Effect of ceramic-impregnated “thermoflow” gloves on patients with raynaud’s syndrome: randomized, placebo-controlled study

Raynaud’s Syndrome Original Research
Effect of Ceramic-Impregnated
“Thermoflow” Gloves on Patients
with Raynaud’s Syndrome:
Randomized, Placebo-Controlled Study
Gordon D. Ko, MD, and David Berbrayer, MD
Abstract
are classically described triphasic with initial pal- OBJECTIVE: To determine the efficacy of
lor (white), followed by a cyanotic phase (blue), ceramic impregnated gloves in the treatment
and lastly by hyperemia (redness). Onset is often of Raynaud’s syndrome. DESIGN: Double-blind,
provoked by cold but may also be brought on by placebo-controlled study. SETTING: Teaching
emotional stress or tobacco. It is a common con- hospital outpatient clinic. PARTICIPANTS:
dition that affects 10-15 percent of the female Ninety-three patients meeting the “Pal” criteria
population.1 Primary Raynaud’s is of idiopathic for Raynaud’s syndrome. INTERVENTIONS:
origin. Secondary Raynaud’s is related to connec- Treatment period of three months with use of
tive tissue diseases, arterial occlusive disease, ceramic-impregnated gloves. MAIN OUTCOME
blood dyscrasias, drugs (e.g., ergot derivatives, MEASURES: Primary end points: Pain visual
beta-blockers, nitroglycerine, chemotherapy analogue scale ratings and diary; Disabilities
agents), toxins, and other miscellaneous disorders.2 of the Arm, Shoulder, Hand questionnaire;
It may also be brought on by repetitive trauma Jamar grip strength; Purdue board test of hand
such as the use of vibration tools (vibration-in- dexterity. Secondary end points: Infrared skin
duced white finger syndrome)3 and is seen in a temperature measurements; seven-point Likert
higher proportion of carpal tunnel syndrome pa- scale rating of treatment. RESULTS: In 60
participants with complete data, improvements
were noted in the visual analogue scale rating
(P=0.001), DASH score (P=0.001), Jamar grip
understood. Theories include the “local fault”5 strength (p=0.002), infrared skin fingertip
within the arterial wall, endothelial cell injury6 temperature (p=0.003), Purdue hand dexterity
with subsequent activation of platelets,7 test (p=0.0001) and the Likert scale (p=0.001)
vasoconstrictors (serotonin, thromboxane),8 free with ceramic gloves over the placebo cotton
radicals,9 and decreased vasodilators (nitric oxide10 gloves. CONCLUSION: The ceramic-
and calcitonin gene-related peptide11). More severe impregnated “thermoflow” gloves have a
cases such as those in systemic sclerosis are clinically important effect in Raynaud’s
characterized by fibrous intimal proliferation, peri- syndrome.
(Altern Med Rev 2002;7(4):327-334)
Dr. Gordon D. Ko MD CCFP(EM) FRCPC – Director ofAlternative Medicine Research, Department ofRehabilitation Medicine, Sunnybrook and Women’s College Introduction
Health Sciences Centre (University of Toronto).
Correspondence address: Canadian Centre for Integrative Medicine, 5954 Hwy 7 East, Markham, Ontario, Canada episodic attacks of vasospasm involving the small arteries/arterioles of the fingers, toes, and less fre- Dr. David Berbrayer MD FCFP FRCPC – Head, Departmentof Rehabilitation Medicine, Sunnybrook and Women’s quently, the nose, tongue, and ears. The attacks College Health Sciences Centre (University of Toronto).
