Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Early Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury

Conditions
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Calcitonin, Neuropathic Pain, Spinal Cord Injury

Intervention / Treatment
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* Drug: Calcitonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcitonin group<br>patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury. | Drug: Calcitonin<br>* patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury.<br>|
| Placebo Comparator: Placebo group<br>patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury. | Drug: Placebo<br>* patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of neuropathic pain | Intensity of neuropathic pain will be evaluated by visual analogue scale (VAS) scores within the 1st 6 months after spinal cord injury | 6 months after spinal cord injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of neuropathic pain | Incidence of neuropathic pain at 1, 3, 6 and 9 months after spinal cord injury | 9 months after spinal cord injury | 
| The incidence of adverse reactions | Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels | 2 weeks after spinal cord injury | 
| The consumption of medications for neuropathic pain | Number of patients required medications for neuropathic pain | 9 months after spinal cord injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcitonin, Neuropathic pain, Spinal cord injury