Pain relief in labour using transcutaneous electrical nerve stimulation (TENS). A TENS/TENS placebo controlled study in two parity groups

Summary. The analgesic effects of transcutaneous electrical nerve stimulation (TENS) in labour and effects on outcome were investigated in a double-blind TENS/TENS placebo controlled trial in 100 primigravidae and 50 women in their third labour. There were no differences between the TENS and the TENS placebo users in terms of pain concept or relief, and only 12 and 13% of primigravidae and 48 and 39% of the para 2 women completed labour without requiring other analgesia in their respective groups. The primigravidae who used either TENS or TENS placebo alone had shorter labours than those who required further analgesia. Although the outcome of labour for mother and infant were similar in the two groups, there was a higher operative delivery rate in women who also had epidural analgesia. There were highly significant differences between the TENS and the TENS placebo users in terms of favourable and unfavourable comments by the mothers and the midwives at 1 and 24 h after delivery. The evident consumer satisfaction for TENS suggests TENS has a part to play in analgesia in labour but the equivocal findings in terms of factors associated with pain relief points to the need for apparatus more specifically designed to cope with the special characteristics of the pain of labour.     

Pain relief in labour using transcutaneous electrical nerve stimulation (TENS). A TENS/TENS placebo controlled study in two parity groups

Summary. The analgesic effects of transcutaneous electrical nerve stimulation (TENS) in labour and effects on outcome were investigated in a double-blind TENS/TENS placebo controlled trial in 100 primigravidae and 50 women in their third labour. There were no differences between the TENS and the TENS placebo users in terms of pain concept or relief, and only 12 and 13% of primigravidae and 48 and 39% of the para 2 women completed labour without requiring other analgesia in their respective groups. The primigravidae who used either TENS or TENS placebo alone had shorter labours than those who required further analgesia. Although the outcome of labour for mother and infant were similar in the two groups, there was a higher operative delivery rate in women who also had epidural analgesia. There were highly significant differences between the TENS and the TENS placebo users in terms of favourable and unfavourable comments by the mothers and the midwives at 1 and 24 h after delivery. The evident consumer satisfaction for TENS suggests TENS has a part to play in analgesia in labour but the equivocal findings in terms of factors associated with pain relief points to the need for apparatus more specifically designed to cope with the special characteristics of the pain of labour.     

Pain relief in labour by transcutaneous electrical nerve stimulation (TENS)

For several years Transcutaneous Electrical Nerve Stimulation (TENS) has been used in the management of chronic and acute pain. The aim of this trial was to determine its effectiveness in providing pain relief during labour as well as its influence on the incidence of requests for epidural analgesia. The experimental group (receiving TENS by a burst – conventional obstetric TENS-apparatus) and the control population (not receiving TENS) consisted of 24 and 35 women respectively. In the experimental group the TENS application was switched off for a period of 15 min. The 24 women were asked to point out the intensity of their pain on a visual analogue scale before, during and after this temporary interruption. Two days postpartum the parturient’s satisfaction was evaluated by two questions, a procedure which revealed that 96% degree of satisfaction. The incidence of epidural analgesia in the experimental group was compared to the control-group. During TENS application the pain scores were significantly lower (p<0.0001), but no statistically significant difference in incidence of epidural analgesia was found between the experimental group and the control group. Received: 15 January 2000 / Accepted: 20 May 2000     

TENS (transcutaneous electrical nerve stimulation) for labour pain

Because TENS is applied inconsistently and not always in line with optimal TENS application theory, this may explain why TENS for labour pain appears to be effective in some individuals and not in others. This article reviews TENS theory, advises upon optimal TENS application for labour pain and discusses some of the limitations of TENS research on labour pain. TENS application for labour pain may include TENS applied to either side of the lower spine, set to 200 mus pulse duration and 100 pulses per second. As pain increases, TENS intensity should be increased and as pain decreases, TENS intensity should be reduced to maintain a strong but pain free intensity of stimulation. This application may particularly reduce back pain during labour.     

The use of transcutaneous electrical nerve stimulation (TENS) for pain relief in labour: a review of the evidence

Objective

to assess the effects of transcutaneous electrical nerve stimulation (TENS) for pain relief in labour.

