Magnesium Injection Ensures Steroid Avoidance During Vaccine, Viremia or Immunocompromise

Recruiting

• Conditions: Steroid Metabolism Disorder
• Interventions: Drug: Magnesium

• Registration Number: NCT05862454
• Lead Sponsor: Salem Anaesthesia Pain Clinic

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.

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 Timeline

• Study Start: 2020-07-02
• Study First Submitted: 2023-05-07
• Study First Submitted QC: 2023-05-07
• Study First Posted: 2023-05-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult chronic pain patients	Magnesium	Cohort of adult chronic pain patients, undergoing interventional injection therapy for pain management at a Canadian pain clinic

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Salem Anaesthesia Pain Clinic; 🇨🇦 Surrey, British Columbia, Canada