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Trial registered on ANZCTR


Registration number
ACTRN12624001049561
Ethics application status
Approved
Date submitted
16/08/2024
Date registered
29/08/2024
Date last updated
1/09/2024
Date data sharing statement initially provided
29/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of physiotherapy in adults with Globus Pharyngeus: A prospective descriptive case series
Scientific title
The role of physiotherapy in adults with Globus Pharyngeus: A prospective descriptive case series
Secondary ID [1] 312745 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Globus Pharyngeus 334777 0
Condition category
Condition code
Musculoskeletal 331338 331338 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will be a prospective, consecutive case series following patients presenting with Globus Pharyngeus to a Physiotherapy clinic that provides care for voice and throat problems. This is an observational study design and patients will receive standard care, as is given for all patients who receive Voice Physiotherapy at the clinic. Standard care is based on clinical judgment and the individual’s presentation will include a combination of laryngeal manual therapy, exercise prescription, and education. The patient’s response to the treatment is being observed, including their reports of change in symptom, and their outcomes, as recorded in outcome measures. Outcomes will be taken initially and reassessed when the therapist in collaboration with the patient considers Globus treatment to be completed. The outcome measures include questionnaires. These are the Vocal Tract Discomfort Scale, the Glasgow-Edinburgh Throat Scale (GETS), and the GROC scale (only on completion of treatment and at the three-month follow-up), which will take the patient approximately 2-3 minutes to complete each. In the Physical assessment, the laryngeal palpatory scale will be completed by the physiotherapist and is anticipated to take 5-10 minutes to complete. At the three-month follow-up, a short semi-structured interview with questions regarding the impact and role of physiotherapy. This is anticipated to take 5 minutes to complete. The overall duration of the observation will be three months, from the time of enrolment to the follow-up appointment, three months after the initial appointment.
Intervention code [1] 329274 0
Not applicable
Comparator / control treatment
No control will be used. Patients will receive usual care. This is an observational study design so care decisions will not be influenced in any way, and outcomes will be reassessed when the therapist in collaboration with the patient considers Globus treatment to have been completed.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339099 0
Vocal Tract Discomfort
Timepoint [1] 339099 0
Initial session, discharge and three-month follow-up.
Primary outcome [2] 339100 0
Globus Pharygeus symptoms
Timepoint [2] 339100 0
Initial session, discharge and three month follow up
Primary outcome [3] 339101 0
Musculoskeletal changes in the laryngeal area
Timepoint [3] 339101 0
Initial session, at discharge and at the three month follow up
Secondary outcome [1] 438549 0
Neck range of motion
Timepoint [1] 438549 0
Initial session, at discharge, and at the three-month follow-up
Secondary outcome [2] 438645 0
The Global Rating of Change Score (GRoC)
Timepoint [2] 438645 0
This will be taken at the three-month follow-up.
Secondary outcome [3] 438646 0
Patient experience
Timepoint [3] 438646 0
Three month follow up
Secondary outcome [4] 438648 0
Nature of their symptoms.
Categories are the presenting problem(s), symptoms, and duration of symptoms as described by the patient.
Timepoint [4] 438648 0
This will be recorded during the initial consultation

Eligibility
Key inclusion criteria
Clients referred to physiotherapy by an ENT specialist with a medical diagnosis of Globus Pharyngeus.

Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children under 16

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study is a prospective case series following patients presenting with Globus Pharyngeus to a Physiotherapy clinic that provides care for voice and throat problems. This will be a consecutive series where the first six clients with a medical diagnosis of Globus Pharyngeus referred to the clinic, who consent to participate will be included in the study. A smaller number of participants allows for detailed individual case reporting that aligns with the descriptive study purpose and is practically achievable as one component of Kristina’s PhD thesis. In line with recommendations for a prospective case series the main analysis will be descriptive rather than statistical Patient characteristics and flow through the study will be reported, including loss to follow-up and other potential areas of bias.
Outcome measures will be tabulated for easy comparison of cases, and common clinical features contributing to people’s symptoms will be discussed. Changes in outcomes pre and post physiotherapy will be reported, identifying and discussing common themes. The interview data will be analysed using a conventional content analysis, describing themes in responses that reflect closely what participants describe.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/09/2024
Actual
Date of last participant enrolment
Anticipated
26/03/2025
Actual
Date of last data collection
Anticipated
26/06/2025
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 26513 0
New Zealand
State/province [1] 26513 0
Canterbury

Funding & Sponsors
Funding source category [1] 317176 0
University
Name [1] 317176 0
University of Otago Maori PhD scholarship
Country [1] 317176 0
New Zealand
Funding source category [2] 317197 0
Charities/Societies/Foundations
Name [2] 317197 0
University of Otago Stanley Paris OMT Scholarship
Country [2] 317197 0
New Zealand
Primary sponsor type
University
Name
University of Otago Stanley Paris OMT scholarship
Address
Country
New Zealand
Secondary sponsor category [1] 319518 0
None
Name [1] 319518 0
Address [1] 319518 0
Country [1] 319518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315920 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 315920 0
Ethics committee country [1] 315920 0
New Zealand
Date submitted for ethics approval [1] 315920 0
15/07/2024
Approval date [1] 315920 0
12/08/2024
Ethics approval number [1] 315920 0

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

Contacts
Principal investigator
Name 136218 0
Mrs Kristina Hockey
Address 136218 0
School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016
Country 136218 0
New Zealand
Phone 136218 0
+64 02108522811
Fax 136218 0
Email 136218 0
saukr318@postgrad.otago.ac.nz
Contact person for public queries
Name 136219 0
Kristina Hockey
Address 136219 0
School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016
Country 136219 0
New Zealand
Phone 136219 0
+64 02108522811
Fax 136219 0
Email 136219 0
saukr318@postgrad.otago.ac.nz
Contact person for scientific queries
Name 136220 0
Kristina Hockey
Address 136220 0
School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016
Country 136220 0
New Zealand
Phone 136220 0
+64 02108522811
Fax 136220 0
Email 136220 0
saukr318@postgrad.otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The raw data may compromise privacy due to the small numbers involved in this study, and detailed case descriptions.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24104Ethical approval    388290-(Uploaded-16-08-2024-08-41-39)-UOHEC H_ApprovalLetter_6535_16_Aug_2024.pdf



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.