Page 328 Alternative Medicine Review ◆ Volume 7, Number 4 ◆ 2002
Copyright2002 Thorne Research, Inc. All Rights Reserved. No Reprint Without Written Permission Original Research Raynaud’s Syndrome
subcutaneous tissue temperatures. Secondary plethysmographic evidence of arterial occlusion, and angiographic evidence of narrowing and organized intraluminal thrombi.12,13 Milder One double-blinded study with 30 patients idiopathic cases due to sympathetic over-activity performed at the Chinese Academy of Medical Sciences documented increased blood volume and flow with impedance plethysmography for the The usual treatment of primary Raynaud’s active limb versus the control side (30 minutes of syndrome involves keeping warm, smoking ces- wear) with p-value < 0.01 for the lower leg and sation, medications (long-acting calcium-channel- <0.05 for the forearm. Clinical effectiveness for blocking drugs,15,16 prostacyclin analogues17), and pain (arthritis, peripheral vascular disease) was psychophysiological therapy (hypnosis,18 behav- correlated with the duration of use per day. Side ior modification,19 skin temperature biofeed- effects were minimal with two patients stopping back20,21). Thermal biofeedback has also been re- due to the development of skin irritation.26 ported to be effec-tive in diabetic clau-dication.22 More ag-gressive approachesinclude sympathetic Table 1. Pal Questionnaire
blocks and surgicals y m p a t h e c t o m y.
Newer approaches Have you ever had episodes when your fingers, toes, ears, tongue, or nose
have turned white or very pale? (2 points)
Do the involved areas become numb or tingle? (1 point)
Does the area throb? (2 points)
Does the white area later turn blue or red? (1 point)
Does the area sweat more when involved? (1 point)
Are there episodes provoked by tobacco? Cold air or water? Emotion?
(2 points)
ture and biofeed-back were the twomost common alter-native therapies rec-ommended by physiatrists (physical medicine and garments,” were approved in May 1997 by the Health Protection Branch in Canada. A random- Institute of Hematology and Hospital for Blood ized, controlled trial was approved by the hospi- Diseases (Chinese Academy of Medical Sciences) tal ethics committee and conducted from Decem- involves the use of ceramic-impregnated garments ber 1999 to May 2000 in the section on Comp- lementary and Alternative Medicine Research, ceramic) that absorb ambient far-infrared radiation Division of Physiatry, Department of Medicine at (0.76 to 4 micrometers wavelength) from the environment and body. This results in thermal Sciences Centre (University of Toronto).
energy being reflected into the underlying tissues,resulting in elevation of the dermal and Alternative Medicine Review ◆ Volume 7, Number 4 ◆ 2002 Page 329
Copyright2002 Thorne Research, Inc. All Rights Reserved. No Reprint Without Written Permission Raynaud’s Syndrome Original Research
Participants and Methods
Patients
participation were approved by the university-based teaching hospital’s ethics committee. All subjects provided written informed consent for were recruited from newspaper advertisements.
Out of a total of 132 telephone respondents, 93met the “Pal” criteria for Raynaud’s. This screen- Treatment
ing tool has been validated and requires a manda-tory yes to question 1 and a total score greater gloves were supplied to half of the participants who were instructed by a blinded consultant as to appropriate use (including duration of wear, hy- Sunnybrook and the Canadian Centre for Integra- giene, and application technique). Placebo gloves tive Medicine. The clinical diagnosis was con- supplied to the other half were identical in appear- firmed by medical evaluation and note made of previous rheumatologist assessment and periph- Allocation to a treatment group (active or eral Doppler studies done with cold stress. One placebo) was carried out by assigning to the sub- female was excluded from the study due to fin- ject the next available randomization number (in- gertip skin ulceration and infection. Three sub- ner label) in the sequence given to the center. The jects did not want to complete the study because sequence of treatments in the randomization list they did not want to wear gloves while vacation- was determined by previous computer-generated ing in Florida. Other exclusions included one sub- random sequence for the pairs of gloves.
ject with severe pulmonary disease, one with re-cent myocardial infarction, and another subject Study Design
with terminal cancer. All subjects were also as- The study consisted of two blocks of three sessed for a history of connective tissue disease months. The first group was recruited and assessed (scleroderma, systemic lupus erythematosus, rheu- in December 1999, followed by a telephone call matoid arthritis, dermatopolymyositis, mixed con- two weeks later to encourage compliance and re- nective tissue disease, etc.), endocrine disease (hy- assessment in February 2000. A second group of pothyroidism, diabetes mellitus), and hematologic subjects were assessed in March 2000 and reas- disease (blood dyscrasia, paraproteinemias).
sessed in May 2000 using the same protocols. The treatment and follow-up periods were double conditions such as carpal tunnel syndrome, fibromyalgia,27 and thoracic outlet syndrome.28Use of cigarettes, caffeine, and alcohol was re- Clinical Outcome Variables
corded. Medication use including birth control All subjects were required to complete the pills, chemotherapy, cold remedies with pseu- following: pain diagram, short-form McGill Pain doephedrine, and migraine pills (ergotamine) was questionnaire, and visual analogue scale for pain recorded. Use of vibrating tools, occupation, and over past week on day of assessment, and a diary handedness were recorded. Also documented was of Raynaud’s attacks. The previously validated use of other medications, such as calcium chan- functional questionnaires known as the DASH nel blockers, and herbal products, such as Ginkgo (Disabilities of the Arm, Shoulder, Hand) ques- biloba and vitamin E, that could affect circula- tionnaire29 and the FIQ (Fibromyalgia Impact tion. Other treatments, such as physiotherapy, bio- Questionnaire)30 were also completed.
feedback and surgical sympathectomy, were noted.
subjects were at least 18 years of age. Pregnantfemales were excluded.
Page 330 Alternative Medicine Review ◆ Volume 7, Number 4 ◆ 2002
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Table 2. Demographics of Treatment and Placebo Groups
Demographics Placebo Active Statistical Significance
Sex Male 4 10
Female 26 20 p=0.64
Likelihood ratio chi-square
Age average in years 51.8 54.1 p=0.47
(standard deviation) (12.3) (12.1) T-test with unequal variances
Body mass index 22.0 24.5 p=0.01
(standard deviation) (3.7) (4.l)
Normal body mass index is classified as 18 to 25. Our subjects on average
fell in this range.
All subjects at the pre- and post-treatment assessment were examined by trained nurses for determined for each subject from data provided by the local meteorological center (Toronto). Mean changes were recorded for each group.
ments done over the fingertips and the finger dor-sum (between the nail bed and the distal interpha- Test-Retest Reliability
langeal joint) of the 2nd to 5th digits. The distal- Test-retest reliability was carried out on dorsal difference was calculated based on previ- eight subjects for subjective and objective outcome ous findings suggesting that a difference > 1°C is measures (done over two consecutive days). The specific for underlying connective tissue disease.31 intra-class correlation coefficients were extremely high for the DASH (90.996), FIQ (0.984), Jamar average grip (0.993), and Purdue percentiles 3. Purdue board test (hand dexterity).
4. Tinel’s sign (percussing over the car- pal tunnel) rated as absent, present:mild, or Tolerability and Safety
present:marked (patient withdraws hand).
5. Phalen’s sign (passive flexion of the telephone call and the post-treatment assessment to report any adverse events. Three subjects com-plained of skin irritation. Otherwise, there were and weight were also recorded and the body massindex calculated. Blood pressure and pulse wererecorded for each arm. The short-form McGill Pain Statistical Analysis
questionnaire and pain diagrams were completed.
Statistical methods followed an intention- At the post-treatment evaluation, subjects to-treat principle and corrected for possible bias also rated their response to treatment using the 5 caused by differences in missing data among groups by using a regression equation based onbaseline variables to impute values for subjects Alternative Medicine Review ◆ Volume 7, Number 4 ◆ 2002 Page 331
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Table 3. Outcome Measures at Baseline in Treatment and Placebo Groups
Outcome Measure Placebo Active Statistical Measure
Visual analogue scale (VAS)
for average pain 0-100 55.1 56.9 p=0.65
Pain diagram:
Bilateral hands 14 15 p=0.95
Hands and feet 12 10 likelihood ratio chi-square
Short-form McGill Pain 14.6 15.8 p=0.66
Disability of the Arm,
Shoulder and Hand
(DASH) score 21.5 24.4 p=0.85
Fibromyalgia Impact
Questionnaire (FIQ) 1.46 1.98 p=0.43
Average fingertip skin
Temperature °C 25.9 26.5 p=0.04
Average finger dorsum
Temperature °C 26.3 27.2 p=0.03
Jamar Grip Strength
Average of left hand in kg 25.0 29.4 p=0.10
right hand 25.5 29.6 p=0.10
Purdue Board Test
Average percentile rating
left 34.9 33.7 p=0.28
right 36.4 35.9 p=0.21
with missing data. Analyses were performed us- Thirty subjects used active gloves over the three ing SAS routines and were conducted by indepen- months and 30 subjects used placebo gloves. Of dent statisticians at the Institute of Clinical and the 33 individuals who did not complete the study, 19 were on active and 14 were on placebo.
subjects were similar in the treatment and placebogroups (Table 2).
