Chronic Low Back Pain Research Project

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108550
First received: April 15, 2005
Last updated: December 20, 2013
Last verified: December 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
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:
  • Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time [ Time Frame: Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9 ] [ Designated as safety issue: No ]
    Self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor word anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. Prior to analysis an order-preserving mean-matching variance-stabilizing transformation was applied to this measure placing it on a continuous 0-1.5 scale. The single values reported below represent adjusted means of transformed pain intensity over all time points.


Secondary Outcome Measures:
  • Roland and Morris Disability Index Scores Adjusted for Time [ Time Frame: Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9 ] [ Designated as safety issue: No ]
    This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The single values reported below represent adjusted means of scores over all time points.


Enrollment: 108
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
Experimental: 1
Gabapentin 300 mg orally three times daily up to a maximum of 1200 mg orally three times daily for 12 weeks
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
Other Name: Neurontin
Sham Comparator: 2
Inert placebo capsules identical in size and shape to the experimental capsules, one to three capsules taken orally three times daily for 12 weeks
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
Other Name: sugar pill

  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, California
  • 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 Descriptor Differential Scale (DDS) > 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)
  • Diagnostic and Statistical Manual (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 aspartate aminotransferase (AST) or alanine transaminase (ALT) > 2 X upper normal limit)
  • Hematologic abnormality (hemoglobin < 9.4 gm/dL; absolute white blood cell (WBC) count < 3000/mm3, platelets < 100,000
  • Pregnancy
  • Immunosuppression
  • Use of experimental drugs or participation in other clinical trials
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00108550     History of Changes
Obsolete Identifiers: NCT01828450
Other Study ID Numbers: CLNA-013-04S
Study First Received: April 15, 2005
Results First Received: July 15, 2013
Last Updated: December 20, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 28, 2014