NCT05862454

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

5.5 years

First QC Date

May 7, 2023

Last Update Submit

January 23, 2025

Conditions

Keywords

MagnesiumSteroid avoidance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sleep quality score, objective measurement using the validated Likert sleep scale

    12 weeks

Study Arms (1)

Adult chronic pain patients

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

Drug: Magnesium

Interventions

Magnesium injection therapy

Also known as: Magnesium injection
Adult chronic pain patients

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • organ insufficiency
  • cognitive disorder
  • inability to provide consent
  • major neuropsychiatric disorder
  • unreliable diary
  • poor treatment compliance
  • previous adverse/allergic reactions to magnesium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

RECRUITING

MeSH Terms

Interventions

Magnesium

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Olu Bamgbade, MD,FRCPC

    Salem Anaesthesia Pain Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olu Bamgbade, MD,FRCPC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2023

First Posted

May 17, 2023

Study Start

July 2, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations