Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000482561
Ethics application status
Approved
Date submitted
5/02/2024
Date registered
19/04/2024
Date last updated
19/04/2024
Date data sharing statement initially provided
19/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility trial for people with musculoskeletal chest pain
Scientific title
Investigating a new approach to care for people with musculoskeletal chest pain: A randomised controlled feasibility trial
Secondary ID [1] 308566 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
musculoskeletal chest pain 328426 0
Condition category
Condition code
Musculoskeletal 325448 325448 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
New approach to care by a physiotherapist, in line with best practice.
From the participant information sheet:
Both groups will receive care from a physiotherapist that is in line with best practice. Participants will be asked to attend up to six sessions of 30-60 minutes over a six-week period, and one session at 12 weeks.
If you are eligible and agree to participate in the study you will be allocated to a group, and the full details of the treatment sessions involved will be discussed with you. The study design allows participants to be fully aware of the treatment involved in their own care, but unaware of the treatment involved in the other group. At the end of the 12 weeks, we will debrief you and explain the approach to care received by the other group, should you wish to explore this.
All sessions will be done in the location where you join the study (School of Physiotherapy in Dunedin or Dunstan hospital in Clyde).
Best practice is informed by a range of resources, including DynaMed. (2022). Costochondritis https://www.dynamed.com/condition/costochondritis
Intervention code [1] 327910 0
Rehabilitation
Comparator / control treatment
Current approach to care by a physiotherapist, in line with best practice.
From the participant information sheet:
Both groups will receive care from a physiotherapist that is in line with best practice. Participants will be asked to attend up to six sessions of 30-60 minutes over a six-week period, and one session at 12 weeks.
If you are eligible and agree to participate in the study you will be allocated to a group, and the full details of the treatment sessions involved will be discussed with you. The study design allows participants to be fully aware of the treatment involved in their own care, but unaware of the treatment involved in the other group. At the end of the 12 weeks, we will debrief you and explain the approach to care received by the other group, should you wish to explore this.
All sessions will be done in the location where you join the study (School of Physiotherapy in Dunedin or Dunstan hospital in Clyde).
Best practice is informed by a range of resources, including DynaMed. (2022). Costochondritis https://www.dynamed.com/condition/costochondritis
Control group
Active

Outcomes
Primary outcome [1] 337298 0
Determine the recruitment potential and the acceptability of randomisation.
This will be assessed as a composite outcome based on:
• Number of potential participants given study invitation in ED (audit of invitations distributed / logbook)
• Number of potential participants screened (after they contacted the study coordinator), as determined by an audit of screening logs.
• Proportion of potential participants screened meeting the eligibility criteria (number of those screened divided by the number of those meeting the eligibility criteria), as determined by an audit of screening records.
• Reasons for exclusion from study for each excluded potential participant, as determined by an audit of screening records.
• Of those meeting the eligibility criteria, the number agreeing to take part in the study
• Recruitment rate, i.e., number of participants recruited divided by the number of sites, then divided by the total number of months of recruitment
• Acceptability of randomisation for participants (by blinding index assessment as described by Bang et al 2004, and study-specific semi-structured interview of participants at 12 weeks post-baseline)
Timepoint [1] 337298 0
• Number of potential participants given study invitation in ED (audit of invitations distributed / logbook) - at the conclusion of the study.
• Number of potential participants screened (after they contacted the study coordinator) - at the conclusion of the study.
• Proportion of potential participants screened meeting the eligibility criteria (number of those screened divided by the number of those meeting the eligibility criteria) - at the conclusion of the study.
• Reasons for exclusion from study for each excluded potential participant - at the conclusion of the study.
• Of those meeting the eligibility criteria, the number agreeing to take part in the study - at the conclusion of the study.
• Recruitment rate, i.e., number of participants recruited divided by the number of sites, then divided by the total number of months of recruitment - at the conclusion of the study.
• Acceptability of randomisation for participants (by seeking feedback from participants at 12 weeks post-baseline)
Primary outcome [2] 337299 0
Determine the feasibility/acceptability of the baseline visit and assessments.
This will be assessed as a composite outcome based on:
• Total time taken for each baseline visit (minutes)
• Proportion of questionnaires completed
• Acceptability of assessment procedures (semi-structured interview; at 12 week post-baseline assessment)
• Additional issues with the assessment/ determine barriers to participation (semi-structured interview, at 12 week post-baseline assessment)
• Proportion of participants randomised who return to complete the assessments in both arms (provide drop-out rates expressed as a percentage of the total number of participants enrolled in the study, with reasons)
Timepoint [2] 337299 0
• Total time taken for each baseline visit (minutes) - on completion of all baseline visits.
• Proportion of all assessment components completed as determined by audit of study records at the conclusion of the study.
• Acceptability of assessment procedures (semi-structured interview; at 12 week post-baseline assessment)
• Additional issues with the assessment/ determine barriers to participation (semi-structured interview, at 12 week post-baseline assessment)
• Proportion of participants randomised who return to complete the assessments in both arms (provide drop-out rates expressed as a percentage of the total number of participants enrolled in the study, with reasons) - at the conclusion of the study
Primary outcome [3] 337300 0
Determine the acceptability of the treatment procedures.
This will be assessed as a composite outcome based on:
• Participant retention at six weeks and 12 weeks post-baseline, as determined by audit of study records of enrolment/withdrawal at each timepoint.
• Acceptability of the interventions (semi-structured interview at 12 week post-baseline assessment)
• Adherence to the interventions, measured as the number of intervention sessions attended and expressed as a percentage of the total number of scheduled sessions, as determined by audit of clinical records
• Determine reasons for non-adherence (follow-up by study coordinator)
• Determine the fidelity of physiotherapy treatment delivered by clinicians (via clinical notes audit)
Timepoint [3] 337300 0
• Participant retention at six weeks and 12 weeks post-baseline
• Acceptability of the interventions (semi-structured interview at 12 week post-baseline assessment)
• Adherence to the interventions, measured as the number of sessions attended and expressed as a percentage of the total number of scheduled sessions - on completion of the study.
• Determine reasons for non-adherence (follow-up by study coordinator)
• Determine the fidelity of physiotherapy treatment delivered by clinicians (via clinical notes audit on completion of the study)
Secondary outcome [1] 431389 0
Determine the suitability of blinding procedures.
This is an additional primary outcome. This will be assessed as a composite outcome based on:
• Proportion of participants successfully blinded to their study group (semi-structured interview at 12 weeks post-baseline assessment)
• Influence of presumed study group allocation on participants (semi-structured interview at 12 weeks post-baseline assessment).
Timepoint [1] 431389 0
• Proportion of participants successfully blinded to their study group (semi-structured interview at 12 weeks post-baseline assessment)
• Influence of presumed study group allocation on participants (semi-structured interview at 12 weeks post-baseline assessment).
Secondary outcome [2] 431390 0
Determine the acceptability of study procedures for clinicians and researchers associated with the study.
This is an additional primary outcome. This will be assessed as a composite outcome based on:
• Feedback from people (clinicians) involved in recruitment (record of communications, debrief on completion of the study).
• Focus group as a research team on completion of the study.
• Feedback from physiotherapy clinicians (record of communications, debrief on completion of the intervention period).
Timepoint [2] 431390 0
• Feedback from people (clinicians) involved in recruitment (record of communications, debrief on completion of the study).
• Focus group as a research team on completion of the study.
• Feedback from physiotherapy clinicians (record of communications, debrief on completion of the intervention period).
Secondary outcome [3] 431391 0
Determine the occurrence of adverse events and access to other health professionals.
This is an additional primary outcome. This will be assessed as a composite outcome based on:
• Total number of participants who reported adverse events. The relatedness to the interventions, the number, duration and severity of the adverse reactions will be reported (assessed by weekly questionnaire designed for this study during weeks 1-6 post-baseline; clinical notes-audit at the conclusion of the study) (Phillips et al., 2019).
• Proportion of participants in the experimental group for which the intervention was modified due to adverse effects (via clinical notes-audit at the conclusion of the study)
• Proportion of participants seeing other health professionals for chest pain within study period; with reasons (assessed by weekly questionnaire designed for this study during weeks 1-6 post-baseline)
Timepoint [3] 431391 0
• Total number of participants who reported adverse events. The relatedness to the interventions, the number, duration and severity of the adverse reactions will be reported (assessed by weekly questionnaire designed for this study during weeks 1-6 post-baseline; clinical notes-audit at the conclusion of the study) (Phillips et al., 2019).
• Proportion of participants in the experimental group for which the intervention was modified due to adverse effects (via clinical notes-audit at the conclusion of the study)
• Proportion of participants seeing other health professionals for chest pain within study period; with reasons (assessed by weekly questionnaire designed for this study during weeks 1-6 post-baseline)
Secondary outcome [4] 431392 0
• Pain intensity based on self-rating of worst pain in past 7 days on 11-point scale: Modified PROMIS v1.0 - Pain Intensity 1a
Timepoint [4] 431392 0
Baseline, weekly during weeks 1-6 post-baseline, and at 12 weeks post-baseline.
Secondary outcome [5] 431972 0
• Pain Interference: PROMIS SF v1.1 – Pain Interference 4a (PROMIS Health Organization and Assessment Center?). Self-rating of how much pain interfered in the past seven days with (i) day to day activities; (ii) work around the home; (iii) ability to participate in social activities; (iv) household chores on five-point Likert scales
Timepoint [5] 431972 0
Baseline, weekly during weeks 1-6 post-baseline, and at 12 weeks post-baseline.
Secondary outcome [6] 431973 0
• Pain medication use. This will be assessed as a composite outcome.
Questions assessing if (1) pain medication was used to manage chest pain in past 7 days; (2) What type of pain medication was used; (3) how often and how much the respective pain medication(s) was used.
Timepoint [6] 431973 0
Baseline, weekly during weeks 1-6 post-baseline, and at 12 weeks post-baseline.
Secondary outcome [7] 431974 0
• Brief Illness Perceptions Questionnaire (Broadbent et al., 2006) Question (1) How much does your chest pain affects your life?
Timepoint [7] 431974 0
Baseline, week 6 and week 12 post-baseline
Secondary outcome [8] 431975 0
• Brief Illness Perceptions Questionnaire (Broadbent et al., 2006) Question (2) How long do you think your chest pain will continue?;
Timepoint [8] 431975 0
Baseline, week 6 and week 12 post-baseline
Secondary outcome [9] 431976 0
• Brief Illness Perceptions Questionnaire (Broadbent et al., 2006) Question (3) How much control do you feel you have over your chest pain?
Timepoint [9] 431976 0
Baseline, week 6 and week 12 post-baseline
Secondary outcome [10] 431977 0
• Brief Illness Perceptions Questionnaire (Broadbent et al., 2006) Question (4) How much do you think your treatment can help your chest pain?;
Timepoint [10] 431977 0
Baseline, week 6 and week 12 post-baseline
Secondary outcome [11] 431978 0
• Brief Illness Perceptions Questionnaire (Broadbent et al., 2006) Question (5) How much do you experience symptoms from your chest pain?
Timepoint [11] 431978 0
Baseline, week 6 and week 12 post-baseline
Secondary outcome [12] 431979 0
• Brief Illness Perceptions Questionnaire (Broadbent et al., 2006) Question (6) How concerned are you about your chest pain?
Timepoint [12] 431979 0
Baseline, week 6 and week 12 post-baseline
Secondary outcome [13] 431980 0
• Brief Illness Perceptions Questionnaire (Broadbent et al., 2006) Question (7) How well do you understand your chest pain?
Timepoint [13] 431980 0
Baseline, week 6 and week 12 post-baseline
Secondary outcome [14] 431981 0
• Brief Illness Perceptions Questionnaire (Broadbent et al., 2006) Question (8) How much does your chest pain affect you emotionally? (e.g., does it make you angry, scared, upset or depressed?);
Timepoint [14] 431981 0
Baseline, week 6 and week 12 post-baseline
Secondary outcome [15] 431982 0
• Brief Illness Perceptions Questionnaire (Broadbent et al., 2006) Question (9) Please list in rank-order the three most important factors that you believe caused your chest pain.
Timepoint [15] 431982 0
Baseline, week 6 and week 12 post-baseline
Secondary outcome [16] 431984 0
• Sleep quality. Single question self-rating of overall sleep quality in the past 7 days on 11-point scale (Snyder et al., 2018).
Timepoint [16] 431984 0
Baseline, week 6 and week 12 post-baseline
Secondary outcome [17] 431985 0
• Global rating of change (GROC): Self-rated change of participant’s condition on an 11-point scale (Kamper et al., 2009). The minimally important difference for the 11-point GROC scale is 2 (Kamper et al., 2009).
Timepoint [17] 431985 0
The GROC will be measured at 6 and 12 weeks post-baseline.
Secondary outcome [18] 431986 0
• Quality of life will be expressed as quality-adjusted life year (QALY) using the EQ-5D-5L questionnaire (Herdman et al., 2011). The EQ-5D-5L is self-rated, comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), with each dimension having five levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). A QALY is a year of life experienced with a particular health-related quality of life and will be expressed as a score ranging from 0 to 1, with 0 = death and 1 = full health. Total QALY will be estimated for each participant by calculating the area under the curve (the product of utility values by time). We will calculate the mean QALYs for each group and adjust for baseline utility scores to minimize bias.
Timepoint [18] 431986 0
EQ-5D-5L measured at baseline, 6 and 12 weeks post-baseline.

Eligibility
Key inclusion criteria
• Presents to ED with an acute episode of chest pain AND receives a primary diagnosis of suspected musculoskeletal chest pain
• Age 16 years or over
• History consistent with musculoskeletal causes (e.g., onset, activity- or position-dependent chest pain)
• Evidence of musculoskeletal dysfunction on physical examination; (i.e., pain reproduction on palpation of sternocostal joint(s) or with deep breathing; pain reproduction and/or restriction with thoracic spine range of motion)
• Able to provide informed consent
• Able to speak and understand English
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-mechanical, potentially serious sources of chest pain (e.g., cardiac, respiratory, infectious, systemic inflammatory, neoplastic processes, other priority non-musculoskeletal pain) as diagnosed by a medical practitioner.
• Chronic overlapping pain conditions diagnosed by a medical practitioner as listed in the Central Sensitisation Inventory, Part B (e.g., restless leg syndrome, chronic fatigue syndrome, fibromyalgia, temporomandibular joint disorder, migraine or tension headaches, irritable bowel syndrome, multiple chemical sensitivities, neck injury (including whiplash), anxiety or panic attacks, depression (Mayer et al., 2012).
• History of fractures or surgery to the chest and thoracic region (e.g., sternotomy), in the past six months.
• Currently receiving treatment involving opioids and/or corticosteroids.

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)
REDCap® will be used to implement the allocation sequence. REDCap® software is a secure, web-based survey tool suitable for data requiring high-security storage (i.e., patient data). Only the research statistician will have user privileges to set up the randomisation page to define the randomisation parameters and upload the previously generated allocation sequence table. The researcher who allocates participants will be able to see the “Randomize” button, but not the underlying allocation sequence. The principal investigator will be set up with user privileges that only allow a view of the allocation dashboard showing overall allocation progress.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to either the Experimental or the Control Group with a 1:1 allocation as per a computer-generated randomisation schedule using permuted blocks of random sizes. The block sizes and allocation sequence will not be disclosed to the researchers who enrol participants or assign interventions to ensure concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive analysis suitable for feasibility outcomes

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/04/2024
Actual
Date of last participant enrolment
Anticipated
7/06/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment outside Australia
Country [1] 26136 0
New Zealand
State/province [1] 26136 0
Otago

Funding & Sponsors
Funding source category [1] 312813 0
Other
Name [1] 312813 0
Stanley Paris Fellowship
Country [1] 312813 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 314458 0
None
Name [1] 314458 0
Address [1] 314458 0
Country [1] 314458 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312097 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 312097 0
Ethics committee country [1] 312097 0
New Zealand
Date submitted for ethics approval [1] 312097 0
15/05/2023
Approval date [1] 312097 0
11/09/2023
Ethics approval number [1] 312097 0
2023 FULL 16757

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123462 0
Dr Ewan Kennedy
Address 123462 0
School of Physiotherapy, 325 Great King Street, Dunedin 9016
Country 123462 0
New Zealand
Phone 123462 0
+64 3 479 7460
Fax 123462 0
Email 123462 0
[email protected]
Contact person for public queries
Name 123463 0
Ewan Kennedy
Address 123463 0
School of Physiotherapy, 325 Great King Street, Dunedin 9016
Country 123463 0
New Zealand
Phone 123463 0
+64 3 479 7460
Fax 123463 0
Email 123463 0
[email protected]
Contact person for scientific queries
Name 123464 0
Ewan Kennedy
Address 123464 0
School of Physiotherapy, 325 Great King Street, Dunedin 9016
Country 123464 0
New Zealand
Phone 123464 0
+64 3 479 7460
Fax 123464 0
Email 123464 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21570Ethical approval    385101-(Uploaded-05-02-2024-09-39-26)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.