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NCT Number: NCT05805683

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

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Key information

Conditions

Calcitonin Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location status: Recruiting

Location contact

Doha M Bakr, MD

SUB_INVESTIGATOR

Osama M Rehab, MD

CONTACT

[email protected]

00201095210806

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcitonin

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

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.

Primary outcomes

  1. 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

  2. Incidence of neuropathic pain

    Time frame: 6 months after spinal cord injury

    Incidence of neuropathic pain at 6 months after spinal cord injury

Secondary outcomes

  1. 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

  2. The incidence of adverse reactions

    Time frame: 2 weeks after spinal cord injury

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

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Osama M Rehab, MD

CONTACT

[email protected]

00201095210806

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 10, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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