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J Acupunct Res > Volume 33(2); 2016 > Article
Choi, Jo, Jung, Kim, and Lee: Alternation of Topical Heat and Cold for Chronic Low Back Pain: A Randomized Controlled Pilot Trial※
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Abstract

Objectives:

This is a pilot study for a large randomized controlled trial to investigate the efficacy and safety of a newly developed contrast therapy device–alternating topical heat and cold – for patients with chronic low back pain. The main objective of this study is to confirm the feasibility of the study design

Methods:

The design was a randomized, 2-arm parallel-group single-blind placebo controlled trial. Patients in each group received real or sham contrast therapy in an acupuncture point 10 times over four weeks. The primary outcome measure was pain intensity on a 100-mm visual analogue scale (VAS). The secondary outcomes were back-related dysfunction based on the Oswestry Disability Index (ODI) the Roland-Morris disability questionnaire (RMDQ) and range of motion of lumbar spine based on the modified Schober test (mSchober test), Finger-to-Floor distance (FTF distance), and Finger-to-Thigh distraction (FTT distraction).

Results:

A total of 30 subjects with chronic low back pain were randomly assigned to a contrast therapy group (n = 15) or a sham group (n = 15). A repeated-measures analysis of variance showed statistically significant group time interaction for VAS, RMDQ, mSchober test and FTF distance (p<0.05). The treatment group showed significant improvement in pain intensity and functional disability as compared to the sham group.

Conclusion:

Contrast therapy may be an effective and safe treatment for chronic low back pain.

Notes

This study was supported by the traditional Korean medicine R&D program funded by the ministry of Health & Welfare through the Korea Health Industry Development Institute (KHIDI) (HI11C2135)

Fig. 1
The device used in this study
acup-33-2-77f1.gif
Fig. 2
Flow diagram describing the patients during the study period
acup-33-2-77f2.gif
Table 1
Total Number and The Reason of Drop-out
Treatment group Sham group
Total drop-out
 Total No of patients 17 15
 No of drop-out 2 0
Drop-out due to
 side effects 0 0
 withdrawn consent 2 0
 special event 0 0
Table 2
Baseline Demographic Characteristics of Participants
Characteristics All Patients (n = 30) Treatment group (n = 15) Sham group (n = 15) p-value
Sex
 Female, n (%) 28 (93.3) 15 (100) 13 (86.7)
 Male, n (%) 2 (6.7) 0 (0) 2 (13.3) 0.483*
Age, years 54.3 ± 13.9 58.5 ± 14.5 50.1 ± 12.4 0.10
BMI, Kg/m2 22.9 ± 2.5 23.5 ± 1.9 22.4 ± 3.0 0.26
VAS score, mm 68.7 ± 11.6 70.5 ± 10.3 66.9 ± 12.9 0.40
ODI score 24.8 ± 9.5 23.1 ± 11.6 26.5 ± 6.8 0.33
RMDQ score 4.9 ± 3.7 5.7 ± 4.4 4.1 ± 2.7 0.41
mSchober test, cm 20.9 ± 1.2 20.9 ± 1.2 20.9 ± 1.2 1 0
FTF distance, mm 222.7 ± 114.1 185.2 ± 114.7 260.2 ± 104.0 0.07
FTT distraction, mm 634.4 ± 35.6 625.2 ± 33.2 643.6 ± 36.6 0.16
BMI: Body Mass Index

BMI: Body Mass Index.

VAS: 100mm Visual Analogue Scale.

ODI: Oswestry Disability Index.

RMDQ: Roland-Morris Disability Questionnaire.

mSchober test: Modified Schober test.

FTF distance: Finger-to-floor distance.

FTT distraction: Finger-to-thigh distraction.

Note: Values are mean ± SD (Standard deviation).

* Fisher’s Exact Test.

Student’s t-test.

Mann-Whitney U-test.

Table 3
Outcome Measures of Pain Intensity, Disability and Range of Motion
Treatment Group Sham Group Group Difference Time Difference Group × Time Difference

n = 15 n = 15
VAS score
 Baseline 0.0381* <0.0001* 0.0034*
  Mean (SD) 70.47 (10.29) 66.87 (12.86)
 2-week follow-up
  Mean (SD) 34.73 (15.39) 46.53 (19.10)

  p-value <0.000 0.0015*

 4-week follow-up
  Mean (SD) 18.07 (12.65) 37.67 (21.15)

  p-value <0.0001* 0.0002*

 Change of 2 vs 4 week§ 0.0001* 0.0032*

ODI score
 Baseline 0.0675 0.0002* 0.1558
  Mean (SD) 23.11 (11.60) 26.53 (6.81)
 2-week follow-up
  Mean (SD) 18.67 (5.01) 22.97 (11.01)

  p-value 0.0460* 0.0498*

 4-week follow-up
  Mean (SD) 14.95 (5.35) 23.27 (10.29)

  p-value 0.0017* 0.0228*

 Change of 2 vs 4 week§ 0.0025* 0.5761

RMDQ score
 Baseline 0.5151 0.0200* 0.0002*
  Mean (SD) 5.67 (4.43) 4.13 (2.67)
 2-week follow-up
  Mean (SD) 3.8 (2.86) 4.47 (2.45)

  p-value 0.0035* 0.7331

 4-week follow-up
  Mean (SD) 2.2 (1.66) 4.87 (2.64)

  p-value 0.0036* 0.8581

 Change of 2 vs 4 week§ 0.0068* 0.9056

mSchober score
 Baseline 0.1078 0.0223* 0.0054*
  Mean (SD) 20.92 (1.22) 20.92 (1.24)
 2-week follow-up
  Mean (SD) 21.16 (1.17) 20.19 (1.23)

  p-value 0.1932 0.9940

 4-week follow-up
  Mean (SD) 21.67 (1.40) 20.65 (1.06)

  p-value 0.0092* 0.9793

 Change of 2 vs 4 week§ 0.0218* 0.0455*

FTF score
 Baseline 0.0005* 0.0527 0.0056*
  Mean (SD) 185.23 (114.70) 260.17 (104.02)
 2-week follow-up
  Mean (SD) 133.73 (88.64) 259.63 (101.11)

  p-value 0.0031* 0.4863

 4-week follow-up
  Mean (SD) 114.47 (67.97) 274.2 (73.11)

  p-value 0.0016* 0.7211

 Change of 2 vs 4 week§ 0.0233* 0.7586

FTT score
 Baseline 0.1684 0.3239 0.9078
  Mean (SD) 625.2 (33.22) 643.6 (36.61)
 2-week follow-up
  Mean (SD) 625.77 (38.19) 650.2 (34.93)

  p-value 0.5379 0.7209

 4-week follow-up
 Mean (SD) 616.23 (35.57) 633.1 (86.47)

p-value 0.1185 0.2870

 Change of 2 vs 4 week§ 0.0162* 0.2127

* Statistically significant at p<0.05

p-value obtained from RMANOVA

Statistical analysis within group was performed by one-tailed paired t-test

§ Statistical analysis change from baseline to 2-weeks and to 4-weeks was performed by one-tailed paired two sample t-test

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