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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805683
• Other study ID #: 36264PR152/3/23
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: Osama M Rehab, MD
• Phone: 00201095210806
• Email: osamarehab[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	Gharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The incidence of adverse reactions	Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels	2 weeks after spinal cord injury
Secondary	The consumption of medications for neuropathic pain	Number of patients required medications for neuropathic pain	9 months after spinal cord injury