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Journal of Back and Musculoskeletal Rehabilitation -1 (2017) 18 1


DOI 10.3233/BMR-160577
IOS Press

Use of low level of continuous heat and


Ibuprofen as an adjunct to physical therapy
improves pain relief, range of motion and the
compliance for home exercise in patients with
nonspecific neck pain: A randomized
controlled trial

o n
si
Jerrold S. Petrofskya, Michael Laymona, Faris Alshammarib , Iman Akef Khowaileda and Haneul Leec,

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a
School of Physical Therapy, Touro University, Henderson, NV, USA
b
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Department of Physical Therapy, Hashemite University, Zarqa, Jordan
c
Department of Physical Therapy, College of Health Science, Gachon University, Incheon, Korea
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Abstract.
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BACKGROUND: It has been well documented at heat reduces pain and increases healing by increasing blood flow in tissue.
OBJECTIVE: The purpose of this study was to see if the use of low level continuous heat (LLCH) and Ibuprofen used as a
home therapy between physical therapy sessions at a clinic resulted in better therapy outcomes in people with chronic neck pain.
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METHODS: Ninety-two patients with chronic nonspecific neck pain were randomly divided into 4 groups; LLCH group, LLCH
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with Ibuprofen (IP) group, sham LLCH with sham IP group, and controls. All subjects underwent 45 minutes of conventional
physical therapy twice a week for 2 weeks. the neck disability index (NDI), subjective pain, range of motion (ROM), strength of
the neck, and home exercise compliance were measured.
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RESULTS: Both LLCH and IP significantly reduced pain and NDI score, and increased ROM (p < 0.01). Home exercise
compliance in LLCH and LLCH with IP group was significantly higher than the placebo and control groups (p < 0.05).
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CONCUSION: The use of LLCH alone and LLCH with IP as an adjunct to conventional physical therapy for chronic neck pain
significantly improved pain attenuation and it causes greater compliance for home.

Keywords: Low level continues heat, pain, ibuprofen, compliance, exercise

1 1. Introduction often seen in athletes due to sports related injuries as 4

well as in the casual weekend warrior [13]. Neck in- 5

2 Neck pain is a common form of pain and only sec- juries are also common in the various occupations. For 6

3 ond to back pain in its incidence in everyday life. It is example, of health care workers, 45% of all upper body 7

daily pain was neck pain [4]. Upper quarter pain disor- 8

ders cause the largest use of over the counter medica- 9


Correspondingauthor: Haneul Lee, Department of Physical tions in this same population [5]. Most of these injuries 10
Therapy, College of Health Science, Gachon University, 191 Ham-
bagmeolo, Yeonsu-gu, Incehon, 406-799, Korea. Tel.: +82 32 820 are associated with heavy work and repetitive use of 11

4335; Fax: +82 32 820 4420; E-mail: leehaneul84@gachon.ac.kr. this area of the body [5,6]. The cost of all work related 12

ISSN 1053-8127/17/$35.00 
c 2017 IOS Press and the authors. All rights reserved
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2 J.S. Petrofsky et al. / Low level heat as an adjunct to physical therapy for neck pain

13 disorders in the States has been estimated at over 215 2. Methods 64

14 billion dollars a year [7].


15 Neck strain and pain are commonly treated with a 2.1. Subjects 65

16 combination of cognitive and physical therapy modali-


17 ties [2,8]. A consequence of not reducing pain through Ninety-two patients between the ages of 1870 un- 66

18 therapeutic intervention is that patients become decon- derwent physical therapy from a licensed physical ther- 67

19 ditioned and lose even more function [9]. Curiously, apist for treatment of neck pain at an outpatient phys- 68

20 with neck pain, there can be cortical reorganization ical therapy center in Southern California. All eligi- 69

21 over time due to cognitive impairment [10]. Thus phys- ble subjects who signed the informed consent were 70

22 ical therapy is necessary for neck pain to prevent these randomly divided into 4 different groups; 31 of the 71

23 issues from becoming worse. subjects used LLCH before home exercise, 30 used 72

