Accepted Manuscript

Effect of Interferential Current Stimulation in Management of Hemiplegic Shoulder

Pain

Suriya-amarit Duangporn, B.Sc. Gaogasigam Chitanongk, Ph.D. Siriphorn Akkradate,

Ph.D Boonyong Sujitra, Ph.D.

PII: S0003-9993(14)00285-8
DOI: 10.1016/j.apmr.2014.04.002
Reference: YAPMR 55805

To appear in: ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION

Received Date: 18 December 2013

Revised Date: 18 March 2014
Accepted Date: 4 April 2014

Please cite this article as: Duangporn S-a, Chitanongk G, Akkradate S, Sujitra B, Effect of Interferential
Current Stimulation in Management of Hemiplegic Shoulder Pain, ARCHIVES OF PHYSICAL
MEDICINE AND REHABILITATION (2014), doi: 10.1016/j.apmr.2014.04.002.

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 ACCEPTED MANUSCRIPT
Running head: IFC in Hemiplegic shoulder pain

Tittle: Effect of Interferential Current Stimulation in Management of Hemiplegic Shoulder

Pain

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Authors: Suriya-amarit Duangporn, B.Sc., Gaogasigam Chitanongk , Ph.D.,

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Siriphorn Akkradate, Ph.D, Boonyong Sujitra, Ph.D.,

Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn

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University, Bangkok; Thailand

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Acknowledgment: The authors would like to thank all participants and the staff of the
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institutional physical therapy clinic and neurological rehabilitation center. This study was
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supported by the research fund of Faculty of Allied Health Sciences, Chulalongkorn

University. The authors declare that there is no conflict of interest in relation to this article.
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Corresponding author: Sujitra Boonyong, Ph.D.

Department of Physical Therapy, Faculty of Allied Health Sciences, Chulalongkorn

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University 154 Chulapat2 Bld., Rama I Road, Wangmai, Pathumwan, Bangkok, Thailand.
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10330. E-mail: Sujitra.B@Chula.ac.th Tel. +668-1787-9047 Fax. +662-218-3768

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Reprints are not available from the author.

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1 Effects of Interferential Current Stimulation in Management of Hemiplegic Shoulder Pain

4 ABSTRACT

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6

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7 Objective: To study the immediate effects of interferential current stimulation (IFC) on

8 shoulder pain and pain-free passive range of motion (PROM) of the shoulder in people with

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9 hemiplegic shoulder pain (HSP).

10 Design: Double-blind, placebo-controlled, clinical trial.

11
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Setting: Institutional physical therapy clinic, neurological rehabilitation center.
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12 Participants: A population-based sample of 30 people with HSP was recruited.
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13 Intervention: Participants were divided into two groups, including IFC and placebo, by a

14 match-paired method (age, gender, and Brunnstrom motor recovery stage). In the IFC group,
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15 participants received IFC for 20 minutes with an amplitude-modulated frequency at 100 Hz

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16 in vector mode. The current intensity was increased until the participants felt a strong tingling

17 sensation.
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18 Main outcome measures: Pain intensity and pain-free PROM of the shoulder until the onset
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19 of pain were measured at baseline and immediately after treatment.

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20 Results: Participants reported a greater reduction in pain during the most painful movement

21 following treatment with IFC than with placebo (p < 0.05). IFC group showed a greater

22 improvement in post-treatment pain-free PROM than the placebo group in shoulder flexion (p

23 < 0.01), abduction (p < 0.01), internal rotation (p < 0.01), and external rotation (p < 0.01).

24 Conclusion: This study provides evidence that IFC is effective for the relief of pain during

25 movement and also increases the pain-free PROM of the shoulder in people with HSP.
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26 Key Words: Stroke; Hemiplegic shoulder pain; Interferential current stimulation; Electrical

27 stimulation.

28

29 List of Abbreviations

30 HSP Hemiplegic shoulder pain

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31 IFC Interferential current stimulation

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32 PROM Passive range of motion

33 NRS Numeric rating scale

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34 ICC Intraclass correlation coefficient

35 MDC Minimal detectable change

36
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37 Hemiplegic shoulder pain (HSP) is one of the most important stroke complications.1
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38 The incidence of HSP in the past decade is approximately 17–37% in people with acute

39 stroke and becomes 47% in people with chronic stroke.2-6 People with HSP suffer from pain.
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40 This pain consequently can limit efforts to restore or maintain shoulder’s range motion.1
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41 Hence, this reduced range of motion decreases the patient’s quality of life,7 delays post-stroke

42 recovery, and may increase their length of stay in the hospital.8 Therefore, the prevention of
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43 further complications after the onset of HSP should be addressed, especially reduction of
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44 shoulder pain to maintain or improve the shoulder’s range of motion in people with HSP.
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45

46 The possible causes of HSP are rotator cuff tears, rotator cuff and deltoid

47 tendinopathy,9-10 and bicipital and supraspinatus tendon tenderness.4 The pathology of these

48 causes mostly involves the deep tissues more than the superficial tissues of the shoulder.

49 Thus, pain management of HSP should consider the onset of HSP as well as the pathological

50 aspects to yield the most effective results in prevention of post-HSP complications.

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51 Interferential current stimulation (IFC) is one of the physical therapy modalities used

52 for relieving pain that is caused by deep tissue injury. IFC is the transcutaneous application of

53 alternating, medium-frequency electrical current for therapeutic purposes.11 IFC has been

54 reported to relieve pain related to shoulder,12 and knee13 conditions and in experimental

55 modeling.14 However, there is a lack of evidence on the effect of IFC in people with HSP.

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56 Therefore, the aim of this study was to investigate the immediate effects of IFC on shoulder

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57 pain and pain-free passive range of motion (PROM) of the shoulder in people with HSP.

58

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59 METHODS

60

61
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62 Research Design
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64 A double-blind, placebo-controlled, clinical trial was used to investigate the effects of

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65 IFC on shoulder pain and pain-free PROM of the shoulder. This study was conducted at an
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66 institutional physical therapy clinic and a neurological rehabilitation center in Thailand.

67 Participants gave informed consent after the purpose and testing procedures of this study
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68 were explained. The study protocols were approved by the Ethic Review Committee for
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69 Research Involving Human Projects (Chulalongkorn University and Prasat Neurological

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70 Institute in Thailand).

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75
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76 Participants

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78 Thirty participants who were diagnosed with their first stroke (ischemic or

79 hemorrhagic) were recruited to the study. All participants met the following criteria: 1) was

80 more than 20 years old; 2) had pain ≥ 3 on an 11-point numerical rating scale (NRS) in the

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81 affected shoulder within 3 months of stroke onset; 3) had adequate communication abilities

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82 (to communicate their pain through a NRS in Thai); 4) had normal light touch and pin-prick

83 sensation on the affected shoulder; 5) had a Brunnstrom motor recovery stage rating of 1–3,15

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84 6) had no cognitive impairment (detected by Mini Mental Status Exam-Thai 2002),16 7) had

85 no history of arrhythmias; 8) had no unresolved pathology and ongoing symptoms in the

86
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affected shoulder prior to the onset of stroke; 9) had no history of cancer or tumors; 10) had
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87 no implanted cardiac pacemaker; 11) had no skin problems, wounds, or infections on the
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88 affected shoulder; 12) had no metal, such as surgical surface staples, external pins, or internal

89 fixations, in the affected shoulder; 13) had no history of Botulinum Toxin or steroid
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90 injections, subscapular nerve block, or surgery at the shoulder joint; 14) had never used
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91 electrical stimulation therapy; and 15) had no history of analgesic medication use in the past

92 12 hours. Participants were excluded if they could not complete the session.
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93
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94 Outcome Measures
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96 Pain intensity Shoulder pain was assessed by an 11-point NRS.17 This tool was

97 simple to use and had high correlation coefficients (0.94–0.96) with the visual analogue scale,

98 verbal rating scale, and faces pain scale-revised. The pain intensity was graded from 0 (no

99 pain) to 10 (the most intense level of pain). The participants were asked to report their pain
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100 level at rest and during movement. The most painful movement score was used for further

101 data analysis.

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103 Pain-free PROM of the shoulder Pain-free PROM of the shoulder was designated as

104 the range of motion attained at the “point of the first onset of pain” and was measured with a

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105 digital goniometer a in six directions. Five directions of the shoulder joint were measured

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106 (flexion, abduction, adduction, internal rotation, and external rotation) while participants

107 were lying in a supine position. Additionally, shoulder extension was measured in the side

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108 lying position. Prior to the present study, the test-retest reliability of the digital goniometer

109 measurement was conducted in 16 healthy participants. The intra-rater reliability in all

110
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movement directions of the shoulder joint ranged from good to high (ICC = 0.73 to 0.97).
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111 The standard error for the measurements and the minimal detectable change (MDC) of the
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112 measurements for all PROM measurements of the shoulder were within 2 and 4.5 degrees,

113 respectively.
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114
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115 Procedure

116
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117 At the beginning of treatment, the first investigator recorded the demographic data
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118 and clinical characteristics of the participants. The demographic data consisted of age,
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119 gender, hemiplegic side, etiology (ischemic or hemorrhagic stroke), stroke duration (the time

120 from stroke onset to the time they entered the program), and pain duration (the time from the

121 onset of pain to the time they entered the program). The clinical characteristics included

122 upper-extremity motor recovery assessment by Brunnstrom stages,15 shoulder muscle tone

123 assessed by the Modified Ashworth Scale (MAS),18 shoulder subluxation assessed by
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124 measuring the subacromial space with the finger breadth unit,19 and upper limb functions

125 measured with Item 6 (Upper limb function) of the Motor Assessment Scale for stroke.20

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127 Then, the participants were divided into two groups by the match-paired method (age,

128 gender, and Brunnstrom motor recovery stage): IFC and placebo groups. This procedure was

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129 performed by the second investigator, who was not involved in any data collection. After

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130 that, participants in both groups were assessed by the first investigator to obtain the

131 pre-treatment data. The pre-treatment data included the NRS scores of shoulder pain at rest

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132 and during the most painful movement and the pain-free PROM of the shoulder in all

133 directions. Once the examination was complete, all participants were helped to a sitting

134
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position with elbow support. The skin overlying the affected shoulder was cleaned with
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135 alcohol. Four electrodes b (56 mm x 56 mm) were placed around the painful area of the

shoulder using the crisscross technique to deliver a quadripolar interferential current.21 The
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136

137 third investigator, a physical therapist who was working at the clinic or rehabilitation center
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138 where the participants received the physical therapy program, was responsible for operating
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139 the IFC machine.c

140
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141 Participants in the IFC group were told that they would receive an electrical
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142 stimulation treatment for pain relief. They were also told that they would feel a strong
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143 tingling but comfortable sensation in the shoulder during the electrical stimulation. The

144 parameters of the interferential current were set. The medium-frequency of the interferential

145 current was 4,000 Hz and 4,100 Hz to produce the amplitude-modulated frequency (AMF) at

146 100 Hz in vector mode.11 The current intensity was adjusted to a level that induced a strong

147 tingling sensation.22 The intensity level was adjusted to ensure that participants maintained

148 the same feeling throughout the treatment.23 The stimulation time was set at 20 minutes.24
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149 For the placebo group, participants were told that they would receive an electrical

150 stimulation treatment for pain relief and that they may or may not feel a very light tingling

151 sensation in the shoulder during the electrical stimulation. A similar procedure was followed

152 to that performed in the IFC group, except the lead wires of the equipment were disconnected

153 and were unable to deliver the interferential current. The jack of the output was covered

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154 throughout the experiment.25

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155

156 After the treatment, all pre-treatment parameters were immediately reassessed by the

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157 first investigator. After finishing the program, all participants were sent back to their physical

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158 therapist and received their conventional physical therapy program.
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159

160 Data Analysis

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161

162 Data analyses were performed with SPSS d for Windows. The descriptive statistics
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163 were used to describe the demographic data and clinical characteristics of the participants.
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164 The independent t-test for continuous data and the Chi-squared test for non-continuous data

165 were used to determine baseline group differences. A two-way mixed analysis of variance
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166 was used to examine the main effects and interactions of the independent factors on pain and
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167 pain-free PROM, group (IFC and placebo), and × time (pre- and post-treatment). A pairwise
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168 comparison was carried out with Bonferroni corrections to identify the direction of pain and

169 pain-free PROM changes. The minimum clinically significant difference between group

170 means and between times means was set at 2 points for the NRS for pain26 and 4.5 degrees

171 for PROM of the shoulder. For all comparisons, the significance level was set at a p-value

172 less than 0.05.

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174 RESULTS

175

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177 Characteristics of participants

178

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179 Thirty patients with HSP (12 males and 18 females) participated in this study. No

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180 adverse effects from the IFC treatments were reported. Their pain duration ranged from 14 to

181 85 days. There was no significant difference in the demographic data or clinical

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182 characteristics between the groups (p > 0.05), as shown in Tables 1 and 2. At baseline, all

183 participants in both groups reported no pain at rest. The pre-treatment parameters including

184
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pain intensity during the most painful movement and the pain-free PROM of the shoulder at
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185 baseline were not different between groups (p > 0.05), as shown in Table 3.
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186

187 Pain intensity

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188
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189 All participants demonstrated no pain at rest in post-treatment. For pain during the

190 most painful movement, participants reported a greater reduction in pain intensity following
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191 treatment with IFC than with placebo (F(1, 28) = 33.64, p < 0.05, η2 = 0.5) (Table 4).
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192
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193 Pain-free PROM of the shoulder

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195 Participants in the IFC group had greater pain-free PROM post-treatment for flexion

196 (F(1, 28) = 32.57, p < 0.01, η2 = 0.5), abduction (F(1, 28) = 50.52, p < 0.01, η2 = 0.4), internal

197 rotation (F(1, 28) = 16.17, p < 0.01, η2 = 0.3), and external rotation (F(1, 28) = 23.30, p < 0.01, η2

198 = 0.4) compared to the placebo group (Table 5).

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199 DISCUSSION

200

201

202 To our knowledge, this is the first study that has compared the immediate effects of

203 IFC on shoulder pain and pain-free PROM of the shoulder in people with HSP. The results of

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204 this study revealed that IFC was an effective modality for pain management in people with

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205 HSP. Pain during the most painful movement was reduced, and the pain-free PROM of the

206 shoulder was also increased in the directions that were previously painful.

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207

208 In this study, the painful movements of the shoulder reported by all participants

209
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included flexion, abduction, internal rotation, and external rotation directions. One of these
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210 directions was also reported as the most painful movement when the shoulder was passively
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211 moved. This pain contributed to the limited range of shoulder motion in the related directions.

212 These HSP characteristics are in accordance with the study by Lo and colleagues in 2003.
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213 They reported that the shoulder movements were restricted in these directions. 27
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214

215 In the present study, the placebo group also had a significant pain reduction during the
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216 most painful movement. However, this pain reduction was not clinically significant. This
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217 placebo effect was consistent with the study using IFC and placebo treatments for the

management of knee pain.13 The authors found that the IFC and placebo groups experienced
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218

219 significantly decreased pain after 10 treatment sessions. In addition, previous evidence

220 suggested that the placebo effect would operate mainly on the affective component of pain

221 and would contribute to the effect of treatment as much as 27%.28 In this study, participants in

222 the placebo group were told that they received electrical stimulation therapy. Thus, they

223 might perceive that they received treatment. This perception could lead to a positive attitude
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224 toward the treatment. This finding provides additional evidence that the placebo effect should

225 not be abandoned, particularly because this study was measuring an analgesia effect.

226

227 This study found that the IFC group demonstrated a greater reduction in pain during

228 the most painful movement than the placebo group, with a large effect size. Previous studies

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229 have shown that IFC has an analgesic effect and reduces pain in a variety of conditions such

as knee pain,13 and frozen shoulder.12 However, the method of IFC’s analgesic effect is

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230

231 unclear. It has been hypothesized that the analgesic effect produced by IFC could be similar

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232 to transcutaneous electrical nerve stimulation.29

233

234
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In addition, the IFC and placebo groups showed significantly increased PROM of the
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235 shoulder in all directions after treatment. These increases were from 0.85–15.80 degrees in
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236 the IFC group and 0.63–3.31 degrees in the placebo group. However, the most notable

237 improvement in the PROM of the shoulder after treatment in the placebo group did not meet
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238 clinical significance even in the best range of motion improvement (shoulder abduction)
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239 (Table 5). According to the minimum clinically significant difference, the amount of

240 acceptable improvement (as a clinical change) in this study was more than 4.5 degrees.
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241
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242 These results suggest that people with HSP gained relief with IFC treatment because
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243 the participants reported immediate short-term pain relief and experienced improved PROM.

