Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged ≥18 years, with spinal cord injury at any level and any degree of completeness in the early stage of trauma.
Disqualifiers
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 .
Trial design
Design model
Parallel
Treatments tested in this trial
Calcitonin
Drugpatients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury.
Placebo
Drugpatients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Calcitonin groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intensity of neuropathic pain
Intensity of neuropathic pain will be evaluated by visual analogue scale (VAS) scores at 6 months after spinal cord injury
Time frame
6 months after spinal cord injury2
Incidence of neuropathic pain
Incidence of neuropathic pain at 6 months after spinal cord injury
Time frame
6 months after spinal cord injurySecondary outcomes
1
Incidence of neuropathic pain
Incidence of neuropathic pain at 1, 3, 9 and 12 months after spinal cord injury
Time frame
12 months after spinal cord injury2
The incidence of adverse reactions
Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels
Time frame
2 weeks after spinal cord injury3
The consumption of medications for neuropathic pain or musculoskeletal pain
Number of patients required medications for neuropathic pain or musculoskeletal pain
Time frame
12 months after spinal cord injury4
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
Time frame
12 months after spinal cord injurySponsors and contacts
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Source ClinicalTrials.gov