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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]

None

Universal Trial Number (UTN)

Trial acronym

CANCAN

Linked study record

Health condition

Health condition(s) or problem(s) studied:

iron deficiency anaemia

chronic pain

anaemia

fatigue level

Blood

Condition category

Condition code

Anaesthesiology

Anaesthetics

Blood

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

Primary outcome [3]

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]

Secondary outcome [1]

The secondary outcome is to measure patients fatigue levels as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.

Timepoint [1]

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]

A secondary outcome is to measure patients pain levels by utilising the visual analogue scale (VAS).

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Brisbane and Women's Hospital Foundation

Address [1]

Block 20 Royal Brisbane and Women’s Hospital, Butterfield St, Herston QLD 4006

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Brisbane and Women's Hospital

Address

Butterfield St, Herston QLD 4029

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee RBWH

Ethics committee address [1]

Butterfield St, Herston QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/11/2019

Approval date [1]

19/12/2019

Ethics approval number [1]

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

Prof Kerstin Wyssusek

Address

Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029

Country

Australia

Phone

+61736468111

Fax

+61736463108

[email protected]

Contact person for public queries

Name

Kerstin Wyssusek

Address

Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029

Country

Australia

Phone

+61736468111

Fax

+61736463108

[email protected]

Contact person for scientific queries

Name

Kerstin Wyssusek

Address

Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029

Country

Australia

Phone

+61736468111

Fax

+61736463108

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5686	Study protocol					378733-(Uploaded-14-11-2019-13-21-08)-Study-related document.pdf
5687	Informed 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.

Trial Review

Documents added manually

Documents added automatically