244 In addition, there are no known side effects of IFC treatment in this patient population or

245 restrictions on the frequency or duration of the treatment. Hence, clinical IFC treatment

246 should be considered as an alternative or complementary intervention for pain relief in people

247 with HSP. However, this study did not investigate the long-term effects or perform follow-up
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248 reassessments. Therefore, further studies are needed to examine the long-term effects of IFC

249 as well as the number of IFC treatment sessions needed for HSP management.

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251 One challenge in people with HSP is the progressive loss of PROM, which seems to

252 be associated with an increase in pain. Thus, it may be better to maintain or restore PROM

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253 through a combination of IFC treatment and PROM activities to achieve long-term benefits.

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254 For example, the use of IFC before a functional training program should create an advantage

255 from the immediate effects of IFC treatment in reducing pain and enhancing increased pain-

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256 free PROM. People with HSP may increase their participation in rehabilitation programs

257 because they will experience less pain.

258
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259 Limitations of the study
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260

261 The results of this study should be interpreted with caution because of a few
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262 limitations. First, the characteristics of the participants in this study met specific criteria.
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263 Hence, the ability to generalize the results of this study to the stroke population is limited.

264 Second, this study only investigated the immediate effects of IFC treatment. Thus, the long-
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265 term effects of IFC treatment in people with HSP remain unknown.
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266
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267 CONCLUSION

268

269

270 The present study revealed the short-term effects of IFC treatment. IFC treatment was

271 effective in relieving pain during movement and also increased the pain-free PROM of the

272 shoulder in people with HSP.

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Table 1: Baseline demographic data of participants in IFC and placebo groups

Variables IFC (N=15) Placebo (N=15) p-value

Age (Year : Mean(SD)) 65.87 (9.35) 67.13 (10.84) 0.73

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Sex (N (%))

Male 6 (40.00%) 6 (40.00%) 1.00

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Female 9 (60.00%) 9 (60.00%)

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Hemiplegic side (N (%))

Left 7 (46.67%) 8 (54.33%) 0.72

Right
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8 (54.33%) 7 (46.67%)
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Hemiplegia etiology (N (%))
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Thromboembolic 7 (46.67%) 10 (66.67%) 0.27

Hemorrhagic 8 (54.33%) 5 (33.33%)

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Hemiplegic duration (Day : Mean(SD)) 95.73 (28.22) 103.87(43.21) 0.55

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Pain duration (Day: Mean(SD)) 57.73 (15.25) 61.40(19.33) 0.57

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Table 2: Baseline clinical characteristics of participants in IFC and placebo groups

N (%)
Variables p-value
IFC (N=15) Placebo (N=15)

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Brunnstrom stage

Stage 1 9 (60.00%) 9 (60.00%) 1.00

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Stage 2 6 (40.00%) 6 (40.00%)

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Motor assessment scale

(Item 6: Upper arm function)

Scale 0
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13 (86.67%) 12 (80.00%) 0.62
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Scale 1 2 (13.33%) 3 (20.00%)
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Shoulder clinical subluxation

Yes 15 (100.00%) 15 (100.00%) 1.00

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No 0 (0.00%) 0 (0.00%)
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Shoulder flexor tone

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Grade 0 10 (66.67%) 9 (60.00%) 0.70

Grade 1 5 (33.33%) 6 (40.00%)

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Shoulder extensor tone

AC

Grade 0 14 (94.33%) 11 (73.33%) 0.14

Grade 1 1 (5.67%) 4 (26.67%)

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Table 2: Baseline clinical characteristics of participants in IFC and placebo groups (Cont.)

