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Trial registered on ANZCTR


Registration number
ACTRN12621000087853
Ethics application status
Approved
Date submitted
11/11/2020
Date registered
1/02/2021
Date last updated
1/02/2021
Date data sharing statement initially provided
1/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Do diagnostic x-rays for spinal pain in patients receiving chiropractic care change patient outcomes? A pilot randomised controlled trial.
Scientific title
Do diagnostic x-rays for spinal pain in patients receiving chiropractic care change patient outcomes? A pilot randomised controlled trial.
Secondary ID [1] 302683 0
Nil known
Universal Trial Number (UTN)
U1111-1261-0262
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Back pain 319598 0
Neck pain 320043 0
Condition category
Condition code
Musculoskeletal 317538 317538 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is referral for spinal X-rays.
Chiropractors will be recruited into the study if they self-report to regularly refer new patients for X-rays and treat patients with spinal manipulation. The participating chiropractor will use clinician judgement as per their standard practice to determine whether a patient requires an X-ray. Patients who the practitioner determines require an X-ray but do not have any suspicion of underlying serious pathology (see inclusion criteria) will be eligible for participation in the study, and for randomisation if they consent to participate.
Participants allocated to the intervention group will receive an X-ray of the relevant spinal region/s (as determined by the treating chiropractor).
X-rays will be taken either onsite (if available) or at an external radiology clinic. If a participant chooses not to have the X-ray, they do not need to do so and this will be recorded as a cross-over between groups. Any further treatment will be provided as determined by the treating chiropractor.
Follow-up surveys to both the patient at 2, 6, and 12 weeks will be used to determine if x-rays were taken as allocated at randomisation.
Intervention code [1] 318964 0
Treatment: Devices
Comparator / control treatment
The control group will not receive spinal X-rays. When the treating chiropractor determines that the participant requires an X-ray, participants allocated to the control group will not receive an immediate X-ray. If the treating chiropractor determines that imaging is subsequently needed during the study period, then the participant will be referred for imaging and this will be recorded as a cross-over between groups. Any further treatment will be provided as determined by the treating chiropractor.
Control group
Active

Outcomes
Primary outcome [1] 325579 0
Participant recruitment as the proportion of patients who meet inclusion criteria and are invited to participate who subsequently consent to participate through audit of a study-specific database completed by the participating chiropractors in Redcap.
Timepoint [1] 325579 0
At the conclusion of the study
Primary outcome [2] 325667 0
Chiropractic practitioner recruitment as the proportion of chiropractors meeting the inclusion criteria who subsequently consent to participate using a study database completed by the research team in Redcap
Timepoint [2] 325667 0
At the conclusion of the study
Primary outcome [3] 325668 0
Completion of follow-up 12-week online questionnaire, administered through Redcap, as the proportion of participants who complete all questions.
12 week questionnaire includes: numerical pain scale, adverse events, satisfaction with care, and either Roland Morris disability questionnaire or neck disability index
Completion of questions will be assessed through the study database, exported from Redcap.
Timepoint [3] 325668 0
At the conclusion of the study
Secondary outcome [1] 388450 0
Cross-over between intervention and control groups. This will be measured in the study database through questions in the 2, 6, and 12 week patient questionnaires regarding whether the patient has obtained x-rays. Cross-over will be considered when a participant in the intervention group does not obtain x-rays or when a participant in the control group does obtain x-rays
Timepoint [1] 388450 0
At 12-weeks post-randomisation
Secondary outcome [2] 388455 0
Receipt of spinal manipulation as a treatment. This will be measured in the study database through questions in the 2, 6, and 12 week clinician questionnaires regarding whether they have used spinal manipulative therapy on the patient or not.
Timepoint [2] 388455 0
At 12-weeks post-randomisation
Secondary outcome [3] 389765 0
Participant recruitment as the proportion of patients presenting with spinal pain who meet the inclusion criteria for the study through audit of a study-specific database completed by the participating chiropractors in Redcap.
Timepoint [3] 389765 0
At the conclusion of the study
Secondary outcome [4] 389766 0
Participant recruitment as the proportion of patients who meet the inclusion criteria who are invited by the clinician to participate through audit of a study-specific database completed by the participating chiropractors in Redcap.
Timepoint [4] 389766 0
At the conclusion of the study
Secondary outcome [5] 389767 0
Chiropractic practitioner recruitment as the proportion of chiropractors approached who meet inclusion criteria using a study database completed by the research team in Redcap
Timepoint [5] 389767 0
At the conclusion of the study
Secondary outcome [6] 389768 0
Completion of follow-up 2-week online questionnaire, administered through Redcap, as the proportion of participants who complete all questions.
2 week questionnaire includes: numerical pain scale, adverse events, satisfaction with care, and either Roland Morris disability questionnaire or neck disability index
Completion of questions will be assessed through the study database, exported from Redcap.
Timepoint [6] 389768 0
At the conclusion of the study
Secondary outcome [7] 389769 0
Completion of follow-up 6-week online questionnaire, administered through Redcap, as the proportion of participants who complete all questions.
6 week questionnaire includes: numerical pain scale, adverse events, satisfaction with care, and either Roland Morris disability questionnaire or neck disability index
Completion of questions will be assessed through the study database, exported from Redcap.
Timepoint [7] 389769 0
At the conclusion of the study

