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Chronic Pain in Spinal Cord Injury

NCT ID: NCT00006428

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-08-31

Study Completion Date

2007-05-31

Brief Summary

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This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.

Detailed Description

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This double masked placebo-controlled trial will randomize patients (n=100) with a greater than 6 month history spinal cord injury and a greater than 3 month history of associated pain to a daily dose of amitriptyline or placebo for 6 weeks. Patients will be examined before randomization by a study physician or nurse masked to their treatment assignment. They will be assessed by telephone interview before, during treatment, at the end of treatment and 4 months later to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain.

Conditions

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Spinal Cord Injuries Pain

Keywords

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Spinal Cord injury (SCI) Chronic Pain Amitriptyline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Amitriptyline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Spinal Cord Injury six months ago or longer
* Pain for 3 months or longer

Exclusion Criteria

* History of cardiovascular disease, seizures, or glaucoma
* Currently taking antidepressant medications
* Currently hyperthyroid or taking thyroid medicine
* Currently pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana Cardenas, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington, Department of Rehabilitation

Locations

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University of Washington, Department of Rehabilitation Medicine

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Leijon G, Boivie J. Central post-stroke pain--a controlled trial of amitriptyline and carbamazepine. Pain. 1989 Jan;36(1):27-36. doi: 10.1016/0304-3959(89)90108-5.

Reference Type BACKGROUND
PMID: 2465530 (View on PubMed)

Max MB, Culnane M, Schafer SC, Gracely RH, Walther DJ, Smoller B, Dubner R. Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood. Neurology. 1987 Apr;37(4):589-96. doi: 10.1212/wnl.37.4.589.

Reference Type BACKGROUND
PMID: 2436092 (View on PubMed)

Sandford PR, Lindblom LB, Haddox JD. Amitriptyline and carbamazepine in the treatment of dysesthetic pain in spinal cord injury. Arch Phys Med Rehabil. 1992 Mar;73(3):300-1.

Reference Type BACKGROUND
PMID: 1543437 (View on PubMed)

Cardenas DD, Warms CA, Turner JA, Marshall H, Brooke MM, Loeser JD. Efficacy of amitriptyline for relief of pain in spinal cord injury: results of a randomized controlled trial. Pain. 2002 Apr;96(3):365-373. doi: 10.1016/S0304-3959(01)00483-3.

Reference Type BACKGROUND
PMID: 11973011 (View on PubMed)

Related Links

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http://depts.washington.edu/rehab/research/chronic.html

University of Washington, Department of Rehabilitation Medicine, Pain Management Study website

http://www.nichd.nih.gov/

For more information about the National Institute of Child Health and Human Development.

Other Identifiers

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P01HD033988

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NICHD-0120

Identifier Type: -

Identifier Source: org_study_id