ORIGINAL ARTICLE

Value of TENS for relief of chronic low back pain with or

without radicular pain
A. Buchmuller
1
, M. Navez
2
, M. Milletre-Bernardin
3
, S. Pouplin
4
, E. Presles
1
, M. Lantri-Minet
3
, B. Tardy
1
,
B. Laurent
2
, J.P. Camdessanch
2
, on behalf of the Lombotens Trial Group*
1 Centre dinvestigation Clinique Epidmiologie Clinique/Essais Cliniques (CIE3), CHU de Saint-Etienne, 42055 Saint-Etienne Cedex 02, France
2 Centre dvaluation et de Traitement de la Douleur (CETD), CHU de Saint-Etienne, 42055 Saint-Etienne Cedex 02, France
3 Dpartement dvaluation et de Traitement de la Douleur, Mdecine Palliative, Ple Neurosciences Cliniques, CHU de Nice, 06002 Nice
Cedex, France
4 Centre dvaluation et de Traitement de la Douleur, CHU de Rouen, 76031 Rouen Cedex, France
*Lombotens Trial Group
Writing committee A. Buchmuller, E. Presles, B. Tardy (Inserm CIE3, CHU de Saint-Etienne, Saint-Etienne, France), M. Navez, B. Laurent, JP. Camdes-
sanch [Centre dvaluation et de traitement de la douleur (CETD), CHU de Saint-Etienne, Saint-Etienne, France], M. Milletre-Bernardin, M. Lantri-
Minet (Centre dEvaluation et de traitement de la douleur, CHU de Nice, Nice, France), S. Pouplin (Centre dEvaluation et de traitement de la douleur,
CHU de Rouen, Rouen, France).
Coordinating Centre A. Buchmuller, J. Techer, G. El Asri (Inserm, CIE3, CHU de Saint-Etienne, Saint-Etienne, France).
Data Monitoring and Statistical Analysis E. Presles, S. Laporte (Inserm, CIE3, CHU de Saint-Etienne, Saint-Etienne, France).
Investigators (number of patients recruited) M. Navez, B. Pandraux, Hpital Bellevue, St-Etienne (31), P. Nayme, Hpital Nord, St-Etienne (23),
M. Lanteri Minet, M. Milletre-Bernardin, V. Lussiez, Nice (52), G. Ducable, S. Pouplin, Rouen (31), V. Dousset, Bordeaux (11), E. Touchard-Toulallan, Caen
(10), P. Roussel, Marseille La Timone (9), E. Serra, L. Douay, Amiens (9), G. Mick, G. Puech, Voiron (8), P. Mertens, Lyon (8), N. Cantagrel, B. Grandmottet,
Toulouse (7), B. Planchet Barraud, Marseille St-Joseph (7), S. Blond, N. Leleu, FX Derousseaux, Lille (5), P. Ginies, Dr, D. Kong A, Siou, Montpellier (5),
L. Boutault, I. Vannier, Tours (4), A. Lepeintre, Evreux (4), JP. Estebe, Rennes (3), P. Vergne-Salle, Limoges (3), F. Tiberghien, JL. Lajoie, V. Piccand,
Besanon (3), A. Serrie, Paris Lariboisire (1), M. Sorel, H. Vrolyk Vergeron, Nemours (1), C. Maindet-Dominici, C. Garin, Reseau Algo 38 de Grenoble (1).
Contributors: All authors are members of the LOMBOTENS Trial Group. AB represented the Coordinating Centre and was a member of the Writing
Committee; MN, MMB, SP and MLM were investigators and members of the Writing Committee; EP was responsible for data monitoring and statistical
analysis and was a member of the Writing Committee; BT, BL and JPC were members of the Writing Committee.
+Trial registration: Clinicaltrials.gov: NTC 00452010
Ethical approval: This study was approved by the Comit de Protection des Personnes (ethics committee) Sud-Est I, Saint-Etienne, France.
Correspondence
Andra Buchmuller
Tel.: +33 477127788; fax: +33 477127820.
E-mail: andrea.buchmuller@chu-st-etienne.fr
Funding sources
This study was funded by the Direction
Gnrale de la Sant (Ministre de la Sant et
des Sports), the Fondation CNP Assurances
and the Institut UPSA Douleurs. Sham TENS
devices were provided free of charge by
CEFAR France. The funding bodies played no
role in the research process, the writing of
the report or the decision to submit the
article for publication.
Conicts of interest
One author (B.L.) is a member of a board
(Lilly).
Accepted for publication
27 September 2011
doi:10.1002/j.1532-2149.2011.00061.x
Abstract
Objectives: To evaluate the efcacy of transcutaneous electrical
neurostimulation (TENS) in patients with chronic low back pain (LBP).
Methods: Design: Prospective, randomized, multicentre, single-blind
study. Setting: Twenty-one French pain centres. Participants: Two hundred
thirty-six consecutive adult patients consulting for chronic LBP, with or
without radicular pain (mean age standard deviation: 53 13 years;
range: 2886 years). Intervention: Patients were randomly assigned to
receive either active (n = 117) or sham (n = 119) TENS in four 1-h daily
treatment sessions for 3 months. Main outcome measures: The primary
outcome measured was improvement of functional status at 6 weeks
(RolandMorris Disability Questionnaire). Secondary outcome measures
were improvement of functional status at 3 months, pain relief (weekly
visual analogue scale assessments), positive functional repercussions of
pain levels on quality of life, a diminution of the use of analgesic and
anti-inammatory medication, satisfaction with the overall treatment
strategy and compliance.
Results: Functional status did not differ between the groups, whether at
6 weeks or 3 months (p = 0.351 at 6 weeks). A signicant improvement
between the rst and last visual analogue scale assessments was observed
656 Eur J Pain 16 (2012) 656665 2011 European Federation of International Association for the Study of Pain Chapters
in patients with either lumbar pain alone or lumbar and radicular pain
treated with active TENS. Other outcome measures did not differ
signicantly between the two groups.
Conclusion: There was no functional benet of TENS in the treatment of
patients with chronic LBP.
1. Introduction
Low back pain (LBP) is a leading cause of work absen-
teeism and visits to healthcare professionals (Anders-
son, 1999; Deveraux, 2004). Around 6090% of the
adult population is at risk of developing LBP at some
point in their lifetime. It is estimated that 1020% of
affected adults develop symptoms of chronic LBP,
dened as persistent pain occurring on most days and
lasting longer than three consecutive months (Von
Korff and Saunders, 1996; Hildebrandt et al., 2004;
Maher, 2004). Chronic LBP has a signicant impact on
functional status, restricting occupational activities
with marked socio-economic repercussions (Van
Tulder et al., 1999; Becker et al., 2011). The use of
multiple complementary treatments is frequent and
active therapies encouraging individuals to participate
in the treatment process are increasingly advocated
(Dogan et al., 2008). One of these methods is transcu-
taneous electrical nerve stimulation (TENS), a non-
invasive treatment that can be self-administered by
patients and is generally associated with few safety
concerns, adverse effects being principally limited to
transient skin irritation. TENS is currently widely used
as an add-on therapy for chronic LBP patients
(Buchmuller-Cordier et al., 2008; Carey et al., 2009).
Despite wide use of this treatment, its efcacy in
relieving chronic LBP has not been established: in the
last review of the Cochrane Database (Khadilkar et al.,
2008), only four studies meeting the criteria for high
methodological quality were included in the qualita-
tive analysis (Deyo et al., 1990; Cheing and Hui-Chan,
1999; Topuz et al., 2004; Jarzem et al., 2005). This
review presented conicting evidence as to whether
TENS was benecial in reducing back pain intensity as
assessed in 235 randomized patients (three studies)
using a visual analogue scale (VAS), and consistent
evidence that it did not improve back-specic func-
tional status in 410 randomized patients (two studies)
using different but validated scales.
We therefore conducted a randomized, single-blind
study in adult patients consulting French pain centres
with chronic LBP, to compare the efcacy of active and
sham TENS in terms of functional disability, short- and
long-term pain relief, quality of life (QOL) and anal-
gesic use. To better dene the appropriate clinical
context for the use of TENS, in terms of neuropathic or
nociceptive pain, both patients presenting LBP with or
without radicular pain were enrolled and the efcacy
of TENS was assessed in these two subgroups (Deyo
et al., 1990; Carroll et al., 2000; Jarzem et al., 2005;
Khadilkar et al., 2008).
2. Methods
Patients aged over 18 years, covered by a national
health insurance policy, and who had consulted a pain
centre during the previous week for chronic LBP
graded on average 40 on a VAS, with or without
radicular pain, were potentially eligible for inclusion.
Diagnosis of a radicular pathology was conrmed
based on the clinical examination. Patients were ineli-
gible for the study if they had been previously treated
with TENS; if they had undergone surgery for radicu-
lopathy within the last 3 months; if they had experi-
enced LBP for less than 3 months; if LBP was
associated with bilateral radiculopathy; if they had
acute or non-stabilized radicular syndrome (sciatalgia,
cruralgia); if any surgery was planned within the next
6 months; if they had a pacemaker; if other non-
pharmacological treatments were planned, including
physiotherapy, acupuncture, mesotherapy, manipula-
tions, wearing a corset, or psychological support; if
their LBP was symptomatic of another condition (i.e.,
compression fractures or progressive inammatory,
neoplastic or infectious conditions); if the physician
had estimated their life expectancy to be less than 3
months; if articular or foraminal inltrations were
planned during the study period; or if the patient was
involved in an ongoing medico-legal dispute.
2.1 Randomization and data collection
This study was approved by the Comit de Protection des
Personnes (ethics committee) Sud-Est I, Saint-Etienne,
France. Eligible patients were included after having
read an information sheet detailing the TENS proce-
dure and noting its potential benets with regard to
pain relief even when no tingling was perceived (as in
the sham TENS procedure). After written informed
A. Buchmuller et al. Value of TENS for relief of chronic low back pain
657 Eur J Pain 16 (2012) 656665 2011 European Federation of International Association for the Study of Pain Chapters
consent had been obtained, randomization was per-
formed at a central location with stratication by
centre and by type of chronic LBP (with or without
radicular pain). To determine the treatment group to
which each patient should be assigned, the investiga-
tor called the study coordination centre, which
assigned the patient according to the randomization
list established for each centre before the start of the
study, based on a computer-generated pseudo-random
number sequence. The data were collected and
recorded by the Centre dInvestigation Clinique de Saint-
Etienne (CIE3).
2.2 Interventions
2.2.1 TENS apparatus and procedure
Active TENS treatment combined two types of electri-
cal stimulation:
(1) Conventional TENS (gate control), characterized
by continuous stimulation at high frequencies (80
100 Hz), with wave durations of 50100 ms and low
intensities, potentially achieving painless paraesthesia
in the part of the body concerned.
(2) burst TENS (acupuncture-like TENS), character-
ized by discontinuous stimulation at low frequencies
(14 Hz), with wave durations of 100400 ms and high
intensities, inducing weak muscle twitches.
The treatment was self-administered using a CEFAR
Primo Pro device and program P5, which associates
continuous high-frequency (80 Hz) stimulation with
bursts of low-frequency (2 Hz) stimulation every 3 s.
For patients suffering from chronic LBP without
radicular pain, two of the four electrodes were placed
on healthy skin on each side of the painful area. For
those experiencing LBP associated with radicular pain,
two electrodes were placed spanning the painful area
of the back and two electrodes on the trajectory of the
troncular nerve involved in the radiculopathy. At the
start of stimulation, the intensity was increased pro-
gressively until the onset of painless tingling, or up to
25 mA if no sensation was perceived by the patient.
After the devices screen read zero, the intensity was
further increased until tolerable impulses were
perceived or up to 30 mA in the absence of any sen-
sation. Stimulation was then continued for 1 h at this
intensity.
The treatment protocol was the same for patients
assigned to sham TENS treatment, except that the
TENS devices provided to this group did not deliver an
electrical current. The four electrodes were placed as
described above, depending on whether LBP was asso-
ciated with radicular pain. The sham treatment was
self-administered, using a CEFAR Primo Pro device
and program P5. The term placebo was not used in
the information leaet. The leaet explained that the
study aimed to evaluate currents of much more vari-
able intensity than usual TENS, and that both TENS
techniques could trigger sensations such as tingling.
The leaet also stated that this did not occur in all
cases and that there was no relation between tingling
and TENS efcacy.
Irrespective of the treatment group, patients were
instructed to complete four 1-h treatment sessions per
day for a total of 3 months. Both active and sham
TENS devices incorporated a mechanism which auto-
matically recorded stimulation frequency and dura-
tion, which were checked at each study visit to verify
compliance.
2.2.2 General study procedure and follow-up
On the day of inclusion, the patients demographic
data, clinical history, and ongoing analgesic,
co-analgesic and other medication were recorded and
the patient independently completed a self-evaluation
questionnaire including the RolandMorris Disability
Questionnaire (RDQ), the Dallas pain questionnaire
and the SF-36 QOL questionnaire. The DN4 Neuro-
pathic Pain Diagnostic Questionnaire (Bouhassira
et al., 2004) and the Quebec Task Force classication
(Spitzer, 1987) were also completed on the day of
inclusion, as well as the mean and maximum levels of
pain during the week preceding the consultation,
using a VAS ranging from 0 (absence of pain) to
100 mm (maximum imaginable pain), were recorded.
The patient was then given a personal diary. This con-
tained detailed instructions on self-administering the
TENS treatment, including a silhouette showing the
correct placement of the electrodes, as well as forms
for noting daily analgesic medication, weekly VAS
assessments of LBP and, if relevant, radicular pain, the
number of TENS sessions accomplished per day, the
analgesic effect noted during and after each session,
and any adverse event experienced after each session.
Follow-up visits at the pain centre were scheduled at
15 days (2 days), 6 weeks (1 week) and 3 months
(1 week) after the start of active or sham TENS
treatment.
2.3 Outcome measures
The primary study objective was to evaluate the ef-
cacy of TENS in terms of functional status at 6 weeks,
assessed using the RDQ. A 4-point decrease was con-
sidered an improvement in functional status.
