None listed
Conditions
Brief summary
Overview: Raynaud's Phenomenon is characterised by spasms of blood vessels in the peripheries and in both hands and feet it can lead to pain, ulceration, and amputation of fingers and toes. It is a common feature of the autoimmune disease, Systemic Sclerosis. The pain and difficulty in using the fingers creates substantial limitations on everyday activities with subsequent decrease in the quality of daily living. A patient of one of the investigators had the initiative to try electrically heated gloves and found them "life changing". This project is a pragmatic clinical trial to examine the usefulness of heated gloves for these patients. Participants will have Raynaud's Phenomenon secondary to Systemic Sclerosis. A cross-over randomised controlled trial design will be used with the interventions being: (a) use of electrically heated gloves, or (b) routine practice. The trial will take place during the Adelaide winter months of July to Sept. The objective of the trial is to determine whether use of electrically heated gloves improves quality of life for patients with Raynaud's Phenomenon compared to their usual practice.
Interventions
A cross-over randomised controlled trial design will be used with the interventions being: (a) use of electric gloves, or (b) routine practice each for 4 weeks with 1 week ‘washout’ between study periods. The trial will take place during the Adelaide winter months of July to Sept. It will not be blinded. Rheumatologists working in a dedicated Systemic Sclerosis clinic will recruit and administer the trial.
Participants can choose any of three settings designated low (38ºC), medium (47 ºC), or hi
A cross-over randomised controlled trial design will be used with the interventions being: (a) use of electric gloves, or (b) routine practice each for 4 weeks with 1 week ‘washout’ between study periods. The trial will take place during the Adelaide winter months of July to Sept. It will not be blinded. Rheumatologists working in a dedicated Systemic Sclerosis clinic will recruit and administer the trial. Participants can choose any of three settings designated low (38ºC), medium (47 ºC), or high (55ºC). The gloves have slimline rechargeable batteries and provide >5 hours heat on the lowest setting. This is a pragmatic trial and participants will choose the frequency and duration of time wearing the gloves. They will keep a daily Raynaud’s Attack Diary which will record the number of attacks, the duration of each and whether or not gloves were worn during an attack. Participants will also complete a Raynaud’s Condition Score which asks the extent of difficulty with Raynaud’s each day.
Sponsors
Central Adelaide Local Health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
i. Raynaud’s phenomenon secondary to SSc, with or without digital ulcers ii. If currently taking medications for Raynaud’s therapy (calcium channel blockers, sildenafil, endothelin receptor antagonists), the dose must have been stable for at least 4 weeks iii. Willingness to try heated gloves
Exclusion criteria
i. Severe joint contractures or severe complicated digital ulcers (eg with infection and/or discharge) preventing comfortable use of heated gloves ii. Sensory impairment eg peripheral neuropathy with loss of heat sensation iii. Any physical or psychiatric illness which the investigator deems would render participation in the trial unsafe or impractical.
Outcome results
None listed