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

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ClinicalTrials.gov Identifier: NCT01799616
Recruitment Status : Unknown
Verified February 2013 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : February 27, 2013
Last Update Posted : February 27, 2013
Sponsor:
Collaborator:
INSERM CIC 501
Information provided by (Responsible Party):
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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

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
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



Primary Outcome Measures :
  1. back pain assessed on a100mm VAS [ Time Frame: at 3 months ]

Secondary Outcome Measures :
  1. - Functional status using EIFEL, Dallas, FABQ, MacTar, and MCII/PASS questionnaires [ Time Frame: at 6 weeks, 3 months, and 6 months ]
  2. Back stiffness assessed by Schober's test and finger-to-floor distance [ Time Frame: at 6 weeks, 3 months, and 6 months ]
  3. Inflammatory pain pattern [ Time Frame: 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

  4. assess the efficacy of a rigid back brace in treating back pain [ Time Frame: 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

  5. Tolerance based on the number and types of side-effects [ Time Frame: at 6 weeks, 3 months, and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799616


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
INSERM CIC 501
Investigators
Principal Investigator: Martin SOUBRIER University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01799616     History of Changes
Other Study ID Numbers: CHU-0148
2012-003569-16
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013

Keywords provided by University Hospital, Clermont-Ferrand:
MODIC changes
Chronic low back pain
Pamidronate
Magnetic resonance imaging
Vertebrae
Intervertebral disc

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Intervertebral Disc Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases