Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
Condition: Neuropathic Pain; Pain; Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Neuralgia; Wounds and Injuries
Study type: Interventional

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.
    

Intervention name(s): Venalafaxine hydrochloride
Intervention type(s): Drug
Intervention description(s): Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)
Other intervention name(s): Effexor XR
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Burning pain; Clinical trial; Effexor; Pain; Spinal cord injury; Venalafaxine; Neuropathic Pain