Search methods

studies were identified from a search of the Cochrane Pregnancy and Childbirth Group’s Trials Register (November 2008).

Selection criteria

randomised controlled trials comparing women receiving TENS for pain relief in labour vs routine care or placebo devices. All types of TENS machines were included.

Data collection and analysis

two review authors assessed all trials identified by the search strategy, carried out data extraction and assessed risk of bias.

Results

14 studies including 1256 women were included: 11 examined TENS applied to the back, two to acupuncture points and one to the cranium. Overall, there was little difference in satisfaction with pain relief or in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (risk ratio 0.41, 95% confidence interval 0.32–0.55). The majority of women using TENS would use it again in a future labour. There was no evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and infants. No adverse events were reported.

Conclusions

there is only limited evidence that TENS reduces pain in labour and it does not seem to have any impact on other outcomes for mothers or infants. The use of TENS at home in early labour has not been evaluated. Although the guidelines of the National Institute for Health and Clinical Excellence recommend that TENS should not be offered to women in labour, women appear to be choosing it and midwives are supporting them in their choice. Given the absence of adverse effects and the limited evidence base, it seems unreasonable to deny women that choice. More robust studies of effectiveness are needed.     

Pain relief in labor by transcutaneous electrical nerve stimulation. Safety aspects

A current density standard for current shapes used in transcutaneous electrical nerve stimulation (TNS) must be established in order to avoid harmful effects. This is especially important when stimulating near vital structures such as the fetal heart. In the absence of an applicable standard, a preliminary safety norm is proposed, based on clinical experience during delivery and experimental measurements in the female bladder. Current densities due to TNS not exceeding 0.5 microamperemeter/mm2 are safe for the fetal heart. A stimulator and electrodes fulfilling the safety criteria proposed in this study have been tested. A filter which suppresses the electrical disturbances occurring during TNS, thereby permitting recording of the fetal heart rate during birth, has also been tested. TNS was given over both the low-back and suprapubic region. Results of clinical tests of the equipment during 15 supervised births are reported. No adverse effect in the mother or newborn infant were observed.     

A comparative study of transcutaneous electrical nerve stimulation (TENS), entonox, pethidine + promazine and lumbar epidural for pain relief in labor

Analgesic effect, labor outcome, safety and consumer satisfaction were compared in 170 primigravid women; 50 using TENS initially for pain relief, 20 using entonox, 50 pethidine + promazine and 50 lumbar epidural. 88% choosing epidural related it fully effective. 90% using entonox, 96% using TENS and 54% given pethidine + promazine found partial relief. 82% of patients given TENS and 80% given pethidine + promazine required additional analgesia. This was also needed by one of the 20 patients choosing entonox. Women using entonox alone had the shortest labors and women using lumbar epidural, the longest. Operative delivery was significantly more common in women receiving lumbar epidural. No significant inter-group differences were noted in cord pH or Apgar scores. Parturients and midwives both gave high consumer satisfaction ratings to all methods--except for pethidine + promazine, whose use must therefore be questioned. The analgesic efficacy of lumbar epidural outweighs any possible side effects. Entonox appears suited to those able to cope with the earlier part of labor, drug-free. Realization of the potential of TENS requires the design of machines specifically to cope with the quality of the pain of labor.     

Transcutaneous electrical nerve stimulation (TENS) in obstetrics

Labour pains have been influenced by TENS (electrodes placed at Th10 to L2) in 78 women (control group comprising 46 women) during delivery. No electrostimulation of the sacral segments was carried through. The two groups were comparable well because of similarities in their age, the babies' size at birth and equal conditions during delivery. The first TENS effect observed was a marked reduction of duration of labour with no increase in pathological cardiotocographic findings. With TENS applied, primiparae have been delivered after an average of 244 minutes (control group after 358 minutes) and multiparae after 159 minutes (control group after 256 minutes). 87 per cent of the TENS group's labour and 61 per cent of the control group's labour were induced. Using TENS, clearly reduced amounts of spasmolytic agents (44:74 per cent) had to be administered during labour. 41 per cent of the TENS group women suffered episiotomy or laceration (control group: 52 per cent). 80 per cent of the women in whom TENS had been applied considered TENS as facilitating childbirth. 68.4 per cent of the primipara TENS group (control group: 18.2 per cent) and 80 per cent of te multipara TENS group (control group: 25 per cent) indicated the labour pains to be absolutely endurable (with TENS applied, the labour pains did not start until about 15 minutes prior to delivery--lack of sacral electrodes?). However, the experience gathered as well as an assessment of the questionnaires filled in, indicate that, with all the technical equipment available, women in labour expect the medical staff to provide them with care, understanding and personal devotion.     

