ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12624000207516

Ethics application status

Approved

Date submitted

1/02/2024

Date registered

1/03/2024

Date last updated

1/03/2024

Date data sharing statement initially provided

1/03/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Just what I wanted to hear. Evaluating reassurance delivered to patients with spinal pain by either a Physiotherapist or medical officer during consultation in an orthopaedic spinal clinic.

Scientific title

Just what I wanted to hear. Evaluating reassurance delivered to patients with spinal pain by either a Physiotherapist or medical officer during consultation in an orthopaedic spinal clinic.

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

back pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

a) Exposure/Intervention
This study will be undertaken within the orthopaedic spinal clinic (OSC) at John Hunter Hospital, a tertiary referral hospital in New South Wales, Australia. The focus of the OSC is to evaluate and determine whether surgery may be helpful for a person’s spinal condition. Following assessment in the OSC patients may be recommended surgery or non-surgical options for their spinal condition such as injection therapies, physical rehabilitation and lifestyle interventions such as smoking cessation or dietitian advice. The focus of this study will be with adult patients referred for back and/or neck pain (Including Radicular/Radiculopathy). These patients will be assessed by either Medical officers or Physiotherapists who discuss each case with the consultant in charge to establish clinic recommendations for ongoing care. The medical officer or Physiotherapist is then responsible for discussing the clinic outcome and recommendations to each patient and communicating the outcome to the patient's referrer.
This evaluation will focus on any patient that is able to undertake non-surgical care recommendations for at least 3 months following the clinic appointment.
b) Data collection.
Participants will complete:
Consultation-based re- assurance questionnaire (CRQ) (Holt & Pincus, 2016)
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Pain self-efficacy questionnaire
Tampa Scale of Kinesiophobia – 11 (TSK-11)
Global Rating of Change Scale (GROC)
Additional questions include - educational level, employment status, recent health expenditure.
Clinicians will complete:
Physiotherapists and medical officers will complete a clinic outcome/survey form with each participant. questions include time taken for consultation, diagnosis, education delivered. This takes 1-3minutes to complete
c) Time taken to complete questionnaires
A consumer who had previously attended the clinic was consulted on the questionnaires. The complete set took up to 15minutes to complete.
d) Participants will complete questionnaires at baseline, 1 day after the OSC clinic appointment and 90days (3 months) following the clinic appointment.

Intervention code [1]

Not applicable

Comparator / control treatment

Comparison between a Physiotherapist and Medical officer as the primary clinician with the Medical officer group the reference comparator.

Control group

Active

Outcomes

Primary outcome [1]

Reassurance

Timepoint [1]

1 day and 12 weeks following Intervention (Spinal Clinic)

Secondary outcome [1]

Composite measure comprising of Pain, Physical Function, Social Participation, Mental Health (anxiety and Depression)

Timepoint [1]

Baseline. 12 weeks following Intervention (Spinal Clinic)

Secondary outcome [2]

Confidence of a person with persistent pain to do a range of activities while in pain

Timepoint [2]

Baseline and Week 12 following Intervention (Spinal Clinic)

Secondary outcome [3]

Pain-related fear avoidance.

Timepoint [3]

Baseline and Week 12 following Intervention (Spinal Clinic)

Secondary outcome [4]

Global Health Change

Timepoint [4]

1 Day and 12 weeks following Intervention (Spinal Clinic)

Eligibility

Key inclusion criteria

Participants over 18 years of age presenting for care in orthopaedic spinal Clinics at JHH during the research period.
Referred for back pain with or without leg pain or neck pain with or without arm pain.
Able to provide consent
Able to undertake non-surgical care for at least 3 months following the clinic appointment.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Cognitive impairment limiting ability to understand or follow recommendations.
Unable to read or speak English and does not have interpreter service support.
Unable to undertake recommended conservative care. Reasons may include terminal disease, spinal tumor, fracture identified, active spinal infection
Assessed as needing urgent (Less than 3 months) surgery.

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Descriptive statistics will be examined for all outcomes by treatment groups (means with SD, medians with interquartile range, or proportions).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

7/03/2024

Actual

Date of last participant enrolment

Anticipated

19/12/2024

Actual

Date of last data collection

Anticipated

20/03/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital - New Lambton

Recruitment postcode(s) [1]

2305 - New Lambton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

John Hunter Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

John Hunter Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

https://www.hnehealth.nsw.gov.au/research-office/research_ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/12/2023

Approval date [1]

19/12/2023

Ethics approval number [1]

Summary

Brief summary

This observational study takes place within Orthopaedic Spinal Clinics where staff consist of Physiotherapists and Medical Officers. The majority of patients are not likely to benefit from surgery. Instead, patients are offered reassurance regarding their spinal condition and advice to promote non-surgical strategies such as a graded activity plan. There is evidence linking reassurance to patient satisfaction and condition management however limited evidence that Physiotherapists and medical officers can equally reassure patents following an assessment in Orthopaedic spinal clinics. The primary aim of this pilot study is to evaluate the level of reassurance reported by patients via the Consultation Based Reassurance questionnaire (CRQ) following exposure to either the Physiotherapist or medical officer model of care in an Orthopaedic Spinal Clinic. Secondary outcomes of interest include pain, functional limitations and confidence managing pain symptoms. Outcomes are assessed at baseline, 1 day following clinic and 3 months following clinic.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Bruce Donald

Address

Physiotherapy Department. John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305

Country

Australia

Phone

+61 2 49223079

Fax

bruce.donald@health.nsw.gov.au

Contact person for public queries

Name

Bruce Donald

Address

Physiotherapy Department. John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305

Country

Australia

Phone

+61 2 49223079

Fax

bruce.donald@health.nsw.gov.au

Contact person for scientific queries

Name

Bruce Donald

Address

Physiotherapy Department. John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305

Country

Australia

Phone

+61 2 49223079

Fax

bruce.donald@health.nsw.gov.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

Not included in ethics approval.

What supporting documents are/will be available?

Doc. No.	Type	Email	Attachment
21555	Study protocol	bruce.donald@health.nsw.gov.au	387266-(Uploaded-01-02-2024-11-55-15)-Study-related document.docx
21560	Ethical approval	bruce.donald@health.nsw.gov.au
21561	Informed consent form	bruce.donald@health.nsw.gov.au

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

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