Background and Aim of Study

Despite several hundred RCTs of exercise for persistent non-specific low back pain (NSLBP), the treatment targets of exercise are unclear. In a systematic review we observed 30 direct and indirect treatment targets of exercise described across 23 RCTs for persistent NSLBP. Since not all treatment targets and outcomes can be assessed in all RCTs, it is therefore important to prioritise these treatment targets through consensus from key stakeholders. These consensus workshops aimed to agree treatment targets for the use of exercise interventions in randomised controlled trials (RCTs) in persistent NSLBP using nominal group workshop (NGW) methodology.

Funding

This report presents independent research commissioned by the National Institute for Health Research (NIHR) (NIHR HTA project number 12/201/09). NEF is a Senior NIHR Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). KK was supported by a HEFCE Senior Clinical Lectureship award. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the Health Technology Assessment programme or the Department of Health.

Background and Purpose

Healthcare for sciatica is usually ‘stepped’ with initial advice and analgesia, then physiotherapy, then more invasive interventions if symptoms continue. The SCOPiC trial tested a stratified care algorithm combining prognostic and clinical characteristics to allocate patients into one of three groups, with matched care pathways, and compared the effectiveness of stratified care (SC) with non-stratified, usual care (UC).

Background

Complex interventions, such as exercise for LBP, often have many treatment targets. Matching a primary outcome to the target(s) of exercise interventions may provide greater standardized mean differences (SMDs) than using an unmatched primary outcome. We aimed to explore whether the conclusions of exercise trials for LBP might differ with i) improved matching of outcomes to treatment targets and ii) the use of composite outcome measures.

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.

Background

Exercise is a complex intervention, and often has more than one treatment target. Results from randomised controlled trials (RCTs) of exercise interventions for chronic low back pain (CLBP) typically show small to moderate effect sizes, but these may differ where outcomes better reflect the targets of interventions. This review aimed to describe what treatment targets, outcome domains and primary outcome measures are used in exercise RCTs, and examined how well the selected outcome domains match the treatment targets used in each RCT.

Introduction

Early intervention is advocated to prevent long-term work absence due to musculoskeletal (MSK) pain. The SWAP trial tested whether adding a vocational advice (VA) service to best current care led to fewer days work absence over 4 months.

Purpose and background

To explore the cost-utility of implementing stratified care for low back pain (LBP) in general practice, compared with usual care, within patient risk subgroups (low, medium and high risk of persistent disabling pain determined by the STarT Back tool).

Background

Pain with radiation to the leg is a common presentation in back pain patients. Radiating leg pain is either referred pain or radicular, commonly described as sciatica. Clinically distinguishing between these types of leg pain is recognized as difficult but important for management purposes. The aim of this study was to investigate inter-therapist agreement when diagnosing referred or radicular pain.

Background and purpose

The STarT Back trial demonstrated benefits from a stratified primary care model that targets low back pain (LBP) treatment according to patient prognosis (low-, medium-, or high-risk). The current IMPaCT Back study implemented this approach in everyday primary care to investigate; i) changes in GPs' and physiotherapists' attitudes, confidence and behaviours, ii) patients' clinical outcomes, and iii) cost-effectiveness.

Background

One untested back pain treatment model is to stratify management depending on prognosis (low, medium or high-risk). This 2-arm RCT investigated: (i) overall clinical and cost-effectiveness of stratified primary care (intervention), versus non-stratified current best practice (control); and (ii) whether low-risk patients had non-inferior outcomes, and medium/high-risk groups had superior outcomes.

Aims

Wales in collaboration with the Welsh Assembly Government, has attempted to start a national ligament register.

Purpose and background

Although low back pain (LBP) with leg pain, is considered by most a poor prognostic indicator, it is at the same time believed to have a favourable natural resolution, and is often treated along similar lines to non-specific LBP, in line with current guidelines. It is unclear whether patients with LBP and leg pain are a distinct subgroup that might benefit from early identification and targeted interventions. We set out to investigate the impact of LBP with leg pain on health outcomes and health resources compared with that of LBP alone, and to explore which factors contribute to the observed disability outcomes.

Purpose of the study: The aim of this study was to develop an individualised assessment tool capable of defining clinically meaningful change within areas identified by each patient as important.

Background: Much work has been dedicated to identifying a definition of successful outcome in LBP. However, what is important to the patient is often not considered, or is poorly assessed. Goals that are important to the individual enhance self-engagement, and can serve as strong motivators of action in rehabilitation. Goal Scaling is a method which enables patients to systematically identify individualised goals, to quantify their achievement, and may provide a valid outcome of genuine importance to the patient.

Methods: A semi-structured interview was developed around the principles of goal attainment scaling, but modified to elicit patient identified individualised goals that incorporate a marker of “minimum important change” within each scale. Patients also completed measures on disability and global change in condition, and were followed-up for six months.

Results: Thirty-five patients referred to a specialised LBP clinic took part in this pilot study. Patients were able to identify specific realistic goals, and understood the concept of minimal important change within their chosen goal areas. At six months, goal attainment scores were responsive to change, associated with disability and global change in condition, and able to distinguish between “improvers” and “non-improvers”.

Conclusion: Goal scaling provided useful additional information about the problems associated with, and the progress of patients with LBP. Work on a self-complete version for use in clinical trials is underway.

Background: Patients with LBP, ‘at risk’ of persistent symptoms, require targeted treatment in primary care. We have therefore developed and validated a new screening tool to classify these patients into appropriate management groups.

Methods: A list of LBP prognostic indicators was compiled by reviewing published studies and analysing existing datasets. Indicators were selected for the tool according to face and construct validity, consistency and strength of association. For each indicator outcome measure (e.g. Pain Catastrophising Scale) an individual question (e.g. ‘I feel that my back pain is terrible and that it is never going to get an better’) was selected for inclusion (ROC analysis). The tool was modelled to classify patients into 3 categories of risk. The screening tool and corresponding complete scales were mailed to 244 consecutive primary care LBP consulters. Individual items were validated against complete scales. Reliability was examined on 53 responders.

Results: This new screening tool classifies patients using 9-items to cover 8 key prognostic indicators. The questionnaires returned by 131 consulters demonstrated excellent construct validity for all individual items. 33% of patients were classified as ‘high risk’ (psychosocial and physical factors), 44% ‘intermediate risk’ (physical factors alone) and 23% ‘low risk’. Discrimination between groups across relevant constructs such as pain, disability, days off work and psychological distress was highly significant. Test-retest reliability was moderate (kappa = 0.54).

Conclusions: A novel LBP screening tool has been validated in primary care and effectively classifies patients ‘at risk’ of persistent symptoms. This will facilitate appropriate targeting of treatment.

Proximal humeral fractures are common and often occur in osteoporotic bone. Suture fixation utilises the rotator cuff tendons as well as bone providing adequate stability and avoids complications associated with metalwork insertion.

Surgical exposure was via a delto-pectoral approach with minimal dissection of the fracture site. Initially a 2 suture technique was utilized with heavy ethibond sutures passed through drill holes either side of the bicipital groove; however, because of concerns about varus instability the technique now uses a third suture placed laterally acting as a tension band to prevent varus collapse. Patients with Neer 2 and 3 part fractures treated with suture fixation were assessed clinically (using the Constant score) and radiologically at a mean of 27 months post fracture.

To date 24 patients have been studied. The average age of the patients in our series was 70.2. All fractures progressed to union with no cases of radiological avascular necrosis. We had 2 cases of mal-union (-one varus and one valgus-), both with a 2-suture technique. One patient had early loss of fixation; re-exploration was performed with stability conferred by a third lateral suture. Active abduction > 120o was achieved in 9 patients with a mean Constant score of 72 compared to 89 on the un-injured contra-lateral side. We have demonstrated that suture fixation of displaced proximal humeral fractures is an effective alternative to fixation using metalwork. The advantages are that minimal soft tissue stripping of the fracture site is required and the potential problems associated with metalwork insertion into osteoporotic bone are avoided. Following one case of varus mal-union with a 2-suture technique we now routinely use a third suture to act as a lateral tension band.

Purpose of the study: To investigate whether video analysis, in addition to self-reported paper audit, could elucidate expected differences in the content of two interventions.

Background: We have completed a randomised clinical trial comparing two types of physiotherapy for subacute low back pain (“hands on” physiotherapy versus a pain management programme). An essential component in conducting clinical trials is to audit the interventions to check for compliance with the protocol. We use two approached:

self complete proforma

Methods: i) Treatment content was recorded on a proforma by the physiotherapists after each session.

ii) A check-list of treatment modalities was constructed from this proforma. Twelve sessions were recorded on video (one new and one review patient for each therapist). The recordings were rated by 3 blinded, independent observers using the checklist. These were compared with the self-report audit forms relating to the same physiotherapy session.

