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

Tanta University

Status: Enrolling

Conditions: Calcitonin; Neuropathic Pain; Spinal Cord Injury

Treatments: Drug: Placebo; Drug: Calcitonin

Study type: Interventional

Funder types: Other

Identifiers

NCT05805683

36264PR152/3/23

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Calcitonin group

Experimental group

Description:

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

Treatment:

Drug: Calcitonin

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo