Pain Assessment and Quality of Life in Back Pain Patients: Role of Milnacipran

• Status: Withdrawn
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

1. To show that patients with greater pain sensitivity will show greater improvement in their symptoms (self-reported pain intensity, mood, sleep, and quality of life) than those with lower pain sensitivity, based on QST, after taking milnacipran.

2. To compare outcome differences (pain intensity, mood, activity interference, sleep, and side effects) with those patients who are either taking or not taking opioids for their pain 10 weeks after being prescribed milnacipran.

3. To show that patients who are older, male, with more medical comorbidities, greater disability, and longer pain duration will report less improvement (pain, mood, sleep, health-related quality of life) and treatment satisfaction while taking milnacipran compared with others without such characteristics.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Forest Laboratories
• Treatments: Levomilnacipran; Milnacipran

Criteria

Inclusion Criteria:

• 18 years or older

• Primary diagnosis of spinal pain for at least 6 months' duration

• Average pain intensity score of 4 or greater

Exclusion Criteria:

• Current diagnosis of cancer or malignant disease

• Acute bone disease

• History of DSM-IV psychotic disorder

• Pregnancy

• Any illness judged by the PI to interfere with treatment

• Any acute condition requiring surgery

• Currently taking SNRI or MAOI