Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001782123
Ethics application status
Approved
Date submitted
14/11/2019
Date registered
17/12/2019
Date last updated
8/01/2020
Date data sharing statement initially provided
17/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A cross-sectional study of iron deficiency anaemia and chronic pain
Scientific title
A cross-sectional study of the relationship between iron deficiency anaemia and chronic pain in patients presenting to a multidisciplinary pain centre in a tertiary referral teaching hospital
Secondary ID [1] 299802 0
None
Universal Trial Number (UTN)
Trial acronym
CANCAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
iron deficiency anaemia 315176 0
chronic pain 315177 0
anaemia 315184 0
fatigue level 315185 0
Blood 315371 0
Condition category
Condition code
Anaesthesiology 313492 313492 0 0
Anaesthetics
Blood 313674 313674 0 0
Anaemia

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients presenting to the RBWH Professor Tess Cramond Multidisciplinary Pain Centre for treatment of a chronic pain condition that they have had for more than 12 months in duration, will be identified by trained research personnel and chronic pain personnel. Patients will be recruited in the clinic or identified prior to their scheduled appointment and telephoned to discuss their potential participation in the study, discuss any concerns, and gain their verbal consent to approach the patient on the day of their outpatients’ appointment. Information to be discussed includes details of the Patient Information Sheet and a telephone script has been designed for this purpose. The phone calls will be conducted by trained research personnel.
On the appointment day, the patient will sign the consent form if agreeable, and will receive a copy of Patient Information Form and signed consent. Data collection and blood sampling (Pathology) will be performed. All data points will be recorded in REDCap, a secure electronic data program.
Each patient will have pain measured on the visual analogue scale, fatigue levels measured with the FACIT score which will take 5 minutes to complete, and a blood sample taken for iron studies. Blood sampling will be obtained via routine venepuncture methods in line with hospital policy. This data will be used to calculate current pain levels, fatigue scores and iron levels in combination to determine the relationship between iron deficiency anaemia and chronic pain.
Intervention code [1] 316055 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321954 0
The primary outcome of this observational pilot study is to assess the prevalence of anaemia in patients with chronic pain assessed by measuring iron levels in blood.
Timepoint [1] 321954 0
The primary timepoint for the recruitment of all 80 participants is to review the chronic pain outpatient appointment list a day prior to patients scheduled appointment and on the day of their appointment over a period of eight months (December 2019 to July 2020). Patients will require venepuncture before or after their scheduled appointment, depending on what is most applicable.
Primary outcome [2] 322318 0
The primary outcome of this observational pilot study is to assess the prevalence of iron deficiency without anaemia in patients with chronic pain assessed by measuring iron levels in blood.
Timepoint [2] 322318 0
The primary timepoint for the recruitment of all 80 participants is to review the chronic pain outpatient appointment list a day prior to patients scheduled appointment and on the day of their appointment over a period of eight months (December 2019 to July 2020). Patients will require venepuncture before or after their scheduled appointment, depending on what is most applicable.
Primary outcome [3] 322319 0
The primary outcome of this observational pilot study is to assess the prevalence of iron deficiency anaemia (IDA) in patients with chronic pain assessed by measuring iron levels in blood.
Timepoint [3] 322319 0
The primary timepoint for the recruitment of all 80 participants is to review the chronic pain outpatient appointment list a day prior to patients scheduled appointment and on the day of their appointment over a period of eight months (December 2019 to July 2020). Patients will require venepuncture before or after their scheduled appointment, depending on what is most applicable.
Secondary outcome [1] 376794 0
The secondary outcome is to measure patients fatigue levels as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.
Timepoint [1] 376794 0

Each patient consented for the study will require 5 minutes to participate in the FACIT Fatigue questionnaire before or after their scheduled chronic pain appointment, depending on what is most applicable.
Secondary outcome [2] 377334 0
A secondary outcome is to measure patients pain levels by utilising the visual analogue scale (VAS).
Timepoint [2] 377334 0
Each patient consented for the study will require 2 minutes to participate in the VAS which will be done before or after their scheduled chronic pain appointment, depending on what is most applicable.

