Chronic Low Back Pain Research Project

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Antidepressive Agents; Gabapentin

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