NCT07093424

Brief Summary

Complex Regional Pain Syndrome (CRPS) is a condition triggered by trauma such as surgery or a fracture. It is characterised by pain and limited mobility that are disproportionate to the severity of the trauma and the clinical course. Magnesium is recognised for its anti-inflammatory and antioxidant properties. The magnesium depletion score (MDS) is a more reliable and comprehensive scoring tool than measuring serum and urine magnesium levels. This score takes into account the patient's use of diuretics and proton pump inhibitors, their alcohol consumption, and their glomerular filtration rate. Impaired magnesium distribution may be a risk factor for CRPS development due to increased nociceptor activity. This study aimed to investigate whether an increased MDS score is a risk factor for CRPS development in individuals with traumatic limb injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

March 1, 2025

Enrollment Period

Same day

First QC Date

June 30, 2025

Last Update Submit

July 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • CRPS development

    crps development will be assessed according to Budapest criteria

    baseline

Study Arms (1)

traumatic extremity injury

Other: scoring

Interventions

scoringOTHER

magnesium depletion score calculation

traumatic extremity injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients admitted to our hospital's physical therapy and rehabilitation outpatient clinics with traumatic extremity injuries

You may qualify if:

  • Male and female patients aged 18-99 years with traumatic extremity injuries

You may not qualify if:

  • History of previous stroke, spinal cord injury
  • Presence of radiculopathy, radicular pain in the affected extremity
  • Previous surgery for cervical discopathy/lumbar discopathy
  • Presence of oncological, haematological diseases
  • History of previous peripheral nerve injury or previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Şişli, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Specialist, principal investigator

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 30, 2025

Study Start

January 1, 2025

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

July 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

only IPD used in the results publication

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations