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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Globus Pharyngeus

Condition category

Condition code

Musculoskeletal

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]

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]

Vocal Tract Discomfort

Timepoint [1]

Initial session, discharge and three-month follow-up.

Primary outcome [2]

Globus Pharygeus symptoms

Timepoint [2]

Initial session, discharge and three month follow up

Primary outcome [3]

Musculoskeletal changes in the laryngeal area

Timepoint [3]

Initial session, at discharge and at the three month follow up

Secondary outcome [1]

Neck range of motion

Timepoint [1]

Initial session, at discharge, and at the three-month follow-up

Secondary outcome [2]

The Global Rating of Change Score (GRoC)

Timepoint [2]

This will be taken at the three-month follow-up.

Secondary outcome [3]

Patient experience

Timepoint [3]

Three month follow up

Secondary outcome [4]

Nature of their symptoms.
Categories are the presenting problem(s), symptoms, and duration of symptoms as described by the patient.

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago Maori PhD scholarship

Address [1]

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

University of Otago Stanley Paris OMT Scholarship

Address [2]

Country [2]

New Zealand

Primary sponsor type

University

Name

University of Otago Stanley Paris OMT scholarship

Address

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

https://www.otago.ac.nz/council/committees/committees/humanethicscommittees

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

15/07/2024

Approval date [1]

12/08/2024

Ethics approval number [1]

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Kristina Hockey

Address

School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016

Country

New Zealand

Phone

+64 02108522811

Fax

saukr318@postgrad.otago.ac.nz

Contact person for public queries

Name

Kristina Hockey

Address

School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016

Country

New Zealand

Phone

+64 02108522811

Fax

saukr318@postgrad.otago.ac.nz

Contact person for scientific queries

Name

Kristina Hockey

Address

School of Physiotherapy, 325 Great King Street, Dunedin North, Dunedin 9016

Country

New Zealand

Phone

+64 02108522811

Fax

saukr318@postgrad.otago.ac.nz

Data sharing statement

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

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.	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.

Trial Review

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