Value of TENS for relief of chronic low back pain A. Buchmuller et al.
658 Eur J Pain 16 (2012) 656665 2011 European Federation of International Association for the Study of Pain Chapters
The secondary objective was to compare the two
groups with respect to pain on a weekly basis, and
with respect to functional status, global improvement
and QOL at 3 months. Secondary outcome measures
comprised:
(1) Pain relief evaluated on the basis of weekly VAS
scores for the lumbar and radicular components of
pain (both overall pain and grading LBP and radicular
pain separately); the criterion for improvement was a
50% decrease in the VAS score (Moore et al., 2008).
(2) Functional status at 3 months, assessed using the
RDQ.
(3) Daily activities, professional/leisure activities,
anxiety/depression, and sociability at 3 months, deter-
mined by means of the Dallas questionnaire.
(4) Overall satisfaction with the pain management
strategy at 6 weeks and at 3 months (percentage of
patients with scoring 50% or more on the satisfaction
scale).
(5) QOL at 3 months relative to D0, assessed using the
SF-36 scale.
(6) Use of analgesic and anti-inammatory medica-
tion between D0 and 3 months.
(7) Compliance with TENS treatment.
2.4 Sample size
We hypothesized an improvement of the primary
outcome at 6 weeks in 30% of patients with LBP
treated in a pain centre (Flor et al., 1992) and that
50% of the patients in the active TENS group would
achieve a decrease of at least four points on the RDQ
at 6 weeks compared with baseline. On this basis, with
an alpha risk of 5%, it was calculated that 103 evalu-
able patients per treatment group would be needed to
achieve an 80% power to detect a difference between
the groups.
2.5 Statistical analysis
Quantitative variables were summarized by means,
standard deviations, medians, minimums and maxi-
mums. Categorical variables were expressed as abso-
lute and relative frequencies. Comparability of the
groups at inclusion was veried using Students t-test
for quantitative variables (or Wilcoxons test if distri-
bution was abnormal) and the chi-squared test or
Fishers exact test for qualitative variables. The
primary endpoint analysis was performed on all
patients included in the study, i.e., all those having
undergone centralized randomization, according to
the intention-to-treat (ITT) principle. For primary
endpoint analysis, patients who did not complete the
6-week follow-up visit were considered as showing no
functional improvement on the basis of the RDQ. With
regard to the secondary outcomes, patients were
included in the analyses of all variables for which their
data were available. The percentages of patients with
improved functional capacity in the two treatment
groups were compared on the basis of the estimated
relative risk and the corresponding 95% condence
interval. Differences between the two treatment
groups were considered statistically signicant at
p < 0.05 (two sided). Subgroup analyses according to
patient initial pathology (LBP with and without
radicular pain, DN4 score <4 and 4, Quebec Task
Force type 1 or 2 and type 3 or 4) were descriptive
only. A heterogeneity test was performed only for the
primary endpoint in order to compare the differences
observed in the two subgroups. The statistical analyses
were accomplished using SAS-Windows

software,
version 9.1 (SAS Institute Inc, Cary, NC, USA).
3. Results
A total of 236 consecutive patients were included in
the study between 14 September 2006 and 11 June
2008, in 21 pain centres located throughout France,
with 117 patients being randomized to the active
TENS and 119 to the sham TENS. The majority of
patients (139; 58.9%) were suffering from LBP asso-
ciated with radicular pain. The two treatment groups
were comparable in terms of demographic and clinical
characteristics at inclusion, with no statistically signi-
cant difference between the groups in any of the vari-
ables analysed (Table 1). Most patients (88.0%) were
taking at least one type of analgesic medication, pre-
dominantly paracetamol (71.6%), with 64% taking
various co-analgesic medications, mainly antidepres-
sants. Follow-up with respect to the primary efcacy
outcome was incomplete for 28 patients (11.9%). At 3
months, follow-up was incomplete for an additional
34 patients (Figure 1).
3.1 Efcacy of active versus sham TENS in the
study population as a whole
The results of the primary and secondary outcome
analyses performed on the total study population are
presented in Table 2.
3.1.1 Primary outcome measure improvement in
functional status at 6 weeks
At 6 weeks, the median score achieved on the RDQ
was 12 in the active TENS group and 13 in the sham
A. Buchmuller et al. Value of TENS for relief of chronic low back pain
659 Eur J Pain 16 (2012) 656665 2011 European Federation of International Association for the Study of Pain Chapters
TENS group, compared with a median baseline score
of 15 in both groups. Improvement was achieved by
29.9% of patients in the active TENS group and 24.3%
in the sham TENS group, and the difference between
the groups did not reach the threshold of statistical
signicance [RR = 1.23 (0.80; 1.89), p = 0.351].
3.1.2 Secondary outcome measures
Improvement in functional status at 3 months was
achieved by 26.4% and 25.0% of patients in the active
and sham TENS groups, respectively, with no statisti-
cally signicant difference between the groups
[RR = 1.05 (0.67; 1.65), p = 0.816].
No statistically signicant difference between the
groups was evident with regard to scores for the
four dimensions of the Dallas score at 3 months
(Table 2).
An improvement of at least 50% in lumbar pain
between the rst and last assessments was achieved by
25.0% of patients in the active TENS group compared
with 6.7% in the sham TENS group (p = 0.0003),
corresponding to a number needed to treat (NNT) of 5.
An improvement of at least 50% in radicular pain
between the rst and last assessments was achieved by
33.8% of patients in the active TENS group and 15.0%
in the sham TENS group (p = 0.0148), also corre-
sponding to a NNT of 5. The median interval between
the rst and last VAS pain assessments was 12 weeks
(Q1Q3: 913) for both patients with lumbar pain
alone and those with lumbar and radicular pain.
There was no statistically signicant difference
between the two groups with regard to overall sat-
isfaction with the pain management strategy mea-
sured at 6 weeks and 3 months. More than half of
the patients were very satised, with a score exceed-
ing 50% on the satisfaction scale (61.6% in the
active TENS group vs. 57.3% in the sham TENS
group at 3 months).
No statistically signicant change in QOL between
baseline and 3 months was detected on the basis of the
SF-36 questionnaire and there was no statistically sig-
nicant difference between the two treatment groups
concerning this parameter.
Table 1 Patient characteristics at inclusion.
Parameter
Active TENS Sham TENS Total population
n = 117 n = 119 n = 236
Men/Women, n/n (%/%) 45/72 (38.5/61.5) 43/76 (36.1/63.9) 88/148 (37.3/62.7)
Age (year), mean SD 52.9 13.0 53.4 12.9 53.1 12.9
Body mass index 30 kg/m
2
22 (19.3) 15 (13.2) 37 (16.2)
Description of pathology
LBP/LBP + RP 46/71 (39.3/60.7) 51/68 (42.9/57.1) 97/139 (41.1/58.9)
Interval between symptom onset and randomization
Median [range] months 40 [1622]
a
34.5 [3423] 36.5 [1622]
Surgery for disk hernia 44 (37.9) 41 (34.7) 85 (36.3)
Surgery for lumbar arthrodesis 8 (6.9) 14 (11.8) 22 (9.4)
Schober index (cm), mean SD 12.8 2.4 13.0 1.5 12.9 2.0
Baseline VAS (mm), mean SD 63 15 66 17 65 16
Maximum VAS (mm), mean SD 85 12 85 12 85 12
DN4 4 points 69 (61.6) 69 (61.1) 138 (61.3)
QTF classication
Type 1 27 (23.7) 32 (27.8) 59 (25.8)
Type 2 32 (28.1) 27 (23.5) 59 (25.8)
Type 3 18 (15.8) 27 (23.5) 45 (19.7)
Type 4 37 (32.5) 29 (25.2) 66 (28.8)
RolandMorris disability scale score
Median [range] months 15 [324] 15 [522] 15 [324]
Description of treatment
At least one analgesic medication per day
b
91 (90.1) 93 (86.1) 184 (88.0)
At least one co-analgesic medication per day
b
68 (66.7) 69 (62.2) 137 (64.3)
Use of class 2 analgesic drug 52 (64.2) 49 (61.2) 101 (62.7)
Non-pharmacological treatment 41 (42.7) 56 (53.8) 97 (48.5)
LBP, low back pain; QTF, Qubec Task Force; RP, radicular pain; SD, standard deviation; TENS, transcutaneous electrical nerve stimulation; VAS, visual
analogue scale.
a
One patient who had suffered from pain for only 1 month was included by error and randomized to the active TENS group.
b
This included paracetamol, non-steroidal anti-inammatory drugs, antidepressants, antiepileptic agents, myorelaxant agents and weak opioid drugs.
Value of TENS for relief of chronic low back pain A. Buchmuller et al.
660 Eur J Pain 16 (2012) 656665 2011 European Federation of International Association for the Study of Pain Chapters
More than 50% of patients did not modify their
medication use from inclusion to the end of the study
period, regardless of their assignment to active or
sham TENS group. Irrespective of the medication con-
sidered, the variation in the median daily dosage
between the rst and last doses did not differ signi-
cantly between the two treatment groups. The median
variations for each medication were zero in both
groups, signifying that half of the patients did not
decrease the dose of medication taken.
Compliance with TENS treatment was good in both
treatment groups, with no statistically signicant dif-
ference between the groups.