24 The health care system in the United States has Ibuprofen plus LLCH before home exercise, 15 used 73

25 been under an increasing burden due to spiraling med- an Ibuprofen placebo each day (1200 mg/day) and 74

26 ical costs and an increase in people who do not have the last 16 had conventional therapy with no heat 75

27 health insurance [11]. Thus any treatment that shortens or NSAIDS. Patients were classified by the Interna- 76

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28 therapy decreases the burden on the health care sys- tional Classification of Functional Disability [29,30]. 77

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29 tem [11,12]. The classification for pain with mobility impairments 78

was [1], neck pain with headaches [2], and neck pain

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79
30 However, one problem encountered in physical ther-
31 apy is the limitation on duration of the treatment ses- with coordination impairments and was seen in about 80

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32 sions. With most injuries and a single diagnosis, only half of the population for each classification. Those 81

with neck pain caused by fractures or spinal damage, 82


33 3 weeks of physical therapy are allowed, this con-
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those who have undergone neck surgery within the last 83
34 sisting of a 4560 minutes of the therapy twice a
year, those with radiculopathy or those with diagnosed 84
week [13]. Commonly, the patients are given home ex-
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35
diabetes were excluded from this study. 85
36 ercise programs to do every day to increase range of
37 motion (ROM) and build muscle tone after and in be-
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2.2. Procedures 86
38 tween each therapy session. Many times, however, pa-
39 tients do not follow these regimes due to pain, causing Once the subject agreed to proceed, they signed the 87
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40 home exercise compliance to be poor [1418]. informed consent form as approved by the Solutions 88
41 It has been demonstrated that heat reduces pain and IRB before they participated in the study. 89
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42 increases healing by increasing blood flow in tissue. An initial evaluation and rehabilitation program was 90
43 Heat is a commonly used modality in physical ther- established which included a home exercise program.
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91
44 apy [1927]. While heat is used in a clinical setting, The LLCH group was given heat neck wraps which 92
45 patients rarely use heat when doing home exercise. It were applied for 6 hours before home exercise, LLCH 93
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46 would seem that if heat increases healing and reduces with IP group used Ibuprofen (1200 mg/day given in 3 94
47 pain, there would be better compliance for home exer- dosages) and LLCH wraps for neck before home exer- 95
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48 cise if heat was used at home. Ibuprofen is also com- cise, 15 used a sham heat wrap and a placebo Ibupro- 96
49 monly used for muscular pain [28]. Previous studies fen each day and the last 16 had only home exer- 97
50 with low level continuous heat (LLCH) reduced pain cise. Intervention with LLCH or Ibuprofen was used 98
51 but patients were also given Ibuprofen at the same on days that they were not being treated in the clinic. 99
52 time. Therefore, it is hard to determine which pain re- They were given home exercise and heat compliance 100
53 lieving modality worked or the relative contribution of logs and visual analog scale (VAS) to be filled out 101

54 each modality. Also heat was applied for only 30 min- each night before exercise and, if they used LLCH, be- 102

55 utes [28], too short a period of time for deep pene- fore and after heat neck wraps were applied. The ex- 103

56 tration. Therefore, the present investigation examined ercise included exercises for extending ROM to stim- 104

57 the contribution of continuous low level heat alone, ulate synovial fluid activation via capsular stimulation. 105

58 ibuprofen alone and the 2 modalities together. The hy- Active ROM (AROM) also stimulates muscle activity 106

59 pothesis was that continuous low level heat wraps, if with lymphatic flow to decrease generalized effusion. 107

60 left on for 6 hours, with and without ibuprofen would The physical therapist was also asked to evaluate their 108

61 increase healing rates of damaged tissue, 2) allow for home compliance, pain and the benefit to them from 109

62 higher compliance for home exercise programs and 3) the heat packs. They filled out the neck disability index 110

63 decrease the disability in people with neck injuries. (NDI) at the beginning and end of the study. 111
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J.S. Petrofsky et al. / Low level heat as an adjunct to physical therapy for neck pain 3

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Fig. 1. The progression of participants through the study.

