Clinical trial NCT00167856: Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
Official title: Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Pain
Spinal Cord Injuries
Keywords: Burning pain
Clinical trial
Effexor
Pain
Spinal cord injury
Venalafaxine
Neuropathic Pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-09-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pain-relieving effects of venlafaxine hydrochloride (Effexor) in chronic neuropathic (burning, shock-like, electric) pain after spinal cord injury (SCI). Although a number of medications have been used to treat SCI pain, no drug has been consistently helpful, and, therefore, many people with SCI continue to have difficult chronic pain. Venlafaxine is a new anti-depressant drug that has not been tested for use in SCI neuropathic pain, but has been helpful for other types of neuropathic pain.

Detailed description: Persistent pain is one of the most common reasons for impaired quality of life following spinal cord injury (SCI). Although numerous interventions are often used to manage neuropathic pain following SCI, most people receive inadequate relief and continue to suffer many years after the original injury. The long-term goal of our pain research is to improve the management of chronic neuropathic pain following SCI.

This study examines the effect of Venlafaxine hydrochloride (VH) in the treatment of chronic neuropathic pain associated with SCI. VH is a second-generation, structurally novel antidepressant medication with a mild side-effect profile compared to these older tricyclic antidepressants (e.g. imipramine and amitriptyline). Previous clinical trials suggest that approximately 60-70% of people with heterogeneous neuropathic pain report at least moderate reductions in pain with older antidepressants. However, reported side-effects have been numerous, and few trials have been conducted on neuropathic pain due to SCI.

The current study is a two-period, 24-week crossover, randomized, placebo-controlled trial. A sample of 60 persons with chronic neuropathic pain and SCI will be randomly assigned to either of two treatment groups (n=30 for each group), in a double-blind fashion. One group will receive VH first and then placebo, whereas the second group will start with the placebo followed by the VH. There will be weekly contacts between the research staff and the study participants to assess pain relief and medication side effects (presence and severity). Several measures of pain intensity, psychosocial well-being, quality of life, and sensory function will be taken throughout the study to examine the effects of VH on neuropathic pain.

We expect that VH will help to relieve neuropathic pain in persons with SCI, and that this decrease in pain intensity will correlate with a reduced psychosocial impact, improved mood, increased participation in daily activities, and increased life satisfaction.

Eligibility criteria: Inclusion Criteria:

* participant must be able to swallow pills
* fluent in English
* incomplete or complete spinal cord injury
* presence of at least moderately severe neuropathic pain at or below the level of injury
* spinal cord injury at least 2 year prior to entering the study
* pain for at least 6 months prior to entering the study
* spinal cord injury level above L1
* participants on anticonvulsants are considered
* approval of primary physician

Exclusion Criteria:

* pregnant women, or those contemplating pregnancy
* prior history of use of Venlafaxine hydrochloride (Effexor)
* current use of MAOI medications
* persons who have a recent (past year) history of alcohol or drug abuse
* persons with a history of renal disease, heart disease or uncontrolled hypertension, liver disease or hepatic cirrhosis, active major medical or psychiatric illness
* persons with a significant post-traumatic encephalopathy from head trauma sustained at SCI
* persons with tardive dyskinesia or narrow angle glaucoma

Primary outcomes:
measure: Pain Intensity as measured by subject pain diaries
timeFrame: Baseline (2 Weeks); Phase 1 (1 week at max dose); Washout (2 weeks); Phase 2 (1 week at max dose)
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: VA Medical Center, Miami
state: Florida
Study officials:
affiliation: VA Medical Center, Miami
name: Eva G. Widerstrom-Noga, DDS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sindrup SH, Jensen TS. Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain. 1999 Dec;83(3):389-400. doi: 10.1016/S0304-3959(99)00154-2.
citation: Defrin R, Ohry A, Blumen N, Urca G. Characterization of chronic pain and somatosensory function in spinal cord injury subjects. Pain. 2001 Jan;89(2-3):253-63. doi: 10.1016/s0304-3959(00)00369-9.
citation: Widerstrom-Noga EG, Felipe-Cuervo E, Yezierski RP. Chronic pain after spinal injury: interference with sleep and daily activities. Arch Phys Med Rehabil. 2001 Nov;82(11):1571-7. doi: 10.1053/apmr.2001.26068.
citation: Tasmuth T, Hartel B, Kalso E. Venlafaxine in neuropathic pain following treatment of breast cancer. Eur J Pain. 2002;6(1):17-24. doi: 10.1053/eujp.2001.0266.
citation: Westgren N, Levi R. Quality of life and traumatic spinal cord injury. Arch Phys Med Rehabil. 1998 Nov;79(11):1433-9. doi: 10.1016/s0003-9993(98)90240-4.