We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences. The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded.Aims
Methods
The purpose of this study was to determine whether
patients with a burst fracture of the thoracolumbar spine treated
by short segment pedicle screw fixation fared better clinically
and radiologically if the affected segment was fused at the same
time. A total of 50 patients were enrolled in a prospective study
and assigned to one of two groups. After the exclusion of three
patients, there were 23 patients in the fusion group and 24 in the
non-fusion group. Follow-up was at a mean of 23.9 months (18 to
30). Functional outcome was evaluated using the Greenough Low Back
Outcome Score. Neurological function was graded using the American
Spinal Injury Association Impairment Scale. Peri-operative blood transfusion requirements and duration of
surgery were significantly higher in the fusion group (p = 0.029
and p <
0.001, respectively). There were no clinical or radiological
differences in outcome between the groups (all outcomes p >
0.05).
The results of this study suggest that adjunctive fusion is unnecessary
when managing patients with a burst fracture of the thoracolumbar
spine with short segment pedicle screw fixation.
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 aim of this study was to compare the effect of a percutaneous
radiofrequency heat lesion at the medial branch of the primary dorsal
ramus with a sham procedure, for the treatment of lumbar facet joint
pain. A randomised sham-controlled double blind multicentre trial was
carried out at the multidisciplinary pain centres of two hospitals.
A total of 60 patients aged >
18 years with a history and physical
examination suggestive of facet joint pain and a decrease of ≥ 2
on a numerical rating scale (NRS 0 to 10) after a diagnostic facet
joint test block were included. In the treatment group, a percutaneous
radiofrequency heat lesion (80oC during 60 seconds per
level) was applied to the medial branch of the primary dorsal ramus.
In the sham group, the same procedure was undertaken without for
the radiofrequency lesion. Both groups also received a graded activity
physiotherapy programme. The primary outcome measure was decrease
in pain. A secondary outcome measure was the Global Perceived Effect scale
(GPE).Aims
Patients and Methods
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
Exercise can be effective in treating Chronic Low Back Pain (CLBP) (Hayden et al 2005). Pilates-based group exercise programmes may be useful in the treatment of CLBP. To carry out a feasibility study of group Pilates exercise course compared to individual physiotherapeutic intervention and a waiting list control, in the treatment of CLBP.Background
Aim
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
To analyse procedural details - specifically vertebral levels treated and injected polymethylmethacrylate (PMMA) volumes - of the publications by Buchbinder et al. 1 and Kallmes et al. 2 in the context of best available basic science. Review Two randomised controlled trials published by the New England Journal of Medicine (NEJM) in 2009 comparing vertebroplasty to sham procedures conclude vertebroplasty to be no more effective than injection of local anaesthetic. This finding contradicts previous publications showing clinical efficacy. Neither investigation provides a breakdown of vertebral levels treated (original publication and supplementary material). Only one investigation provides information on fill volumes with average of 2.8 ml +/− 1.2 ml SD. The available basic science indicates a minimum fill volume of 13-16% of the vertebral body volume to be necessary for a relevant biomechanical effect on restoration of vertebral strength, according to which only vertebrae of the upper to mid thoracic spine could reasonably have received a biomechanically effective fill with the declared average volume of 2.8 ml +/− 1.2 ml SD. The available data of the NEJM publications strongly indicates that the treatment arm includes insufficiently treated patients. The technical information provided by the NEJM publications is insufficient to conclusively prove or disprove the clinical efficacy of vertebroplasty.
To evaluate if adding clonidine to a standard nerve root block containing local anaesthetic and steroid improved the outcome of patients with severe lumbar nerve root pain secondary to MRI proven lumbar disc prolapse. We undertook a single blind, prospective, randomised controlled trial evaluating 100 consecutive patients with nerve root pain secondary to lumbar disc prolapse undergoing trans-foraminal epidural steroid injection either with or without the addition of clonidine. 50 patients were allocated to each arm of the study. The primary outcome measure was the avoidance of a second procedure- repeat injection or micro-discectomy surgery. Secondary outcome measures were also studied: pain scores for leg and back pain using a visual analogue scale (VAS), the Roland Morris Disability Questionnaire (RMDQ) and the Measure Your Own Medical Outcome Profile (MYMOP). Follow up was carried out at 6 weeks, 6 months and 1 year.Purpose:
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
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
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
The purpose of this study is to compare the pre and post-operative magnetic resonance image clarity of titanium and PEEK based cervical arthroplasty devices at the level of implantation and adjacent level discs. This is a prospective, blinded, randomised study on imaging of cervical arthroplasty devices. The pre and postoperative MRI images of 16 patients who underwent cervical arthroplasty using Prestige LP(r) (Medtronic Sofamor Danek) and NuNec(tm) Cervical Arthroplasty System (Pioneer Surgical Technology, Marquette, Mich., USA) were assessed. Two independent radiologists who were blinded and provided with a sets of random images to score using a four point Jarvick grading system. Statistical analysis was completed using SPSS 16.0 statistical package (SPSS Inc, Chicago, IL) and analysis included comparing MR image quality before and after cervical arthroplasty at the operated and adjacent levels, and in between two types of implant. The pre-operative MR image quality at operated and adjacent levels was excellent in both groups. In the post-operative images, the adjacent level visualisation was adequate in both groups without much difference in average scores. However, at operated level, the quality of MR images in the NuNec group (PEEK on PEEK articulating disc) was excellent and clear visualisation of the cord, central canal, foramen and disc.Aim
Methodology and Results
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
Back pain impinges upon all aspects of life, has a reported UK lifetime prevalence as high as 84% and considering approximately a third of our lives are spent asleep the paucity of research into the effect a mattress has on back pain and sleep is surprising. Mood changes, effecting an increase in pain perception, due to sleep loss may also lead to a downward spiral of increasing back pain and greater sleep loss. A controllable factor in this spiral, affecting both aspects, is the mattress but to the authors' knowledge none currently available on the market have any robust, published research to objectively support any claims made and at best being ‘endorsed’ by experts. This may lead to possible misinterpretation of efficacy and leave professionals at a loss with what to advise when questioned. Method: A three month, randomised, controlled, double blind crossover field study is proposed to take place in the participants own homes, ensuring the most natural sleep environment. Data collection: Three 28 day phases 1 - Baseline data, participants sleeping on their own mattress 2 - Random allocation of mattresses, half allocated test and half control 3 - Crossover of test and control mattress Subjective measures of back pain and sleep quality will be collected utilising a daily sleep diary and visual analogue scales. Objective measures of sleep quality using activity monitors during sleep.Purpose and Background
Methods and Data collection
Lumbar paraspinal muscle dysfunction and low back pain are strongly correlated. Muscle atrophy is common in LBP and is recognised by MRI scan. Corticosteroid injections and physical rehabilitation programs are advocated for treatment of LBP. The purpose is to evaluate efficacy of specific lumbar multifidus muscle retraining exercises and perifacet multifidus injections in treatment of Low Back Pain (LBP) and referred leg pain. 63 patients with non-specific LBP, with or without leg pain, were randomised to three treatment groups. MR images of paraspinal muscle and the atrophy classified. A-Control group, standard physiotherapy for 10 weeks. B-Multifidus rehabilitation program for 10 weeks. C-Perifacet injection (multifidus injection) with methylprednisolone. ODI was primary outcome measure and the SF-36, modified Zung Depression Index and others were secondary outcome measures.Purpose
Method
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
