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Clinical Trials/NCT05862454
NCT05862454
Recruiting
Not Applicable

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

Salem Anaesthesia Pain Clinic1 site in 1 country150 target enrollmentJuly 2, 2020

Overview

Phase
Not Applicable
Intervention
Magnesium
Conditions
Steroid Metabolism Disorder
Sponsor
Salem Anaesthesia Pain Clinic
Enrollment
150
Locations
1
Primary Endpoint
Pain score, objective measurement using the validated Numeric Pain Rating scale
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2, 2020
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Salem Anaesthesia Pain Clinic
Responsible Party
Sponsor

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

Arms & Interventions

Adult chronic pain patients

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

Intervention: Magnesium

Outcomes

Primary Outcomes

Pain score, objective measurement using the validated Numeric Pain Rating scale

Time Frame: 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 Outcomes

  • Sleep quality score, objective measurement using the validated Likert sleep scale(12 weeks)

Study Sites (1)

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