Transcutaneous electrical nerve stimulation (TENS) for the treatment of primary dysmenorrhea: a randomized crossover comparison with placebo TENS and ibuprofen

In a randomized four-way crossover study, 32 women with primary dysmenorrhea were treated with transcutaneous electrical nerve stimulation (TENS) for two cycles, placebo (sham) TENS for one cycle, or ibuprofen 400 mg four times a day for one cycle. The TENS setting used was 100 pulses per second with 100-microsecond pulse widths. The subjects were allowed to adjust the amplitude to a comfortable level. The pain rescue medication was ibuprofen 400 mg as needed, up to 1600 mg/day. Significantly more subjects who had TENS treatment did not require rescue medication or required less backup ibuprofen at 0-4, 4-8, and 8-12 hours after the onset of dysmenorrhea and starting treatment, as well as during the first 24 hours and for the duration of the menstrual flow, when compared with placebo TENS or ibuprofen-treated cycles (Tukey multiple comparison, P less than .01). Transcutaneous electrical nerve stimulation significantly delayed the need for ibuprofen by an average of 5.9 hours, compared with 0.7 hours when using ibuprofen alone (P less than .05, paired t test). Transcutaneous electrical nerve stimulation alone provided good to excellent subjective pain relief in 42.4% of subjects, compared with 3.2% with placebo TENS, and significantly reduced diarrhea, menstrual flow, clot formation, and fatigue compared with placebo TENS. Transcutaneous electrical nerve stimulation plus less ibuprofen provided pain relief equivalent to that obtained with ibuprofen alone (71 and 75% of the subjects, respectively). We conclude that TENS is a safe, effective, non-medication method for managing primary dysmenorrhea and that TENS plus ibuprofen was the best overall treatment, as indicated by pain relief.     

Efficacy of transcutaneous electrical nerve stimulation for pain relief in women undergoing office endometrial biopsy

Aim  

To evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for decreasing pain related with office endometrial biopsy.     

A pilot study on using acupuncture and transcutaneous electrical nerve stimulation to treat chronic non-specific low back pain

ObjectiveThe present study tests whether a combined treatment of acupuncture and transcutaneous electrical nerve stimulation (TENS) is more effective than acupuncture or TENS alone for treating chronic low back pain (LBP).MethodsThirty-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).ResultsThe 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.ConclusionCombined acupuncture and TENS treatment is effective in pain relief and QOL of low back improvement for the sampled patients suffering from chronic LBP.     

Pain relief in labor by transcutaneous electrical nerve stimulation. Testing of a modified stimulation technique and evaluation of the neurological and biochemical condition of the newborn infant

In this prospective randomized study of pain relief in labor, the effect of transcutaneous electrical nerve stimulation (TNS) performed over both the low-back and suprapubic region was evaluated and compared with a control group not receiving TNS. Both high frequency and pulse train TNS were used. The study included 24 induced labors. In the TNS group, conventional methods were added when needed, while in the control group only conventional methods were used. Assessment of low-back and suprapubic pain was performed by the parturient each hour during the first stage. In the TNS group most of the parturients reported minimal or moderate low-back pain throughout labor, while parturients in the control group reported an increased intensity of low-back pain as labor progressed. The effect of suprapubic pain was insignificant in both groups. Neither TNS nor nitrous oxide-oxygen mixture and pethidine could reduce this pain component. Course of labor, uterine activity and fetal heart patterns were similar in the two groups. The neonates were evaluated with Apgar score, assays of blood samples from the umbilical vein including blood lactate, plasma hypoxanthine and blood gas, and neurobehavioral assessment on two occasions. All newborn infants were in good condition and no significant differences between the two groups could be demonstrated.     

A prospective controlled study of neonatal morbidities in infants born at 36 weeks or more gestation to Women with diet-controlled gestational diabetes (GDM-class Al).