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112 2.3. Interventions contraction, 1 = visible contraction with no movement, 143

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2 = movement with no gravity, 3 = movement against 144

113 All subjects underwent 1 hour of conventional phys- gravity only, 4 = movement against gravity some resis- 145
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114 ical therapy which included thermo therapy, joint mo- tance, 5 = movement against full resistance) However, 146

115 bility, stretching, isometric exercise, and postural ex- for purpose of data entry and statistical comparisons, 147
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116 ercise twice per week for 2 weeks at the outpatient this scale was converted to a 12 point numeric scale 148

117 clinic. In addition to that, they were asked to accom- that could be analyzed with simple statistical measures. 149
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118 plish 1 hour of therapeutic exercise which included The neck disability index (NDI) is a modification of 150

119 stretching and isometric exercise at home each day the Oswestry Low Back Pain Disability Index. It is a 151

120 they were not in the clinic. The LLCH was applied with patient-completed, condition-specific functional status 152
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121 a dry heat neck wrap (ThermaCare, Pfizer Consumer questionnaire with 10 items including pain, personal 153

122 Healthcare, Richmond, VA). The wrap was applied as care, lifting, reading, headaches, concentration, work, 154
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123 per manufacturers instructions around the back of the driving, sleeping and recreation. The NDI has suffi- 155

neck. It was kept on for 6 hours or, if less, was re- cient support and usefulness to retain its current sta-
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124 156

125 ported by the subject. 400 mg Ibuprofen was dosed ev- tus as the most commonly used self-report measure for 157

126 ery 6 hours three times per day for a total daily dose of neck pain [31]. A score of less than 5 is considered 158
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127 1200 mg (per label) for 6 days or a placebo was given. no significant neck pain and therefore triggered subject 159

exclusion. 160
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128 2.4. Outcome measurements Subjects scored, for each day they participated and 161

used heat as a % score for how much they left the heat 162

129 Neck pain was measure by VAS. Subjects placed a on. For example, if they used heat for 3 hours and were 163

130 vertical mark across a 10 cm horizontal line such that to use if for 6 hours, they would score 50%. 164

131 the closer they marked near the 10 cm point, the greater
132 was their pain. The first step in calculating the com- 2.5. Statistical analysis 165

133 bined pain scale was to multiply the visual analog score
134 by 10. Data was summarized as means and SD using SPSS. 166

135 Neck AROM determined with the patient in the sit- The characteristics of the subjects were compared 167

136 ting position. They were asked to move their neck in among the 4 independent groups using one-way anal- 168

137 flexion and extension, left and right rotation and left ysis of variance (ANOVA) for the quantitative vari- 169

138 and right bending. A digital goniometer was used to ables. Since the distribution of these variables was nor- 170

139 measure AROM. All measures were taken by a trained mal, an one-way ANOVA for the quantitative variables 171

140 and licensed physical therapist. was conducted to compare outcome measures among 172

141 Measures of neck muscle strength were on a 5 point groups. LSD pairwise comparisons test for multiple 173

142 scale with plus and minus for 2, 3, 4 and 5. (0 = no comparisons was used to compare means of variables 174
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4 J.S. Petrofsky et al. / Low level heat as an adjunct to physical therapy for neck pain

Table 1
General characteristic of subjects
LLCH group (n = 26) LLCH + IP group (n = 24) Placebo group (n = 11) Control group (n = 11)
Age (years) 52.8 13.5 53.4 11.5 49.7 10.5 52.6 18.3
Gender (women, %) 18 (69.2) 17 (70.8) 8 (72.7) 8 (72.7)
Height (cm) 168.0 10.9 167.2 9.4 169.8 8.9 167.2 6.8
Weight (kg) 19.9 18.8 74.7 14.0 86.1 14.0 76.6 14.2
BMI (kg/m2 ) 28.1 5.0 26.7 4.4 30.2 4.2 27.2 3.7
Duration of pain (years) 2.3 1.3 2.7 1.1 2.2 1.0 2.1 1.1
*No significant difference in general characteristics among 4 groups.

Table 2
Neck disability score and neck pain at pre and post intervention and mean change
Group/variables Pre Post Mean changes (CI)
Disability score (%)
LLCH 37.6 17.4 19.0 12.5 18.6 (12.0 to 25.11)
LLCH + Ibuprofen 39.8 15.0 15.8 11.4 24.0 (16.6 to 31.1)

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Placebo 35.5 9.7 25.3 12.1 10.3 (5.6 to 15.0)
Control 36.0 13.1 29.6 10.4 6.4 (3.0 to 9.8)

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Subjective pain (mm)

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LLCH 48.5 21.8 34.8 22.1 14.7 (4.0 to 21.4)
LLCH + Ibuprofen 50.7 18.9 35.2 22.5

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17.8 (8.1 to 27.4)
Placebo 45.9 22.0 40.6 25.6 9.6 (10.6 to 33.9)
Control 50.9 17.5 41.0 18.2 8.9 (6.6 to 24.0)
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Values are mean SD; Abbreviation: CI, confidence interval; *significant difference between pre and post intervention (P < 0.05); #Significant
difference in changes from pre to post intervention between LLCH and placebo group (P < 0.05).
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Table 3
175 between any two different groups. In each group, com- Compliances at pre and post intervention and mean change
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176 parisons between baseline and post intervention were


LLCH LLCH + IP Placebo Control
177 assessed using the paired t-test. The level of signifi-
Compliance 73.7 25.9 76.3 21.2 51.2 22.4 56.1 25.4
cance was set at p < 0.05.
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178
(Exercise)
Compliance 79.8 24.9 82.2 26.4 67.8 29.4
(LLCH wrap)
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179 3. Results Values are mean SD.


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180 Three subjects from the LLCH group and 2 subjects 17.8 in the LLCH with IP group, 14.7 in the LLCH 200
181 from the LLCH with Ibuprofen group withdrew due alone group, 9.6 in the placebo group, and 8.9 in the
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201
182 to personal reasons. Placebo and Control groups lost 1
control group (Table 2). 202
183 and 3 subjects each during the study for personal rea-
The NDI score was significant reduced in all groups 203
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184 sons.
after 2 weeks (p < 0.001). Also, there were significant 204
185 For the statistical analysis, subjects who had NDI
difference in mean changes from pre and post among 205
186 score less than 5 (considered as no pain) were excluded
four groups (p = 0.005). LLCH with IP group had 206
187 for the statistical analysis. Therefore, 72 participants
188 (26 in the LLCH, 24 in the LLCH with IP, 11 in the greatest reduction in the score and it was significantly 207

189 placebo, and 11 in the control group) completed the different from the other groups (p = 0.008). However, 208

190 study (Fig. 1). There were no significant differences in there was no significant difference in changes in NDI 209

191 general characteristic among the 4 groups (Table 1). score between LLCH and LLCH with IP groups (Ta- 210

192 There was a significant reduction in subjective pain ble 2). 211

193 all groups (p < 0.005). LLCH with IP caused a sig- The neck AROM significantly increased in all six 212

194 nificantly greater reduction in pain than LLCH alone planes by around degrees in the LLCH and LLCH with 213

195 (p = 0.049). Pain was reduced with 2 weeks of con- Ibuprofen groups (p < 0.01). There was no signifi- 214

196 ventional physical therapy but the reduction in pain in cant difference between the LLCH and LLCH with IP 215

197 the placebo and control group were significantly less groups in neck left and right rotation (p > 0.05). The 216

198 than that of the LLCH and LLCH with IP groups (p < placebo and control group, the change over the 2 weeks 217

199 0.05). The change in pain over the 2 weeks averaged was small averaging just a few degrees and was signif- 218
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J.S. Petrofsky et al. / Low level heat as an adjunct to physical therapy for neck pain 5

25

20
Acve range of moon (dgree)

15 LLCH
LLCH+IP
Placebo
10
Control

0
Flexion Extension LF_L LF_R Rotaon_L Rotaon_R

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Fig. 2. Changes in active range of motion in neck flexion, extension, lateral left and right rotation, and left and right flexion.

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2

1.6

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LLCH
LLCH+IP
muscle strength

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1.2
Placebo
Control
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0.8
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0.4
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0
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Flexion Extension LF_L LF_R Rotaon_L Rotaon_R

Fig. 3. Changes in muscle strength in neck flexion, extension, lateral left and right rotation, and left and right flexion.
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219 icantly less than that see for the LLCH and LLCH with 4. Discussion 236
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220 IP groups (p < 0.01, Fig. 2).


221 For the neck muscle strength, the average increase in Neck pain is a major contributor to loss of work and 237
222 strength after 2 weeks of therapy was significant (p < a reduction in the quality of life [3234]. The inter- 238
223 0.01) in LLCH and LLCH with IP groups but there was national association for the study of pain defines neck 239
224 no significant difference among 4 groups. The control
pain as any pain on the posterior cervical spine in the 240
225 group had significant less of an increase in strength for
neck region [32]. The incidence is between 3050% 241
226 left rotation (p < 0.01, Fig. 3).
227 The compliance for home exercise was significantly of the population with women having more prevalent 242

228 difference among all groups (p = 0.009) and it was neck pain [33,34]. Upper cervical pain can present as a 243

229 better in the LLCH and LLCH with IP groups than the migraine headache [35,36]. The spinal segments in the 244

230 placebo and control groups, probably due to the greater neck are connected through the facet joints [37]. The 245

231 pain relief with LLCH and LLCH with IP (p < 0.05, capsular ligaments are the main stabilizing structures 246

232 Table 2). However, there was no significant difference of the facet joints and give the cervical spine stability 247

233 between LLCH and LLCH with IP groups. It closely and flexibility [38]. Some believe damage to these lig- 248

234 matched the patients reports of using LLCH and ac- aments or the facets themselves are a major source of 249

235 complishing home exercise. neck pain [32]. This is due to the fact that chronic neck 250
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6 J.S. Petrofsky et al. / Low level heat as an adjunct to physical therapy for neck pain

251 pain often reflects a state of instability in the cervical Conflict of interest 301

252 spine. With any neck pain, since the neck continuously
253 moves even when the person is sitting at a desk, it can The authors declare that there are no conflicts of in- 302

254 heal slowly, if at all, due to continuous use movement terest. 303

255 of the neck.


256 Common types of therapy in a clinical setting for
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389 Trivedi M, et al. The ability of the skin to absorb heat; the PH, Ferreira ML. Applying joint mobilization at different cer- 453
390 effect of repeated exposure and age. Med Sci Monit. 2011; vical vertebral levels does not influence immediate pain re- 454
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391 17(1): CR1-8. duction in patients with chronic neck pain: A randomized clin- 455
392 [23] Petrofsky J, Paluso D, Anderson D, Swan K, Yim JE, Mu- ical trial. The Journal of Manual & Manipulative Therapy. 456
393 rugesan V, et al. The contribution of skin blood flow in warm- 2009; 17(2): 95-100. 457
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394 ing the skin after the application of local heat; the duality of [39] Kim DH, Yoon KB, Park S, Jin TE, An YJ, Schepis EA, 458
395 the Pennes heat equation. Med Eng Phys. 2011; 33(3): 325-9. et al. Comparison of NSAID patch given as monotherapy 459
396 [24] Petrofsky JS, Lohman E, Suh HJ, Garcia J, Anders A, Sut- and NSAID patch in combination with transcutaneous electric 460
ct

