Chronic Pain in Spinal Cord Injury

Management of Chronic Pain in Rehabilitation Project I - Management of Chronic Pain in Persons With Spinal Cord Injury

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00006428

Enrollment

100

Registered

2000-11-02

Start date

1996-08-31

Completion date

2007-05-31

Last updated

2012-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Spinal Cord Injuries

Keywords

Spinal Cord injury (SCI), Chronic Pain, Amitriptyline

Brief summary

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

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.

Interventions

DRUGAmitriptyline

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026