A Trial of Ischemic Preconditioning in Raynaud's Phenomenon (RP)
Raynaud Disease, Raynaud's Phenomenon
About this trial
This is an interventional treatment trial for Raynaud Disease focused on measuring ischemic preconditioning, Raynaud's Phenomenon, (RP)
Eligibility Criteria
Inclusion Criteria:
- Primary or secondary RP, as diagnosed by a rheumatologist
- Clinical need for treatment for RP
- At least 7 RP attacks per week
- Systolic blood pressure above 80mmHg
- Willing to provide informed consent
Exclusion Criteria:
- New or changed dose of drugs used for RP treatment in the last 2 weeks: calcium channel blockers, alpha1-adrenergic blockers, angiotensin II receptor antagonists, nitroglycerin, prostaglandins, pentoxifylline, endothelin antagonists and/or phosphodiesterase type 5 inhibitors.
- Non-compliance with past therapies
Sites / Locations
- Rheumatology Clinic, St. Joseph's Health Care
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active Arm - 200 mmHg
Placebo Arm - 60 mmHg
Patients who start in the active arm of the study will receive ischemic preconditioning (IPC) treatment consisting of applying the blood pressure cuff to a pressure of 200 mmHg for 2 minutes and thirty seconds with a resting period of two minutes and thirty seconds between treatments. This procedure is performed four times, for a total of twenty minutes per treatment. This treatment will be done three times a week. Patients may choose to treat at home with a portable manual blood pressure machine or may be treated in clinic by research staff. Patients will receive treatment for two weeks followed by a wash-out period (no treatment) of two weeks. Patients will then receive the placebo treatment. This completes their participation in the study.
Patients who start in the placebo arm will receive placebo treatment, consisting of applying the blood pressure cuff to a pressure of 60 mmHg for 2 minutes and thirty seconds with a resting period of two minutes and thirty seconds between treatments. This procedure is performed four times, for a total of twenty minutes per treatment. This treatment will be done three times a week for two weeks followed by a two week wash-out and then two weeks in the active treatment phase, thus completing their participation in the study.