Trial Review

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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] 311451 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
back pain 332745 0
Condition category
Condition code
Musculoskeletal 329466 329466 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 329622 329622 0 0
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] 327896 0
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] 337279 0
Reassurance
Timepoint [1] 337279 0
1 day and 12 weeks following Intervention (Spinal Clinic)
Secondary outcome [1] 431303 0
Composite measure comprising of Pain, Physical Function, Social Participation, Mental Health (anxiety and Depression)
Timepoint [1] 431303 0
Baseline. 12 weeks following Intervention (Spinal Clinic)
Secondary outcome [2] 431304 0
Confidence of a person with persistent pain to do a range of activities while in pain
Timepoint [2] 431304 0
Baseline and Week 12 following Intervention (Spinal Clinic)
Secondary outcome [3] 431305 0
Pain-related fear avoidance.
Timepoint [3] 431305 0
Baseline and Week 12 following Intervention (Spinal Clinic)
Secondary outcome [4] 431307 0
Global Health Change
Timepoint [4] 431307 0
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?
No
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
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26130 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 41989 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 315731 0
Hospital
Name [1] 315731 0
John Hunter Hospital
Country [1] 315731 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Country
Australia
Secondary sponsor category [1] 317840 0
None
Name [1] 317840 0
Address [1] 317840 0
Country [1] 317840 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314594 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 314594 0
https://www.hnehealth.nsw.gov.au/research-office/research_ethics
Ethics committee country [1] 314594 0
Australia
Date submitted for ethics approval [1] 314594 0
15/12/2023
Approval date [1] 314594 0
19/12/2023
Ethics approval number [1] 314594 0

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 132122 0
Mr Bruce Donald
Address 132122 0
Physiotherapy Department. John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country 132122 0
Australia
Phone 132122 0
+61 2 49223079
Fax 132122 0
Email 132122 0
[email protected]
Contact person for public queries
Name 132123 0
Bruce Donald
Address 132123 0
Physiotherapy Department. John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country 132123 0
Australia
Phone 132123 0
+61 2 49223079
Fax 132123 0
Email 132123 0
[email protected]
Contact person for scientific queries
Name 132124 0
Bruce Donald
Address 132124 0
Physiotherapy Department. John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country 132124 0
Australia
Phone 132124 0
+61 2 49223079
Fax 132124 0
Email 132124 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
Not included in ethics approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21555Study protocol  [email protected] 387266-(Uploaded-01-02-2024-11-55-15)-Study-related document.docx
21560Ethical approval  [email protected]
21561Informed consent form  [email protected]



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.