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Chronic Low Back Pain Research Project
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, August 2008
Sponsored by: 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

MedlinePlus related topics: Antidepressants Back Pain
Drug Information available for: Gabapentin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Efficacy of Antidepressants in Chronic Back Pain

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 ]

Estimated Enrollment: 130
Study Start Date: October 2004
Estimated Study Completion Date: September 2009
Estimated 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

Contacts
Contact: Judy Ortega, BA (858) 642-3830 judith.ortega@va.gov
Contact: Shetal Patel, PhD (858) 642-3830 backpainresearch@vapop.ucsd.edu

Locations
United States, California
VA San Diego Healthcare System, San Diego Recruiting
San Diego, California, United States, 92161
Contact: Judy Ortega, BA     858-642-3830     judith.ortega@va.gov    
Contact: Shetal Patel, PhD     (858) 642-3830     backpainresearch@vapop.ucsd.edu    
Principal Investigator: Joseph H. Atkinson, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph H. Atkinson, MD VA San Diego Healthcare System, San Diego
  More Information

Responsible Party: Department of Veterans Affairs ( Atkinson, Joseph - Principal Investigator )
Study ID Numbers: CLNA-013-04S
Study First Received: April 15, 2005
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00108550  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Excitatory Amino Acids
Calcium, Dietary
Signs and Symptoms
Gabapentin
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

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

ClinicalTrials.gov processed this record on January 15, 2009