Eligibility
Key inclusion criteria
Inclusion criteria for patients:
• New episode of spinal pain, defined as no prior episode with greater than or equal to 2/10 numerical pain score lasting more than 24 hours within the previous month
• Treating chiropractor intending to refer the patient for X-ray, for reasons outside current X-ray guidelines.
• Treating chiropractor intending to use spinal manipulative therapy as a treatment option
• Ability to read and understand English to consent to the research and complete the questionnaires.

Inclusion criteria for chiropractors:
• Chiropractors who self-report regularly treating patients presenting with spinal pain
• Chiropractors who self-report that they use spinal manipulative therapy with the majority of their spinal pain patients
• Chiropractors who self-report regularly (but not always) referring patients for X-rays (referring between 20-80% of new patients for X-ray)
• Willing to randomise patients to be X-rayed
• Practice within Sydney or immediate surrounds.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Under 18 years of age
• Pregnancy
• Treating chiropractor suspects serious underlying pathology requiring further investigation or referral (e.g. cancer, infection, fracture, cauda equina syndrome, myelopathy, progressive neurological symptoms, chest or abdominal pathology)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to intervention/control groups through REDCap software after return of consent and baseline questionnaire
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random number lists
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations were based on participant recruitment proportions. The 95% confidence interval approach suggested for sample size calculation for feasibility trials was used. For this pilot study, 10 chiropractors will be recruited. If 50% of eligible chiropractors agree to participate (i.e. 20 invited) then the confidence intervals for agreeing to participate will extend from 30% to 70%. If only 33% agree to participate (i.e. 30 invited), then confidence intervals will range from 19% to 51%. Chiropractors will be asked to recruit patients, with the aim to recruit a total of 50 patients. If 75% of eligible patients agree to participate (i.e. 67 invited) then the confidence intervals for agreeing to participate will extend from 63% to 84%. If only 50% agree to participate (i.e. 100 invited), then confidence intervals will range from 40% to 60%.

Feasibility outcomes will be analysed as proportions with 95% confidence intervals.
1. Participant recruitment as the proportion of:
a. participants presenting with spinal pain who meet the inclusion criteria for the study
b. participants who meet the inclusion criteria that are invited by the treating chiropractor to participate
c. participants who meet inclusion criteria and are invited to participate who subsequently consent to participate
2. Chiropractic practitioner recruitment as the proportion of:
a. chiropractors approached who meet inclusion criteria
b. chiropractors meeting the inclusion criteria who subsequently consent to participate
3. Complete data collection/follow ups in intervention and control groups
4. Participant cross-over between intervention and control groups
5. Participant who receive spinal manipulative therapy in intervention and control groups

Qualitative analysis will be formed on participant and chiropractor responses to reasons for:
1. Chiropractors not consenting to participate
2. Chiropractors not informing patients of the study
3. Participants not interested in receiving information about the study
4. Participants not consenting to participate
5. Participant cross-over between intervention and control groups

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307122 0
Other Collaborative groups
Name [1] 307122 0
Macquarie Chiropractic Alumni Research Fund (MtCaRF)
Address [1] 307122 0
PO Box 1516
Macquarie Centre NSW 2113
Country [1] 307122 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 307768 0
None
Name [1] 307768 0
Address [1] 307768 0
Country [1] 307768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307234 0
Macquarie University Human Research Ethics Committee (HREC)
Ethics committee address [1] 307234 0
Research Hub, Building C5C East
Macquarie University
NSW 2109 Australia
Ethics committee country [1] 307234 0
Australia
Date submitted for ethics approval [1] 307234 0
13/09/2020
Approval date [1] 307234 0
29/10/2020
Ethics approval number [1] 307234 0
52020912721836

Summary
Brief summary
Many chiropractors believe that X-rays are needed to detect findings that will either contraindicate or change the application of spinal manipulative therapy. Without X-rays, these chiropractors believe that they may perform sub-optimal and potentially unsafe care. Although this belief is in contrast to recommendations in clinical practice guidelines, current evidence is unavailable to confirm or refute this belief. The limited research available indicates that X-rays do not improve outcomes in patients with acute low back pain when managed with usual medical care. No studies have assessed the effect of X-rays on patient outcomes when patient management includes spinal manipulative therapy. The effect of X-ray use on areas other than the low back, or on adverse events after spinal manipulative therapy have also not been examined.

A large-scale fully powered effectiveness trial will provide important information to inform chiropractic clinical practice regarding the appropriate use of X-rays for spinal pain, to maximise patient outcomes and limit potential risks. This proposed pilot randomised controlled trial aims to provide critical feasibility data prior to performing a large-scale effectiveness trial. This study will inform the ability to recruit patients and chiropractors, the willingness of chiropractors to treat patients without X-ray, and the amount of patient loss to follow-up or cross-over rates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106502 0
Dr Hazel Jenkins
Address 106502 0
Department of Chiropractic, Room 347, 17 Wally's Walk, Macquarie University, 2109, NSW
Country 106502 0
Australia
Phone 106502 0
+61298509383
Fax 106502 0
Email 106502 0
hazel.jenkins@mq.edu.au
Contact person for public queries
Name 106503 0
Dr Hazel Jenkins
Address 106503 0
Department of Chiropractic, Room 347, 17 Wally's Walk, Macquarie University, 2109, NSW
Country 106503 0
Australia
Phone 106503 0
+61298509383
Fax 106503 0
Email 106503 0
hazel.jenkins@mq.edu.au
Contact person for scientific queries
Name 106504 0
Dr Hazel Jenkins
Address 106504 0
Department of Chiropractic, Room 347, 17 Wally's Walk, Macquarie University, 2109, NSW
Country 106504 0
Australia
Phone 106504 0
+61298509383
Fax 106504 0
Email 106504 0
hazel.jenkins@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data of all data collected during the trial
When will data be available (start and end dates)?
From the conclusion of the study, after data has been organised, for five years: January 2022 till December 2026
Available to whom?
Researchers on request
Available for what types of analyses?
For future Human Research Ethics Committee approved research projects which are an extension of, or closely related to, this proposed study
How or where can data be obtained?
By request to the chief investigator via email: hazel.jenkins@mq.edu.au
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 10017 0
Informed consent form
Citation [1] 10017 0
Link [1] 10017 0
Email [1] 10017 0
hazel.jenkins@mq.edu.au
Other [1] 10017 0
Attachment [1] 10017 0
Type [2] 10018 0
Ethical approval
Citation [2] 10018 0
Link [2] 10018 0
Email [2] 10018 0
hazel.jenkins@mq.edu.au
Other [2] 10018 0
Attachment [2] 10018 0
Summary results
No Results