Senin, 17 Maret 2014

Transcutaneus Electric Nerve Stimulation (TENS) for relief pain: A systematic Review



Transcutaneus Electricity Nerve Stimulation (TENS)  to relief pain during Labour :
A systematic Review of

Endang Koni Suryaningsih1,  Meei-Ling Gau CNM., R.N., PhD2.
1 Student of International Nurse-Midwifery Master of Science Program, National Taipei University of Nursing and Health Sciences
2 Lecturer of Department of  Nurse-Midwifery Master of Science Program, National Taipei University of  Nursing and Health Sciences

1.      Asses the Patient
A pregnant women 37 weeks, 27 years old, come to the “Midwifery’s private clinic to consult her pregnant.  This is her first pregnant. The result of her examination, there is no problem on her pregnant, no risk factors was findings, so the Midwife judge that she can deliver her baby with normal. But She  was fear of childbirth.  according to her neighbor, there is any method, something like tools or equipment that can make pain will relief. It was something like electrode and applied on our back, with electricity voltage. She want to know which one can relief pain, with TENS or not.
Anatomy of a good clinical question :eding occur?  Is there any change on her reproductive system?
v  Problem : labour, pain
v  Intervention : Transcutaneus Electricity Nervous Stimulate (TENS)
v  Comparison : with standar care
v  Outcome : relief pain labour

2.      Ask the question
For our patient, the clinical question is :
In the first stage labor, is TENS more effectively to relief pain rather than without treatment or other treatment?
It is a therapy question and the best evidence would be a randomized controlled trial (RCT).

3.      Acquire evidence
The PubMed, and CINAhL database were searched for articles using by keywords : “TENS”, “Labor Pain”. Of the 90 articles initially identified in the database search,  5 articles were selected for careful evaluation, 85 of these were excluded after analyzing. See figure 1 (adopt from (F.D. Mello) ).
Five full texts were evaluated for eligibility. The eligible articles are :

A.    Transcutaneous nerve stimulation (TENS) during the first stage labor : a
 Randomized

Abstract
Our objective was to study the efficacy of transcutaneous electrical nerve stimulation (TENS ) in reducing pain during the first stage of labour. Using a prospective randomized placebo-controlled, double blinding critical trial, a patient-controlled analgesia system was used to measured difference in outcome. Trial took place is labor unit at the St. Antonius Hospital Nieuwegein, The Netherlands, during a period of 18 months. Forty- six patient, during the first stage of labour, were treat with TENS, and 48 with a placebo apparatus. Main outcomes measures were pain relief, among of administrated analgesics, obstetrical and neonatal outcomes, and side effects. No significant differences occurred between groups in the number of request pethidin/ promethazine. The fetal outcome in both group was the same. TENS and placebo was considered equally effective both patients and staff. In conclusion, TENS was not more effective than placebo apparatus in relieving pain during the first stage of labour. No adverse side- effects occurred.

B.     Pain relief by applying transcutaneous electrical nerve stimulation (TENS) on acupuncture points during the first stage of labor : A randomized double-blind placebo-
Abstract
Transcutaneous electrical nerve stimulation (TENS) is one of the non-pharmacological means of pain relief for labor and delivery. We aimed to investigate the efficacy and safety of TENS specific acupuncture points for reducing pain in the first stage of labor. In this double-blind, placebo-controlled trial, we randomly assigned healthy full-term parturients in active phase of first-stage labor either TENS on four acupuncture points (Hegu [L1 4]  and Sanyinjao [Sp 6]) (n=52) or the TENS placebo (n=53). Visual Analogue Scale (VAS) score was used to asses pain before at 30 and 60 minutes after treatment. The primary outcome was the rate of Visual Analogue Scale (VAS) score decrease ≥3 in each group. A questionnaire was given at 24 hour post-partum to evaluate the satisfaction of pain relieving method and willingness to have the same treatment again. Mode of delivery and neonatal effect was measured as secondary outcome. One hundred women were eligible for analysis. TENS group experience VAS score reduction  ≥ 3 significantly more common then the TENS placebo group (31/50 [ 62%]) vs. (7/50 [14%], P< 0.001 ). Willingness of using the some analgesic method for a future childbirth was also significantly different (TENS ; 48/50 [96%] vs. TENS placebo ; 33/50 [66%], P< 0.001 ). Operative delivery was increased in the TENS group (12/50 [24%] vs. 4/50 [8%], P< 0.05 ), but he neonatal outcome were not different. The application of TENS on specific acupuncture points could be a non-invasive adjunct for pain relief in the first stage labor.

