Magnesium Injection Ensures Steroid Avoidance During Vaccine, Viremia or Immunocompromise

Magnesium Injection Ensures Analgesia and Steroid Avoidance During Vaccination, Viremia or Immunocompromise

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.

Study Overview

• Status: Recruiting
• Conditions: Steroid Metabolism Disorder
• Intervention / Treatment: Drug: Magnesium

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Olu Bamgbade, MD,FRCPC; Phone Number: 17786286600; Email: salem.painclinic@gmail.com

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3S 7J1
      • Recruiting
      • Salem Anaesthesia Pain Clinic
      • Contact: Olumuyiwa Bamgbade, MD, FRCPC; Phone Number: +17786286600; Email: salem.painclinic@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score, objective measurement using the validated Numeric Pain Rating scale	Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality score, objective measurement using the validated Likert sleep scale	Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Magnesium; Steroid avoidance
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Virus Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Metabolic Diseases; Viremia
• Other Study ID Numbers: SalemAnes2022 Mg Steroid Avoid

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No