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A
Randomized, Multi-Center, Single-Blind, Placebo-Controlled Comparative Study
to Determine the Efficacy of Topical Heatwrap Therapy Among Subjects with
Low Back Pain.
 A Randomized Controlled, Multi-center, Single Blind Study to Evaluate the Therapeutic Benefits of Overnight Usage of ThermaCare HeatWraps while Sleeping versus a Bedtime Dose of Oral Placebo for the Treatment of Acute, Muscular Low Back Pain. The objective of this study was to evaluate the efficacy of continuous low-level heatwrap therapy worn while sleeping for the daytime treatment of acute, non-specific low back pain. Study was a prospective, randomized, parallel, single (investigator) blind, placebo-controlled, multi-center clinical trial comparing therapy with a ThermaCare HeatWrap to oral placebo in 27 men and 49 women, aged 18 -55 years, with sub acute, nonspecific low back pain. Subjects were randomly assigned to one of two groups for comparison of efficacy [heatwrap (n=33) or oral placebo (n=34)] or one of two small blinding groups [unheated wrap (n=5) or oral ibuprofen (n=4)] for 3 consecutive nights of treatment with 2 days of follow-up. The primary efficacy measure was morning pain relief at hour 0 on days 2- 4. Secondary efficacy measures included pain relief (day 2-4 hours 0-8 mean, day 4 and day 5 mean scores), reduction in muscle stiffness, lateral trunk flexibility and disability. The results of the study show that heatwrap therapy provided significant improvement over placebo for days 2-4 hour 0 mean pain relief (p=0.00005); day 2-4 hours 0-8 pain relief (p=0.00005); mean pain relief on day 4 and day 5 (p=0.0001); reduction in muscle stiffness (p=0.00075); increased days 2-4 quality of sleep (p=0.0095); decreased days 2-4 sleep onset difficulty (p=0.0185); increased day 4 lateral flexibility (p=0.00145); and decreased day 4 and day 5 low back disability. Adverse events were mild and infrequent. Overnight use of heatwrap therapy was associated with effective next day pain relief, reduced muscle stiffness, improved trunk flexibility and improved sleep, with effects sustained more than 48 hours after treatment stopped.
A Randomized, Controlled, Multi-Center, Single-Blind, Study to Compare the Efficacy of Topical HeatWrap Therapy to Oral Acetaminophen and Ibuprofen Treatments in Subjects with Acute, Muscular Low Back Pain. The objective of this study was to compare the efficacy of continuous low-level heatwrap therapy (40°C, 8 hours/day) to ibuprofen (1200 mg/day) and acetaminophen (4000 mg/day) in 371 subjects with acute non-specific low back pain. Study was a prospective, randomized, single (investigator) blind, comparative efficacy trial. Subjects were randomly assigned to treatment: heatwrap (n=113), acetaminophen (n=113), or ibuprofen (n=106) for efficacy evaluation; oral placebo (n=20) or unheated back wrap (n=19) for blinding. Outcome measures included pain relief, muscle stiffness, lateral trunk flexibility, and disability. Efficacy was measured over two treatment days and two follow-up days. Results: Day 1 pain relief for the heatwrap (mean = 2.00) was higher than ibuprofen (1.51, P = 0.0007) and acetaminophen (1.32, P =0.0001). Extended (day 3-4) mean pain relief for the heatwrap was also higher than ibuprofen (P = 0.0001) and acetaminophen (P = 0.0009). Lateral trunk flexibility was improved with the heatwrap during treatment and follow-up (P £ 0.009 versus acetaminophen, P £ 0.001 versus ibuprofen). Day 1 reduction in muscle stiffness with the heatwrap was greater than acetaminophen (P = 0.001). Disability was reduced with the heatwrap versus ibuprofen (P = 0.01) and acetaminophen (P = 0.0007) on day 4. All adverse events were non-serious, with the highest rate (10.4%) reported in the ibuprofen group. The conclusion was that continuous low-level heatwrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain.
A Randomized Single Blind (Investigator), Placebo Controlled, Parallel Design Study to Compare the Efficacy of a Wearable Topical Heat Patch to Oral Ibuprofen and Oral Placebo in Subjects with Primary Dysmenorrhea. The objective of this study was to compare the level of and duration of efficacy from the single maximum label recommended doses of the ThermaCare Menstrual HeatWrap (approximately 8 hours of wear) in comparison to oral ibuprofen (400 mg) and oral placebo in women with primary dysmenorrhea. Study was a prospective, randomized, multiple-site, single (investigator) blind, parallel, inactive (placebo) controlled study. Subjects (n=147) were randomized to one of four treatment groups: heated menstrual patch (n=47), oral placebo (2 tablets) (n=44), oral ibuprofen (2 tablets, 400 mg total dose) (n=47), or an unheated menstrual patch (for the purposes of blinding only) (n=9). Efficacy and safety were monitored for 3 days upon treatment initiation. Backup medication (ibuprofen) was provided to subjects to be used as necessary during the study. Outcome measures included pain relief, pain affect, abdominal muscle tightness and Menstrual Quality of Life. Results. The ThermaCare group experienced significantly greater mean pain relief (p=0.03) on day one during the eight hours of wear when compared to the oral placebo group, and additionally, for two hours following wrap removal (hours 9 and 10). Pain relief in the heatwrap group remained significantly greater (p < 0.05) at the 24 hour and 48 hour time point when compared to placebo. Parity between ThermaCare (mean = 2.06) and ibuprofen (mean = 1.97, p = 0.78) was observed for the day 1/hours 0-6 mean pain relief score. Moreover, no significant differences between these two groups were observed at any time point throughout the study for pain relief or any other declared efficacy endpoints. The ThermaCare group experienced significantly less abdominal muscle tightness on day one during the eight hours of wear when compared to placebo (p = 0.03) and also on days 2-3. ThermaCare was associated with a significant decrease in overall severity of symptoms rated on the Menstrual Quality of Life scale during the first 24 hours compared to the placebo group (p = 0.006), with this difference also observed after 48 hours (p = 0.03). The conclusion was that both ThermaCare and oral ibuprofen provided therapeutic benefits for treatment of primary dysmenorrhea when compared to an oral placebo treatment.
The objective of this
study was to evaluate the therapeutic effects of ThermaCare HeatWrap versus
an oral placebo in subjects with wrist pain. Study was a prospective,
randomized, multiple-site, single (investigator) blind, parallel, inactive
(placebo) controlled study including 66 subjects with wrist pain that
was either from osteoarthritis (n=12) or the result of a strain or sprain
(n=54) who were randomized to one of four treatment groups: heatwrap (40°C),
oral placebo (2 tablets), oral acetaminophen (2 tablets, 1000 mg total
dose four times daily), or an unheated wrap (for the purposes of blinding
only). Outcome measures included pain relief, joint stiffness, and patient
rated wrist evaluation and grip strength. Results. ThermaCare was associated
with significant increase in the overall mean pain relief over the treatment
period when compared to placebo (p<0.05). ThermaCare was associated
with significant improvements in grip strength on day 3 when compared
to placebo (p<0.05). It was concluded that ThermaCare provides therapeutic
benefits when used to treat wrist pain resulting from strains, sprains,
and osteoarthritis.