C.    Transcutaneous Electrical Nerve Stimulation on Acupoints Relieves Labor Pain : A Non- randomized Controlled Study
Abstract
Objective : To investigate the efficacy of transcutaneous electrical nerve stimulation (TENS) on four specific acupuncture points Hegu (LI4), Neiguan (PC6), Danshu (BL19) and Weishu (BL21) for reducing pain in labor. Methods: A total of 160 voluntary nulliparous women who were willing to receive TENS for analgesia were assigned to the treatment group after cervical dilation of more than 2 cm. Another 145 nullipara were recruited as the control group. Visual analogue scale (VAS) was used to assess the pain before and 0.5 h after the application of TENS.  Then, VAS was assessed every one hour until delivery. Percentage of VAS score decreased by > 25% was the primary outcome, the delivery mode and neonatal outcome were measured as secondary outcomes. Adverse reactions were also recorded during TENS. Results: The : The percentage of VAS score decreased by > 25% was 68.6% in the TENS treatment group. Maternal delivery mode and neonatal outcomes were not significantly different between the two group. In addition, the incidence of postpartum hemorrhage in the TENS treatment group was less than the control group ( P <0.05). There was no adverse reaction recorded with TENS on acupoints. Conclusion: As a novel and non-invasive approach, TENS on specific acupoints including Hegu (LI4), Neiguan (PC6), Danshu (BL19) and Weishu (BL21) was an effective method for analgesia in labor.

D.    Transcutaneous electrical nerve stimulation TENS for adjuvant pain-relief during labor and delivery
Abstract
Objecti ®e: We examined the efficacy of transcutaneous electrical nerve stimulation TENS in general and the new Ž. Freemom TENS device LifeCare, Israel in particular, for pain relief during labor and delivery. Methods: The study Ž . Ž . group consisted of 104 women. Forty-six nulliparas 44.2% and 58 multiparas 55.8% , all of whom used the TENS device for pain relief during labor. All participants completed a questionnaire on the degree of pain relief afforded them by TENS during the delivery and related questions. The objective evaluation was based on the documented Žlabor and delivery parameters including medical interventions during delivery. Results: The majority of subjects 72% . of the nulliparas and 69% of the multiparas considered TENS effective for the relief of pain during labor. Most of Ž. them 67% of the nulliparas and 60% of the multiparas responded positively to the use of TENS in future deliveries. Sixty-five percent of the multiparas considered TENS at least as effective as the other pain relief methods they had used before. TENS significantly reduced the duration of the first stage of labor P-0.001 for nulliparas, P-0.005 for multiparas and it significantly decreased the amount of analgesics administered to individual patients. No significant difference was found in fetal heart rate tracings, Apgar scores and cord blood pH between the study group and an equal number of matched controls who used other forms of pain management. Conclusions: TENS is an effective non-pharmacological, non-invasive adjuvant pain relief modality for use in labor and delivery. TENS application reduced the duration of the first stage of labor and the amount of analgesic drug administered. There were no adverse effects on mothers or newborns. Q 1998 International Federation of Gynecology and Obstetrics
E.     Pain relief in labour using Transcutaneus Electical Nervous Stimulation (TENS). A TENS/TENS Placebo Controll in two parity groups
{Robert F. Harison,  #198}
Abstract
The analgesic of Transcutaneus Electrical Nerve Stimulation in labour and effect on outcome were investigated in 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 user in term of pain concepts or relief, and only 12 and 13% primigravida and 48 and 39% of the para 2 women completed labour without requiring other analgesia in their respective group. The primigravidae who used either TENS or TENS Placebo alone had shorter labour than whose required further analgesia . although the outcome of labour for mother and infant were similar in two groups, there was a higher operative delivery rate in woman who also had epidural analgesia. There were highly significant differences between the TENS and the TENS Placebo user in terms and favourable comment.


4.      Five Journals summary
No
Title
Research  Method
1.
Transcutaneous nerve stimulation (TENS) during the first stage labor : a
 Randomized

Women scored their opinion about the effectiveness of the treatment on a VAS. The TENS group scored 5.8 and the placebo group 6.0 (not significant). In the TENS group 61% would ask for TENS again during their next labour, 117. would refuse, and 2870 were ambiguous. In the pla- cebo group these numbers were 56910,21Toand 23V0,re- spectively. The mean intensity of the stimulation during contrac- tions was 2.3 (range 1–5) in the TENS group and 2.7 (range 1–6) in the placebo group. In between contractions the stimulation was also lower in the TENS group (2.3) than in the placebo group (2.6), both not being significantly different. No patients experienced difficulties in handling the TENS apparatus.