Eligibility
Key inclusion criteria
Patients equal to or older than 18 years of age.
Patient experiencing Chronic pain for more than 12 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with known or suspected blood disorders
Pregnancy
Known medication with iron supplements including intravenous iron
Surgery within the last 6 months

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample Size
A sample size of 80 will be obtained as a pilot sample in preparation for a larger cohort study. In the healthy Australian population, it is expected that approximately 20% of people have anaemia 8.70% have iron deficient anaemia (non-pregnant women). Although the exact percentage of chronic pain patients with iron deficiency and anaemia is unknown, it is expected it may be similar or higher than the healthy population. The sample size chosen will be adequate in providing an estimate of the percentage with iron deficiency.

Statistical Analysis
Descriptive statistical analyses will be performed. Categorical variables will be described using number (percent) and continuous variables using mean (standard deviation) or median (interquartile range) as appropriate. The relationship between iron deficiency anaemia and pain will be explored using a “Kruskall-Wallis test”. Test will be declared statistically significant at the two-sided a<0.05 level. Analyses will be performed in STATA 15.

Data collection and blood sampling (Pathology) will be performed. All data points will be recorded in REDCap, a secure electronic data program.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/01/2020
Actual
Date of last participant enrolment
Anticipated
27/11/2020
Actual
Date of last data collection
Anticipated
18/12/2020
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 28438 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 304264 0
Charities/Societies/Foundations
Name [1] 304264 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 304264 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield St, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 304514 0
None
Name [1] 304514 0
Address [1] 304514 0
Country [1] 304514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304719 0
Human Research Ethics Committee RBWH
Ethics committee address [1] 304719 0
Butterfield St, Herston QLD 4029
Ethics committee country [1] 304719 0
Australia
Date submitted for ethics approval [1] 304719 0
14/11/2019
Approval date [1] 304719 0
19/12/2019
Ethics approval number [1] 304719 0

Summary
Brief summary
Approximately 30% of the world’s population suffer from anaemia, a condition characterised by decreased levels of red blood cells in the blood, resulting in a reduced capacity to carry oxygen. Iron deficiency anaemia (IDA) is the most common type of anaemia and is often overlooked, especially in people with chronic conditions. The purpose of this study is to assess the prevalence of anaemia, iron deficiency without anaemia and IDA in patients with chronic pain. Patients with chronic pain can present with chronic inflammatory conditions and often experience a reduced health-related quality of life which is an important target of therapeutic interventions. Iron deficiency, even in the absence of anaemia, can be debilitating, and may exacerbate any underlying chronic disease, leading to increased morbidity and mortality. The most common symptoms of IDA are fatigue, weakness, dizziness, headache, lethargy, but it is hypothesised that IDA can also lead to pain. Treatment for this form of anaemia is simple, effective and safe. We hypothesise that chronic pain patients may contribute to a higher prevalence of IDA.





Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 97990 0
Prof Kerstin Wyssusek
Address 97990 0
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 97990 0
Australia
Phone 97990 0
+61736468111
Fax 97990 0
+61736463108
Email 97990 0
[email protected]
Contact person for public queries
Name 97991 0
Prof Kerstin Wyssusek
Address 97991 0
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 97991 0
Australia
Phone 97991 0
+61736468111
Fax 97991 0
+61736463108
Email 97991 0
[email protected]
Contact person for scientific queries
Name 97992 0
Prof Kerstin Wyssusek
Address 97992 0
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 97992 0
Australia
Phone 97992 0
+61736468111
Fax 97992 0
+61736463108
Email 97992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5686Study protocol    378733-(Uploaded-14-11-2019-13-21-08)-Study-related document.pdf
5687Informed consent form    378733-(Uploaded-14-11-2019-13-23-43)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.