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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT01799616

Collaborator

INSERM CIC 501 (Other)

Enrollment

Location

Arms

25.9

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intervertebral Disc Degeneration Modic I Discopathy Back Pain Low Back Pain Magnetic Resonance Imaging (MRI)	Drug: Pamidronate Other: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2015

Anticipated Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Pamidronate
Other: 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	Other: Placebo

Arm

Intervention/Treatment

Experimental: Pamidronate

Drug: Pamidronate

Other: Placebo

Other: Placebo

Outcome Measures

Primary Outcome Measures

back pain assessed on a100mm VAS [at 3 months]

Secondary Outcome Measures

- Functional status using EIFEL, Dallas, FABQ, MacTar, and MCII/PASS questionnaires [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
Tolerance based on the number and types of side-effects [at 6 weeks, 3 months, and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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