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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 123 - 123
1 Apr 2012
Slator N Tsegaye M Balamurali G Elmalky M Pillay R
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Royal Liverpool University Hospital, Liverpool, UK

To retrospectively review outcomes in patients who underwent vertebroplasty in Liverpool in response to recent level 1 publications claiming vertebroplasty to be no better than sham procedure assessed using 2 criteria. We reviewed cases between 2006 and 2009 looking at 5 criteria for procedure.

Visual Analogue Score (VAS)

Oswestry disability index scores (ODI)

96 patients identified. 10 patients excluded (inadequate data recorded) (n=86). Operated levels n=134 (thoracic n=61, lumbar n=71, sacral n=2).

Presenting symptoms included back pain (86/86) and point tenderness was present in 90% (77/86). Average length of symptoms was 11.50 months with 28% reporting greater than 12 months. 72% recalled definite onset of symptoms with 90% being associated with a low velocity injury. Radiological findings showed an average of 54% height collapse and 91% showing high signal on STIR MRI sequences. Number of levels operated – 3 or more (n=9 VAS 5.3 ODI 10.6); 1 to 2 levels (n= 77 VAS 3.7 ODI 13.9)

Average improvement in VAS score was 3.8.and ODI 13.6

47% (40/86) of patients met all 5 current criteria recommended for operation (VAS 3.7, ODI 14). 53% (46/86) of patients met 2-5 criteria (VAS 3.8, ODI 13.4).

There was improvement in pain scores in 91% of patients with an average pre-op VAS 7.8 and post-op VAS 4.0. There was no significant difference in patients meeting all 5 criteria compared to those meeting 2-5 criteria.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 19 - 19
1 Sep 2019
Schreijenberg M Lin C McLachlan A Williams C Kamper S Koes B Maher C Billot L
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Introduction. The PACE trial was the first randomized controlled trial (RCT) investigating the efficacy of paracetamol in acute low back pain. Non-compliance to study medication was considered to be a limitation of this RCT. In contrast to conventional statistical methods, complier average causal effects (CACE) analysis may provide unbiased estimates of the effects for participants compliant to paracetamol. Methods. Intention to treat (ITT), as-treated, propensity weighted CACE and joint modeling CACE estimates were calculated for pain intensity, disability, global perceived effect and function at two weeks of follow up with compliance defined as an average of at least four tablets per day during the first two weeks of the trial. For pain intensity, exploratory analyses were conducted using additional time points and definitions of compliance. Results. 547 participants had been randomized to placebo and 550 to regular paracetamol; of the latter group, 72% of patients was classified as compliers. Mean differences in pain intensity between paracetamol and placebo using the main time point and definition of compliance were non-significant (ITT 0.11, p = 0.49; as-treated 0.29, p = 0.12; propensity weighed CACE −0.12, p = 0.51; joint modeling CACE 0.28, p = 0.13); similar results were obtained for disability, global perceived effect and function and for additional time points and definitions of compliance. Conclusion. In compliers, paracetamol had no significant effect on pain intensity when compared to placebo; this supports the conclusions from the original analysis. However, these calculations are based on patient-reported compliance, which may not perfectly represent actual medication consumption. Conflicts of interest: AM has received funding for a postgraduate research scholarship from GlaxoSmithKline. CM has received funding to review teaching materials prepared by GlaxoSmithKline. The other authors declare no competing interests. Sources of funding: The PACE trial was an investigator-initiated study funded by a project grant from National Health and Medical Research Council of Australia. GlaxoSmithKline Australia provided subsequent supplementary funding and the paracetamol and matched placebo. CM is supported by Australian Research Council Future Fellowships FT-100100603. CL is supported by a Career Development Fellowship from the National Health and Medical Research Council, Australia (APP1061400). This secondary analysis of the PACE data has been supported by a program grant of the Dutch Arthritis Foundation and by the Foundation “De Drie Lichten” in The Netherlands


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 29 - 29
1 Oct 2022
Hohenschurz-Schmidt D Vase L Scott W Annoni M Barth J Bennell K Renella CB Bialosky J Braithwaite F Finnerup N de C Williams AC Carlino E Cerritelli F Chaibi A Cherkin D Colloca L Côte P Darnall B Evans R Fabre L Faria V French S Gerger H Häuser W Hinman R Ho D Janssens T Jensen K Lunde SJ Keefe F Kerns R Koechlin H Kongsted A Michener L Moerman D Musial F Newell D Nicholas M Palermo T Palermo S Pashko S Peerdeman K Pogatzki-Zahn E Puhl A Roberts L Rossettini G Johnston C Matthiesen ST Underwood M Vaucher P Wartolowska K Weimer K Werner C Rice A Draper-Rodi J
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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


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 55 - 55
1 Sep 2019
Alhashel A Alamri E Sparkes V
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Purpose & Background. The ability to jump higher is a key factor for athletic performance and relies on many factors including spinal movement and trunk muscle activity. Manual therapy including Mulligan' Sustained Natural Apophyseal Glide (SNAG) techniques are proposed to increase spinal movement and thus function. The evidence pf the effect of manual therapy on muscle activity is limited. We aimed to determine the immediate effects of an extension SNAG on the lower lumbar spine on jump height and rectus abdominis (RA), external oblique (EO), multifidus (M) and iliocostalis Lumborum (IL) muscle activity during the flight phase of vertical jump compared to a placebo intervention (flat hand pressure). Method. Eighteen healthy participants (16 males, age 28.11±5.01 years, weight 70.58±11.9 kg, height 1.70±0.07m, body mass index 24.28±3.30)from Cardiff University were randomly allocated to either an extension SNAG or placebo intervention. Surface Electromyography was normalised to maximum voluntary contraction and was collected during the flight phase of the jump and jump height was measured using jump and reach test. Results. There was a significant increase (p=0.01) in jump height for the SNAG group. No significant differences in RA, EO, M, IL muscle activity was noted between SNAG and placebo interventions In EO, LES and M descriptive analysis showed a decrease in muscle activity in on average 14 of the subjects. Conclusion. SNAG mobilisation can produce an immediate increase in jump height but no significant changes in muscle activity in healthy subjects. Further work is warranted in subjects with low back pain. No Conflict of Interests. No funding was obtained


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 10 - 10
1 Oct 2019
Jensen O Andersen M Østgård R Andersen N Rolving N
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Background and purpose. Modic changes (MC) are a risk factor for development of chronic low back pain (CLBP). There is no agreement about the cause of inflammation in MC, but autoimmunity has been suggested. The aim of the study was to investigate whether treatment with lactic acid bacteria for 100 days was associated with change of disability and pain, via a change in the gut microbiota inducing a change in the immune system, in patients with CLBP and type 1 MC during one year follow-up. Methods. Eighty-nine patients with CLBP and type 1 MC were randomized to receive either one capsule Lactobacillus Rhamnosis GG or placebo capsules twice daily for 100 days. Results. Missing values at one year were 4% and 3% in the disability and pain variables, respectively. The predefined outcomes disability and back and leg pain only changed little during follow-up with no statistically significant differences between groups. At one year, back pain had decreased by 1.1 more on a 0–10 scale (95% CI 0.20- 1.97) in the experimental group than in the control group. There were no differences regarding other predefined outcomes, i.e. global effect or percentage with minimal disability at one year. Nine percent of the patients reported gastrointestinal side-effects without difference between groups. Conclusions. No differences were found between groups regarding the predefined outcomes. Overall, the study confirmed that CLBP with MC1 is a grave back pain disorder, with little tendency to improvement. During follow-up, disability of the whole cohort was reduced by just 17%. Conflicts of interest: No conflicts of interest. Sources of funding: The study has been supported by The Danish Rheumatism Association and Peter and Helga Kornings Fond


The Bone & Joint Journal
Vol. 100-B, Issue 10 | Pages 1364 - 1371
1 Oct 2018
Joswig H Neff A Ruppert C Hildebrandt G Stienen MN

Aims

The aim of this study was to determine the efficacy of repeat epidural steroid injections as a form of treatment for patients with insufficiently controlled or recurrent radicular pain due to a lumbar or cervical disc herniation.

Patients and Methods

A cohort of 102 patients was prospectively followed, after an epidural steroid injection for radicular symptoms due to lumbar disc herniation, in 57 patients, and cervical disc herniation, in 45 patients. Those patients with persistent pain who requested a second injection were prospectively followed for one year. Radicular and local pain were assessed on a visual analogue scale (VAS), functional outcome with the Oswestry Disability Index (ODI) or the Neck Pain and Disability Index (NPAD), as well as health-related quality of life (HRQoL) using the 12-Item Short-Form Health Survey questionnaire (SF-12).


The Bone & Joint Journal
Vol. 98-B, Issue 11 | Pages 1526 - 1533
1 Nov 2016
van Tilburg CWJ Stronks DL Groeneweg JG Huygen FJPM

Aims

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.

Patients and Methods

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).


Bone & Joint 360
Vol. 3, Issue 4 | Pages 41 - 44
1 Aug 2014
Shah N Matthews S

Whiplash injury is surrounded by controversy in both the medical and legal world. The debate on whether it is either a potentially serious medical condition or a social problem is ongoing. This paper briefly examines a selection of studies on low velocity whiplash injury (LVWI) and whiplash associated disorder (WAD) and touches upon the pathophysiological and epidemiological considerations, cultural and geographical differences and the effect of litigation on chronicity. The study concludes that the evidence for significant physical injury after LVWI is poor, and if significant disability is present after such injury, it will have to be explained in terms of psychosocial factors.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 2 | Pages 152 - 157
1 Feb 2012
Longo UG Loppini M Denaro L Maffulli N Denaro V

Osteoporotic vertebral compression fractures (VCFs) are an increasing public health problem. Recently, randomised controlled trials on the use of kyphoplasty and vertebroplasty in the treatment of these fractures have been published, but no definitive conclusions have been reached on the role of these interventions. The major problem encountered when trying to perform a meta-analysis of the available studies for the use of cementoplasty in patients with a VCF is that conservative management has not been standardised. Forms of conservative treatment commonly used in these patients include bed rest, analgesic medication, physiotherapy and bracing.

In this review, we report the best evidence available on the conservative care of patients with osteoporotic VCFs and associated back pain, focusing on the role of the most commonly used spinal orthoses. Although orthoses are used for the management of these patients, to date, there has been only one randomised controlled trial published evaluating their value. Until the best conservative management for patients with VCFs is defined and standardised, no conclusions can be drawn on the superiority or otherwise of cementoplasty techniques over conservative management.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 9 | Pages 1149 - 1153
1 Sep 2011
Muijs SPJ van Erkel AR Dijkstra PDS

Vertebral compression fractures are the most prevalent complication of osteoporosis and percutaneous vertebroplasty (PVP) has emerged as a promising addition to the methods of treating the debilitating pain they may cause.

Since PVP was first reported in the literature in 1987, more than 600 clinical papers have been published on the subject. Most report excellent improvements in pain relief and quality of life. However, these papers have been based mostly on uncontrolled cohort studies with a wide variety of inclusion and exclusion criteria. In 2009, two high-profile randomised controlled trials were published in the New England Journal of Medicine which led care providers throughout the world to question the value of PVP. After more than two decades a number of important questions about the mechanism and the effectiveness of this procedure remain unanswered.


The Bone & Joint Journal
Vol. 95-B, Issue 7 | Pages 868 - 873
1 Jul 2013
Cho SK Lu Y Lee D

Dysphagia is a common complication of anterior surgery of the cervical spine. The incidence of post-operative dysphagia may be as high as 71% within the first two weeks after surgery, but gradually decreases during the following months. However, 12% to 14% of patients may have some persistent dysphagia one year after the procedure. It has been shown that female gender, advanced age, multilevel surgery, longer operating time and severe pre-operative neck pain may be risk factors. Although the aetiology remains unclear and is probably multifactorial, proposed causes include oesophageal retraction, prominence of the cervical plate and prevertebral swelling. Recently, pre-operative tracheal traction exercises and the use of retropharyngeal steroids have been proposed as methods of reducing post-operative dysphagia.

We performed a systematic review to assess the incidence, aetiology, risk factors, methods of assessment and management of dysphagia following anterior cervical spinal surgery.

Cite this article: Bone Joint J 2013;95-B:868–73.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 11 | Pages 1442 - 1447
1 Nov 2012
Sharma H Lee SWJ Cole AA

Spinal stenosis and disc herniation are the two most frequent causes of lumbosacral nerve root compression. This can result in muscle weakness and present with or without pain. The difficulty when managing patients with these conditions is knowing when surgery is better than non-operative treatment: the evidence is controversial. Younger patients with a lesser degree of weakness for a shorter period of time have been shown to respond better to surgical treatment than older patients with greater weakness for longer. However, they also constitute a group that fares better without surgery. The main indication for surgical treatment in the management of patients with lumbosacral nerve root compression should be pain rather than weakness.


Bone & Joint Research
Vol. 1, Issue 9 | Pages 198 - 204
1 Sep 2012
Iwase T Takebayashi T Tanimoto K Terashima Y Miyakawa T Kobayashi T Tohse N Yamashita T

Objectives

In order to elucidate the influence of sympathetic nerves on lumbar radiculopathy, we investigated whether sympathectomy attenuated pain behaviour and altered the electrical properties of the dorsal root ganglion (DRG) neurons in a rat model of lumbar root constriction.

Methods

Sprague-Dawley rats were divided into three experimental groups. In the root constriction group, the left L5 spinal nerve root was ligated proximal to the DRG as a lumbar radiculopathy model. In the root constriction + sympathectomy group, sympathectomy was performed after the root constriction procedure. In the control group, no procedures were performed. In order to evaluate the pain relief effect of sympathectomy, behavioural analysis using mechanical and thermal stimulation was performed. In order to evaluate the excitability of the DRG neurons, we recorded action potentials of the isolated single DRG neuron by the whole-cell patch-clamp method.