OBJECTIVE: Infants of gestational diabetes mellitus (GDM)-A1 women are unlikely to experience the marked excursion in maternal glucose levels that may characterize insulin-requiring GDM (class-A2) or insulin-dependent diabetes (IDDM). However, infants born to GDM-A1 women are traditionally managed like infants born to GDM-A2 or IDDM women. AIMS: To examine monitoring protocols for infants of GDM-A1 women, and to examine the efficacy of early and frequent feedings to prevent and to treat hypoglycemia. METHODS: A total of 92 of 101 infants born to GDM-A1 women (diabetic group) and 68 of 83 infants born to nondiabetic women (control group) at > or=36 weeks of gestation were prospectively monitored for the development of hypoglycemia and other morbidities. Blood glucose screening was performed in the diabetic group every 30-60 minutes three times, starting soon after birth and then at 3-hour intervals for 24 hours. Liberal feedings were started shortly after birth and provided every 3 hours for at least 24 hours. All women with GDM-A1 had an HbA1c measured before delivery. RESULTS: Both the diabetic and control groups had similar demographics, including LGA incidence. Blood glucose readings before feedings were low (<40 mg/dl) in 24 of 92 infants (26.1%) from the diabetic group and in 20 of 68 control infants (29%). After the start of oral feedings, all but four diabetic and three control infants had subsequent glucose readings > or =40 mg/dl. No infant had symptoms of hypoglycemia and none from the diabetic group had birth trauma, hypoxic-ischemic encephalopathy, polycythemia, hypocalcemia, or hypomagnesemia. Hypoglycemic episodes in the infants from the diabetic group could be managed with oral feedings alone. Birth weight, gestational age, sex, Apgar scores, and maternal HbA1c levels could not predict low glucose readings on initial screening in infants from the diabetic group. CONCLUSION: The incidence of hypoglycemia in infants born to GDM-A1 women at > or =36 weeks of gestation is similar to control infants born to nondiabetic women. Low blood glucose levels during the first few hours of life can be prevented or treated with early and frequent oral feeding.     

The efficacy and safety of PSD503 (phenylephrine 20%, w/w) for topical application in women with stress urinary incontinence. A phase II, multicentre, double-blind, placebo controlled, 2-way cross over study

ObjectivePSD503 is a topical gel containing phenylephrine 20% weight/weight (w/w) intended for vaginal application close to the area of the urethral sphincter in women with SUI and has been used in patients with faecal incontinence. The primary objective of this proof of concept study was to evaluate the efficacy of PSD503 in women with SUI as measured by the change in pad weight following an exercise stress pad test. The secondary objectives were to evaluate plasma concentrations of PSD503, BP changes and pulse rate over 3 h following administration and to assess safety and tolerability.Study designThis was a phase II multi-centre, double-blind, placebo-controlled, 2 way cross-over study. Women were assessed objectively pre and post PSD503 administration using a standardised exercise stress pad test. Safety was assessed by monitoring pulse, BP and plasma levels of PSD503 over 3 h following administration. A power calculation suggested a >80% power to demonstrate (at the 5% level of significance) a difference between treatments of 10–20 g with a sample size of 30 patients.Results14 patients were screened and 12 patients randomised over 20 months. Projections indicated the study would not attain its full quota within 1 year and it was terminated early. Treatment with PSD503 resulted in a greater reduction in pad weight gain than placebo, when expressed as both a percentage change (median % change: placebo – 38.00%, PSD503 – 54.33%) and absolute change (median absolute change: placebo – 10.0 g, 20% (w/w) PSD503 – 22.0 g) from pre-dose leakage. PSD503 was absorbed into the blood within 1 h (median concentration 1.490 ng/ml). Plasma concentrations at 3 h (median 1.305 ng/ml) were less than that at 1 h and lower than plasma concentrations seen following phenylephrine-containing cold remedies. There were no withdrawals, serious adverse events and it was well tolerated overall.ConclusionThis is the first proof of concept study to demonstrate that a topical α adrenergic agonist gel is rapidly and consistently absorbed vaginally and may have a role in the management of female SUI. However, since recruitment was difficult this may indicate that whilst objectively effective, acceptability in clinical practice may be poor.     

