Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000807358
Ethics application status
Approved
Date submitted
26/05/2017
Date registered
2/06/2017
Date last updated
23/07/2019
Date data sharing statement initially provided
23/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Shuzi Technology on Pain and Quality of Life
Scientific title
Effects of Shuzi Technology on Pain and Quality of Life in adults diagnosed with Rheumatoid Arthritis, Osteoarthritis and Arthritis
Secondary ID [1] 291955 0
Nil
Universal Trial Number (UTN)
UTN-1111-1196-7402
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis 303500 0
Osteo-Arthritis 303501 0
Rheumatoid Arthritis 303502 0
Condition category
Condition code
Inflammatory and Immune System 302735 302735 0 0
Rheumatoid arthritis
Musculoskeletal 302736 302736 0 0
Osteoarthritis
Musculoskeletal 302737 302737 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend the New Zealand Centre of Integrated Health Clinic for an initial consultation with the Co-ordinating Investigator, where a Patient Information Sheet (PIS), Consent form and Quality of Life Survey (SF36), Pain Scale and Arthritis Impact Measurement Scale (AIMS2) questionnaire will be completed and signed. A Registered Nurse will assess and review all documentation to ensure the inclusion criteria is met. If the participant meets the criteria they will be entered into the study and assigned a Candidate ID. At this time the candidates will be randomised to an intervention or placebo group.
Participants in the intervention group will have a Shuzi sports bracelet inserted with the technology. The Shuzi sports bracelet is a nylon bracelet embedded with a 2mm x 0.5mm metal disc composed of gold, nickel, zinc, and copper. Prior to embedding the metal disk into the bracelet, the disk is exposed to audio frequencies which were determined over a year of research and experiments to provide a proprietary range that is between 20Hz and 20kHz for 60 minutes, using a computer program. The volume of the audio is 85dB, Participants will wear it continuously for six weeks including sleeping and showering. A diary will be issued to the participant to complete each day. This will record if they have worn the bracelet or removed it for any reason.
Participants will, at the end of week 1 and again at the end of week 3, complete the Pain Scale and AIMS2 questionnaires which will be available online via Survey Monkey software.
After the participant has worn the bracelet for 6 weeks they will return to the clinic for a final consultation with the Co-ordinating Investigator and completion of another SF36 questionnaire, Pain Scale, AIMS2 and Bracelet comfort questionnaire and return the bracelet and diary.
Intervention code [1] 298082 0
Treatment: Devices
Comparator / control treatment
All participants wear a bracelet. 1/2 of the group will wear a nylon bracelet with the technology inserted in the bracelet and 1/2 will wear a nylon bracelet without the metal disk.
Control group
Placebo

Outcomes
Primary outcome [1] 302133 0
Pain Rating Scale, 10-point NRS for pain
Timepoint [1] 302133 0
Timeline 1: Baseline, Timeline 2: 1 week, Timeline 3: 3 weeks and Timeline 4: 6 weeks
Secondary outcome [1] 334905 0
Arthritis Impact Measurement Scale
Timepoint [1] 334905 0
Timeline 1: Baseline, Timeline 2: 1 week, Timeline 3: 3 weeks and Timeline 4: 6 weeks
Secondary outcome [2] 334906 0
Quality of Life Survey SF36
Timepoint [2] 334906 0
Timeline 1: Baseline, Timeline 2: 1 week, Timeline 3: 3 weeks and Timeline 4: 6 weeks
Secondary outcome [3] 335408 0
Bracelet Comfort Questionnaire - designed specifically for this study
Timepoint [3] 335408 0
Week 6

Eligibility
Key inclusion criteria
Diagnosed with Rheumatoid Arthritis, Osteoarthritis or Arthritis by a GP or specialist
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy

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)
Standard randomisation software with sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Standard randomisation software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Method: A statistical calculation was completed and the target sample size was 308 based on the number of arthritis cases in the Bay of Plenty.
Analysis:
NUMERIC RATING SCALE (NRS) FOR PAIN
The NRS for pain is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases. The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0–10. Higher scores indicate greater pain intensity.

