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

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05805683

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Calcitonin Neuropathic Pain Spinal Cord Injury	Drug: Calcitonin Drug: Placebo	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Calcitonin group 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: 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 Comparator: Placebo group patients in this group will receive 1 ml of saline placebo solution 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.

Arm

Intervention/Treatment

Experimental: Calcitonin group

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: 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 Comparator: Placebo group

patients in this group will receive 1 ml of saline placebo solution 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.

Outcome Measures

Primary Outcome Measures

Intensity of neuropathic pain [6 months after spinal cord injury]
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 [9 months after spinal cord injury]
Incidence of neuropathic pain at 1, 3, 6 and 9 months after spinal cord injury
The incidence of adverse reactions [2 weeks after spinal cord injury]
Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels
The consumption of medications for neuropathic pain [9 months after spinal cord injury]
Number of patients required medications for neuropathic pain