3.1.3 Safety
Twelve patients presented a serious adverse event
during the study: ve in the active TENS group and
seven in the sham TENS group. None of these events
was considered to be attributable to the treatment
studied. Skin irritation was observed in 11 patients in
the active TENS group (leading to study discontinua-
tion in one patient) and in three patients in the sham
TENS group.
3.2 Subgroup analyses according to the
existence of a neuropathic component of pain
Whatever the method used to dene the presence of
neuropathic pain (clinical assessment, DN4 or Quebec
Task Force scores), a trend in favour of active TENS
was observed in patients with radicular or neuropathic
pain in terms of functional status (Figure 2). A similar
trend was observed with regard to VAS scores for both
lumbar and radicular pain intensity (Figures 3 and 4).
4. Discussion
This multicentre single-blind study was designed to
evaluate the efcacy of TENS in improving functional
disability in patients with chronic LBP. At 6 weeks, no
statistically signicant difference in functional status
Figure 1 Treatment and follow-up of study patients. Of the 22 and 31 patients in the active and sham transcutaneous electrical nerve stimulation (TENS)
groups, respectively, who dropped out of the study prematurely, all declared that the TENS procedure was too constraining. VAS, visual analogue scale.
A. Buchmuller et al. Value of TENS for relief of chronic low back pain
661 Eur J Pain 16 (2012) 656665 2011 European Federation of International Association for the Study of Pain Chapters
improvement was observed between patients receiv-
ing active and sham TENS and a similar result was
obtained at 3 months. In contrast, the weekly evalu-
ation of pain intensity recorded in patients diaries
showed a highly signicant difference in favour of
active TENS in both the lumbar and radicular compo-
nents of pain. This effect on pain intensity was par-
ticularly marked in the subgroup of patients with LBP
associated with radicular pain. In the population as a
whole, this positive effect of active TENS did not lead
to either decreased medication intake or improved
QOL, despite clear overall satisfaction with the pain
management strategy.
Our choice to include patients with and without
radicular pain could be a matter for debate. However,
there is some evidence that radiculopathy may be a
mixed pain syndrome including a neuropathic com-
ponent (Flor et al., 1992; Baron and Binder, 2004;
Moore et al., 2008), and so patients may experience a
mixture of neuropathic and nociceptive pain. In this
respect, it is important to note that patients with and
without radicular pain were also included in two of
the four studies considered in the Cochrane Database
for TENS evaluation in chronic LBP (Deyo et al., 1990;
Jarzem et al., 2005; Khadilkar et al., 2008).
The relevance of the primary outcome measure
used to judge the effect of TENS on functional status,
a decrease of four points in the RDQ score, may be
debatable. However, a decrease of 3.5 points in the
RDQ score was previously reported to be the
minimum clinically important change (Ostelo and de
Vet, 2005), and a decrease of ve points has recently
been proposed by an international expert panel
(Ostelo et al., 2008). The inclusion of patients with
and without radicular pain, as specied in the study
protocol, permitted assessment of the efcacy of TENS
in relieving both neuropathic and nociceptive pain.
Interestingly, this improvement of pain intensity in
Table 2 Outcome measures.
Parameter
Active TENS
n = 117
Sham TENS
n = 119 p-value
Functional status
Improvement on RolandMorris disability questionnaire, n/N (%)
At 6 weeks 32/107
a
(29.9) 28/115
a
(24.3) 0.351
At 3 months 29/110 (26.4)
b
28/112 (25.0)
b
0.816
Pain relief VAS
Improvement of lumbar VAS between rst and last VAS
50%, n/N (%) 26/104 (25.0) 7/104 (6.7) 0.0003
Improvement of radicular VAS between rst and last VAS
50%, n/N (%) 22/65 (33.8) 9/60 (15.0) 0.015
Satisfaction with pain management strategy
c
Score on satisfaction scale > 50%, n/N (%)
At 6 weeks 51/96 (53.1) 55/96 (57.3) 0.562
At 3 months 53/86 (61.6) 43/75 (57.3) 0.580
Quality of life SF-36 (mean SD)
At 3 months
Aggregate score for physical dimensions 35.3 7.3 34.3 7.8 0.218
Aggregate score for psychological dimensions 39.3 12.4 39.1 11.1 0.959
Functional repercussion of pain Dallas score
At 3 months
Score for everyday activities, median [range] 69 [0100] 69 [1296] 0.843
Score for professional and leisure activities, median [range] 70 [0100] 70 [1095] 0.970
Score for anxiety and depression, median [range] 42.5 [095] 42.5 [0100] 0.950
Score for sociability, median [range] 30 [0100] 35 [080] 0.796
Compliance with TENS treatment
Mean number of TENS sessions per day, median [range] 3.6 [0.89.7] 3.7 [0.74.8] 0.203
SD, standard deviation; TENS, transcutaneous electrical nerve stimulation; VAS, visual analogue scale.
a
Acomplete RolandMorris Disability Questionnaire (RDQ) performed both at inclusion and at 6 weeks was not evaluable for 10 patients in the active TENS
group and four patients in the sham TENS group.
b
A complete RDQ performed both at inclusion and at 3 months was not evaluable for seven patients in the active TENS group and seven patients in the
sham TENS group.
c
The outcome was measured at the 6-week and 3-month visits on a scale ranging from 0% to 100%.
Value of TENS for relief of chronic low back pain A. Buchmuller et al.
662 Eur J Pain 16 (2012) 656665 2011 European Federation of International Association for the Study of Pain Chapters
favour of active TENS treatment in the group of
patients with radicular pain was observed for both
components of pain: lumbar and radicular.
Compared with the other four high-quality ran-
domized studies evaluating TENS efcacy (Deyo et al.,
1990; Cheing and Hui-Chan, 1999, Topuz et al., 2004;
Jarzem et al., 2005), our study is the rst in which the
results are reported using an ITT analysis and in which
long-term follow-up outcomes are reported. Com-
pared with the four other studies evaluating TENS
efcacy, our study population was larger and pre-
sented more severe LBP: only one of the previous
studies included more than 200 patients (Jarzem et al.,
2005). In that study, 18% of the patients included had
undergone prior back surgery and the mean RDQ
score was 10.5. In our study, in contrast, 46% of the
Figure 2 Improvement in RolandMorris Disability Questionnaire score at 6 weeks, subgroup analysis. CI, condence interval; QTF, Qubec Task Force;
TENS, transcutaneous electrical nerve stimulation.
Figure 3 Lumbar pain relief: visual analogue scale improvement between rst and last assessments, subgroup analysis. CI, condence interval; QTF,
Qubec Task Force; TENS, transcutaneous electrical nerve stimulation.
A. Buchmuller et al. Value of TENS for relief of chronic low back pain
663 Eur J Pain 16 (2012) 656665 2011 European Federation of International Association for the Study of Pain Chapters
patients had previously undergone back surgery and
the median RDQ score was 15. In addition, our TENS
treatment strategy, with sessions of 240 min/day for 3
months, appears to be more aggressive than those
employed in the other studies (ranging from ve
20-min sessions for 2 weeks to 3 h/day for 4 weeks).
Despite the inclusion of more patients with severe LBP
in our study, and a more intensive schedule of TENS
treatment, the 26% premature discontinuation rate at
3 months was similar to the 30% rate reported in a
large study in which the duration of TENS treatment
was 4 weeks (Jarzem et al., 2005). The high-
compliance rates seen in both treatment groups in our
study also conrm that self-administered TENS is a
treatment option that patients readily submit to.
TENS may conceivably modify not only the nocicep-
tive component of lumbar pain, but also the neuro-
pathic component. As the treatment protocol com-
prised a combined program of conventional (gate
control) and acupuncture-like TENS, the improve-
ment of lumbar pain could not be attributed to
acupuncture-like TENS alone. As previously reported
(Freynhagen and Baron, 2009), part of this lumbar
pain could therefore be related to a neuropathic com-
ponent. Interestingly, a third of the 97 patients in our
pure LBP group had a baseline DN4 score > 4 in the
lumbar pain description. Finally, participants reported
a high level of overall satisfaction with the pain man-
agement strategy; even those treated with sham TENS,
demonstrating that a valid placebo control is possible
in a LBP trial (Machado et al., 2008). However, as the
main effect of pain intensity improvement was noted
in the subgroup of patients with LBP and radicular
pain, it might be worth performing a further random-
ized study focusing on that population.
5. Conclusion
The overall results of this study do not support the
use of TENS in the treatment of patients with chronic
LBP.
Acknowledgements
We thank the Direction Gnrale de la Sant (Ministre de la
Sant et des Sports), the Fondation CNP Assurances and the
Institut UPSA Douleurs for their nancial support. We also
thank CEFAR France, which provided the sham TENS
devices free of charge, and Nolie Buisson-Descombes for
reviewing the English manuscript.
References
Andersson GBJ. Epidemiologic features of chronic low-back
pain. Lancet 1999;354:5815.
Baron R, Binder A. How neuropathic is sciatica? The mixed
pain concept. Orthopade 2004;33:56875.
Becker A, Held H, Redaelli M, Chenot JF, Leonhardt C,
Keller S, et al. Implementation of a guideline for low back
pain management in primary care a cost-effectiveness
analysis. Spine (Phila Pa 1976) 2011. [Epub ahead of
print].
Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M,
Masquelier E, et al. Development and validation of the
Neuropathic Pain Symptom Inventory. Pain 2004;
108:24857.
Buchmuller-Cordier A, Navez N, Presles E, Venet E, Dupont
O, Laurent B. Premire enqute nationale sur les tech-
niques non mdicamenteuses utilises en Centres
dEvaluation et de Traitement de la Douleur (CETD) pour
la prise en charge de la douleur chronique de ladulte.
Douleurs 2008;9:31519.
Figure 4 Radicular pain relief: visual analogue scale improvement between rst and last assessments, subgroup analysis. CI, condence interval; QTF,
Qubec Task Force; TENS, transcutaneous electrical nerve stimulation.
Value of TENS for relief of chronic low back pain A. Buchmuller et al.
664 Eur J Pain 16 (2012) 656665 2011 European Federation of International Association for the Study of Pain Chapters
Carey TS, Freburger JK, Homes GM, Castel L, Darter J, Agans
R, et al. A long way to go: practice patterns and evidence
in chronic low back pain care. Spine 2009;34:718
24.
Carroll D, Moore RA, McQuay HJ, Fairman F, Tramer M,
Leijon G. Transcutaneous electrical nerve stimulation
(TENS) for chronic pain. Cochrane Database Syst Rev
2000;(4):CD003222.
Cheing GL, Hui-Chan CW. Transcutaneous electrical nerve
stimulation: nonparallel antinociceptive effects on chronic
clinical pain and acute experimental pain. Arch Phys Med
Rehabil 1999;80:30512.
Deveraux MW. Low back pain. Prim Care Clin Ofce Pract
2004;31:3351.
Deyo RA, Walsh NE, Martin DC, Schoenfeld LS, Ramamur-
thy S. A controlled trial of transcutaneous electrical stimu-
lation (TENS) and exercise for chronic low-back pain. N
Engl J Med 1990;322:162734.
Dogan SK, Tur BS, Kurtais Y, Atay MB. Comparison of three
different approaches in the treatment of chronic low back
pain. Clin Rheumatol 2008;27:87381.
Flor H, Fydirch T, Turk DC. Efcacy of multidisciplinary pain
treatment centers: a meta-analytic review. Pain
1992;49:22130.
Freynhagen R, Baron R. The evaluation of neuropathic com-
ponents in low back pain. Curr Pain Headache Rep
2009;13:18590.
Hildebrandt J, Ursin H, Mannion AF, Airaksinen O, Brox JI,
Cedraschi C, et al. European guidelines for the management of
chronic non specic low back pain. 2004. http://www.
backpaineurope.org/web/les/WG2_Guidelines.pdf,
accessed 11 December 2011.
Jarzem P, Harvey EJ, Arcaro N, Kazarowski J. Transcutane-
ous electrical nerve stimulation (TENS) for chronic low
back pain. J Musculoskeletal Pain 2005;13:38.
Khadilkar A, Odebyi DO, Brosseau L, Wells GA. Transcuta-
neous electrical nerve stimulation (TENS) versus placebo
for chronic low-back pain. Cochrane Database Syst Rev
2008;(4):CD003008.
Machado LAC, Kamper SJ, Herbert RD, Maher CG, McAuley
JH. Imperfect placebos are common in low back pain trials:
a systematic review of the literature. Eur Spine J
2008;17:889904.
Maher CG. Effective physical treatment for chronic low back
pain. Orthop Clin North Am 2004;35:5764.
Moore RA, Moore OA, Derry S, McQuay HJ. Numbers
needed to treat calculated from responder rates give a
better indication of efcacy in osteoarthritis trials than
mean pain scores. Arthritis Res Ther 2008;10:R39.
Ostelo RW, de Vet HC. Clinically important outcomes in low
back pain. Best Pract Res Clin Rheumatol 2005;19:593
607.
Ostelo RW, Deyo RA, Stratford G, Waddell G, Croft P, Von
Korff M, et al. Interpreting change scores for pain and
functional status in low back pain: towards international
consensus regarding minimal important change. Spine
2008;33:904.
Spitzer WO. Scientic approach to the assessment and man-
agement of activity-related spinal disorders. A monograph
for clinicians. Report of the Quebec Task Force on Spinal
Disorders. Spine 1987;12:S159.
Topuz O, Ozdan E, Ozgen M, Ardic F. Efcacy of transcu-
taneous electrical nerve stipulation and percutaneous elec-
trical neuromodulation therapy in chronic low back pain.
J Back Musculoskelet Rehabil 2004;17:12733.
Van Tulder MW, Koes BW, Assendelft WJJ, Bouter LM. The
effectiveness of conservative treatment of acute and
chronic low back pain. Amsterdam: EMGO Institute; 1999.
Von Korff M, Saunders K. The course of back pain in primary
care. Spine 1996;21:28837.
A. Buchmuller et al. Value of TENS for relief of chronic low back pain
665 Eur J Pain 16 (2012) 656665 2011 European Federation of International Association for the Study of Pain Chapters