Effect of Early Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
Overview
- Phase
- Not Applicable
- Intervention
- Calcitonin
- Conditions
- Calcitonin
- Sponsor
- Tanta University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Intensity of neuropathic pain
- Status
- Recruiting
- Last Updated
- 12 months ago
Overview
Brief Summary
This prospective randomized double blinded study will be conducted to evaluate the effect of early pharmacologic intervention with calcitonin on the incidence or the severity of neuropathic pain after spinal cord injury
Detailed Description
Pain after spinal cord injury can be classified into five categories: musculoskeletal, visceral, at-level, above-level, and below-level neuropathic pain. Calcitonin has previously been shown to be effective in the management of acute pain following amputation, vertebral fractures and other neuropathic conditions. Also it was used in a previous study to prevent complex regional pain syndrome in severe hemiplegic patients after stroke
Investigators
Osama Rehab
lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university
Tanta University
Eligibility Criteria
Inclusion Criteria
- •Patients aged ≥18 years, with spinal cord injury at any level and any degree of completeness in the early stage of trauma.
Exclusion Criteria
- •Intake of anticonvulsants medications.
- •Evidence of neuropathic pain.
- •Evidence of previous allergic reaction to calcitonin.
- •Patients with renal, hepatic and cardiac dysfunction or neurological disorders .
- •brain damage or major trauma to extremities or abdomen.
Arms & Interventions
Calcitonin group
patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury.
Intervention: Calcitonin
Placebo group
patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury.
Intervention: Placebo
Outcomes
Primary Outcomes
Intensity of neuropathic pain
Time Frame: 6 months after spinal cord injury
Intensity of neuropathic pain will be evaluated by visual analogue scale (VAS) scores within the 1st 6 months after spinal cord injury
Incidence of chronic pain
Time Frame: 12 months after spinal cord injury
Incidence of chronic pain at 12 months after spinal cord injury
Secondary Outcomes
- Intensity of nociceptive pain(12 months after spinal cord injury)
- Incidence of neuropathic pain(12 months after spinal cord injury)
- The incidence of adverse reactions(2 weeks after spinal cord injury)
- The consumption of medications for neuropathic pain or musculoskeletal pain(12 months after spinal cord injury)
- Intensity of neuropathic pain(12 months after spinal cord injury)