Purpose of the Study. To develop an online self-assessment and self-management tool (BACKonLINE™) for discerning between people with characteristics of predominantly centrally (CD) or peripherally (PD) driven LBP. Background. Low back pain (LBP) may worsen with time, making appropriate treatment important. In the NHS Physiotherapy services LBP patients may wait for 14–24 weeks for treatments. Many factors contribute to LBP, but it is predominantly initially viewed as a result of peripheral tissue damage. However, evidence show that persistent LBP is associated with amplification in pain processing in the central nervous system (central sensitisation). Sometimes, this may drive symptoms, resulting in poorer outcomes and requiring longer management. Timely assessment and appropriate management is therefore paramount. Method. Design: 2-round Delphi study. Sample: Purposive sample of international LBP physiotherapy experts. For Round1, series of questions were developed using literature search on characterising clinical features of LBP with predominantly CD or PD pain. Participants were asked to score questions on a 7-point Likert scale on their importance in differentiating between CD and PD pain. Round2, sent to Round1 participants, aimed to reach final consensus on BACKonLINE™. Consensus for both rounds was pre-set at ≥70%. Results. In Round1, 38 experts participated. Out of 55 questions, 33 (60%) reached consensus. Participants added 11 new questions. Round2 included 44 questions and sent to Round1 participants. In Round2, 40 (90.9%) questions reached final consensus. Conclusion. This study displays an agreement among LBP physiotherapy experts on the importance of characterising CD and PD pain. Forty (90.9%) questions reached final consensus and formulated BACKonLINE™. Conflicts of interest. No conflicts of interest. Sources of funding. Civil Service Commission, Kuwait

Aim. To develop a clinical core set of outcome measures that is accepted for relevance, feasibility and validity by stakeholders and useful for a) interaction between patient and professional, b) internal quality improvement, and c) external transparency in patients with NSLBP in primary care physical therapy. Method. We used a consensus-driven modified RAND-UCLA Delphi technique. We conducted seven separate steps with panellists (physical therapists, patient representatives, health insurers) to select accepted outcomes. These seven steps consisted of a literature search, two online surveys, patient interviews, an experts meeting, a consensus meeting and final approval of an advisory board. Results of previous steps were discussed during the consensus meeting, and then panellists voted for inclusion per measure. The final core set was rated on relevance and feasibility on a 9-point Likert scale, when the median was ≥7 the core set was accepted. Results. 34 panellists in two online surveys, five panellists in an expert committee, ten patients for semi-structured interviews and 26 panellists in a consensus meeting participated in the study. 12 outcome measures were rated and discussed and finally six outcome measures were accepted. The final core set was accepted with a median of 7. Conclusion. This study present an outcome set that is accepted by stakeholders as having added value for a) interaction between patient and professional, b) internal quality improvement, and c) external transparency in patients with NSLBP in primary care physical therapy. In a next project this outcome set will be tested on his reliability and feasibility in a large pilot. No conflicts of interest. Sources of funding: Health insurance company CZ, the Netherlands

Background. Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. Objectives. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions. Methods. Three Delphi rounds with 64 experts in placebo research and/or non-pharmacological clinical trials were conducted. The panel was presented with a systematic review and meta-analysis of control and blinding methods. A draft guidance document included 63 consensus items (≥80% agreement) and was discussed with patient partners. Finally, the draft guidance and results from stakeholder interviews were discussed at consensus meetings with Delphi participants and patient representatives. Results. Forty-four experts completed the process. When treatment efficacy or mechanisms are to be studied, the advocated principle is to design control interventions as similar as possible to the tested intervention, apart from the components that the study examines. Structured reasoning in the planning phase, early engagement with stakeholders, feasibility work, and piloting will enhance the quality and acceptability of control interventions. With participant blinding being a primary objective, blinding effectiveness should be routinely assessed and reported. Transparent and detailed reporting will improve interpretability and repeatability of clinical trials. Conclusion. This guideline provides the much-needed standards to enhance the quality of efficacy clinical trials in physical, psychological, and self-management intervention research, ultimately improving patient care. Study registration: . https://osf.io/jmyhq/. Conflict of interest: The authors declare no competing interests. Sources of Funding: Alain and Sheila Diamond Charitable Trust PhD Studentship

Background. Guidelines recommend epidural steroid injections (ESI) for treating severe disc-related sciatica based on trial data showing modest reductions in leg pain, disability and surgery avoidance. Despite their widespread use, there is no clear evidence about which patients are more likely to benefit from ESI. The aim of this study was to generate consensus on potential predictors of outcome following ESI for disc-related sciatica to include in data collection in a future cohort study. Methods. A list of potential predictors of outcome following ESI was generated from existing literature and a consensus meeting with seven experts. Items were subsequently presented in a two-round on-line modified Delphi study to generate consensus among experts on which items are agreed as potential predictors of outcome from ESI (consensus defined as 70% agreement with ranking of remaining items). Results. An initial list of 53 items was generated and 90 experts were invited from seven countries to participate in the on-line Delphi study. Response rates were 48% (n=44) and 73% (n=33) for round 1 and 2 respectively. Twenty-eight additional items suggested by participants in round 1 were included in round 2. Of the 81 items, 14 reached consensus; across domains of medication use, previous surgery, pain intensity, psychosocial factors, imaging findings and type of injection. Highest ranked of remaining items included work-related and clinical assessment items. Conclusion. Based on expert consensus, items that can be routinely collected in clinical practice were identified as potential predictors of outcomes following ESI. These will be tested in a future multicentre cohort study. Conflicts of interest: No conflicts of interest. Sources of funding: This study is supported by Health Education England and the National Institute for Health Research (HEE/ NIHR ICA Programme Clinical Lectureship, Dr Siobhan Stynes, NIHR300441). The views expressed are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care

