Clinical trial NCT06665516: Frequency and Impact of Iron Deficiency in Pain Clinic Patients
Official title: Frequency and Impact of Iron Deficiency in Pain Clinic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Iron Deficiency
Fibromyalgia
Keywords: iron deficiency
fibromyalgia
iron infusion therapy
chronic pain
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients attending the DeGroote Pain Clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who have iron deficiency at the DeGroote Pain Clinic
timeFrame: from enrollment to end of treatment after 3 months
Secondary outcomes:
measure: Participation rate and frequency of positive responses to the questionnaire with the intent of assessing the feasability and value of a more extensive study.
timeFrame: a week after end of treatment.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: DeGroote Pain Clinic
state: Ontario
Study officials:
References:
citation: Murray CJL; GBD 2021 Collaborators. Findings from the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):2259-2262. doi: 10.1016/S0140-6736(24)00769-4. No abstract available.
citation: GBD 2021 Anaemia Collaborators. Prevalence, years lived with disability, and trends in anaemia burden by severity and cause, 1990-2021: findings from the Global Burden of Disease Study 2021. Lancet Haematol. 2023 Sep;10(9):e713-e734. doi: 10.1016/S2352-3026(23)00160-6. Epub 2023 Jul 31.
citation: Pasricha SR, Tye-Din J, Muckenthaler MU, Swinkels DW. Iron deficiency. Lancet. 2021 Jan 16;397(10270):233-248. doi: 10.1016/S0140-6736(20)32594-0. Epub 2020 Dec 4.
citation: Dugan C, MacLean B, Cabolis K, Abeysiri S, Khong A, Sajic M, Richards T; Women's Health research Collaborative. The misogyny of iron deficiency. Anaesthesia. 2021 Apr;76 Suppl 4:56-62. doi: 10.1111/anae.15432.