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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcitonin group | Experimental | patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury. |
|
| Placebo group | Placebo Comparator | patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitonin | Drug | patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of neuropathic pain | Intensity of neuropathic pain will be evaluated by visual analogue scale (VAS) scores at 6 months after spinal cord injury | 6 months after spinal cord injury |
| Incidence of neuropathic pain | Incidence of neuropathic pain at 6 months after spinal cord injury | 6 months after spinal cord injury |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of neuropathic pain | Incidence of neuropathic pain at 1, 3, 9 and 12 months after spinal cord injury | 12 months after spinal cord injury |
| The incidence of adverse reactions | Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osama M Rehab, MD | Contact | 00201095210806 | osamarehab@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | Gharbia Governorate | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author
The data will be available upon a reasonable request from the corresponding author after the end of study for 1 year
The data will be available upon a reasonable request from the corresponding author
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002116 | Calcitonin |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013963 | Thyroid Hormones |
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Parallel Assignment
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| Placebo | Drug | patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury. |
|
| 2 weeks after spinal cord injury |
| The consumption of medications for neuropathic pain or musculoskeletal pain | Number of patients required medications for neuropathic pain or musculoskeletal pain | 12 months after spinal cord injury |
| Intensity of neuropathic pain | 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 | 12 months after spinal cord injury |
| Intensity of nociceptive pain | 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 | 12 months after spinal cord injury |
| Medications used for neuropathic pain management | The number of medications used for treating neuropathic pain will be recorded | 12 months after spinal cord injury |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |