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This article was downloaded by:[Schiøtz, H. A.]On: 13 November 2007Access Details: [subscription number 784717713]Publisher: Informa HealthcareInforma Ltd Registered in England and Wales Registered Number: 1072954Registered office: Mortimer House, 37-41 Mortimer Street, London W1T 3JH, UK 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 This article maybe used for research, teaching and private study purposes. Any substantial or systematic reproduction,re-distribution, re-selling, loan or sub-licensing, systematic supply or distribution in any form to anyone is expresslyforbidden.
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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 Downloaded By: [Schiøtz, H. A.] At: 08:57 13 November 2007 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:[email protected] 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 Downloaded By: [Schiøtz, H. A.] At: 08:57 13 November 2007 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.
Journal of Obstetrics and Gynecology Canada 27:765 – 770.
The study design was chosen to save resources, as each Cruise AS, Amonoo-Kuofi K, Srouji I, Kanagalingam J, Georgalas C, Patel NN et al. 2006. A randomized trial of Rapid Rhino participant acting as her own control reduces the required Riemann and Telfa nasal packs following endoscopic sinus number of participants for statistical analysis, but the lack surgery. Clinical Otolaryngology 31:25 – 32.
of a placebo group does raise the possibility of the results Davis AR, Westhoff C, O’Connell K, Gallagher N. 2005. Oral being due to the placebo effect. However, several factors contraceptives for dysmenorrhea in adolescent girls: a rando- count against this: (1) the reduction in perceived pain mized trial. Obstetrics and Gynecology 106:97 – 104.
during active cycles was both clinically meaningful and Dawood MY, Ramos J. 1990. Transcutaneous electrical nerve statistically highly significant, (2) there was a significant stimulation for the treatment of primary dysmenorrhoea: a reduction in use of analgesic tablets during active cycles, as randomized crossover comparison with placebo and ibuprofen.
evaluated both as mean tablet consumption and number of Obstetrics and Gynecology 75:656 – 660.
women not requiring analgesics, (3) 14 participants have Dawood Y. 2006. Primary dysmenorrhea. Advances in pathogen- esis and management. Obstetrics and Gynecology 108:428 – continued to use the device more than 6 months post-study and (4) all have recommended it to friends.
Douglas R, Hawke L, Wormald P-J. 2006. Topical anaesthesia Almost all the participants (18/21) preferred programme before nasendoscopy: a randomized controlled trial of co- A among the three different programmes available on the phenylcaine compared with lignocaine. Clinical Otolaryngology device. The settings in programme A (110 Hz, 110 msek) correspond to those which have previously been shown to Johnson M. 2002. Transcutaneous electrical nerve stimulation work against dysmenorrhoea (Johnson 2002; Proctor et al.
(TENS). In: Kitchen S, editor. Electrotherapy: evidence-based practice. 11th ed. Edinburgh: Churchill Livingstone. pp 259 – Treatment options not requiring medication are needed, as some women cannot or do not wish to take medicines.
Kelly AM. 1998. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? In addition, a supplement is needed when medical Academic Emergency Medicine 5:1086 – 1090.
treatment gives insufficient relief. High frequency TENS, Marjoribanks J, Proctor ML, Farquhar C. 2003. Nonsteroidal anti- Downloaded By: [Schiøtz, H. A.] At: 08:57 13 November 2007 such as with the OVA device, appears to be a useful inflammatory drugs for primary dysmenorrhoea. Cochrane treatment modality. The OVA device is small and can be Database of Systematic Reviews 4:CD001751.
discreetly hidden underneath the user’s clothes. TENS Milsom I, Hedner N, Mannheimer C. 1994. A comparative study treatment is safe; there were no adverse events in the study.
of the effect of high-intensity transcutaneous nerve stimulation TENS treatment does, however, entail more work for the and oral naproxen on intrauterine pressure and menstrual pain user than taking a tablet, and this is illustrated by four of in patients with primary dysmenorrhea. American Journal of our participants not continuing to use the device for this Obstetrics and Gynecology 170:123 – 129.
Proctor ML, Roberts H, Farquhar CM. 2001. Combined oral contraceptive pill (OCP) as treatment for primary dysmenor-rhoea. Cochrane Database of Systematic Reviews 2:CD002120.
Proctor ML, Smith CA, Farquhar CM, Stones RW. 2002.
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for primary dysmenorrhoea. Cochrane Database of Systematic Intraperitoneal gas drain to reduce pain after laparoscopy: randomized masked trial. Obstetrics and Gynecology 98:97 – Proctor M, Farquhar C. 2006. Diagnosis and management of dysmenorrhoea. British Medical Journal 332:1134 – 1138.
Appell RA, Juma S, Wells WG, Lenihan JP, Klimberg IW, Kanellos A et al. 2006. Transurethral radiofrequency collagenmicromodelling for the treatment of female stress urinaryincontinence. Neurourology and Urodynamics 25:331 – 336.

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