Back to resultsCalcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
Primary Purpose
Calcitonin, Neuropathic Pain, Spinal Cord Injury
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Calcitonin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Calcitonin focused on measuring Calcitonin, Neuropathic pain, 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.
Sites / Locations
- Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Calcitonin group
Placebo group
Arm Description
patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury.
patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of neuropathic pain
Incidence of neuropathic pain at 1, 3, 6 and 9 months after spinal cord injury
The incidence of adverse reactions
Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels
The consumption of medications for neuropathic pain
Number of patients required medications for neuropathic pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05805683
Brief Title
Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
Official Title
Effect of Early Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcitonin, Neuropathic Pain, Spinal Cord Injury
Keywords
Calcitonin, Neuropathic pain, Spinal cord injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Calcitonin group
Arm Type
Experimental
Arm Description
patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury.
Intervention Type
Drug
Intervention Name(s)
Calcitonin
Intervention Description
patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Intensity of neuropathic pain
Description
Intensity of neuropathic pain will be evaluated by visual analogue scale (VAS) scores within the 1st 6 months after spinal cord injury
Time Frame
6 months after spinal cord injury
Secondary Outcome Measure Information:
Title
Incidence of neuropathic pain
Description
Incidence of neuropathic pain at 1, 3, 6 and 9 months after spinal cord injury
Time Frame
9 months after spinal cord injury
Title
The incidence of adverse reactions
Description
Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels
Time Frame
2 weeks after spinal cord injury
Title
The consumption of medications for neuropathic pain
Description
Number of patients required medications for neuropathic pain
Time Frame
9 months after spinal cord injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osama M Rehab, MD
Phone
00201095210806
Email
osamarehab@med.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Gharbiya
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama M Rehab, MD
Phone
00201095210806
Email
osamarehab@med.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
Doha M Bakr, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request from the corresponding author
IPD Sharing Time Frame
The data will be available upon a reasonable request from the corresponding author after the end of study for 1 year
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author
Learn more about this trial
Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
We'll reach out to this number within 24 hrs