Clinical trial NCT01799616: Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intervertebral Disc Degeneration
Modic I Discopathy
Back Pain
Low Back Pain
Magnetic Resonance Imaging (MRI)
Keywords: MODIC changes
Chronic low back pain
Pamidronate
Magnetic resonance imaging
Vertebrae
Intervertebral disc
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: INSERM CIC 501
First posted: 2013-02-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pamidronate is effective and well-tolerated in the treatment of painful degenerative disk disease, also known as Modic type 1 changes

Detailed description: Erosive degenerative disk disease, also known as Modic type 1 changes, is usually characterized by low back pain, with an inflammatory pain pattern, as seen in spondylarthropathies. Intravenous pamidronate has proven effective in patients with ankylosing spondylitis, and in painful bone diseases in general. We therefore hypothesized that pamidronate would be effective in treating back pain associated with Modic type 1 changes.

This study aimed to determine pamidronate's efficiency in reducing pain, with the primary outcome being a between-group difference of 30 points on a 100mm VAS at 3 months. Secondary outcomes are the improvement in functional status and the drug's tolerance. Primary and secondary outcome criteria will be assessed at each visit (inclusion, at 6 weeks, 3 months, and 6 months). If the primary goal is not attained, a rigid or semi-rigid back brace will be proposed to the patient, regardless of the treatment group.

In total, 48 patients will need to be recruited. These patients will be randomly assigned to one of the two groups, with each group comprising 24 patients: one group will be given pamidronate and the other placebo. Pamidronate will be administered at a dose of 90mg per day, 2 days in a row, and every patient, regardless of the treatment group, will be given paracetamol, in order to maintain blinding by preventing drug-induced fever.

Eligibility criteria: Inclusion Criteria:

* - Age from 18 to 60 years old
* Low back pain
* Daily pain since at least 3 months
* VAS for pain \> 40/100 during the last 48 hours
* Inefficiency, intolerance, or contraindication to NSAIDS
* Inefficiency of a rigid or half-rigid back brace
* Modic 1 discopathy (diagnosed on MRI and confirmed by trained radiologist)
* Dental check-up within the last 6 months
* Signed informed consent

Exclusion Criteria:

* - Static disorders of the spine
* Contraindication to pamidronate (hypocalcemia, severe kidney failure, or allergy)
* Underage patients, patients under the protection of the law
* Previous treatment with bisphosphonates
* Pregnancy
* Local or general infection
* Previous discal surgery
* Systemic corticosteroid therapy in the last month
* Epidural or facet joint corticosteroid injection in the last month
* History of septic spondylodiscitis
* Ankylosing spondylitis
* Low back pain associated with radiculalgia
* Active psychiatric disorder
* Inability to read or understand French
* Body temperature above 38°C (fever) or Erythrocyte Sedimentation Rate above 20mm/hour

Primary outcomes:
measure: back pain assessed on a100mm VAS
timeFrame: at 3 months
Secondary outcomes:
measure: - Functional status using EIFEL, Dallas, FABQ, MacTar, and MCII/PASS questionnaires
timeFrame: at 6 weeks, 3 months, and 6 months
measure: Back stiffness assessed by Schober's test and finger-to-floor distance
timeFrame: at 6 weeks, 3 months, and 6 months
measure: Inflammatory pain pattern
timeFrame: at 6 weeks, 3 months, and 6 months
measure: assess the efficacy of a rigid back brace in treating back pain
timeFrame: at 6 weeks, 3 months, and 6 months
measure: Tolerance based on the number and types of side-effects
timeFrame: at 6 weeks, 3 months, and 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martin SOUBRIER
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cecchetti S, Pereira B, Roche A, Deschaumes C, Abdi D, Coudeyre E, Dubost JJ, Mathieu S, Malochet-Guinamand S, Tournadre A, Couderc M, Vayssade M, Daron C, Soubrier M. Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial. Trials. 2014 Apr 9;15:117. doi: 10.1186/1745-6215-15-117.