CalcitoninNCT05805683
Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
A study testing Calcitonin in people with Calcitonin and Neuropathic Pain, run by Tanta University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Calcitonin, Neuropathic Pain, Spinal Cord Injury
- What is being tested?
- Calcitonin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years, with spinal cord injury at any level and any degree of completeness in the early stage of trauma.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, Gharbia Governorate, 31527
Osama M Rehab, MD, 00201095210806, osamarehab@med.tanta.edu.eg
Doha M Bakr, MD
About this study
Official title: Effect of Early 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
Read the 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
- Conditions
- Calcitonin, Neuropathic Pain, Spinal Cord Injury
- Being tested
- Calcitonin, Placebo
- Keywords
- Calcitonin, Neuropathic pain, Spinal cord injury
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Calcitonin group | Experimental | patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury. Receives: Drug: Calcitonin |
| Placebo group | Placebo comparator | patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of neuropathic pain
Intensity of neuropathic pain will be evaluated by visual analogue scale (VAS) scores at 6 months after spinal cord injury
Measured: 6 months after spinal cord injury
Incidence of neuropathic pain
Incidence of neuropathic pain at 6 months after spinal cord injury
Measured: 6 months after spinal cord injury
Secondary outcomes (6)
Incidence of neuropathic pain
Incidence of neuropathic pain at 1, 3, 9 and 12 months after spinal cord injury
Measured: 12 months after spinal cord injury
The incidence of adverse reactions
Nausea, vomiting, disturbance of serum Calcium, Magnesium and Phosphorus levels
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months after spinal cord injury
Medications used for neuropathic pain management
The number of medications used for treating neuropathic pain will be recorded
Measured: 12 months after spinal cord injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 May 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalcitoninStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805683
- Sponsor's protocol ID
- 36264PR152/3/23
- Status last verified
- May 2026
- First submitted
- 28 Mar 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05805683
- Acronym / sponsor ID
- 36264PR152/3/23
- Conditions
- Calcitonin, Neuropathic Pain, Spinal Cord Injury
- Keywords
- Calcitonin, Neuropathic pain, Spinal cord injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Calcitonin group | Experimental | Drug: Calcitoninpatients 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 comparator | Drug: Placebopatients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥18 years, with spinal cord injury at any level and any degree of completeness in the early stage of trauma.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcitoninpatients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury. | Drug | Calcitonin group |
| Placebopatients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury. | Drug | Placebo group |
Primary outcome
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
Incidence of neuropathic pain
Time frame: 6 months after spinal cord injury
Incidence of neuropathic pain at 6 months after spinal cord injury
6 secondary outcomes
Incidence of neuropathic pain
Time frame: 12 months after spinal cord injury
The incidence of adverse reactions
Time frame: 2 weeks after spinal cord injury
The consumption of medications for neuropathic pain or musculoskeletal pain
Time frame: 12 months after spinal cord injury
Intensity of neuropathic pain
Time frame: 12 months after spinal cord injury
Intensity of nociceptive pain
Time frame: 12 months after spinal cord injury
Medications used for neuropathic pain management
Time frame: 12 months after spinal cord injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcitonin in people with Calcitonin and Neuropathic Pain, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama M Rehab, MD (00201095210806, osamarehab@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of neuropathic pain (time frame: 6 months after spinal cord injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.