NCT00006448

Brief Summary

Pain is a major problem for people after spinal cord injuries and amputations. This is a study to test how pain is affected by adding methadone to a six-week program of weekly physical therapy, relaxation training and counseling. Individuals who qualify for this study will receive a comprehensive medical and physical therapy evaluation.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2000

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Last Updated

September 26, 2016

Status Verified

March 1, 2003

Enrollment Period

4.9 years

First QC Date

November 4, 2000

Last Update Submit

September 23, 2016

Conditions

Spinal Cord InjuriesAmputation, TraumaticPain

Keywords

Spinal cord injuryAmputationPain management

Interventions

cognitive therapyBEHAVIORAL
Physical TherapyPROCEDURE
MethadoneDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with spinal cord injury or amputation, who have persistent pain of three months or longer duration.

You may not qualify if:

  • Pregnant women
  • Allergy to latex, methadone, or diphenhydramine
  • Surgery planned
  • History of substance abuse in past two years
  • History of major psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesAmputation, TraumaticPainAgnosia

Interventions

Cognitive Behavioral TherapyPhysical Therapy ModalitiesMethadone

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesTherapeuticsRehabilitationKetonesOrganic Chemicals

Study Officials

  • Thomas E. Rudy, Ph.D.

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

November 4, 2000

First Posted

November 6, 2000

Study Start

August 1, 1996

Primary Completion

July 1, 2001

Last Updated

September 26, 2016

Record last verified: 2003-03

Locations

US(1)