397 terfield C, Grabicki J, Khandge C. Determination of the con- nerve stimulation, a heating pad, or topical capsaicin in the 461
398 ductive heat exchange of the skin in relation to environmental treatment of patients with myofascial pain syndrome of the 462
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399 temperature. J Appl Res Clin Exp Ther. 2006; 6: 157-69. upper trapezius: A pilot study. Pain Med. 2014. 463
400 [25] Petrofsky JS. A device to measure heat flow through the skin [40] Graham N, Gross AR, Carlesso LC, Santaguida PL, Mac- 464
401 in people with diabetes. Diabetes Technol Ther. 2010; 12(9): dermid JC, Walton D, et al. An ICON overview on physical 465
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402 737-43. modalities for neck pain and associated disorders. The Open 466
403 [26] Petrofsky JS, Lawson D, Suh HJ, Rossi C, Zapata K, Broad- Orthopaedics Journal. 2013; 7: 440-60. 467
404 well E, et al. The influence of local versus global heat on the [41] Michlovitz SL, Bellew JW, Nolan T. Modalities for therapeu- 468
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405 healing of chronic wounds in patients with diabetes. Diabetes tic intervention. 5th; ed. Philadelphia: FA. Davis Co.; 2012. 469
406 Technol Ther. 2007; 9(6): 535-44. xxix, 460 p. 470
407 [27] Willems E, Knigge U, Jorgensen H, Kjaer A, Warberg J. Ef- [42] Nolan T, Michlovitz SL. Modalities for therapeutic interven- 471
408 fect of blockade of postsynaptic H1 or H2 receptors or acti- tion. 4th; ed. Philadelphia: FA. Davis Co.; 2005. xxiii, 309 p. 472
409 vation of presynaptic H3 receptors on catecholamine-induced [43] Petrofsky JS, Laymon M. Heat transfer to deep tissue: the ef- 473
410 stimulation of ACTH and prolactin secretion. Eur J En- fect of body fat and heating modality. J Med Eng Technol. 474
411 docrinol. 2000; 142(6): 637-41. 2009; 33(5): 337-48. 475
412 [28] Garra G, Singer AJ, Leno R, Taira BR, Gupta N, Mathaikutty [44] Petrofsky JS, Bains G, Raju C, Lohman E, Berk L, Prowse M, 476
413 B, et al. Heat or cold packs for neck and back strain: A ran- et al. The effect of the moisture content of a local heat source 477
414 domized controlled trial of efficacy. Acad Emerg Med. 2010; on the blood flow response of the skin. Arch Dermatol Res. 478
415 17(5): 484-9. 2009; 301(8): 581-5. 479
416 [29] Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, [45] McLellan K, Petrofsky JS, Bains G, Zimmerman G, Prowse 480
417 Whitman JM, et al. Neck pain: Clinical practice guidelines M, Lee S. The effects of skin moisture and subcutaneous fat 481
418 linked to the international classification of functioning, dis- thickness on the ability of the skin to dissipate heat in young 482
419 ability, and health from the orthopedic section of the ameri- and old subjects, with and without diabetes, at three environ- 483
420 can physical therapy association. J Orthop Sports Phys Ther. mental room temperatures. Med Eng Phys. 2009; 31(2): 165- 484
421 2008; 38(9): A1-A34. 72. 485
422 [30] Cleland JA, Childs JD, Whitman JM. Psychometric properties [46] Petrofsky JS, Lohman E, 3rd, Suh HJ, Garcia J, Anders A, 486
423 of the neck disability index and numeric pain rating scale in Sutterfield C, et al. The effect of aging on conductive heat 487
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488 exchange in the skin at two environmental temperatures. Med for treating acute nonspecific low back pain. Arch Phys Med 496
489 Sci Monit. 2006; 12(10): CR400-8. Rehabil. 2003; 84(3): 329-34. 497
490 [47] Petrofsky J, Bains G, Prowse M, Gunda S, Berk L, Raju C, [49] Nadler SF, Steiner DJ, Erasala GN, Hengehold DA, Hin- 498
491 et al. Does skin moisture influence the blood flow response to kle RT, Beth Goodale M, et al. Continuous low-level heat 499
492 local heat? A re-evaluation of the Pennes model. J Med Eng wrap therapy provides more efficacy than Ibuprofen and ac- 500
493 Technol. 2009; 33(7): 532-7. etaminophen for acute low back pain. Spine (Phila Pa 1976). 501
494 [48] Nadler SF, Steiner DJ, Erasala GN, Hengehold DA, Abeln 2002; 27(10): 1012-7. 502
495 SB, Weingand KW. Continuous low-level heatwrap therapy

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