Comparable to a previous study (Bundsen et al. 1981) 75% of women were found to suffer from low back pain and 50% experienced pain in the lower abdomen. Again, there were no significant differences between TENS and placebo groups. The attending nurse gave her/his opinion about TENS on a VAS. The outcome was 5.5 for the TENS group and 4.4 for the placebo group, again not significant. The TENS signal disturbed the foetal heart tracing sig- nal in 18 (3970)patients of the TENS group. This occurred in two patients of the placebo group.
2.
Pain relief by applying transcutaneous electrical nerve stimulation (TENS) on acupuncture points during the first stage of labor : A randomized double-blind placebo-

After the assigned treatment, the median VAS scores in first stage of labor at 30 and 60 minute after the TENS showed significant lower in the TENS Group than Placebo group (30 minute, TENS vs. TENS Placebo group : 4.5 [1-10] vs 7 [2-210], P,0.001; 60 min ; 6 [3-9] vs. 7.5 [4-10], P<0.001). the difference VAS between before and after application in TENS  group was significant (P<0.001) but insignificant in TEN S Placebo (P=35). The rates of VAS score decrease ≥3 of the two  groups (TENS vs TENS Placebo) were significantly different (62% [31/50] vs. 14% [7/50], P<0.001. based on ITT analysis with those five participants having precipitous labour counted as failure to achieve VAS decrease ≥3, the difference between the two groups remained significan (60% [31/52] vs. 13% [ 7/53], P<0.001. of the 31 women with VAS score decrease ≥ 3  of the TENS  group, 19 (61.3%) needed only one application for the entire first stage of labor.
Regarding the pain outcomes according to parity, the median VAS score in first stage of labour at 30 min was significant in both primiparous and multiparous groups (primiparous, TENS vs. TENS Placebo : 5 [3-10] vs. 7 [4-10], P< 0.001; multiparous , TENS vs. Placebo ; 4 [1-7] vs 6[2-10], P< 0.001). the rates of VAS scores decrease ≥ 3 were also significantly different in both primiparous and multiparous groups (primiparous, 60% [18/30] vs. 11.4% [4/35], P<0.001; multiparous, 65% [13/20] vs 20% [3/15], P=0.02.

3.
Transcutaneous Electrical Nerve Stimulation on Acupoints Relieves Labor Pain : A Non- randomized Controlled Study

The durations of active phase of the first stage, the second stage and the third stage of labor, the oxytocin usage, incidence of instrumental and caesarean delivery, were not significantly different between the two groups ( P >0.05). Although the latent phase in TENS group was significantly longer than that in the control group (287.6± 144.3 vs . 213.8±116.7 min, P <0.05). The postpartum blood loss in TENS group was significantly lesser than that in the control group (135.7±43.5 mL vs . 166.1± 54.5 mL, P <0.05)
VAS scores declined as a result of the application of TENS. Compared with the pain level of the zero-time point before TENS treatment, the scores declined prominently during the first 0.5 after TENS therapy ( P <0.01).

The mean VAS score decreased from initial 8.76±1.32 scores to 6.78 ±1.72 scores ( P <0.05). The mean time to show effective analgesia was 12.05±7.21 min. It took 56.55±48.0 min (range: 9-105 min) for VAS scores to decrease from the initial level (8.76±1.32) to the lowest (5.39±1.88). Thereafter, the VAS scores rose slowly, but still lower than the initial value until the fifth hour ( P <0.01). After 5 h, the VAS scores increased dramatically. And 68% of pregnant women receiving TENS treatment felt marked pain relief, only two of them (0.6%) felt effective, and 31.4% of them responded ineffective.
4.
Transcutaneous electrical nerve stimulation TENS for adjuvant pain-relief during labor and delivery

Data were gathered for nulliparas and multiparas separately. TENS was considered efficacious i.e. it reduced the level of pain by 4 points or more on a scale of 1 -10 by 72% of the nulliparas 33/46  and 69% of the multiparas  40/58 . Most of the participants in both sub-groups who favored TENS 67% of the nulliparas, . 60% of the multiparas stated that they would use TENS again for their next labor.

Compared to the group of match controls, the use of TENS significantly reduced the  duration of the first stage of labor, nulliparas, 720"235 minute in the study group, 856"255 minute in the control group; for multiparas, 520"163 min and 612"184 min, respectively.
Of the TENS users, 67% of the nulliparas and 60% of the multiparas asked for additional analgesia meperidine or epidural  block . However, all these requests were made at a significantly higher degree of cervical dilatation  compared to the controlled group nulliparas, 5.2 "1.1 cm and 2.5"0.5 cm; multiparas, 7.1"2.1 .cm and 4.0 "1.5 cm, respectively . Rates of pathological FHR tracings, as well as 1 and 5 min Apgar scores and cord blood pH, were similar in the TENS participants and the control

5.
Pain relief in labour using Transcutaneus Electical Nervous Stimulation (TENS). A TENS/TENS Placebo Controll in two parity groups

Primigravida who complete labour without requiring further analgesia were only 12 and 14% in the TENS and TENS placebo in the para 2 women the respective percentages rose to 48 and 39%. There were no significant differences between any sub groups regarding number requiring further analgesia or when it was first given in relation to duration of labour or cervical dilatation.  The duration of labor was shorter in the primigravidae who used either TENS and TENS Placebo alone than in those needing further analgesia. Two ways analysis of variance of these patient using factor TENS /TENS Placebo and whether or not patients had further analgesia showed that patient who did not require further analgesia had significantly shorter labour (P=<0.005).