Results: Analysis of the videos showed good levels of agreement (67%) between the 3 observers. Agreement between the video content and paper audit was also good (84%, _ = 0.59). The complete paper audit revealed clear differences between the treatment arms. Patients undergoing the “handson” treatment received manual therapy, whereas patients in the pain management group had specific issues addressed in the course of the consultation.

Conclusions: Feasible, reliable methods of confirming the content of interventions delivered in pragmatic trials are difficult to achieve. Self report paper audits are simple but rely upon the honesty and accuracy of the completer, and may not pick up subtle differences in approach. Video recording is time consuming, may be threatening to the treating practitioner and patient, and is difficult to analyse. A compromise approach involving sample video recordings along with paper self complete audit was able to validate the content of the treatments delivered.

Purpose of the study: The aim of this ongoing research is to develop and utilise an individualised, patient-centred approach to outcome measurement in LBP. Specifically, we aim to develop an assessment tool capable of defining “clinically meaningful change” within each patient.

Background: Much work has been dedicated to identifying a definition of successful outcome in LBP. A consensus meeting suggested that 5 discrete domains merit measurement (back specific function, generic health status, pain, work disability and patient satisfaction). Validated tools exist which measure each of these domains. However, how to define what constitutes a “clinically meaningful improvement” as distinct from a “statistically significant change” remains problematic.

Patient satisfaction has been identified as a key dimension in the assessment of outcome in LBP. However what outcome is important to the patient is often not considered, or is poorly assessed. Goal Attainment Scaling (GAS) is a method for systematically targeting individualised goals, and quantifying their achievement. This will provide a valid outcome measure of genuine importance to the patient.

Methods: A semi-structured interview is being developed around the principles of GAS, but specifically modified to elicit patient identified individualised goals that incorporate a marker of “minimum important change” within each scale.

Results: Pilot work has shown that patients can identify meaningful individual goals, which will serve as individualised outcome measures. Furthermore, the notion of achieving a “minimum important change” based around these concepts and within these target scales appears to be generally understood.

Conclusions: Development of an individualised assessment tool capable of defining “clinically meaningful change” within each patient is ongoing. Future work will focus on identifying associations between this individualised outcome and other widely used measures in LBP research, and in establishing the clinical practicality of this approach for use in treatment trials.

To assess the results of this technique for stabilisation of severe spondylolisthesis, 12 patients with symptomatic severe spondylolisthesis underwent this procedure. The slipped L5 vertebra was stabilized using a hollow medullary screw through the posterior part of the body of S1 into the slipped L5 body, supplemented with pedicle screws into L5 and S1 with posterolateral fusion.

At one year follow-up, all but one patient had improved in leg pain. 2 patients were aware of the prominent pedicle screws. 360° fusion was achieved without any progression of spondylolisthesis. Thus 360° fusion for severe L5-S1 spondylo-listhesis can be achieved effectively using this technique.

Purpose: To assess the results of this technique for stabilisation of severe spondylolisthesis.

Method: Twelve patients with symptomatic severe spondylolisthesis were treated with this technique. All the patients had significant symptoms, inspite of conservative measures. The mean duration of symptoms was 3.5 years. The fixation technique was purely done through a posterior approach, with extensive posterior decompression. Stabilisation of the slipped L₅ vertebra was achieved with a trans sacral screw. The point of entry of the screw being the posterior part of the body of S₁ and it traverses the L₅-S₁ disc space into the L₅ body. A hollow medullary screw passed over a guide wire helps achieve the fixation. This fixation is supplemented with pedicle screws into L₅ and S₁ and posterolateral bone grafting. Thus an anterior and posterior fusion was achieved and the severe slip fixed in-situ.

Results: The mean follow-up was 1 year. All but one (8%) patient had improvement in leg pain. 2(16%) patients were aware of the prominent metalwork (pedicle screws). Good 360° fusion was achieved using this technique in all the patients. There was no progression of spondylolisthesis.

Conclusion: Thus, anterior and posterior in-situ fusion for severe L₅-S₁ spondylolisthesis can be achieved effectively using a single incision via a transsacral approach.