Use of a recombinant human follicle-stimulating hormone:recombinant human luteinizing hormone (r-hFSH:r-hLH) 2:1 combination for controlled ovarian stimulation during assisted reproductive technology treatment: A real-world study of routine practice in the Russian Federation

Two observational studies in the Russian Federation described patient demographics/clinical decision for treatment with recombinant human follicle-stimulating hormone:recombinant human luteinizing hormone (r-hFSH:r-hLH) 2:1 combination for ovarian stimulation (OS) during assisted reproductive technology (ART) and outcomes, respectively. The first (prospective) study enrolled 500 patients. After post-hoc regrouping to assign patients to discrete groups, 378 (75.6%) met the local Russian label for an r-hFSH:r-hLH 2:1 combination, 105 (21%) were treated according to other physician preference, and 17 (3.4%) met only the ESHRE Bologna criteria for a poor ovarian response. The clinical pregnancy rate per cycle was 30.4%. A total of 158/175 (90.3%) women achieving clinical pregnancy in the prospective study participated in the second (retrospective) study. The live birth rate per cycle was 25.8%. No new safety concerns were reported. These results support the use of the r-hFSH:r-hLH 2:1 combination in patients with a poor/suboptimal response to OS for ART treatment in the Russian Federation.     

A group-comparative,randomized, double-blind comparison of the efficacy and efficiency of two fixed daily dose regimens (100- and 200-IU) of recombinant follicle stimulating hormone (rFSH,Puregon) in Asian women undergoing ovarian stimulation for IVF/ICSI

Purpose : To compare the efficacy, efficacy and safety of a fixed daily dose of recombinant FSH (Puregon®) of a 100- and 200-IU regimen in Asian women undergoing ovarian stimulation for IVF/ICSI. Methods : This was a prospective, randomized, double-blind, multicenter (n = 9) study. Prior to the start of rFSH, all women were pretreated with a gonadotropin releasing hormone agonist (GnRH-a) for pituitary downregulation. Results : A total of 330 women were treated with rFSH: 163 subjects with 100 IU and 167 subjects with . In the 200 IU treatment group, significantly more oocytes were retrieved compared to the 100 IU group (9.6 vs. 5.0 oocytes, p < 0.001). The total dose rFSH needed to develop at least three follicles with a diameter of 17 mm was significantly lower in the 100 IU treatment group (1194 vs. 2034 IU, p < 0.001). Although more cycle cancellations were seen in the 100 IU group (24 vs. 13%), the ongoing pregnancy rate per started cycle was comparable between both groups (16.6% in the 100 IU group vs. 15.0% in the 200 IU group). Conclusions : The use of a 100 IU fixed dose is less effective in terms of the number of oocytes retrieved and the higher cancellation rate, but more efficient as indicated by a lower total recombinant FSH dose needed.     

A phase IIA study of the topoisomerase I inhibitor, exatecan mesylate (DX-8951f), administered at two different dose schedules in patients with platinum- and taxane-resistant/refractory ovarian cancer

OBJECTIVES: There is an urgent need for new agents with activity in platinum- and taxane-resistant epithelial ovarian cancer. Exatecan mesylate is a novel topoisomerase I inhibitor with potent activity against ovarian cancer in vitro. A multicentre phase IIA study was conducted in patients with platinum- and taxane-resistant epithelial ovarian cancer. PATIENTS AND METHODS: Fifty-seven patients with bidimensionally measurable ovarian cancer, previously exposed to platinum and taxanes, whose disease had relapsed within 6 months of platinum-containing chemotherapy were randomised to one of two intravenous schedules of exatecan mesylate; 0.3 mg/m(2) daily for 5 days every 3 weeks (Arm A) or 2.1 mg/m(2) weekly for 3 weeks out of 4 (Arm B). RESULTS: There were no responses in the weekly arm and a radiological response rate of 5.3% (95% CI 0.3-21.8%) in the daily arm. Principal toxicities were myelosuppression and emesis. Grade 3/4 neutropenia occurred in 29% of patients in Arm A and 6% patients in Arm B. Seventy-one percent of patients in Arm A required red cell transfusions while on treatment. CONCLUSIONS: Exatecan is well tolerated in this poor prognosis group of patients but only has modest single agent activity when administered in a daily regimen.