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Magnesium Injection Ensures Steroid Avoidance During Vaccine, Viremia or Immunocompromise

Sponsor
Salem Anaesthesia Pain Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05862454
Collaborator
(none)
150
Enrollment
1
Location
23.9
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Steroid injections are used for interventional pain management. However, their side-effect of immunosuppression may increase the risk of infections. Magnesium is an alternative anti-nociceptive injection that may be used instead of steroids.

Prospective observational study of patients who received magnesium injection for interventional pain therapy, instead of steroid injection. Post-injection data collection includes numerical rating pain score, and sleep quality score. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Corticosteroid injections are used for interventional pain management. The immunosuppression effect of steroid injection may increase the risk of infections. Magnesium is an alternative anti-nociceptive agent that may be used for interventional pain injection therapy, instead of steroids.

Prospective observational clinical study of pain clinic patients who received magnesium injection for interventional pain therapy, instead of steroid injection. Post-injection data collection includes numerical rating pain score, and sleep quality score. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant. Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Magnesium Injection Ensures Analgesia and Steroid Avoidance During Vaccination, Viremia or Immunocompromise
Actual Study Start Date :
Jan 2, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Adult chronic pain patients

Cohort of adult chronic pain patients, undergoing interventional injection therapy for pain management at a Canadian pain clinic

Drug: Magnesium
Magnesium injection therapy
Other Names:
  • Magnesium injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain score, objective measurement using the validated Numeric Pain Rating scale [12 weeks]

      Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain

    Secondary Outcome Measures

    1. Sleep quality score, objective measurement using the validated Likert sleep scale [12 weeks]

      Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • adult chronic pain patients

    • previous interventional injection therapy

    • consent for interventional injection therapy

    • good treatment compliance

    • regular sleep diary

    • regular pain diary

    • informed consent for diary review

    • consent for clinical record quality assurance review

    Exclusion Criteria:

    • organ insufficiency

    • cognitive disorder

    • inability to provide consent

    • major neuropsychiatric disorder

    • unreliable diary

    • poor treatment compliance

    • previous adverse/allergic reactions to magnesium

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Salem Anaesthesia Pain Clinic Surrey British Columbia Canada V3S 7J1

    Sponsors and Collaborators

    • Salem Anaesthesia Pain Clinic

    Investigators

    • Principal Investigator: Olu Bamgbade, MD,FRCPC, Salem Anaesthesia Pain Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Salem Anaesthesia Pain Clinic
    ClinicalTrials.gov Identifier:
    NCT05862454
    Other Study ID Numbers:
    • SalemAnes2022 Mg Steroid Avoid
    First Posted:
    May 17, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Salem Anaesthesia Pain Clinic
    Magnesium
    Steroid avoidance
    Additional relevant MeSH terms:
    Viremia
    Metabolic Diseases

    Study Results

    No Results Posted as of May 18, 2023