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.
Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
Status
Recruiting
Phase
Not applicable
Enrollment
126
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Full 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
Treatment arms and agents.
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.
Timeline
From registration to results.
First posted
Apr 10, 2023
Study start
May 1, 2023
Primary completion
May 1, 2027
Study completion
May 1, 2028
Results posted
Not reported
Registry updated
May 14, 2026
Outcomes
What the study measures.
Primary outcomes
Intensity of neuropathic pain
Time frame · 6 months after spinal cord injury
Intensity of neuropathic pain will be evaluated by visual analogue scale (VAS) scores at 6 months after spinal cord injury
Incidence of neuropathic pain
Time frame · 6 months after spinal cord injury
Incidence of neuropathic pain at 6 months after spinal cord injury
Secondary outcomes
Incidence of neuropathic pain
Time frame · 12 months after spinal cord injury
Incidence of neuropathic pain at 1, 3, 9 and 12 months after spinal cord injury
The incidence of adverse reactions
Time frame · 2 weeks after spinal cord injury
Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels
The consumption of medications for neuropathic pain or musculoskeletal pain
Time frame · 12 months after spinal cord injury
Number of patients required medications for neuropathic pain or musculoskeletal pain
Intensity of neuropathic pain
Time frame · 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
Intensity of nociceptive pain
Time frame · 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
Medications used for neuropathic pain management
Time frame · 12 months after spinal cord injury
The number of medications used for treating neuropathic pain will be recorded
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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.
Study locations
1 registered sites.
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Tanta University
Tanta, Gharbia Governorate, Egypt
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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