ARTHRITIS IMPACT MEASUREMENT SCALES 2 (AIMS2)
The AIMS2 is an arthritis-specific health status measure that assesses physical functioning, pain, psychological status, social interactions and support, health perceptions, and demographic and treatment information. The total AIMS2 has 78 questions. High scores indicate poor health. No cut off values or normative values are available but scale scores may be adjusted to account for comorbidities. AIMS2 scales were originally discussed as 3 or 5 dimensions of health status. However, many studies discuss the measure using 5 dimensions: physical function, symptom, affect, social interaction, and role.

Quality of Life (SF36):
For each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning). You calculate these scores through using a two-step system. These translated scores are taken and the mean average for each of the eight scales is worked out. Translated scores for each of the scale items are added up to calculate the average.

BRACELET COMFORT:
This questionnaire consists of three questions, using a simple yes or no response. These will be added up to calculate an average.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
3/07/2017
Actual
15/01/2018
Date of last participant enrolment
Anticipated
Actual
17/05/2019
Date of last data collection
Anticipated
17/05/2019
Actual
17/05/2019
Sample size
Target
308
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 8904 0
New Zealand
State/province [1] 8904 0

Funding & Sponsors
Funding source category [1] 296469 0
Commercial sector/Industry
Name [1] 296469 0
Shuzi New Zealand Ltd
Country [1] 296469 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
New Zealand Centre of Integrated Health
Address
Suite 6, Promed House, 71 10th Avenue
Tauranga 3110
Country
New Zealand
Secondary sponsor category [1] 295424 0
Individual
Name [1] 295424 0
Dr Anna Goodwin
Address [1] 295424 0
New Zealand Centre of Integrated Health
Suite 6, Promed House
71 10th Ave, Tauranga 3110
Country [1] 295424 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297691 0
Health and Disability Ethics Committee
Ethics committee address [1] 297691 0
Ministry of Health
Ethics Department
Freyberg Building
Reception - Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 297691 0
New Zealand
Date submitted for ethics approval [1] 297691 0
05/06/2017
Approval date [1] 297691 0
17/10/2017
Ethics approval number [1] 297691 0
17/NTB/133

Summary
Brief summary
The Shuzi bracelet has been available for a number of years on the market place and reported changes to date are reduced pain, a sense of calmness and reduction of arthritic symptoms. In order for the Shuzi technology to be recognised as a product that can provide support to people living with arthritis conditions, a robust research trial showing the effects of the technology to pain and quality of life is required. 200 participants will be recruited from the Tauranga area. To be eligible for enrollment individuals will be diagnosed with either Rheumatoid Arthritis, Osteoarthritis or Arthritis. At the initial consultation the participant will fill out and sign a Patient Info Sheet, Consent Form, SF36 Quality of Life Survey (QOL), Pain Scale and Arthritis Impact Measurement Scale (AIMS2). All documentation will be reviewed to ensure inclusion criteria is met. If met, the participant will receive a Shuzi bracelet. This study does have a control group of 100 candidates and therefore only 100 will receive a bracelet with the technology built into the bracelet and the remaining 100 candidates will have a bracelet with no technology. Participants will wear the bracelet for 6 weeks including sleeping and showering. A diary will be provided to record if the bracelet has been removed. At week one and week three another QOL, Pain Scale and AIMS2 will be completed via Survey Monkey or attendance at the NZCIH Clinic. At 6 weeks the participant will return to complete the QOL, Pain Scale, AIMS2 and Bracelet comfort questionnaire and return the bracelet and diary. Analysis will of be completed of the questionnaires completed as outlined in the protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74842 0
Dr Anna Goodwin
Address 74842 0
New Zealand Centre of Integrated Health
Suite 6, Promed House, 71 10th Ave
Tauranga 3110
Country 74842 0
New Zealand
Phone 74842 0
+64275203112
Fax 74842 0
+64775715507
Email 74842 0
[email protected]
Contact person for public queries
Name 74843 0
Ms Desiree De Spong
Address 74843 0
New Zealand Centre of Integrated Health
Suite 6, Promed House, 71 10th Ave, Tauranga 3110
or
PO Box 15066, Tauranga 31`44
Country 74843 0
New Zealand
Phone 74843 0
+64275443424
Fax 74843 0
+6475715507
Email 74843 0
[email protected]
Contact person for scientific queries
Name 74844 0
Dr Anna Rolleston
Address 74844 0
Cardiac Clinic
103 Third Ave
Tauranga 3110
Country 74844 0
New Zealand
Phone 74844 0
+6475786624
Fax 74844 0
Email 74844 0
[email protected]

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.