Raynaud's Phenomenon (RP) is the most common vasospastic disorder encountered by hand surgeons with an estimated prevalence of 5% in the general population. It's manifestations are broad, and can range from minor to severe. Sometimes it can be refractory to treatments. The goal of this study is to evaluate the efficacy of Botulinum toxin (BT) in the treatment of treatment refractory RP by objective and subjective measures.
Raynaud's Phenomenon (RP) is the most common vasospastic (i.e. conditions where small blood vessels near the surface of the skin have spasms that limit blood flow) disorder encountered by hand surgeons with an estimated prevalence of 5% in the general population. The clinical manifestations are broad, and can range from minor pain, cold sensitivity and color changes to impaired hand function, intolerable pain and tissue loss/digital ulceration. Treatment algorithms include activity modification and medical therapies. However, refractory RP can warrant surgical intervention, such as peri-arterial sympathectomy, of which has significant associated morbidity. While the exact mechanism is still being elucidated, several retrospective reviews have demonstrated efficacy of BT in the treatment of RP. Specifically, increases in post treatment perfusion have been demonstrated and clinical evidence of improvement in pain scores and tissue loss are reported. However, the literature varies in regard to injection technique (location and dose) and duration of action. The goal of this study is to evaluate the efficacy of BT in the treatment of treatment refractory RP by objective and subjective measures. This study will perform a single-site double-blinded, randomized, placebo-controlled trial evaluating two different doses of BT (10 units and 20 units) injected into each patient's fingers of both hands versus injection of a normal saline control, given that there is currently no widely accepted standard of care for the treatment of BT. Following injection, patients will be evaluated in regular intervals to assess for impact on finger temperature, oxygenation, patient reported outcome measures (PROMs), and effect on tissue loss. The study will take place under Emory University School of Medicine, specifically the Upper Extremity Division. Patients may also be originally seen under the Rheumatology Division and subsequently referred to the Upper Extremity Division for study participation. In total, the study aims to recruit 36 patients. There will be no outside recruitment or advertisement materials. With this research study, the study team seeks to establish a standardized injection technique and dosage for this disease and to determine duration of symptom alleviation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects will be randomized 1:1:1 into three different groups: 1) placebo 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
Emory University Hospital
Atlanta, Georgia, United States
Finger Temperature Measure
Finger temperature measure of each finger on each hand was recorded on each digit before treatment and at the allotted follow-up intervals; the average of all digits on both hands was combined and recorded as the value for each point in data collection.
Time frame: Baseline, 4 weeks, 12 weeks, 24 weeks post injection
Tissue Oximetry Measure for Each Finger
Tissue Oximetry of each finger on each hand was recorded on each digit before treatment and at the allotted follow-up intervals. The average of all digits on both hands was combined and reported.
Time frame: Baseline, 4 weeks, 12 weeks, 24 weeks post injection
Raynaud Condition Score
The Raynaud's Condition Score (RCS) is a validated outcome measure used to assess the level of difficulty experienced due to RP each day (anchored from "no difficulty" to "extreme difficulty"). Scale of 0-10 based on how patients rate any difficulty with their hands the day of assessment, a score of 0 is the minimum score and is interpreted as a best outcome (being described to patients as "no difficulty"), while a score of 10 is the maximum score and is interpreted as the worst outcome (being described to patients as "extreme difficulty")
Time frame: Performed at 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.
Visual Analog Scale (VAS) Pain Score
The visual analogue scale or visual analogue scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints.VAS scores ranged from 0 (no pain) to 10 (worst imaginable pain) Higher VAS scores indicate greater pain severity Week 16 and week 20 measurements were performed via telephone interview.
Time frame: Performed at 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.
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PROMIS Pain Interference Scale
The visual analogue scale (VAS) is a psychometric response scale that can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints. Scale of 0-10, a minimum score of 0 is viewed as a favorable outcome and described to patients as having "no pain", a score of 10 is the maximum score and is viewed as an unfavorable outcome and described to patients as having "worst pain"
Time frame: 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.
Hand Subjectivity Value
Patients provided ratings of their subjective hand function from 0 to 100. Higher ratings mean better outcomes. Week 16 and week 20 measurements were performed via telephone interview.
Time frame: Performed at 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.
QUICK Dash Assessment
The QuickDASH is an 11-item questionnaire that measures physical function and symptoms in individuals with one or more upper-limb musculoskeletal disorders. It includes a disability/symptom section (11 items, scored 1-5) and optional work or sport/music modules (4 items each, scored 1-5). Each response option is associated with a percentage value on a 0-100 scale: 1 (no symptoms) = 0.0, 2 (mild symptoms) = 2.3, 3 (moderate symptoms) = 4.5, 4 (severe symptoms) = 6.8, and 5 (extreme symptoms) = 9.1. After all questions are scored, the item scores are summed and divided by 100 to generate the final percentage score. Scores range from 0% to 100%, where 0% is the most favorable outcome, indicating no symptoms or limitations in physical activities, and 100% is the least favorable outcome, indicating extreme symptoms and severe limitations in physical activities. Higher scores reflect greater disability and symptom severity.
Time frame: Performed at 4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks.