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Chronic Low Back Pain Research Project

CompletedPhase 2NCT00108550
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Efficacy of Antidepressants in Chronic Back Pain
Interventions
Sponsor
US Department of Veterans Affairs
Organization
VA Office of Research and Development
Start date
2004-10
Primary completion
2009-07
Sex
All
Age range
from 21 Years to 70 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 thr…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00108550