Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication

NCT00388414 | Completed Results

• 1 other identifier: F1J-MC-I006
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Duloxetine has recently been shown to be effective in reducing the pain in chronic pain patients. Duloxetine is known to exert a central mechanism, however the precise human brain structures responsible for mediating its pain-relieving properties are not known. We will use functional magnetic resonance imaging (FMRI) to investigate the neural and functional correlates of pain.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Pain

  Brief Pain Inventory (BPI) scores were obtained at baseline, weeks 1, 2, 6, 7, 8, and 12, and a follow-up visit one week after completing the study. Responses are rated on a scale from 0-10, with 0 = no pain and 10 = pain as bad as you can imagine. Placebo and duloxetine pain scores calculated by averaging pain scores from each visit after baseline. Values were converted to percent change in pain: \[(baseline pain - end point pain)/baseline pain\] x 100.

  3 months

• Neural Correlates of Pain Relief

  Scores reflect the average connectivity strength of that region of interest to the rest of the cortex. There were no minimum or maximum values on this scale. Higher scores reflect stronger connectivity, and lower scores reflect less connectivity (all scores fell within -3 and 3). Subscales are averaged.

  3 months

Study Arms (2)

Placebo - sugar pill

PLACEBO COMPARATOR

Drug: Placebo

Duloxetine

EXPERIMENTAL

Drug: duloxetine

Interventions

duloxetine DRUG

30-60mg of duloxetine daily

Duloxetine

Placebo DRUG

Placebo pill once daily

Placebo - sugar pill

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Back Pain
• Must be able to comply with study visit schedule and other study requirements

You may not qualify if:

• Known hypersensitivity to duloxetine or any of the inactive ingredients
• Uncontrolled narrow-angle glaucoma

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Links

• Description of the study and recruitment details

MeSH Terms

Conditions

Low Back Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
• Organization: Stanford University

smackey@stanford.edu

(650) 498-6477

Study Officials

• Sean Mackey

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Redlich Professor

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 16, 2006
• Study Start: September 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 11, 2017
• Results First Posted: December 11, 2017

Record last verified: 2017-11

Locations

US (1)