Of the 93 subjects initially assessed, 60 For the likelihood ratio chi-square, there (65%) completed the necessary forms and fol- were also no significant differences between the lowed through with the post-treatment evaluation.
two groups for the mean PAL criteria (p = 0.61), Page 332 Alternative Medicine Review ◆ Volume 7, Number 4 ◆ 2002
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Table 4. Post-Treatment Results for Active and
group were left-hand dominant(p = 0.15).
Before After pvalue
use of medication for Raynaud’s, inthe active group 17 were not taking VAS (SEM) 56.9 (4.5) 50.8 (4.3) 0.001
Placebo 55.1 (4.1) 57.9 (4.1) 0.20
DASH 24.4 (4.0) 19.1 (3.9) 0.001
Placebo 21.5 (3.2) 23.9 (3.2) 0.18
was on both types of drugs. In thecontrol group, 20 were not taking FIQ 1.99 (0.50) 1.64 (0.43) 0.75
Placebo 1.46 (0.37) 1.28 (0.45) 0.32
nel blocker alone, and two were tak-ing both types. The likelihood ratio Fingertip temp 26.46 (0.37) 27.54 (0.37) 0.003
Finger dorsum 27.20 (0.51) 28.13 (0.44) 0.09
Placebo 25.87 (0.25) 26.39 (0.38) 0.29
26.35 (0.37) 26.47 (0.46) 0.19
tween the two groups in the use ofphysiotherapy, biofeedback, and al- Jamar left 29.4 (3.1) 34.6 (2.8) 0.002
Jamar right 29.6 (3.1) 36.3 (2.8) 0.0001
Placebo 25.0 (3.1) 25.0 (3.1)
25.5 (3.4) 26.0 (3.3)
Baseline outcome measures weresimilar between the two groups prior Purdue left 33.7 (0.9) 42.0 (1.3) 0.0001
Purdue right 35.9 (0.9) 44.0 (1.3) 0.0001
Placebo 34.9 (1.6) 36.9 (1.8)
36.4 (1.6) 38.6 (1.8)
drome, was present in 21 of 60subjects.
Likert active 5.66 0.001
placebo 4.13
tically significant for the activegroup, are outlined in Table 4 for Likert scale scoring is:
1. markedly worse
2. moderately worse
3. somewhat worse
Discussion
4. no change
5. somewhat improved
6. moderately improved
7. markedly improved
in the management of Raynaud’ssymptoms. Significant improve-ments were documented in both sub- presence of associated diseases (p = 0.09), smok- ers (p = 0.09), caffeine intake (p = 0.22), alcohol fort and in objective measures of temperature, grip, use (p = 0.19), relevant medication use (p = 0.08), and herbals such as Ginkgo or vitamin E (p = 0.13).
There was a difference in use of vibratory toolswith three in the active group compared to none Alternative Medicine Review ◆ Volume 7, Number 4 ◆ 2002 Page 333
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Kahaleh MB. Vascular disease in scleroderma.
corded by diary also suggested improvement in Endothelial T lymphocyte-fibroblast interac-tions. Rheum Dis Clin North Am 1990;16:53- the actively treated group. However, incompletely filled diaries prevented a statistical analysis. The Saniabadi AR, Lowe GD, Belch JJ, et al. The subjective rating by the Likert scale suggests the novel effect of a new prostacyclin analogue active group had somewhat to moderate improve- ment, whereas the placebo group overall experi- platelets in whole blood. Thromb Haemost Limitations to this study include the lack of more advanced measurements of peripheral Raynaud’s phenomenon with ketanserin, a selective antagonist of serotonin2 (5-HT2)receptor. Arthritis Rheum 1984;27:139-146.
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would add more to the objective measures. Fu- Increased susceptibility to oxidation of low- ture studies would be helpful in documenting re- density lipoproteins isolated from patients with sponse rates over a longer period of time and with systemic sclerosis. Arthritis Rheum Acknowledgements
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Maricq HR. Capillaroscopy in Raynaud’ssyndrome. Vasc Med Rev 1992;3:3-20.
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