N (%)
Variables p-value

PT
IFC (N=15) Placebo (N=15)

Shoulder abductor tone

RI
Grade 0 13 (87.67%) 10 (66.67%) 0.20

SC
Grade 1 2 (13.33%) 5 (33.33%)

Shoulder adductor tone

Grade 0
U
13 (87.67%) 11 (73.33%) 0.36
AN
Grade 1 2 (13.33%) 4 (26.67%)
M

Shoulder internal rotator tone

Grade 0 13 (87.67%) 9 (60.00%) 0.10

D

Grade 1 2 (13.33%) 6 (40.00%)

TE

Shoulder external rotator tone

EP

Grade 1 14 (94.33%) 11 (73.33%) 0.14

Grade 2 1 (5.67%) 4 (26.67%)

C
AC
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Table 3: Means (SDs) of pretreatment data in IFC and placebo groups at baseline

Variables IFC (N=15) Placebo (N=15) p-value

Pain intensity (NRS)

PT
On the most painful movement 6.73 (1.03) 6.27 (1.22) 0.29

Pain-free PROM of the shoulder

RI
(degree)

SC
Flexion 131.23 (18.15) 119.65 (23.01) 0.14

Extension 36.59 (2.46) 35.33 (3.00) 0.23

U
Abduction 113.89 (30.20) 112.15 (25.89) 0.87
AN
Adduction 33.13 (4.23) 33.43 (3.37) 0.84

Internal rotation 47.40 (16.16) 47.59 (15.22) 0.97

M

External rotation 50.51 (17.67) 52.08 (17.04) 0.81

D
TE
C EP
AC
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Table 4: Pain on the most painful movement (means (SD)) at pre- and post-treatment and

mean change (95% CI)

Group Pre Post Mean change (95% CI)

PT
IFC group 6.73(1.03) 4.00 (1.36)*
-2.73 (-3.22 to -2.25)

Placebo group 6.27(1.22) 5.47 (1.68)* -0.80 (-1.28 to -0.32)

RI
U SC
AN
M
D
TE
C EP
AC

Abbreviations: CI, confidence interval

*Significant difference between pre- and post-treatment (p < 0.05)


Significant difference between IFC and placebo at post-treatment (p < 0.05)
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Table 5: Pain-free PROM of the shoulder in all directions (means (SD)) at pre- and post-

treatment and mean change (95% CI)

Mean change
Group/Variable Pre Post

PT
(95% CI)

Shoulder flexion (degree)

RI
IFC group 131.23 (18.15) 142.53 (17.60)*
11.30 (9.05 to 13.56)

SC
Placebo group 119.65 (23.01) 122.07 (22.93)* 2.4 (0.17 to 4.47)

Shoulder extension (degree)

U
IFC group 36.59 (2.46) 37.44 (2.54)* 0.85 (0.45 to1.25)
AN
Placebo group 35.33 (3.00) 35.96 (3.04)* 0.63 (0.23 to1.04)

Shoulder abduction (degree)

M

IFC group 113.89 (30.20) 129.69 (26.96)* 15.8 (11.80 to 19.79)

Placebo group 112.15 (25.89) 115.46 (26.18) 3.31 (-0.68 to 7.30)

D

Shoulder adduction (degree)

TE

IFC group 33.13 (4.23) 34.13 (4.01)* 1.00 (0.65 to 1.35)

EP

Placebo group 33.43 (3.37) 34.16 (3.51)* 0.73 (0.38 to 1.08)

Shoulder internal rotation (degree)

C

IFC group 47.40 (16.16) 52.9 (15.84)* 5.5 (4.16 to 6.84)

AC

Placebo group 47.59 (15.22) 49.37 (14.45)* 1.78 (0.44 to 3.12)

Shoulder external rotation (degree)

IFC group 50.51 (17.67) 57.52 (16.29)* 7.01 (5.28 to 8.75)

Placebo group 52.08 (17.04) 53.30 (17.35) 1.22 (-0.52 to 2.96)

Abbreviations: CI, confidence interval

*Significant difference between pre- and post-treatment (p < 0.05)


Significant difference between IFC and placebo at post-treatment (p < 0.05)