Back Pain is a worldwide problem that often interferes with work, daily activities and sleep. The stress and disability experienced at night by individuals with Low Back Pain (LBP) could be reduced by targeted treatments designed specifically for this period. This study aimed to assess the clinical effectiveness of a spinal alignment cushion in the management of LBP when compared to a control group of standardised care. 71 individuals (30 males, 41 females) with LBP were recruited to the 4-week intervention after screening using the Red Flags and STarT Back tools. Participants were randomly assigned to either the control (standardised care) or intervention group (standardised care plus spinal alignment cushion). Pre and post assessments were taken using the Roland Morris Disability Questionnaire (RMDQ) (0–24), the Core Outcomes Measure Index (COMI) (0–10), and a Pain and Comfort during Sleep VAS Assessment. Each post assessment was analysed using ANCOVA with corresponding pre-assessment as covariate. Significant differences were seen in the RMDQ in favour of the intervention group (P = 0.034) over the four week period. Significant differences were also seen in favour of the intervention group in the COMI score (P=0.008), the frequency (P=0.004) and intensity of back pain (P=0.000), joint/muscle stiffness (P=0.046) and intensity of back stiffness (P=0.022).Background
Methods & Results
The STarT Back risk-stratification approach uses the STarT Back Tool to categorise patients with low back pain (LBP) at low, medium or high-risk of persistent disabling pain, in order to match treatments. The MATCH trial (NCT02286141) evaluated the effect of implementing an adaptation of this approach in a United States healthcare setting. This was a pragmatic cluster randomised trial with a pre-intervention baseline period. Six primary care clinics were pair-randomised, three to an intensive stratified care quality improvement intervention and three as controls. LBP patients were invited to provide outcomes two weeks after their primary care visit, and two and six months later. Primary outcomes were physical function (RMDQ) and pain (0–10 NRS), and secondary outcomes including healthcare use and treatments provided received. Analysis was intention-to-treat.Purpose & Background
Methods
Balloon kyphoplasty (BKP) is a minimally invasive treatment for vertebral fractures (VCF) aiming to correct deformity using balloon tamps and bone cement to stabilize the body. Patients with 1 - 3 non-traumatic acute VCF were enrolled within three months of diagnosis and randomly assigned to receive either BKP (N=149) or nonsurgical care (N=151). Follow-up was 2 years. The mean SF-36 physical component summary (PCS) score improved 5.1 points (95%CI, 2.8-7.4; p<0.0001) more in the kyphoplasty than the nonsurgical group at one month, the primary endpoint of the study. Kyphoplasty improved the PCS score by an average of 3.0 points (95%CI, 1.6-5.4; p=0.002) during the two-year follow-up. There was a significant interaction between treatment and follow-up time (p=0.003), indicating that the treatment effect over the year is not uniform across follow-up; a result from early improvement that persists in the kyphoplasty group whereas the nonsurgical group shows more incremental improvement over time. Overall, patients assigned to kyphoplasty also had statistically significant improvements over the two years compared to the control group in global quality of life (EQ-5D), pain relief (VAS), back disability (RMDQ) and days of limited activity (within a two-week period). There was no statistical significant difference between groups in the number of patients with adverse events or new VCF's over 24 months. Compared to the control, BKP improved quality of life and reduced back pain and disability and did not increase adverse events including the risk of new vertebral fractures over 2 years.
