Calcitonin, Neuropathic Pain, Spinal Cord Injury
Conditions
Keywords
Calcitonin, Neuropathic pain, Spinal cord injury
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
Interventions
DRUGCalcitonin
patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury.
DRUGPlacebo
patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of neuropathic pain | 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 | 12 months after spinal cord injury | Incidence of chronic pain at 12 months after spinal cord injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The consumption of medications for neuropathic pain or musculoskeletal pain | 12 months after spinal cord injury | Number of patients required medications for neuropathic pain or musculoskeletal pain |
| Incidence of neuropathic pain | 12 months after spinal cord injury | Incidence of neuropathic pain at 1, 3, 6, 9 and 12 months after spinal cord injury |
| Intensity of nociceptive pain | 12 months after spinal cord injury | Intensity of musculoskeletal pain will be evaluated by visual analogue scale (VAS) score which ranges from 0 = no pain to 10= worst pain at 1, 3, 6, 9 and 12 months after spinal cord injury |
| Intensity of neuropathic pain | 12 months after spinal cord injury | Intensity of neuropathic pain will be evaluated by the visual analogue scale (VAS) score which ranges from 0 = no pain to 10= worst pain at 12 months after spinal cord injury |
| The incidence of adverse reactions | 2 weeks after spinal cord injury | Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels |
Countries
Egypt
Contacts
Primary ContactOsama M Rehab, MD
Outcome results
None listed