management ◽  
Low Back ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background The Self-management of Osteoarthritis (OA) and Low back pain (LBP) through Activity and Skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. Results 14 clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (Intervention: mean (SD) =4.92 (1.31), range 2-7; UP: mean (SD) =5.08 (2.43), range 1-9). 120 participants (83.3% of n=144 expected) were recruited (Intervention n=59; UP n=61), with follow up data obtained from 80.8% (n=97) at 6 weeks, 84.2% (n=101) at 2 months and 71.7% (n=86) at 6 months. Most participants received treatment as allocated (Intervention n=49; UP n=54). The qualitative interviews (12 participants; 10 PTs) found the Intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between group effects. Conclusions While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. Trial Registration: ISRCTN Registry, ISRCTN49875385, Registered 26 March 2014. https://doi.org/10.1186/ISRCTN49875385

scholarly journals Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e040543
Author(s):  
Adam W A Geraghty ◽  
Lisa Roberts ◽  
Jonathan Hill ◽  
Nadine E Foster ◽  
Lucy Yardley ◽  
...  
Keyword(s):  
Primary Care ◽  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Internet Intervention ◽  
Self Management ◽  
Low Back ◽  
Telephone Support ◽  
Randomised Controlled

IntroductionSelf-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.Methods and analysisA three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.Ethics and disseminationThis trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.Trial registration numberISRCTN14736486.

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