Outcomes of Labour
There were no real differences in the occurrence of normal and operative deliveries between TENS and TENS Placebo user either in the primigravidae  or the para 2 patients. The 38 primigravidae who also choose an epidural only three of the 13 TENS users and eight of the 25 TENS Placebo user had non operative delivery. Theer were  no significant difference of APGAR Scores between the groups at 1 or 5 minute.



5.      Appraisal the evidence
No
Author
Were patients randomized?
Was group allocation concealed?
Were patients in the study groups similar with respect to known prognostic variables?
To what extent was the study blinded?
Was follow-up complete?
Were patients analyzed in the groups to which they were first allocated?
Aside the experimental intervention, were the group treat equally?

1
Transcutaneous nerve stimulation (TENS) during the first stage labor : a Randomized
Yes
No mention

Yes
Yes
Yes

Yes
Yes
2
Pain relief by applying transcutaneous electrical nerve stimulation (TENS) on acupuncture points during the first stage of labor : A randomized double-blind placebo-

Yes
No describe
No Mention
Yes

Yes
Yes
Yes
3
Transcutaneous Electrical Nerve Stimulation on Acupoints Relieves Labor Pain : A Non- randomized Controlled Study

Yes

No describe
No describe
Inadequate.

No

Not mentioned.
Yes
No
Author
Were patients randomized?
Was group allocation concealed?
Were patients in the study groups similar with respect to known prognostic variables?
To what extent was the study blinded?
Was follow-up complete?
Were patients analyzed in the groups to which they were first allocated?
Aside the experimental intervention, were the group treat equally?

4
Transcutaneous electrical nerve stimulation TENS for adjuvant pain-relief during labor and delivery

No describe, only mention control and study group
No describe
Yes
No Describe
Yes
Yes
Yes
5
Pain relief in labour using Transcutaneus Electical Nervous Stimulation (TENS). A TENS/TENS Placebo Controll in two parity groups
Yes

.Yes

Yes
Yes
Yes
Yes
Yes



Question
Answer
1.       
Were the study patients similar to my population of interest? 
In general, the respondents have the same characteristics in Indonesian’s population. Race and demographic are different. Mostly, Indonesia society, are feeling close minded regarding something new, especially in medical field, because they concerned about safety that could be harm to their health. In this case, the patients need role model  who give the example , if it is work, they would be to try.

2.       
Does your population match the study inclusion criteria?
If not, are there compelling reasons why the results should not apply to your population?

No at all. Acupuncture  has significant effective to relief labour pain than TENS, and if TENS used in the specific points. TENS has significantly effect to relief labor pain rather than other method,. In Indonesia, using an cupuncture as a method to reduce pain in labour never had been before, so it is not common (for this time). Moreover, to obtain this skill, someone need to present specialist training. Regarding TENS, it could be and possible to apply in  Indonesia.
3.       
Were all clinically important outcomes considered? 
What were the primary and secondary endpoints studied?

From those literature review, primary outcome of research was the rate of VAS score decrease, and the secondary were the mode of delivery.
4.       
Are the likely treatment benefits worth the potential harm and costs?

TENS are likely treatment benefits and no potential harm. But maybe likely potential cost should be considered to provide TENS devices in the hospital or other healthcare facilities. To operate this device, require certain skill, so this device is only be provided in the hospital or other health facilities and also should be under control health provider. Skin irritated due to application of electrode device has been reported but the consequently is not negligible compare with the outcomes.

5.       
Will the results help in caring for my patient?

Yes, TENS help in caring for my patients. This device could become an option method to reduce pain labor during first stage.



6.      Conclusion :

Ø There was inconsistent result, whether TENS can be used effectively to reduce pain labor (without acupuncture points). It due to those 5 journals have different  method about frequency  and duration to apply TENS. Consistency result to apply TENS during first stage of labour, on acupuncture points and the duration minimum 30 minutes intermittent with voltage 100-150Hz.
Ø  The use of TENS at home in early labour has not been evaluated. TENS is widely available in hospital settings and under control health provider 

Ø  Need information and counseling about TENS since antenatal class
Reference



 

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