ANZCTR - Registration

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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

14/01/2024

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]

Nil known

Universal Trial Number (UTN)

U1111-1261-0262

Trial acronym

DETECT

Linked study record

Health condition

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

Back pain

Neck pain

Condition category

Condition code

Musculoskeletal

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]

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]

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]

At the conclusion of the study

Primary outcome [2]

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]

At the conclusion of the study

Primary outcome [3]

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]

At the conclusion of the study

Secondary outcome [1]

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]

At 12-weeks post-randomisation

Secondary outcome [2]

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]

At 12-weeks post-randomisation

Secondary outcome [3]

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]

At the conclusion of the study

Secondary outcome [4]

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]

At the conclusion of the study

Secondary outcome [5]

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]

At the conclusion of the study

Secondary outcome [6]

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]

At the conclusion of the study

Secondary outcome [7]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

15/02/2021

Actual

1/03/2021

Date of last participant enrolment

Anticipated

31/07/2021

Actual

16/06/2022

Date of last data collection

Anticipated

31/10/2021

Actual

16/10/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Macquarie Chiropractic Alumni Research Fund (MtCaRF)

Address [1]

PO Box 1516
Macquarie Centre NSW 2113

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Balaclava Rd, Macquarie Park NSW 2109

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee (HREC)

Ethics committee address [1]

Research Hub, Building C5C East
Macquarie University
NSW 2109 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/09/2020

Approval date [1]

29/10/2020

Ethics approval number [1]

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

Dr Hazel Jenkins

Address

Department of Chiropractic, Room 347, 17 Wally's Walk, Macquarie University, 2109, NSW

Country

Australia

Phone

+61298509383

Fax

hazel.jenkins@mq.edu.au

Contact person for public queries

Name

Hazel Jenkins

Address

Department of Chiropractic, Room 347, 17 Wally's Walk, Macquarie University, 2109, NSW

Country

Australia

Phone

+61298509383

Fax

hazel.jenkins@mq.edu.au

Contact person for scientific queries

Name

Hazel Jenkins

Address

Department of Chiropractic, Room 347, 17 Wally's Walk, Macquarie University, 2109, NSW

Country

Australia

Phone

+61298509383

Fax

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 2023 till December 2027

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10017	Informed consent form			hazel.jenkins@mq.edu.au
10018	Ethical approval			hazel.jenkins@mq.edu.au

Results publications and other study-related documents

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No additional documents have been identified.

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