Frequency and Impact of Iron Deficiency in Pain Clinic Patients

Not yet recruiting

• Conditions: Iron Deficiency; Fibromyalgia

• Registration Number: NCT06665516
• Lead Sponsor: McMaster University

Brief Summary

The goal of this study is to measure the proportion of patients who have iron deficiency and if iron deficiency is treated what is the outcome. This will be done by testing ferritin and hemoglobin levels of female patients at the DeGroote Pain Clinic and administering the appropriate iron supplementation treatment (oral/infusion) if necessary. Participants will fill out a questionnaire to assess positive impact of iron supplementation treatment.

Detailed Description

The study is an observational clinical audit, with an unblinded clinical intervention. Iron deficiency and some chronic pain syndromes like fibromyalgia are more common in women of reproductive age. Iron deficiency can present with symptoms that are similar to those of fibromyalgia, but once recognized, iron deficiency is typically easily treated. We intend to poll patients at the DeGroote Pain Clinic based on information from studies conducted in Australia and Great Britain. We will determine who is at risk for iron deficiency based upon symptoms such as heavy periods, history of pregnancy, blood donation, diet, and any previous iron deficiency. We will then confirm the results with lab testing, and provide treatment if necessary. Our goal is to find out the percentage of women with chronic pain who also have iron deficiency, and assess the effect of treating iron deficiency on their pain symptoms.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Study Start: 2024-11-01
• Primary Completion: 2025-03-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Patient at the DeGroote Pain Clinic
• Menstruating women between the ages of 18-49
• Willingness to complete the questionnaire, and undergo laboratory tests if indicated.

Exclusion Criteria

• The only exclusion criteria is unwillingness to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who have iron deficiency at the DeGroote Pain Clinic	from enrollment to end of treatment after 3 months	Women patients arriving for pain clinic visits will be asked if they wish to participate in this audit and complete a screening questionnaire. Responses indicating iron deficiency will be offered laboratory testing for CBC and ferritin. If a patient is overtly anemic ( \> 120 \[Hb\] g/l), or ferritin less than \< 100 ug/ml, they will be offered iron replacement therapy through either oral therapy or IV iron infusion therapy.

Secondary Outcome Measures

Name	Time	Method
Participation rate and frequency of positive responses to the questionnaire with the intent of assessing the feasability and value of a more extensive study.	a week after end of treatment.	Patients dealing with iron deficiency symptoms will provided treatment, whose efficacy will be measured through our self-report questionnaire given at the end of treatment. If positive, the data and research gathered will be used to run a larger trial.

Trial Locations

Locations (1)

DeGroote Pain Clinic; 🇨🇦 Hamilton, Ontario, Canada