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Research

The British Association of Spine Surgeons (BASS) has opened the below listing for members to advertise, announce and spread the details of ongoing trials, so that this can be used effectively with mutual benefits, i.e., 1. the members (group) conducting the trial can get more participants recruited from varied regions and 2. allows the members from different regions to participate in a multi-centre trial. This also gives the opportunity for further trials to be organised via BASS and can be used to progress the quality of research in the UK under BASS. Also, we welcome any new suggestions and ideas which after discussion in the BASS executive will be able to help the members.

If you wish to add your research project to this listing, please email research@spinesurgeons.ac.uk

BASS also has options to distribute surveys to a wider clinical audience, including BASS members. Please visit our dedicated page (https://spinesurgeons.ac.uk/News/10526125) regarding this which has details and information on the ways BASS can assist with survey distributions.

Kind regards,
Pal Lakshmanan - Research Lead, BASS Executive


Please Note: BASS are not responsible for the content of these research trials/articles. For any questions or queries regarding specific trials or piece of research, please contact the author.


  • 14/12/2021 17:44 | Anonymous

    Link to Leaflet HERE

    THE MODIC TRIAL is open for recruitment for participants with moderate to severe Chronic Low Back Pain with Modic 1 or Modic 1 and 2. 

    A First in Human study evaluating an intradiscal antibiotic formulation in the treatment of Chronic Low Back Pain with Modic 1 or Modic 1 and 2, THE MODIC TRIAL was set up following pioneering work by Dr Hanne Albert which demonstrated the efficacy of 100 days of oral antibiotics.  The clinical evidence and associated side effects of oral antibiotic treatment was recently reviewed in The Spine Journal

    THE MODIC TRIAL is a multi-centre, randomised, double-blind, placebo-controlled trial taking place in the UK, Europe and New Zealand where Regulatory and Ethics approval have been obtained. 

    All subjects will have Gd-enhanced MRI scans at baseline, 6 months and 12 months to assess the inflammation/Modic changes in the targeted disc. Efficacy will be assessed over 12 months using patient reported pain and disability scales.

    The key inclusion criteria are:

           Aged 18-70 years

           CLBP in the area L1 to S1 associated with vertebral body endplate bone oedema (Modic 1) or vertebral body endplate bone oedema and fat (Modic 1 and 2), at a single lumbar level

           CLBP has lasted > 6 months

           Moderate-severe pain, back pain greater than leg pain

           Moderate-severe disability

           There is no clear alternative cause for back pain

           Failure of standard of care therapies

           The target lumbar disc must not have lost more than half its anticipated height at its centre


    If you have any patients who are suitable and would like to take part in a clinical trial, referrals can be made to research sites in the UK:

    City

    Principal Investigator

    E mail

    Phone

    Coventry

    Mr Robert Sneath

    robert.sneath@uhcw.nhs.uk

    +44 2476965067

    Oxford

    Dr Matthew Scarborough

    Matthew.scarborough@ouh.nhs.uk

    Preston

    Dr Shiva Tripathi

    FIH@LTHTR.nhs.uk

    Shiva.Tripathi@lthtr.nhs.uk

     +44 1772 524185    

    THE MODIC TRIAL is sponsored by Persica Pharmaceuticals Ltd.

    Further information can be found at themodictrial.com, clinicaltrials.gov and at persicapharmaceuticals.com


  • 28/10/2021 12:43 | Anonymous

    PDF Document Here

    Background

    Chymodiactin, the previously available product used widely in Europe, North America and many other countries obtained FDA approval in  1982 and also MHRA approval, ceased to be available in 2002.  Abbott Laboratories  had recently bought Knoll Pharma, a subsidiary of BASF, who owned the rights to the product, to gain access to the D2E7 molecule, which became the drug Humira. However Abbot decided not to continue with Chymodiactin and it ceased to be available.  DisCure Medical has been set up with plans to re-introduce Chymodiactin which still has FDA and MHRA approval. However due to the time lapse, some relatively minor changes in the manufacturing process are likely to necessitate a reintroduction by means of a clinical trial as proposed.

    Study Design

    The study is a single arm prospective study.

    Patients with contained disc herniations at the L4-5 and L5-S1 levels will be randomized to injection of 1000 or 2000 pKat of Chymopapain.

    Inclusion Criteria

    A contained lumbar disc herniation at the L4-5 or L5-S1 level as determined by an MRI, and clinical symptoms corresponding to the location of the herniation.

    VAS Leg pain of 50 mm or greater and the ODI exceeding 30.

    Examination will have restriction of spinal movements and straight leg raising restricted to at least 45 degrees on the painful leg, with a positive bow string sign,  with or without cross-over pain to the opposite leg.

    They will have adequate non-operative treatment for 6 or more weeks which may include medication (NSAIDs and/or analgesics), physical therapy, or spinal injection (epidural or root block), will be between 20 and 65 years of age and have had no previous spinal surgical intervention.

    Exclusion Criteria

    Disc herniations at more than one level.

    Disc herniation extruding through the posterior longitudinal ligament or sequestrated.

    Spinal Injection within 3 weeks of informed consent. (epidural or root- block)

    Previous spine surgery.

    Cauda equina syndrome or a severe rapidly progressing neurologic deficit.

    Lumbar spinal stenosis, spondylolisthesis, scoliosis, spinal tumor, spinal infection, ankylosing spondylitis.

    Interested?

    If you are interested in being involved in this study, please contact me ,

    Professor Douglas Wardlaw.  Email dwardlaw@btinternet.com


  • 14/06/2021 15:02 | Anonymous

    DENS_StudyDiagram_protocol_newsletter May 2021.pdf

    The Duration of External Neck Stabilisation (DENS) study is a randomised controlled trial comparing early removal of a hard collar with treatment in a hard collar for 12 weeks in older or frail adults with odontoid (dens) fractures. The primary outcome measure is QoL assessed using the EQ-5D-5L at 12 weeks following injury.  The aim of the study is to determine whether management without a collar improves outcome, compared to management with a collar. Cost efficiency will be assessed over the observed 12 months using standard NICE reference case methodology.

    We are currently awaiting  REC approval and hope to begin site set up and recruitment from August 2021. If you are interested in taking part and have not already completed a feasiblity study for your site,  please contact the Trial Manager, Angela Niven (Dens.Trial@ed.ac.uk) or the Chief Investigator, Paul Brennan (paul.brennan@ed.ac.uk

    https://www.ed.ac.uk/usher/edinburgh-clinical-trials/our-studies/all-current-studies/dens



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