Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001303639
Ethics application status
Approved
Date submitted
22/11/2023
Date registered
14/12/2023
Date last updated
14/12/2023
Date data sharing statement initially provided
14/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of hot-water immersion for targeting joint pain in patients with mild-moderate osteoarthritis
Scientific title
Efficacy of hot-water immersion for targetting joint pain in patients with mild-moderate osteoarthritis
Secondary ID [1] 311005 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 332118 0
Condition category
Condition code
Musculoskeletal 328847 328847 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete 2 water immersion sessions and a control session (in a randomised order): 1) 30-min whole-body hot-water immersion (40°C; chest depth), 2) 30-min lower-limb hot-water immersion (40°C; below knee depth).

There will be a 4-day washout between exposures.

1. 30-min whole-body hot-water immersion (40°C)
Location: School of Physical Education, Sport and Exercise Sciences Aquatic Facility (University of Otago, Dunedin).
Supervision: This session will be supervised by an American College of Sports Medicine (ACSM) registered clinical exercise physiologist (CEP), and the primary investigator (PI) or a research assistant; all supervising researchers are first aid trained. Attendance and session particulars (e.g., physiological indices etc.) will be recorded at each session by the supervising researcher.
Exposure: Participants will complete a single 30-min hot water immersion session in 40 °C water. Participants will be seated upright with water approximately nipple level.
Duration: 30 min.

2. 30-min lower-limb hot-water immersion (40°C)
Location: School of Physical Education, Sport and Exercise Sciences Aquatic Facility (University of Otago, Dunedin).
Supervision: This session will be supervised by an American College of Sports Medicine (ACSM) registered clinical exercise physiologist (CEP), and the PI or a research assistant; all supervising researchers are first aid trained. Attendance and session particulars (e.g., physiological indices etc.) will be recorded at each session by the supervising researcher.
Exposure: Participants will complete a single 30-min hot water immersion session in 40 °C water. Participants will be seated upright with water approximately below knee level.
Duration: 30 min.
Intervention code [1] 327447 0
Treatment: Other
Comparator / control treatment
30-min control (no exposure).

Location: School of Physical Education, Sport and Exercise Sciences Aquatic Facility (University of Otago, Dunedin).
Supervision: This session will be supervised by an American College of Sports Medicine (ACSM) registered clinical exercise physiologist (CEP), and the PI or a research assistant; all supervising researchers are first aid trained. Attendance and session particulars (e.g., physiological indices etc.) will be recorded at each session by the supervising researcher.
Exposure: Participants will complete a single 30-min resting session (i.e., no exposure/water immersion). Participants will be seated upright in a chair.
Duration: 30 min.
Control group
Active

Outcomes
Primary outcome [1] 336643 0
Joint pain
Timepoint [1] 336643 0
Pre-exposure, during exposure (every 10 mins), immediately post-completion of exposure, 1 hr post-completion of exposure, 2 hr post-completion of exposure, 3 hr post-completion of exposure, before bed, upon waking and 1 hr after waking.
Secondary outcome [1] 429140 0
Blood pressure
Timepoint [1] 429140 0
Pre-exposure, during exposure (every 10 mins) and immediately post-completion of exposure.
Secondary outcome [2] 429141 0
Heart rate
Timepoint [2] 429141 0
Pre-exposure, during exposure (every 10 mins) and immediately post-completion of exposure.
Secondary outcome [3] 429143 0
Physical activity
Timepoint [3] 429143 0
Across the 24-h post-completion of exposure.

Eligibility
Key inclusion criteria
- Has mild-moderate osteoarthritis;
- Patient gives written consent;
- Patient is able to travel to the study centre to complete all sessions
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe osteoarthritis;
- Contraindication to maximal exercise testing;
- Angina;
- Recent myocardial infarction (< 3 months ago);
- Implanted cardiac device (i.e. implantable cardioverter-defibrillator, pacemaker etc.);
- Heat intolerance;
- Pregnancy;
- History of large blood pressure decreases or fainting;
- Any other medical condition deemed a significant risk to study participation.

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)
Allocation will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/12/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25980 0
New Zealand
State/province [1] 25980 0

Funding & Sponsors
Funding source category [1] 315268 0
Charities/Societies/Foundations
Name [1] 315268 0
Arthritis New Zealand
Country [1] 315268 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago PO Box 56 Dunedin 9054 New Zealand
Country
New Zealand
Secondary sponsor category [1] 317307 0
None
Name [1] 317307 0
Address [1] 317307 0
Country [1] 317307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314188 0
University of Otago Human Ethics Committee - Health
Ethics committee address [1] 314188 0
University of Otago PO Box 56 Dunedin 9054 New Zealand
Ethics committee country [1] 314188 0
New Zealand
Date submitted for ethics approval [1] 314188 0
04/11/2023
Approval date [1] 314188 0
21/11/2023
Ethics approval number [1] 314188 0

Summary
Brief summary
This pilot study will be a 3x3 randomised, controlled cross-over design trial. Twenty participants with mild or moderate hip or knee osteoarthritis will be recruited from the community. Participants will complete 3 sessions: 1) 30-min whole-body hot water immersion (40°C; immersed to chest depth), 2) 30-min lower-limb hot water immersion (40°C; immersed to just above ankle depth), and 3) control (no exposure). To quantify the intensity and duration of any analgesic effect, participants will rate their joint pain using the visual analogue pain scale; this will be recorded pre-exposure, every 5-10 min during exposure, immediately post-exposure, and then at regular intervals (at home via a pain diary) across 24 hours. Our hypothesis is that both forms of immersion will lower joint pain during and after exposure, more than control (no exposure).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130722 0
Dr Brendon Roxburgh
Address 130722 0
Department of Surgical Sciences Level 4, Dunedin Public Hospital 201 Great King Street, Central Dunedin, Dunedin 9016
Country 130722 0
New Zealand
Phone 130722 0
+64 274632376
Fax 130722 0
Email 130722 0
brendon.roxburgh@otago.ac.nz
Contact person for public queries
Name 130723 0
Dr Brendon Roxburgh
Address 130723 0
Department of Surgical Sciences Level 4, Dunedin Public Hospital 201 Great King Street, Central Dunedin, Dunedin 9016
Country 130723 0
New Zealand
Phone 130723 0
+64 274632376
Fax 130723 0
Email 130723 0
brendon.roxburgh@otago.ac.nz
Contact person for scientific queries
Name 130724 0
Dr Brendon Roxburgh
Address 130724 0
Department of Surgical Sciences Level 4, Dunedin Public Hospital 201 Great King Street, Central Dunedin, Dunedin 9016
Country 130724 0
New Zealand
Phone 130724 0
+64 274632376
Fax 130724 0
Email 130724 0
brendon.roxburgh@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


What supporting documents are/will be available?

No Supporting Document Provided



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.