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Trial registered on ANZCTR


Registration number
ACTRN12616000917437
Ethics application status
Approved
Date submitted
5/07/2016
Date registered
11/07/2016
Date last updated
11/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Is the use of Niagara Thermo Cycle Pad effective for knee pain?
Scientific title
Is the use of Niagara Thermo Cyclo Pad effective for knee pain in osteoarthritis?
Secondary ID [1] 289121 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 298662 0
Condition category
Condition code
Musculoskeletal 298726 298726 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test the use of two different Niagara Thermo Cyclo Pad units (the Niagara Thermo Cyclo Pad unit, and the Niagara Thermo Cyclo Pad hand held unit) against a sham/control unit, used twice daily for 20 minutes for 4 weeks. The units will be used on the ‘study/target knee’ throughout the entire 4 week period, which is the most painful, eligible knee at screening.

The two intervention units include:

1) Use of Niagara Thermo Cyclo Pad unit on heat and vibrate setting (heat is set to 8 degrees above the ambient temperature, vibrate setting 3 (32-35 Hz)).

2) Use of Niagara Thermo Cyclo Pad on heat and vibrate setting (as above), combined with the use of the Niagara Thermo Cyclo Pad hand held unit on vibrate setting (35 Hz).

Use of the Niagara Thermo Cyclo Pad involves placing the Cyclo Pad on your seat/chair/couch with the pad placed under the hamstring and the round motor end positioned directly and firmly under the study knee. The vibrate setting will be set to level 3 (32-35 Hz) and the heat setting is set to 8 degrees above the ambient temperature, therefore it will change based on the temperature of the room it is used in.

Use of the Niagara Thermo Cyclo Pad hand held unit involves placing the hand unit lengthways on the top of the thigh/quadriceps with the black Rubber cup attachment pressing against the top of the knee (where the knee is most painful) and holding it in place until the treatment has finished. The vibrate setting will be set to 35 Hz.

The units vibrate and heat settings will be programmed into the units by CT Healthcare so that they will not able to be altered by the participants and the participants and study staff remain blinded.

Participants will be trained in the use of the devices by a study nurse who will be trained by CT Healthcare in the operation of the units. The training session with participants will be approximately 10 minutes, or until the study nurse is satisfied the participant knows how to operate the unit/units.

Adherence will be measured using a daily diary where participants will be required to record how much they used the device.
Intervention code [1] 294665 0
Treatment: Devices
Comparator / control treatment
Use of Niagara Thermo Cyclo Pad unit on sham setting (low vibrate, approximately 5 Hz) and no heat.
Control group
Placebo

Outcomes
Primary outcome [1] 298204 0
Knee pain as assessed by the VAS pain scale.
Timepoint [1] 298204 0
Assessed at 4 weeks
Secondary outcome [1] 323483 0
Knee pain as assessed by the VAS pain scale
Timepoint [1] 323483 0
1, 2 and 3 weeks
Secondary outcome [2] 325486 0
Knee pain as assessed by the WOMAC pain scale
Timepoint [2] 325486 0
1, 2, 3 and 4 weeks
Secondary outcome [3] 325487 0
Knee stiffness as assessed by the WOMAC stiffness scale
Timepoint [3] 325487 0
1, 2, 3 and 4 weeks
Secondary outcome [4] 325488 0
Knee symptoms as assessed by the WOMAC physical function scale
Timepoint [4] 325488 0
1, 2, 3 and 4 weeks
Secondary outcome [5] 325489 0
Leg strength as assessed by dynamometer
Timepoint [5] 325489 0
4 weeks
Secondary outcome [6] 325490 0
Time taken to stand from a seated position as assessed by the Time Up and Go test (TUG)
Timepoint [6] 325490 0
4 weeks
Secondary outcome [7] 325491 0
Quality of life as assessed by the Australian Quality of Life Scale (AQoL) total score
Timepoint [7] 325491 0
4 weeks

Eligibility
Key inclusion criteria
1. Significant knee pain (>=40/100 on 100mm VAS) for at least 6 months.
2. Age 50 years or over.
3. Clinical knee osteoarthritis as confirmed by the ACR criteria.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe knee OA (joint space narrowing on x-ray of Grade 3 using the OARSI atlas.
2. Forms of arthritis other than osteoarthritis.
3. Significant knee injury within last 6 months.
4. Abnormal sensation to heat, cold or vibration.
5. Use of any investigational drug(s) and/or devices within 30 days prior to randomisation.
6. The participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
7. Unable or unwilling to comply with the requirements of this study protocol, including use of the Thermo Cyclopad units.
8. Unable or unwilling to provide written informed consent.