SOURCES Abeln SB, Weingand KW, Erasala G, Hengehold D, Barnes PW, Steiner D. Overnight treatment with continuous low level topical heat therapy provides effective relief of low back pain. Journal of the American Pharmaceutical Association. 2000; 41(2):307. Akin MD, Weingand KW, Hengehold DA, Goodale MB, Hinkle RT, Smith RP. The use of continuous topical heat in the treatment of dysmenorrhea. Obstetrics & Gynecology. 2001;97:343-49. Erasala GN, Rubin JM, Tuthill TA, Fowlkes JB, de Drue SE, Hengehold DA, Weingand KW. The effect of topical heat treatment on trapezius muscle blood flow using power doppler ultrasound. Proceedings, Annual Conference and Exposition of the American Physical Therapy Association, June 20-24, 2001. Harris H, Stevenson S, Baldwin A, Weingand KW, and Dudley G. Strength and Soreness after eccentric exercise. Medicine and Science in Sports and Exercise 1998; 30(5): S102. Mulkern, R.V., N. McDannold, K. Hynynen, J. Fielding, L. Panych, F.A. Jolesz, and K. Weingand. Temperature distribution changes in low back muscles during applied topical heat: a magnetic resonance thermometry study. Proceedings of the seventeenth annual meeting of the International Society of Magnetic Resonance in Medicine. Philadelphia, PA, May 22-28, 1999, p. 1054. Nadler S, DePrince ML, Stitik T, Reisman S, Hengehold D, and Weingand KW. Experimentally induced trapezius fatigue and the effects of topical heat on the EMG power density spectrum. Archives of Physical Medicine and Rehabilitation 1999; 80:1123. Nadler S, Weingand KW, and Kruse R. Therapeutic Heat and Cold Modalities: When, Why and How to use them. Medicine and Science in Sports and Exercise 2000; 32(S5), S77. Nadler S, Weingand KW, Stitik T, Kruse R. Therapeutic Modalities: Why, When and Which to Use". Biomechanics. 2001; 8(1). Nadler S, Feinber JH, Reisman S, Stitik T, DePrince ML, Weingand KW et al. The effect of topical heat on the EMG power density spectrum in subjects with myofascial pain and normal controls. American Journal of Physical Medicine & Rehabilitation. 2001; [In press]. Reid RW, Foley JM, Prior BM, Weingand KW, and Meyer RA. Mild topical heat increases popliteal blood flow as measured by MRI. Medicine and Science in Sports and Exercise 1999; 31(5): S208. Simmonds MJ, Weingand KW, Lee CE, Vongsirinavarat M, and Jones S. The effect of a single treatment of heat and exercise on pain and performance in patients with low back problems. Physical Therapy 80(5). 2000. Steiner D, Erasala G, Hengehold D, Goodale MB, and Weingand KW. Continuous low-level heat therapy for acute muscular low back pain. Proceedings of the 19th Annual Scientific Meeting of the American Pain Society 2000, pg. 112. Steiner D, Erasala G, Hengehold D, Goodale MB, and Weingand KW. Continuous low-level heat therapy for trapezius myalgia. Proceedings of the 19th Annual Scientific Meeting of the American Pain Society 2000, pg 171. 2000. Weingand KW, Hengehold D, Knight E, Hinkle R, Combs L, McNutt B, Harris H, Stevenson S, and Dudley G. Topical heat provides pain relief of delayed onset muscle soreness of the distal quadriceps muscles. Medicine and Science in Sports and Exercise 31(5). 1999. Weingand KW, Hengehold D, Knight E, Hinkle R, Combs L, McNutt B, Harris H, Stevenson S, and Dudley G. Does unilateral topical heat treatment provide bilateral pain relief of delayed onset muscle soreness of the thigh? Proceedings of the 9th World Congress on Pain-International Association for the Study of Pain, Vienna Austria , 454. 8-27-1999. Weingand KW, Erasala G, Hengehold D, Goodale MB, Steiner D, and Nadler S. Continuous low-level heat therapy is effective for treating low back pain. Proceedings, Low back pain and disability: unraveling the puzzle. 11-30-2000. Zinger M, Weingand KW, Robins JC, Petty S, Sagel P, and Thomas MA. Symptomatic relief of primary dysmenorrhea with transdermal heat. Presented at the Society of Gynecological Investigators Year 2001 Annual Meeting.
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