None listed
Conditions
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.
Interventions
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 th
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.
Sponsors
New Zealand Centre of Integrated Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Diagnosed with Rheumatoid Arthritis, Osteoarthritis or Arthritis by a GP or specialist
Exclusion criteria
Pregnancy
Outcome results
None listed