Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trialReport as inadecuate




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Trials

, 15:117

First Online: 09 April 2014Received: 02 August 2013Accepted: 21 March 2014DOI: 10.1186-1745-6215-15-117

Cite this article as: Cecchetti, S., Pereira, B., Roche, A. et al. Trials 2014 15: 117. doi:10.1186-1745-6215-15-117

Abstract

BackgroundErosive degenerative disc disease, also known as Modic type 1 changes, is usually characterized by low back pain with an inflammatory pain pattern, as seen in spondyloarthropathies. Intravenous pamidronate has proven to be effective in patients with ankylosing spondylitis who are refractory to nonsteroidal antiinflammatory drugs, and in painful bone diseases in general, such as Paget’s disease, fibrous dysplasia or vertebral fractures. We therefore hypothesize that pamidronate would be effective in treating low back pain associated with Modic type 1 changes.

Methods-DesignThis study, called PEPTIDE short for the French title -Etude Prospective sur l’Efficacité et la tolérance du PamidronaTe dans les dIscopathies Degeneratives Erosives-, will be a double-blind, randomized, placebo-controlled, parallel group, phase two clinical trial. A total of 48 patients will be recruited. These patients will be randomly assigned to one of the two groups, with 24 patients in each group: one group will be given pamidronate and the other a placebo. Pamidronate will be administered at a dose of 90 mg per day for two days consecutively, and every patient, irrespective of treatment group, will be given paracetamol to maintain blinding by preventing drug-induced fever. The primary outcome measure is a between-group difference of 30 points on a 100 mm Visual Analogue Scale VAS at three months. Secondary outcome measures are improvement in functional status and the drug’s safety. Primary and secondary outcome measures will be assessed at each visit inclusion, at six weeks, three months, and six months. If the primary goal is not attained, the patient will be offered a rigid or semi-rigid back brace, irrespective of the treatment group.

DiscussionTo date, only local treatments, for example intradiscal corticosteroid therapy, lumbar arthrodesis or back braces have been studied in randomized, controlled trials, with controversial results. This trial is currently ongoing and, if conclusive, should provide physicians with an acceptable alternative to those treatments. The results should be publicly available in spring 2015.

Trial registrationClinicalTrials.gov number, NCT01799616.

KeywordsModic type 1 changes Chronic pain Pamidronate Randomized Controlled Trial AbbreviationsANOVAANalysis Of Variance

CBCcomplete blood count

CTXC-terminal telopeptide

EDDDerosive degenerative disc disease

EIFELFrench adaptation of the Roland-Morris Low Back Pain Questionnaire

ESRerythrocyte sedimentation rate

FABQFear Avoidance Beliefs Questionnaire

hs-CRPhigh-sensitivity C-reactive protein

LBPlow back pain

MacTarMcMaster Toronto Arthritis Patient Preference Disability Questionnaire

MCII-PASSMinimum Clinically Important Improvement-Patient Acceptable Symptom State

MRImagnetic resonance imaging

MSmorning stiffness

NSAIDsnonsteroidal antiinflammatory drugs

PEPTIDEshort for the French title -Etude Prospective sur l’Efficacité et la tolérance du PamidronaTe dans les dIscopathies Degeneratives Erosives-

PTHparathyroid hormone

SAPHOSynovitis Acne Pustulosis Hyperostosis Osteitis

VASvisual analogue scale

VESCvertebral endplate signal changes.

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Author: Stella Cecchetti - Bruno Pereira - Antoine Roche - Christophe Deschaumes - Dihya Abdi - Emmanuel Coudeyre - Jean-Jacques Du

Source: https://link.springer.com/







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