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

Plain-language guide to NCT05805683: not phased randomized trial of Calcitonin, 126 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05805683
Phase
not phased
Status
recruiting participants
Start
2023-05-01
Completion (planned or actual)
2027-05-01
Participants
126 (estimated)
Design
randomized, triple-blind, prevention
Conditions studied
Calcitonin; Neuropathic Pain; Spinal Cord Injury
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Calcitonin.

It had two arms (groups): Calcitonin group (experimental) and Placebo group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Pain after spinal cord injury can be classified into five categories: musculoskeletal, visceral, at-level, above-level, and below-level neuropathic pain.

Who Took Part

Enrollment: 126 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients aged ≥18 years, with spinal cord injury at any level and any degree of completeness in the early stage of trauma.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: intake of anticonvulsants medications; evidence of neuropathic pain; evidence of previous allergic reaction to calcitonin.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Calcitonin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Calcitonin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2023-05-01 with completion listed for 2027-05-01.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Intensity of neuropathic pain (time frame: 6 months after spinal cord injury). Incidence of neuropathic pain (time frame: 6 months after spinal cord injury).

It also tracked 6 secondary outcomes, for example Incidence of neuropathic pain, The incidence of adverse reactions, The consumption of medications for neuropathic pain or musculoskeletal pain, Intensity of neuropathic pain, Intensity of nociceptive pain and Medications used for neuropathic pain management.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Calcitonin in 126 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Calcitonin compound page, all human trials.

Our Notes on the Compound

Calcitonin: A 32-amino-acid hormone that lowers blood calcium; salmon calcitonin (Miacalcin) has been used for Paget disease and osteoporosis.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.