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

Tanta University50 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Calcitonin Neuropathic Pain Spinal Cord Injury

Interventions

CalcitoninDRUG

patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 6 months after spinal cord injury

Incidence of chronic pain

Incidence of chronic pain at 12 months after spinal cord injury

Time frame: 12 months after spinal cord injury

Secondary Outcomes

Incidence of neuropathic pain

Incidence of neuropathic pain at 1, 3, 6, 9 and 12 months after spinal cord injury

Time frame: 12 months after spinal cord injury

The incidence of adverse reactions

Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels

Time frame: 2 weeks after spinal cord injury

The consumption of medications for neuropathic pain or musculoskeletal pain

Number of patients required medications for neuropathic pain or musculoskeletal pain

Time frame: 12 months after spinal cord injury

Intensity of neuropathic pain

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

Time frame: 12 months after spinal cord injury

Intensity of nociceptive pain

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

Central Contacts

Osama M Rehab, MD

CONTACT

00201095210806 osamarehab@med.tanta.edu.eg

Data from ClinicalTrials.gov

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