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

Not Applicable

Recruiting

• Conditions: Neuropathic Pain; Calcitonin; Spinal Cord Injury
• Interventions: Drug: Calcitonin; Drug: Placebo

• Registration Number: NCT05805683
• Lead Sponsor: Tanta University

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

Study Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-10
• Study Start: 2023-05-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcitonin group	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 group	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.

Primary Outcome Measures

Name	Time	Method
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
Incidence of chronic pain	12 months after spinal cord injury	Incidence of chronic pain at 12 months after spinal cord injury

Secondary Outcome Measures

Name	Time	Method
Intensity of nociceptive pain	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
Incidence of neuropathic pain	12 months after spinal cord injury	Incidence of neuropathic pain at 1, 3, 6, 9 and 12 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 or musculoskeletal pain	12 months after spinal cord injury	Number of patients required medications for neuropathic pain or musculoskeletal pain
Intensity of neuropathic pain	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

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Gharbiya, Egypt