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)
Randomisation will be by computer generated random numbers, and conducted by a staff member with no direct involvement in the study. All assessors will be blinded to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be intention to treat as randomised.

As this is the first trial of these products, the effect size of the interventions beyond placebo is not known. However, the minimum clinically important improvement in pain VAS score for absolute improvement is approximately 15mm on a 100mm VAS scale; therefore for a treatment to be clinically important, the active treatment needs to have 15mm greater reduction compared to placebo or comparator over the treatment horizon of the study (4 weeks), over and above the change over time reported in each group (placebo effect). We expect standard deviations of approximately 25. We will use alpha of 5% and power 80%. We plan to recruit 20 patients in each group for a pilot study to determine the likely effect size; this will enable us to appropriately power a larger follow-up study. This will equate to 60 patients total.

Data will be entered into a central database in Hobart using the teleform system which we have extensive experience with. It will then be analysed in house statisticians using standard models for clinical trials. We will use a modified intent to treat (ITT) approach for data analysis, where all patients who were randomised to receive treatment will be included in the analysis. Secondly, missing data will be accounted for in the analyses using appropriate techniques eg Stata’s multiple imputation (MI) functions, using 10 imputations per observation, from non-missing baseline data, using multivariate normal regression to generate outcome data.

Change in outcomes will be assessed using the difference between the factor at baseline and follow-up using linear regression if continuous, ordered binomial if outcome is ordered categorical, and log binomial / logistic regression if binary. Data will be analysed by including the treatment as a variable in the analysis, enabling the effect of treatment to be determined.

We will examine the pattern of change using repeated measures regression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2016
Actual
Date of last participant enrolment
Anticipated
31/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 293526 0
Commercial sector/Industry
Name [1] 293526 0
CT Healthcare Pty Ltd
Country [1] 293526 0
Australia
Primary sponsor type
Individual
Name
Prof Graeme Jones
Address
Menzies Institute for Medical Research, University of Tasmania
Private Bag 23
Hobart, Tasmania
7000
Country
Australia
Secondary sponsor category [1] 292346 0
None
Name [1] 292346 0
Address [1] 292346 0
Country [1] 292346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294964 0
Health and Medical Human Research Ethics Committee
Ethics committee address [1] 294964 0
University of Tasmania
Churchill Avenue
SANDY BAY TAS 7005
Ethics committee country [1] 294964 0
Australia
Date submitted for ethics approval [1] 294964 0
Approval date [1] 294964 0
24/02/2016
Ethics approval number [1] 294964 0
H0015466

Summary
Brief summary
This study aims to assess the efficacy of use of two different Niagara Thermo Cyclo Pad units, used twice daily for 20 minutes for four weeks on knee pain, stiffness and symptoms in knee osteoarthritis patients, using a randomised, placebo–controlled double–blind design over four weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65542 0
Prof Graeme Jones
Address 65542 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool Street
HOBART TAS 7000
Country 65542 0
Australia
Phone 65542 0
+61 3 6226 7705
Fax 65542 0
+61 3 6226 7704
Email 65542 0
[email protected]
Contact person for public queries
Name 65543 0
Laura Laslett
Address 65543 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool Street
HOBART TAS 7000
Country 65543 0
Australia
Phone 65543 0
+61 3 6226 7736
Fax 65543 0
Email 65543 0
[email protected]
Contact person for scientific queries
Name 65544 0
Laura Laslett
Address 65544 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool Street
HOBART TAS 7000
Country 65544 0
Australia
Phone 65544 0
+61 3 6226 7736
Fax 65544 0
Email 65544 0
[email protected]

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