Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease

Phase 2

• Conditions: Intervertebral Disc Degeneration; Low Back Pain; Magnetic Resonance Imaging (MRI); Modic I Discopathy; Back Pain
• Interventions: Other: Placebo; Drug: Pamidronate

• Registration Number: NCT01799616
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-25
• Last Update Submitted: 2013-02-25
• Study First Posted: 2013-02-27
• Last Update Posted: 2013-02-27
• Primary Completion: 2015-01
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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	Pamidronate	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

Primary Outcome Measures

Name	Time	Method
back pain assessed on a100mm VAS	at 3 months

Secondary Outcome Measures

Name	Time	Method
Tolerance based on the number and types of side-effects	at 6 weeks, 3 months, and 6 months
Back stiffness assessed by Schober's test and finger-to-floor distance	at 6 weeks, 3 months, and 6 months
Inflammatory pain pattern	at 6 weeks, 3 months, and 6 months	Inflammatory pain pattern: number of nightly awakenings, as well as duration and intensity of morning stiffness on a 100mm VAS
assess the efficacy of a rigid back brace in treating back pain	at 6 weeks, 3 months, and 6 months	In case of failure to reduce the pain with pamidronate at 3 months: assess the efficacy of a rigid back brace in treating back pain
- Functional status using EIFEL, Dallas, FABQ, MacTar, and MCII/PASS questionnaires	at 6 weeks, 3 months, and 6 months

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France