Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain

August 10, 2022 updated by: Wayne Goodman MD, Baylor College of Medicine

Pilot Study of Use of Duloxetine for the Treatment of Phantom Limb Pain

This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Micheal E. DeBakey Veterans Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Chronic PLP > 6 months
  2. Short-Form McGill Pain Questionnaire Sensory Pain Rating Index raw score ≥ 16
  3. Age ≥ 18 years old
  4. Inpatient or Outpatient
  5. Able to come to all appointments, in the opinion of the investigator
  6. Able to give informed consent, in opinion of investigator

Exclusion Criteria:

  1. Current Major Depressive disorder, Anxiety Disorder, or Psychotic disorder assessed by the Mini International Neuropsychiatric Interview (MINI)
  2. Substance abuse or dependence within the last six months, as assessed by the MINI
  3. Known Diabetes Mellitus to exclude diabetic peripheral neuropathy
  4. History of coronary artery disease, hepatic disease, renal disease
  5. Other pain syndromes
  6. Any unstable medical conditions in the opinion of the investigator
  7. Other psychotropic medications excluding hypnotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
McGill Short Form Pain Questionairre

Secondary Outcome Measures

Outcome Measure
Fiser Side effect scale
visual analog pain scale
Present Pain intensity
Tylenol # 3 consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Asif Chaudhry, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

January 19, 2007

First Submitted That Met QC Criteria

January 19, 2007

First Posted (ESTIMATE)

January 22, 2007

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19539

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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