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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2027-05-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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Calcitonin Neuropathic Pain Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Calcitonin

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes