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Chronic Low Back Pain Research Project
This study has been completed.
First Received: April 15, 2005   Last Updated: September 17, 2009   History of Changes
Sponsor: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108550
  Purpose

The purpose of this study is to determine whether gabapentin is efficacious as an analgesic for chronic low back pain.


Condition Intervention Phase
Chronic Low Back Pain
Drug: gabapentin
Drug: Inert placebo
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Antidepressants in Chronic Back Pain

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Mean pain intensity (Descriptor Differential Scale) at exit [ Time Frame: 12 weeks post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 12 weeks post randomization ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: 12 weeks post randomization ] [ Designated as safety issue: No ]
  • Quality of Well-Being [ Time Frame: 12 weeks post randomization ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: October 2004
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Gabapentin 300 to 3600 mg daily by mouth
Drug: gabapentin
Gabapentin 300m on Day 1, with daily or weekly increase to 3600 mg (maximum) by mouth by Week 5 of the 12-week trial
2: Sham Comparator
Inert placebo capsule identical in size and shape to the experimental capsule
Drug: Inert placebo
Inactive placebo capsule, one capsule on Day 1 with daily or weekly increase to 9 capsules daily by Week 5 of the 12-week trial

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be resident of the county of San Diego, CA
  • Ages 21-70 inclusive
  • Low back pain (T-6 or below, secondary to degenerative disk or degenerative joint disease) present "on a daily basis" for the previous 6 months or longer, of at least "moderate" intensity determined by DDS (Descriptor Differential Scale) > 7
  • English-speaking, literate, able to understand the study and communicate with the study team
  • Presently not a candidate for back surgery (one prior back surgery permitted if it was > 5 years ago and resulted in complete relief)
  • Discontinued muscle relaxants, anticonvulsants, antidepressants, and opioids at least two weeks before screening and agree to discontinue throughout study (can remain on stable dose of NSAIDs)
  • If female, not pregnant or lactating; agrees to use reliable contraception throughout the study, and has negative pregnancy test at screening
  • Gives informed consent.

Exclusion Criteria:

  • A major coexisting medical illness (e.g., diabetes, renal or hepatic disease, chronic obstructive pulmonary disease, cancer, or class III or IV organic heart disease) that might increase risks of gabapentin, or major surgical or non-surgical intervention for any disorder within the past 12 months, since rehabilitation from treatment may confound study outcomes
  • Significant coexisting orthopedic or pain problems; sciatica (pain, weakness, or dysesthesia solely in distribution of a lumbar spinal nerve, with or without reflex change) or back pain due to other disorders (e.g., fibromyalgia, vertebral fracture, osteomyelitis, metastatic cancer, rheumatoid arthritis; spinal stenosis)
  • DSM-IV diagnosis of alcohol or other substance abuse or dependence (within the previous 12 months or positive urine toxicology at screening), current major depression or dysthymia; or lifetime bipolar disorder (I or II) (excluded because gabapentin is antidepressive and antimanic); or major anxiety disorder (e.g., panic disorder; or psychosis; or lifetime presence of cognitive impairment disorder (e.g. dementia)
  • History of multiple adverse drug reactions or known allergy to gabapentin
  • Use of psychotropics (e.g., antidepressants, anxiolytics), which would need to be continued during the study, or other drugs or agents (i.e., herbal preparations) which might interact with the study drug
  • Prior treatment with the study drug
  • Use of systemic corticosteroids or corticosteroid injections within three months of screening; or concurrent behavioral therapies, chiropractic treatment, or transcutaneous electrical nerve stimulation unit
  • Renal impairment (creatinine > 1.8 mg/dL)
  • Hepatic impairment (bilirubin > 1.5 X upper normal limit, or AST or ALT > 2 X upper normal limit)
  • Hematologic abnormality (hemoglobin < 9.4 gm/dL; absolute WBC count < 3000/mm3, platelets < 100,000
  • Pregnancy
  • Immunosuppression
  • Use of experimental drugs or participation in other clinical trials
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108550

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph H. Atkinson, MD VA San Diego Healthcare System, San Diego
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Atkinson, Joseph - Principal Investigator )
Study ID Numbers: CLNA-013-04S
Study First Received: April 15, 2005
Last Updated: September 17, 2009
ClinicalTrials.gov Identifier: NCT00108550     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
analgesia
antidepressant agents
back pain
pain

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Pain
Membrane Transport Modulators
Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Analgesics
Antidepressive Agents
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Nervous System Diseases
Central Nervous System Depressants
Low Back Pain
Cardiovascular Agents
Antimanic Agents
Back Pain
Pharmacologic Actions
Neurologic Manifestations
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on March 18, 2010