Alternation of Topical Heat and Cold for Chronic Low Back Pain: A Randomized Controlled Pilot Trial

Article information

Acupunct. 2016;33(2):77-87
1Department of Acupuncture & Moxibustion, Dongguk University Ilsan International Hospital
2College of Korean Medicine, Dongguk University
*Corresponding author: Department of Acupuncture & Moxibustion, Dongguk University Ilsan International Hospital, 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 410-773, Republic of Korea, Tel: +82-31-961-9124, E-mail: chuckman@dongguk.edu
Received 2016 May 10; Revised 2016 May 29; Accepted 2016 June 01.

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.

Fig. 1

The device used in this study

Fig. 2

Flow diagram describing the patients during the study period

Total Number and The Reason of Drop-out

Baseline Demographic Characteristics of Participants

Outcome Measures of Pain Intensity, Disability and Range of Motion

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)

References

1. Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum 2012;64(6):2028–37.
2. Gaul C, Schmidt T, Czaja E, Eismann R, Zierz S. Attitudes towards complementary and alternative medicine in chronic pain syndromes: a questionnaire-based comparison between primary headache and low back pain. BMC Complement Altern Med 2011;11(1):89.
3. Melzack R, Vetere P, Finch L. Transcutaneous Electrical Nerve Stimulation for Low Back Pain A Comparison of TENS and Massage for Pain and Range of Motion. Phys Ther 1983;63(4):489–93.
4. Lehmann TR, Russell DW, Spratt KF, et al. Efficacy of electroacupuncture and TENS in the rehabilitation of chronic low back pain patients. Pain 1986;26(3):277–90.
5. Ghoname ES, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. JAMA 1999;281(9):818–23.
6. Ghoname ES, Craig WF, White PF, et al. The effect of stimulus frequency on the analgesic response to percutaneous electrical nerve stimulation in patients with chronic low back pain. Anesth Analg 1999;88(4):841–6.
7. Hamza MA, Ghoname EA, White PF, et al. Effect of the duration of electrical stimulation on the analgesic response in patients with low back pain. Anesthesiology 1999;91(6):1622–7.
8. Yokoyama M, Sun X, Oku S, et al. Comparison of percutaneous electrical nerve stimulation with transcutaneous electrical nerve stimulation for long-term pain relief in patients with chronic low back pain. Anesth Analg 2004;98(6):1552–6.
9. Lehmann JF, de Lateur BJ. Therapeutic heat Therapeutic heat and cold Baltimore: Williams & Wilkins; 1990. p. 417–23.
10. French SD, Cameron M, Walker BF, Reggars JW, Esterman AJ. A Cochrane review of superficial heat or cold for low back pain. Spine 2006;31(9):998–1006.
11. Prentice W. Therapeutic modalities in sports medicine 4th editionth ed. Bostaon: WCB/McGraw Hill; 1999. p. 187–189.
12. van Middelkoop M, Rubinstein SM, Kuijpers T, et al. A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain. Eur Spine J 2011;20(1):19–39.
13. McCaffery M. Nursing approaches to nonpharmacological pain control. Int J Nurs Stud 1990;27(1):1–5.
14. Fritzell P, Hägg O, Wessberg P, Nordwall A. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine 2001;26(23):2521–32.
15. Roland M, Fairbank J. The Roland-Morris disability questionnaire and the Oswestry disability questionnaire. Spine 2000;25(24):3115–24.
16. Feeley N, Cossette S, Côté J, et al. The importance of piloting an RCT intervention. Can J Nurs Res 2009;41(2):85–99.
17. Gorenberg M, Schiff E, Schwartz K, Eizenberg E. A novel image-guided, automatic, high-intensity neurostimualtion device for the treatment of nonspecific low back pain. Pain Res Treat 2011;2011:152307.
18. Nadler SF, Steiner DJ, Erasala GN, Hengehold DA, Abeln SB, Weingand KW. Continuous low-level heatwrap therapy for treating acute nonspecific low back pain. Arch Phys Med Rehabil 2003;84(3):329–34.
19. Nadler SF, Weingand K, Kruse RJ. The physiologic basis and clinical applications of cryotherapy and thermotherapy for the pain practitioner. Pain physician 2004;7(3):395–9.
20. Turner JA, Deyo RA, Loeser JD, Von Korff M, Fordyce WE. The importance of placebo effects in pain treatment and research. JAMA 1994;271(20):1609–14.
21. Nelson JM, Walmsley RP, Stevenson JM. Relative lumbar and pelvic motion during loaded spinal flexion/extension. Spine 1995;20(2):199–204.
22. Aure OF, Nilsen JH, Vasseljen O. Manual therapy and exercise therapy in patients with chronic low back pain: a randomized, controlled trial with 1-year follow-up. Spine 2003;28(6):525–31.

Article information Continued

Fig. 1

The device used in this study

Fig. 2

Flow diagram describing the patients during the study period

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