Background and purpose:. Inconsistent outcome reporting is a problematic issue in systematic reviews of clinical trials in non-specific LBP (NSLBP). To facilitate statistical pooling and improve reliability of reviews, the development of a core outcome set (COS) is recommended. In 1998, Deyo et al. proposed a standardized set of domains and measurement instruments for LBP clinical research. An international steering committee (ISC) was formed to update 1998 recommendations, and to determine, at first, which outcome domains should be included in a COS for clinical trials in NSLBP. Methods:. The ISC used the OMERACT framework 2.0 to draw a list of potential core domains. This list was presented in a 3-round Delphi survey, in which researchers, clinicians and patients were invited to participate. Criteria for consensus were established a-priori and quantitative responses were analysed together with arguments provided by Delphi participants. The ISC discussed the results and made final decisions. Results:. 280 ‘experts’ were selected and invited to participate in the Delphi survey. Response rates in the three rounds were: 52%, 50%, and 45%. A list of 41 potential core domains was presented but 28 of them did not reach sufficient consensus to be presented in the third round, where overall consensus was reached on three domains: ‘physical functioning’, ‘pain intensity’ and ‘health-related quality of life’. Conclusion:. ‘Physical functioning’, ‘pain intensity’ and ‘health-related quality of life’ were included in this COS, together with the reporting on ‘number of deaths’. The next step in the development of this COS will be to determine which measurement instruments are most fit-for-purpose to measure these outcome domains

Background & purpose. Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains. Methods & Results. The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL. Conclusion. A core outcome measurement set is available for clinical trials in patients with nsLBP. High quality clinimetric studies directly comparing recommended and not recommended instruments are required. Conflict of interest: None. Source of funding: EUROSPINE, The Spine Society of Europe

Purpose of the study and background. The preliminary study aimed to establish clinical and research expert opinion with regards to the key components of an assessment of a person with Mechanical Low Back Pain (MLBP). We aimed to identify the key subjective questions and objective tests which would be helpful for clinicians to develop the most appropriate self-management exercise programme. This is the first part of the study to develop the ‘Back-to-Fit’ digital tool offering personalised self-management exercise solutions for people with MLBP. Summary of the methods. A Bristol online survey which included a questionnaire with a series of open and closed questions was developed using the literature and was distributed among clinicians/researchers with a background in the clinical management of MLBP. The questionnaire included 6 demographic questions followed by sections related to subjective questions and objective tests of the MLBP assessment. 71 participants responded to the survey. Results. In the subjective assessment component, ≥80% level of agreement was obtained for 17 of 26 proposed subjective questions and 05 of the 21 suggested objective tests. Two more questions and two objective tests to be included in the assessment had been suggested by the partcipants. Conclusion. These expert agreements on questions and opinions provides an indication of the key subjective and objective components to be included in a self-assessment tool in a personalised self-management platform for MLBP. Further testing with a multiple round Delphi study in a large sample of experts is now required to obtain consensus for the above findings. Conflicts of interest: No conflicts of interest. Sources of funding: Biomechanics and Bioengineering Research Centre Versus Arthritis, Cardiff University, UK

Purpose of the Study. To assess the test-retest reliability, construct validity and determine the cut-off scoret of BACKonLINE™ for people with LBP. Background. Appropriate treatment for Low back pain (LBP) is vital, however patients can wait for 14–24 weeks on NHS Physiotherapy lists. Many factors contribute to LBP and initially can be due to peripheral tissue damage. However, persistent LBP is associated with amplification in pain processing in the central nervous system (central sensitisation-CS). CS often results in poorer outcomes and often requires longer management making timely assessment and appropriate management crucial. An online self-assessment and self-management tool (BACKonLINE™) for discerning between characteristics of predominantly centrally (CD) or peripherally (PD) driven LBP was developed using a Delphi study. Method. Same subject, test-retest reliability and construct validity study (two sessions). Sample of 35 volunteers with LBP. In session 1, participants completed BACKonLINE™ and validated questionnaires (Oswestry Disability Index, StartBack, Tampa scale for Kinesiophobia, Pain Anxiety Symptom Scale Short Form 20). Participants repeated the process one week later. BACKonLINE's Cut-off score was determined by plotting results against StartBack using ROC curve analysis. Results. BACKonLINE™ showed excellent test-retest reliability (ICC= 0.913; 95%CI=0.832–0.956). When assessing construct validity, the aforementioned questionnaires demonstrated moderate correlation with BACKonLINE™ (Pearson's r range= 0.42–0.67, p-value<0.005). ROC analysis determined that scores higher than 42 in BACKonLINE™ indicate CD LBP while scores ≤42 indicate PD LBP. Conclusion. The study shows that BACKonLINE™ has excellent test-retest reliability, and good construct validity within a LBP population. However, further studies with larger sample sizes should be conducted before the implementation of BACKonLINE™. Conflicts of interest: No conflicts of interest. Sources of funding: Civil Service Commission, Kuwait