Complementary Therapies in Clinical Practice 15 (2009) 22–25

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Complementary Therapies in Clinical Practice

journal homepage: www.elsevier.com/locate/ctnm

A pilot study on using acupuncture and transcutaneous electrical nerve

stimulation to treat chronic non-specific low back pain
Kazunori Itoh a, *, Satoko Itoh b, Yasukazu Katsumi b, Hiroshi Kitakoji a
a
Department of Clinical Acupuncture and Moxibustion, Meiji University of Integrative Medicine, Kyoto 629-0392, Japan
b
Department of Orthopaedic Surgery, Meiji University of Integrative Medicine, Kyoto 629-0392, Japan

a b s t r a c t

Keywords: Objective: The present study tests whether a combined treatment of acupuncture and transcutaneous
TENS
electrical nerve stimulation (TENS) is more effective than acupuncture or TENS alone for treating chronic
Acupuncture
low back pain (LBP).
Chronic low back pain
Alternative medicine Methods: Thirty-two patients with chronic LBP were randomly allocated to four groups. The acupuncture
group (ACP) received only acupuncture treatment at selected acupoints for low back pain; the TENS
group (TENS) received only TENS treatment at pain areas; the acupuncture and TENS group (A&T)
received both acupuncture and TENS treatments; the control group (CT) received topical poultice (only
when necessary). Each group received specific weekly treatment five times during the study. Outcome
measures were pain intensity in terms of visual analogue scale (VAS) and QOL of low back in terms of
Roland-Morris Disability Questionnaire (RDQ).
Results: The ACP, TENS and A&T groups all reported lower VAS and RDQ scores. Significant reduction in
pain intensity (P < 0.008) and significant improvement in QOL (P < 0.008) were shown in the A&T group.
Conclusion: Combined acupuncture and TENS treatment is effective in pain relief and QOL of low back
improvement for the sampled patients suffering from chronic LBP.
Ó 2008 Elsevier Ltd. All rights reserved.

1. Introduction patients themselves due to its portability and simplicity. Several

studies examined the efficacy of acupuncture and TENS treatment
Low back pain (LBP) is a major health problem in modern for such conditions; however, the results were inconclusive.4–8
society.1 Seventy to eight-five percent of the population will Acupuncture and TENS were found effective in treating pain and
experience LBP at some time in their lives.1 Each year, 5–10% of the dysfunction in patients with LBP.4–8 A systematic review covering
workforce is off work because of their LBP, but most of them are off seven randomised controlled trials concluded that acupuncture
for less than seven days. Almost 90% of all patients with acute LBP and TENS were effective in reducing pain; however, differences in
recover quite rapidly, regardless of therapy. The remaining 10% are efficacy between acupuncture and TENS were inconclusive.4–8
at risk of developing chronic pain and disability and account for The present study aims to test whether TENS or a combined
more than 90% of the social costs for back incapacity.2 The treatment of acupuncture and TENS is more effective than
proportion of elderly patients who have LBP is greater than that of acupuncture or TENS alone for treating chronic non-specific LBP in
young adults. older patients.
On the other hand, anti-inflammatory drugs used to treat the
symptoms of this disorder usually have various side effects.3 When 2. Methods
drugs are not adequately effective, replacement treatment is often
recommended.4 Patients with chronic pain increasingly seek 2.1. Patients
alternative methods for pain relief, particularly transcutaneous
electrical nerve stimulation (TENS)5,6 and acupuncture.7,8 TENS has Outpatients aged 60 years or older with LBP were recruited from
the advantage of being efficacious, inexpensive, simple and the Meiji University of Oriental Medicine Hospital. Inclusion criteria
essentially free of side effects. TENS may also be used at home by for the present study were: (1) lumbar or lumbosacral low back
pain for six months or longer; (2) no radiation of low back pain; (3)
normal neurological findings of lumbosacral nerve, including deep
* Corresponding author. Tel.: þ81 771 72 1181; fax: þ81 771 72 0394. tendon reflexes, plantar response, voluntary muscle action, straight
E-mail address: k_itoh@meiji-u.ac.jp (K. Itoh). leg raising, and sensory function; and (4) not receiving acupuncture

1744-3881/$ – see front matter Ó 2008 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ctcp.2008.09.003
 K. Itoh et al. / Complementary Therapies in Clinical Practice 15 (2009) 22–25 23

treatment for more than six months. Exclusion criteria were: (1) 2.4. Evaluation
major trauma or systemic disease; and (2) receiving conflicting or
ongoing co-interventions. Patients under drug treatment were Primary outcome measures were: (1) pain intensity, quantified
included if there had been no change in medicine and its dosage for with a 10 cm visual analogue scale (VAS, 0–100 mm) and (2) pain
one month or longer. This study was approved by the Ethics disability measured with the Roland Morris Questionnaire (RDQ, 0–
Committee of the Meiji University of Integrative Medicine. 24 points).13 The RDQ consists of 24 questions each with two
All enrolled patients gave their written informed consent. possible responses.
According to a block randomised allocation table (generated by The VAS scores were measured immediately before the first
Sample Size, version 2.0, Int), the enrolled patients were allocated treatment and subsequently at one, two, three, four, five and ten
to (1) the control (CT) group, (2) the acupuncture (ACP) group, (3) weeks after the first treatment. The RDQ scores were measured
the transcutaneous electrical nerve stimulation (TENS) group or (4) immediately before the first treatment and subsequently five and
the acupuncture and TENS (A&T) group. ten weeks after the first treatment. Each VAS and RDQ score was
measured immediately before treatment of the specified week.
2.2. Design
2.5. Statistical analysis
The design of this study was a randomly controlled clinical trial
using a block randomised procedure. Each patient received a total Repeated measures analysis of variance (ANOVA) was used to
of five treatments, once per week, and follow-up was measured for study the changes in the VAS and RDQ scores in the three groups.
ten weeks after the first treatment. Changes in the time course among groups were considered
significant when the interaction was significant at a level of 0.008
(0.05/6). After detection of significant changes in the overall time
2.3. Treatment course with repeated measures ANOVA, pair comparisons were
detected with Bonferroni correction. StatView for Windows
2.3.1. Control (CT) group (version 5.0) or SYSTAT 10 (SYSTAT Inc) was used for the statistical
The CT group patients did not receive any specific treatment, but analysis. The results with P values of less than 0.05 were considered
when necessary, were allowed to use topical poultice containing statistically significant.
methylsalicylic acid.
3. Results
2.3.2. Acupuncture (ACP) group
The ACP group patients received acupuncture treatment at
3.1. Patients
selected acupoints for 15 min on the affected LBP. The selected
acupoints are widely accepted for treating LBP,9–12 namely Shenshu
A total of 32 patients (20 women, 12 men; aged 61–81 years)
(BL23), Dachangshu (BL25), Ciliao (BL32), Weizhong (BL40), Kun-
were randomly allocated to four groups for specific treatment. No
lum (BL60), huantiao(GB30) and Yanglingquan (GB 34). Disposable
significant difference was found in baseline variables including age,
stainless steel needles (0.2 mm  40 mm, Seirin Co Ltd) were
disease, pain duration, and VAS among the four groups.
inserted into the muscle to a depth of 10 mm using ‘sparrow
One patient in the ACP, two patients in the TENS group, one
pecking’ acupuncture technique (alternate pushing and pulling of
patient in the A&T group, and one patient in the CT group dropped
the needle) by acupuncturists who had four years of acupuncture
out as they had not responded to the respective treatment. In
training and three to eight years of clinical experience. When the
addition, one patient in the A&T group dropped out due to adverse
subject felt dull pain or the acupuncture sensation (de qi) was
effects (i.e. deterioration of symptoms). The dropout rate was not
achieved, the needle manipulation was stopped and the needle was
significantly different among the groups. The analyses were per-
left in place for ten more minutes.
formed on the 26 patients who completed the study and provided
required information (see Fig. 1).
2.3.3. Transcutaneous electrical nerve stimulation (TENS) group
The TENS group patients received treatment at the affected LBP
for 15 min from a single-channel portable TENS unit (model HV- 3.2. Pain intensity scores (VAS)
F3000, OMRON Healthcare Co Ltd, Japan), which sends between
two electrodes a premixed amplitude-modulated frequency of The mean VAS scores decreased in all groups during treatment,
122 Hz (beat frequency) generated by two medium frequency although the exact time courses varied (see Table 1). In the A&T
sinusoidal waves of 4.0 and 4.122 kHz (feed frequency). Surface group, the pre-treatment (0-week) VAS score and 4-week or
disposable electrodes of 809 mm2 and 5688 mm2 were placed on 5-week VAS score were significantly different (P < 0.008 by
the point with the most tenderness and the near side of the point. Bonferroni multiple comparisons). However, differences between
Two electrodes were different in size (ratio: 1:7). The smaller one the pre-treatment (0-week) scores and 5-week scores of the ACP,
was placed on the site of tenderness. The intensity of TENS was TENS and CT groups were not statistically significant.
adjusted so that a tingling sensation 2–3 times of the subject’s During the first five weeks of treatment, while the ACP and A&T
sensory threshold was produced. groups all reported lower mean pain intensity than the CT group,
the only statistically significant reduction was in A&T group.
2.3.4. Acupuncture and transcutaneous electrical nerve stimulation
(A&T) group 3.3. RDQ scores
The treatment for the A&T group combined the treatments for
the ACP and TENS groups. The patients received 15 min of TENS, The RDQ scores decreased in all groups during treatment,
and then 15 min of acupuncture treatment at the affected LBP. although the exact time courses varied (see Table 2). In the A&T
We confirmed that the subjects in all groups were not taking any group, the pre-treatment (0-week) RDQ score and 5-week RDQ
other co-interventions including analgesics, anti-inflammatory score were significantly different (P < 0.008 by Bonferroni multiple
agents or poultice containing methylsalicylic acid during the study comparisons). By the end of the fifth week of treatment, the ACP,
period. TENS and A&T groups reported lower RDQ scores than the CT group.
24 K. Itoh et al. / Complementary Therapies in Clinical Practice 15 (2009) 22–25

Assessed for eligibility

(n=32)

Enrollment
Excluded (n=0)

Randomised (n=32)

Allocated to TENS Allocated to ACP Allocated to A&T Allocated to CT

(n=8) (n=8) (n=8) (n=8)
Allocation
Received intervention (n=8) Received intervention (n=8) Received intervention (n=8) Received intervention (n=8)
Did not receive intervention (n=0) Did not receive intervention (n=0) Did not receive intervention (n=0) Did not receive intervention (n=0)

Lost to follow-up (n=2) Lost to follow -up (n=1) Lost to follow -up (n=2) Lost to follow -up (n=1)
Follow-up Discontinued intervention (n=2) Discontinued intervention (n=1) Discontinued intervention (n=2) Discontinued intervention (n=1)

Analysed (n=6) Analysed (n=7) Analysed (n=6) Analysed (n=7)

Analysis Excluded from analysis (n=2) Excluded from analysis (n=1) Excluded from analysis (n=2) Excluded from analysis (n=1)

Fig 1. Participation flow in the study.

Table 1 treatment was significantly more effective in terms of VAS and RDQ
Pain intensity scores (VAS). scores than other treatments.
Week TENS (n ¼ 6) ACP (n ¼ 7) A&T (n ¼ 6) CT (n ¼ 7) The present study demonstrated that acupuncture and TENS
0 63.8 (16.5) 60.0 (19.8) 62.3 (12.2) 63.7 (19.0) treatments were effective in pain relief. TENS is a common modality
1 61.0 (24.1) 47.6 (18.5) 53.2 (8.6) 58.3 (21.6) for treating musculoskeletal pain.14 TENS excited large-diameter
2 57.7 (27.2) 47.4 (24.0) 48.0 (6.1) 57.4 (19.7) afferent fibres.15 According to the gate control theory,16 TENS may
3 55.5 (23.5) 43.9 (21.7) 44.8 (5.6) 55.4 (19.7)
stimulate the large-diameter afferent fibres, which may reduce the
4 51.5 (25.7) 39.1 (27.6) 40.8 (5.7)* 56.3 (21.0)
5 53.2 (25.1) 37.4 (25.9 36.6 (8.0)* 53.1 (27.9) transmission of pain signals through the small nociceptive afferent
10 58.0 (23.7) 43.3 (25.7) 49.2 (10.3) 58.1 (28.9) fibres, thereby inhibiting pain discrimination and perception. TENS
Data are expressed as mean (SD).
has been shown to produce antinociceptive effects similar to those
*P < 0.008. of acupuncture17,18 with slow onset and gradual offset that persists
after the stimulation stops.19 Acupuncture excited small-diameter
afferent fibres.20,21 Similar to descending inhibition and/or diffuse
Table 2 noxious inhibitory controls (DNICs) in the brain system, acupunc-
Roland Morris Questionnaire (RMQ) scores.
ture may stimulate the small-diameter afferent fibres, which may
Week TENS (n ¼ 6) ACP (n ¼ 8) A&T (n ¼ 6) CT (n ¼ 7) reduce the transmission of pain signals, thereby inhibiting pain
0 8.2 (4.1) 7.9 (3.1) 6.8 (1.2) 9.0 (4.9) discrimination and perception.22 Moreover, acupuncture is used as
5 6.2 (3.4) 5.4 (3.4) 3.8 (0.8)* 7.3 (4.3) an effective treatment for improving lumbar function such as range
10 7.5 (3.6) 6.7 (4.8) 6.5 (1.6) 7.7 (4.6) of motion.10 It is possible that acupuncture affects tension and
Data are expressed as mean (SD). blood flow in the muscle. The present study demonstrated that
*P < 0.008. acupuncture was effective in improving the QOL of LBP patients.
Our other studies consistently showed that combined treatment
of acupuncture and TENS was more effective than individual
However, the differences between the treatment groups were not
treatments on Knee osteoarthritis.23 TENS was effective for the
statistically significant.
immediate relief of pain, while acupuncture was effective in long-
term pain relief and improvement of patients’ QOL. In the present
study, the A&T group reported lower mean pain intensity and lower
4. Discussion mean RDQ scores than other groups. Therefore, treatment of
chronic pain may need combined treatment of acupuncture and
TENS and acupuncture are non-pharmacological treatment TENS.
methods for a variety of pain conditions. This pilot study assessed
the effects of acupuncture and TENS on chronic LBP for later clinical
trials.
The ACP, TENS and A&T groups showed decreases in pain 5. Conclusion
intensity (VAS scores) compared to the CT group during treatment
(see Table 1). The treatment groups showed lower RDQ scores than The present study clearly demonstrated that combined
that of the CT group at week 5 of treatment (see Table 2). These acupuncture and TENS treatment is effective for pain relief in terms
results suggest that acupuncture and TENS treatments have posi- of VAS and QOL improvement in terms of RDQ in patients suffering
tive effects on the QOL of the chronic LBP patients, and that A&T from chronic LBP. Large scale clinical trials are warranted.
 K. Itoh et al. / Complementary Therapies in Clinical Practice 15 (2009) 22–25 25

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