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

Chronic Phantom Limb Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00425230
• Other study ID #: H-19539
• Status: Terminated
• Phase: N/A
• Start date: January 2007
• Est. completion date: June 2007

Study information

• Verified date: August 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Phantom Limb Pain
• Phantom Limb

Intervention

Drug:
• Duloxetine

Locations

Country	Name	City	State
United States	Micheal E. DeBakey Veterans Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	McGill Short Form Pain Questionairre
Secondary	Fiser Side effect scale
Secondary	visual analog pain scale
Secondary	Present Pain intensity
Secondary	Tylenol # 3 consumption