Chronic Low Back Pain Research Project

NCT00108550 | Completed Phase 2 Results DMC

• 1 other identifier: CLNA-013-04S
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Low Back Pain

Keywords

analgesia; antidepressant agents; back pain; pain

Outcome Measures

Primary Outcomes (1)

• Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time

  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.

  Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9

Secondary Outcomes (1)

• Roland and Morris Disability Index Scores Adjusted for Time

  Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9

Study Arms (2)

1

EXPERIMENTAL

Gabapentin 300 mg orally three times daily up to a maximum of 1200 mg orally three times daily for 12 weeks

Drug: gabapentin

2

SHAM COMPARATOR

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

Interventions

gabapentin DRUG

Gabapentin 300m on Day 1, with daily or weekly increase to 3600 mg (maximum) by mouth by Week 5 of the 12-week trial

Also known as: Neurontin

1

Inert placebo DRUG

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

Also known as: sugar pill

2

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

Related Publications (1)

• Atkinson JH, Slater MA, Capparelli EV, Patel SM, Wolfson T, Gamst A, Abramson IS, Wallace MS, Funk SD, Rutledge TR, Wetherell JL, Matthews SC, Zisook S, Garfin SR. A randomized controlled trial of gabapentin for chronic low back pain with and without a radiating component. Pain. 2016 Jul;157(7):1499-1507. doi: 10.1097/j.pain.0000000000000554.

  PMID: 26963844 DERIVED

MeSH Terms

Conditions

Agnosia; Back Pain; Pain

Interventions

Gabapentin; Sugars

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

Limitations and Caveats

Limitations include small sample size, high rate of early termination, and moderate baseline levels of pain intensity and disability in everyday function which may have limited ability to detect an effect.

Results Point of Contact

• Title: J. H. Atkinson MD
• Organization: VA San Diego Healthcare System

joseph.atkinson@va.gov

858-642-3775

Study Officials

• Joseph H. Atkinson, MD

  VA San Diego Healthcare System, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2005
• First Posted: April 18, 2005
• Study Start: October 1, 2004
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 10, 2014
• Results First Posted: February 10, 2014

Record last verified: 2013-12

Locations

US (1)