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

May 11, 2026 updated by: Osama Rehab, Tanta University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt, 31527
        • Recruiting
        • Tanta University
        • Sub-Investigator:
          • Doha M Bakr, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
6 months after spinal cord injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse reactions
Time Frame: 2 weeks after spinal cord injury
Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels
2 weeks after spinal cord injury
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
12 months after spinal cord injury
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
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
12 months after spinal cord injury
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
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
12 months after spinal cord injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR152/3/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe