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Publication details, including instructions for authors and subscription information:Treatment of dysmenorrhoea with a new TENS device(OVA)H. A. Schiøtz a; M. Jettestad a; D. Al-Heeti a
a Department of Obstetrics and Gynaecology, Hospital of Vestfold, Tønsberg,Norway
Online Publication Date: 01 January 2007To cite this Article: Schiøtz, H. A., Jettestad, M. and Al-Heeti, D. (2007) 'Treatmentof dysmenorrhoea with a new TENS device (OVA)', Journal of Obstetrics andGynaecology, 27:7, 726 - 728To link to this article: DOI: 10.1080/01443610701612805
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Journal of Obstetrics and Gynaecology, October 2007; 27(7): 726 – 728
Treatment of dysmenorrhoea with a new TENS device (OVA)
H. A. SCHIØTZ, M. JETTESTAD & D. AL-HEETI
Department of Obstetrics and Gynaecology, Hospital of Vestfold, Tønsberg, Norway
SummaryTranscutaneous electrical nerve stimulation (TENS) is an established method for pain relief in dysmenorrhoea, which doesnot involve the use of medication. This prospective study evaluated the clinical utility of a new, very small and light, highfrequency TENS device in 21 menstruating women during four menstrual cycles. The efficacy measures were pain reliefevaluated on a VAS scale and reduction in use of analgesic tablets. All the participants subjectively found the device useful. There was a statistically significant drop in mean pain score from 6.73 to 5.18 points (p ¼ 0.0009). Concurrent use ofanalgesic tablets was also significantly reduced (p ¼ 0.03) and seven women stopped taking analgesics while using the device(p ¼ 0.02). There were no adverse events. On follow-up 6 – 8 months post study, 14 of the women were still using the deviceregularly. This TENS device appears to be a useful treatment alternative for dysmenorrhoea.
Treatment with TENS has the advantages of being
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controlled by the patient and does not involve the use of
Dysmenorrhoea is a widespread female problem which
medication. TENS is inexpensive and virtually without risk,
causes reduced quality of life, a need for medical treatment,
and there are few contraindications. High frequency, low
and absence from school or work. A recent Canadian study
intensity current is normally used. TENS works by
found that 60% of menstruating women had primary
stimulating large diameter, cutaneous, proprioceptic Ab
dysmenorrhoea with 51% reporting limitations of daily
nerve fibres without activating the thinner Ad and C pain
activities and 17% reporting absenteeism; 60% had moder-
fibres. According to the pain gate theory, pain signals from
ate or severe pain (Burnett et al. 2005). Dysmenorrhoea is
the uterus are prevented from entering the spinal cord,
caused by increased prostaglandin secretion from the
thereby preventing the perception of pain. In addition,
endometrium causing abnormal uterine contractions lead-
TENS can stimulate release of b-endorphins, which also
ing to reduced uterine blood flow and ischaemic pain
helps to relieve pain (Dawood 2006). It has been suggested
that TENS may also reduce ischaemic pain by improving
When treatment of dysmenorrhoea is required, the pri-
local uterine blood circulation (Milsom et al. 1994), but this
mary modalities used are non-steroidal anti-inflammatory
has not been documented. The effect is usually evident
drugs (NSAIDs) and oral contraceptives (OC). NSAIDs
within minutes of applying the TENS (Milsom et al. 1994).
have a documented effect and are widely used (Marjor-
Standard devices for TENS are typically too large and
ibanks et al. 2003). Treatment with hormonal contraception
heavy for easy use during everyday activities. A new TENS
is also well established. A Cochrane review in 2001
device named OVA, specifically developed for treatment of
concluded that medium and high dose OCs are effective
dysmenorrhoea, has recently been marketed (TensCare,
in relieving dysmenorrhoea, but that proof was lacking for
Surrey, UK). It is small and light, and can be clipped
the modern low dose OCs (Proctor et al. 2001). However, a
invisibly on to the user’s clothes and be used during daily
recent study showed that low dose (20 mg) OCs are also
activities. Its specifications are given in Table I. The user can
effective (Davis et al. 2005). Other treatment options have
choose between three preset programmes, all with high
recently been described in two excellent reviews (Dawood
frequency stimulation. The user controls the intensity and
However, medical treatment may be undesirable for
This study was done to test the clinical utility of the OVA
personal reasons, may give insufficient relief, or be contra-
TENS device in women with primary dysmenorrhoea.
indicated. Medical treatment may also cause adverse events,limiting its use. Non-medical treatment options are there-
fore warranted. Transcutaneous electric nerve stimulation(TENS) has been used for several decades in the treatment
The study was approved by the regional ethics committee,
of dysmenorrhoea, and a Cochrane review in 2002
reported to ClinicalTrials.gov and participants gave in-
concluded that high frequency (50 – 120 Hz) TENS is
formed consent. It was designed as a prospective clinical
effective, while the evidence for low frequency TENS was
participants used the OVA device during every other cycle,
Correspondence: H. A. Schiøtz, Department of Obstetrics and Gynaecology, Hospital of Vestfold, PO Box 2168, N-3103 Tønsberg, Norway. E-mail:firstname.lastname@example.org
ISSN 0144-3615 print/ISSN 1364-6893 online Ó 2007 Informa UK Ltd. DOI: 10.1080/01443610701612805
while the remaining cycles acted as controls. They were
randomised to either start with active treatment orobservation. Comparing active cycles and observation
The two-sided t-test for paired data and w2 tests were used
cycles, the primary outcome measure was relief of pain
with level of significance at p ¼ 0.05.
on a Visual Analogue Scale (VAS) and the secondaryoutcome measure was change in use of analgesic medica-
tion. Participants were free to use pain medication asneeded.
Mean duration of menstrual bleeding was 5 days (range 2 –
A priori power calculation had shown that 16 participants
7, SD 1.04), and mean number of days with dysmenor-
would be needed to demonstrate a difference of 2 VAS
rhoea was 3 days (range 0 – 6, SD 1.43). There was no
points assuming a 0.05 and b 0.1. A total of 22 volunteers
significant difference in duration of menstrual bleeding or
with primary dysmenorrhoea were included from Septem-
pain with or without the device (p ¼ 0.86).
ber to December 2005. One woman aged 46 developed
As can be seen from Table II, there was a highly
amenorrhoea before the first study cycle and was excluded;
significant reduction in pain scores and number of
the remaining 21 women all completed the study. Their
analgesic tablets used. All participants stated that they
mean age was 24 years (range 12 – 41); seven were under
had found the device useful; 18 women (86%) had a lower
20 years old, 10 between 20 and 29, three between 30 and
pain score with treatment than without, and seven (35%)
39 and one was 41 years old. Their mean score for pre-
did not need to take analgesics while using the device.
study dysmenorrhoea was 6.87 VAS points (median 7,
Some 18 participants stated that they preferred programme
range 2 – 10, SD 2.12). A total of 20 participants (95%)
A on the device, three preferred programme B and none
habitually used analgesic tablets for dysmenorrhoea.
programme C. Mean duration of use was 4.1 h/day (range
During each menstruation throughout the study, parti-
cipants rated their pain on a 10-point VAS scale (0 ¼ no
Although all participants found the device useful, two
pain, 10 ¼ worst possible pain) and noted any use of
actually had an increased pain score with use. One of these
analgesic tablets, duration of the use of the OVA device and
two stated that while the device had little effect on her pain,
which programme(s) they used, and duration of menstrua-
she had not experienced her usual cycle-related migraine
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tion. The forms were mailed to us at the end of each
attacks during treatment with the device.
menstruation, allowing for a degree of blinding between
At 6 – 8 months post-study, 14 participants were still
cycles. The participants were instructed to attach the skin
using the device regularly at least every other cycle. Among
electrodes suprapubically on either side of the midline, or
the seven women not using the device, two stated that this
on the lower back in the case of insufficient effect with
was due to lack of effect; four because using it required too
abdominal placement and dysmenorrhoea experienced
much effort and taking tablets was easier; and one had
amenorrhoea due to injectable gestagen contraception. All
Participants were allowed to keep the devices after study
participants recommended the device to friends.
completion. At 6 – 8 months after the last study cycle, allparticipants answered a questionnaire on continued use of
There are many treatment options for dysmenorrhoeatoday – high frequency TENS being one (Dawood 2006;Proctor and Farquhar 2006). Treatment with TENS has
Table I. Specifications of the OVA TENS device
the advantage of not involving medicines, and beingcontrolled by the user. The analgesic effect of TENS in
dysmenorrhoea is similar to that of naproxen (Milsom et al.
1994) and somewhat inferior to that of ibuprofen (Dawood
Flat, 3 volt lithium, lasting 8 h at 52 mA
Our study showed a statistically highly significant
reduction in pain scores with TENS treatment using the
new OVA device, while the need for analgesic medication
was halved. Is the reduction in pain scores also clinically
significant? In the literature, a change of 0.9 – 1.5 (or 2) on
a 0 – 10 point scale or a 10% difference between groups is
usually considered to be clinically significant (Kelly 1998;
Abbot et al. 2001; Douglas et al. 2006; Cruise et al. 2006;
Table II. Pain scores and use of analgesic tablets with and without the OVA device
Appell et al. 2006). In our study, the reduction was 1.55
Burnett MA, Antao V, Black A, Feldman K, Grenville A, Lea R
VAS points, corresponding to 23%, indicating that our
et al. 2005. Prevalence of primary dysmenorrhoea in Canada.
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being due to the placebo effect. However, several factors
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