Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Calcitonin, Placebo.
- Who it may be relevant to
- Registry conditions: Calcitonin, Neuropathic Pain, Spinal Cord Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Early Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
Overview
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
- Drug Calcitonin
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 Placebo
patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury.
Primary outcome measures
- Intensity of neuropathic pain [Time frame: 6 months after spinal cord injury]
- Incidence of neuropathic pain [Time frame: 6 months after spinal cord injury]
Secondary outcome measures (6)
- Incidence of neuropathic pain [Time frame: 12 months after spinal cord injury]
- The incidence of adverse reactions [Time frame: 2 weeks after spinal cord injury]
- The consumption of medications for neuropathic pain or musculoskeletal pain [Time frame: 12 months after spinal cord injury]
- Intensity of neuropathic pain [Time frame: 12 months after spinal cord injury]
- Intensity of nociceptive pain [Time frame: 12 months after spinal cord injury]
- Medications used for neuropathic pain management [Time frame: 12 months after spinal cord injury]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT05805683 · 36264PR152/3/23