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

NCT05805683 | Recruiting

• 1 other identifier: 36264PR152/3/23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Calcitonin; Neuropathic Pain; Spinal Cord Injury

Keywords

Calcitonin; Neuropathic pain; Spinal cord injury

Outcome Measures

Primary Outcomes (2)

• 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

• Incidence of chronic pain

  Incidence of chronic pain at 12 months after spinal cord injury

  12 months after spinal cord injury

Secondary Outcomes (5)

• Incidence of neuropathic pain

  12 months after spinal cord injury

• The incidence of adverse reactions

  2 weeks after spinal cord injury

• The consumption of medications for neuropathic pain or musculoskeletal pain

  12 months after spinal cord injury

• Intensity of neuropathic pain

  12 months after spinal cord injury

• Intensity of nociceptive pain

  12 months after spinal cord injury

Study Arms (2)

Calcitonin group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Calcitonin DRUG

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 group

Placebo DRUG

patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years, with spinal cord injury at any level and any degree of completeness in the early stage of trauma.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Interventions

Calcitonin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroid Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

Osama M Rehab, MD

CONTACT

00201095210806; osamarehab@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of study for 1 year
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)