Clinical trial NCT05862454: Magnesium Injection Ensures Steroid Avoidance During Vaccine, Viremia or Immunocompromise
Official title: Magnesium Injection Ensures Analgesia and Steroid Avoidance During Vaccination, Viremia or Immunocompromise
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Steroid Metabolism Disorder
Keywords: Magnesium
Steroid avoidance
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of consecutive adult patients, undergoing interventional injection therapy for pain management at a Canadian 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score, objective measurement using the validated Numeric Pain Rating scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Sleep quality score, objective measurement using the validated Likert sleep scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olu Bamgbade, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: