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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
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Scientific title
The role of physiotherapy in adults with Globus Pharyngeus: A prospective descriptive case series
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Secondary ID [1]
312745
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Globus Pharyngeus
334777
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Condition category
Condition code
Musculoskeletal
331338
331338
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
329274
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Not applicable
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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.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Vocal Tract Discomfort
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Assessment method [1]
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Vocal Tract Discomfort Scale (Woznicka et al., 2012)
VTDS is commonly used in a range of voice disorders to categorize types of throat discomfort by frequency and severity as rated by the patient.
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Timepoint [1]
339099
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Initial session, discharge and three-month follow-up.
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Primary outcome [2]
339100
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Globus Pharygeus symptoms
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Assessment method [2]
339100
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Glasgow-Edinburgh Throat Scale (Deary et al., 1995)
GETS is a 10-item questionnaire used to help identify globus patients. The scale covers symptoms, function and also the potential psychological involvement in Globus.
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Timepoint [2]
339100
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Initial session, discharge and three month follow up
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Primary outcome [3]
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Musculoskeletal changes in the laryngeal area
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Assessment method [3]
339101
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Laryngeal palpatory scale (Jafari et al., 2020)
The LPS is a clinician-based, 4-point Likert-type scale that assesses a range of factors in the laryngeal area. This includes pain, posture, muscle condition, laryngeal and hyoid position, and movement limitation.
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Timepoint [3]
339101
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Initial session, at discharge and at the three month follow up
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Secondary outcome [1]
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Neck range of motion
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Assessment method [1]
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Physiological movements will be measured, including, flexion, extension, side flexion, and rotation. If a restriction in movement is observed in any movement, then it will be recorded in the patient notes as the direction movement, and the presence of restriction, as observed by the physiotherapist. Neck restriction will be defined as more than 20 degrees in any direction as observed visually.
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Timepoint [1]
438549
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Initial session, at discharge, and at the three-month follow-up
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Secondary outcome [2]
438645
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The Global Rating of Change Score (GRoC)
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Assessment method [2]
438645
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GROC 15 point scale (Kamper et al., 2009).
The GROC is a frequently used outcome measure that is used independently to measure improvements in a patient's condition or as an anchor for other outcome measures. Patients will be asked to select an option from a 15-point scale to report the degree to which their condition changed since the treatment began.
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Timepoint [2]
438645
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This will be taken at the three-month follow-up.
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Secondary outcome [3]
438646
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Patient experience
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Assessment method [3]
438646
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Short semi-structured interviews with questions regarding the impact and role of physiotherapy. The questions will cover the patient's experience, the impact of voice physiotherapy, and their views of the voice physiotherapy role and service.
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Timepoint [3]
438646
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Three month follow up
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Secondary outcome [4]
438648
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Nature of their symptoms.
Categories are the presenting problem(s), symptoms, and duration of symptoms as described by the patient.
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Assessment method [4]
438648
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This data will be collected from the patient notes based on patients' descriptions of their presenting problem(s), as is a routine component of the physiotherapy assessment.
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Timepoint [4]
438648
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This will be recorded during the initial consultation
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Eligibility
Key inclusion criteria
Clients referred to physiotherapy by an ENT specialist with a medical diagnosis of Globus Pharyngeus.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Children under 16
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
9/09/2024
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Actual
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Date of last participant enrolment
Anticipated
26/03/2025
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Actual
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Date of last data collection
Anticipated
26/06/2025
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Actual
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Sample size
Target
6
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26513
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New Zealand
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State/province [1]
26513
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Canterbury
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Funding & Sponsors
Funding source category [1]
317176
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University
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Name [1]
317176
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University of Otago Maori PhD scholarship
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Address [1]
317176
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Country [1]
317176
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New Zealand
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Funding source category [2]
317197
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Charities/Societies/Foundations
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Name [2]
317197
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University of Otago Stanley Paris OMT Scholarship
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Address [2]
317197
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Country [2]
317197
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New Zealand
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Primary sponsor type
University
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Name
University of Otago Stanley Paris OMT scholarship
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
319518
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Address [1]
319518
0
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Country [1]
319518
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315920
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University of Otago Human Ethics Committee (Health)
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Ethics committee address [1]
315920
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https://www.otago.ac.nz/council/committees/committees/humanethicscommittees
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Ethics committee country [1]
315920
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New Zealand
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Date submitted for ethics approval [1]
315920
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15/07/2024
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Approval date [1]
315920
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12/08/2024
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Ethics approval number [1]
315920
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Summary
Brief summary
Globus Pharyngeus, otherwise known as Globus, is the sensation of a foreign body or a lump in the throat. Though there is currently no standard treatment, increasingly it has been described as a result of muscular tension, which suggests that people with Globus may substantially benefit from intervention that focuses on the musculoskeletal system, such as physiotherapy. This study aims to understand the clinical characteristics and outcomes for individuals receiving physiotherapy treatment for Globus Pharyngeus and to use this information to improve health services for individuals with the condition. A prospective, observational case series design was chosen to align with the study aims and to best evaluate the potential for physiotherapy to benefit people with Globus Pharyngeus.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
136218
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Mrs Kristina Hockey
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Address
136218
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School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016
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Country
136218
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New Zealand
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Phone
136218
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+64 02108522811
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Fax
136218
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Email
136218
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[email protected]
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Contact person for public queries
Name
136219
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Kristina Hockey
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Address
136219
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School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016
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Country
136219
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New Zealand
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Phone
136219
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+64 02108522811
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Fax
136219
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Email
136219
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[email protected]
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Contact person for scientific queries
Name
136220
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Kristina Hockey
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Address
136220
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School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016
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Country
136220
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New Zealand
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Phone
136220
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+64 02108522811
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Fax
136220
0
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Email
136220
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24104
Ethical 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.
Download to PDF