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. The SWAP trial was a cluster randomised controlled trial in 6 general practices, 3 randomised to best current care (control), 3 randomised to best current care and the VA service (intervention). Patients were ≥18 years, absent from work ≤6 months or struggling at work due to MSK pain. Primary outcome was number of days absent over 4 months. Exploratory subgroup analyses examined whether the effect was larger for patients with spinal pain compared to other MSK pain.Introduction
Methods
The primary aim of the study was to test the feasibility of conducting a full RCT with economic analysis and help to inform the provision of physiotherapy in a specific sub-group of patients with sciatica 60 patients waiting for primary, unilateral, single level, lumbar micro-discectomy surgery were recruited and randomised into two groups. The intervention group received a new spinal physiotherapy regimen. Primary outcome measure was the number of patients who did not require surgery at the time of consent clinic. Secondary measures were the Visual Analogue Scale (VAS) Oswestry Disability Index (ODI) and EQ5DL, taken at recruitment, 1 week before surgery and 2 weeks and 3 months after surgery.Purpose of study and background
Methods
Recruitment to time and target in clinical trials is a key challenge requiring careful estimation of numbers of potential participants. The SCOPiC trial ((HTA 12/201/09) (ISRCTN75449581)) is investigating the clinical and cost-effectiveness of stratified care for patients with sciatica in primary care. Here, we describe the approaches followed to achieve recruitment of our required sample size (n=470), the challenges encountered and required adaptations. We used recruitment data from the SCOPiC trial and its internal pilot, to show the differences between estimated and actual numbers of patients from consultation to participation in the trial. Patients were consented to the trial if they had a clinical diagnosis of sciatica (with at least 70% confidence) and met the trial eligibility criteria.Background
Methods
The musculoskeletal system is a common, but often overlooked, cause of chest pain. Little is known about the efficacy of spinal manipulation for this condition. The purpose of the present study is to evaluate the relative effectiveness of two conservative treatment approaches for acute musculoskeletal chest pain, 1) a spinal manipulation-based therapy as a typical example of chiropractic treatment and 2) self-management as an example of minimal intervention. In a non-blinded, randomised controlled trial set at an emergency cardiology department and four outpatient chiropractic clinics, 115 consecutive patients with acute chest pain and no clear medical diagnosis at initial presentation were included. After a baseline evaluation, patients with musculoskeletal chest pain were randomized to four weeks of chiropractic treatment or self-management, with post-treatment questionnaire follow-up four and 12 weeks later. Primary outcome measures were numeric change in pain intensity (11-point box numerical rating scale) and self-perceived change in pain (7-point ordinal scale). Secondary measures included Medical Outcomes Study Short Form 36 (SF-36) scores, change in pain intensity (chest, thoracic spine, neck and shoulder/arm), and self-perceived change in general health. Preliminary results will be available at the time of presentation.Background and purpose
Methods and results
The available treatments for NSLBP (Non-Specific Low Back Pain) provide, typically, small to moderate average benefits to patients. The aim of this pilot cluster RCT was to test the hypothesis that the use of a patient decision aid together with an informed shared decision making consultation would produce better outcomes in satisfaction with treatment at four month follow-up. We developed a DSP (Decision Support Package). We randomised the physiotherapists and trained those in the intervention arm in informed shared decision making and communication. Participants were recruited from a local physiotherapy department and those allocated to an appointment with an intervention therapist were sent a copy of the DSP in the post. Participants then attended their appointment as usual.Background
Methods
To identify any difference in clinical outcome between Intra-Capsular facet (IF) and Peri-facet (PF) injections in patients with low back pain (LBP). IF and PF joint steroid injections have been used for treatment of LBP with varied reports of pain relief for many years. Patients randomised into IF and PF groups. Bilateral L4/5 and L5/S1 levels injected. 40mg of Depo-Medrone with Lignocaine (total 1ml) in IF group. 80mg of Depo-Medrone with 1ml of 0.5% Chirocaine (total 3ml) in PF group. Pain visual analogue score (VAS) and analgesic chart – completed till six months.Objective
Methods
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]. 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.Background and purpose
Methods
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. 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.Purposes of the study and background
Summary of methods and results
Purpose of the study. To investigate the feasibility of undertaking a definitive
Our aim was to perform a systematic review of the literature
to assess the incidence of post-operative epidural haematomas and
wound infections after one-, or two-level, non-complex, lumbar surgery
for degenerative disease in patients with, or without post-operative
wound drainage. Studies were identified from PubMed and EMBASE, up to and including
27 August 2015, for papers describing one- or two-level lumbar discectomy
and/or laminectomy for degenerative disease in adults which reported
any form of subcutaneous or subfascial drainage.Aims
Patients and Methods
Adolescent idiopathic scoliosis affects about
3% of children. Non-operative measures are aimed at altering the natural
history to maintain the size of the curve below 40° at skeletal
maturity. The application of braces to treat spinal deformity pre-dates
the era of evidence-based medicine, and there is a paucity of irrefutable
prospective evidence in the literature to support their use and
their effectiveness has been questioned. This review considers this evidence. The weight of the evidence
is in favour of bracing over observation. The most recent literature
has moved away from addressing this question, and instead focuses
on developments in the design of braces and ways to improve compliance. Cite this article:
In a prospective observational study we compared the two-year outcome of lumbar fusion by a simple technique using translaminar screws (n = 57) with a more extensive method using transforaminal lumbar interbody fusion and pedicular screw fixation (n = 63) in consecutive patients with degenerative disease of the lumbar spine. Outcome was assessed using the validated multidimensional Core Outcome Measures Index. Blood loss and operating time were significantly lower in the translaminar screw group (p <
0.01). The complication rates were similar in each group (2% to 4%). In all, 91% of the patients returned their questionnaire at two-years. The groups did not differ in Core Outcome Measures Index score reduction, 3.6 ( The two fusion techniques differed markedly in their extent and the cost of the implants, but were associated with almost identical patient-orientated outcomes. Extensive three-point stabilisation is not always required to achieve satisfactory patient-orientated results at two years.
