Back Pain, Sciatica
Conditions
Keywords
analgesia, Back pain, sciatica
Brief summary
The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.
Interventions
DRUGDesipramine
Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL)
DRUGFluoxetine
Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL)
DRUGBenztropine
Daily dose 0.125 to 0.5mg
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Chronic back pain (pain on a daily basis for six months or longer) * Age 18-65 * No major medical illness
Exclusion criteria
* medical contraindication to tricyclic antidepressants * recent alcohol or substance use disorder * bipolar disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptor Differential Scale Pain Intensity | 12 weeks post baseline |
Countries
United States
Outcome results
None listed