Accepted Manuscript

TENS and heat therapy for pain relief and quality of life improvement in individuals
with primary dysmenorrhea: A systematic review

Ukachukwu Okoroafor Abaraogu, Chidinma Samantha Tabansi-Ochuogu, Sylvester

Emeka Igwe

PII: S1744-3881(16)30032-9
DOI: 10.1016/j.ctcp.2016.05.001
Reference: CTCP 648

To appear in: Complementary Therapies in Clinical Practice

Received Date: 25 March 2016

Accepted Date: 5 May 2016

Please cite this article as: Abaraogu UO, Tabansi-Ochuogu CS, Igwe SE, TENS and heat therapy for
pain relief and quality of life improvement in individuals with primary dysmenorrhea: A systematic review,
Complementary Therapies in Clinical Practice (2016), doi: 10.1016/j.ctcp.2016.05.001.

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 ACCEPTED MANUSCRIPT

Title: TENS and Heat Therapy for Pain Relief and Quality of Life Improvement in

Individuals with Primary Dysmenorrhea: A Systematic Review

Short title: Effect of Manual Therapy on Primary Dysmenorrhea.

Authors: 1,2*Ukachukwu Okoroafor Abaraogu (BMR,MScPT), 3Chidinma Samantha Tabansi-

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Ochuogu (BMR PT) 1Sylvester Emeka Igwe (BMR PT, PhD).

Authors Affiliations: 1School of Health and Life Sciences Glasgow Caledonian University

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United Kingdom. 2Department of Medical Rehabilitation Faculty of Health Science and
Technology College Medicine University of Nigeria. 3Physiotherapy Department University of
Calabar Teaching Hospital

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Correspondence: *Abaraogu Ukachukwu Okoroafor │Department of Medical Rehabilitation
Faculty of Health Science and Technology College Medicine University of Nigeria Enugu
Campus 400006 Enugu Nigeria Email: ukachukwu.abaraogu@unn.edu.ng

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Title: TENS and Heat Therapy for Pain Relief and Quality of Life Improvement in
Individuals with Primary Dysmenorrhea: A Systematic Review
ABSTRACT
The present systematic review aimed to synthesize evidence for the effectiveness of TENS and
heat therapy interventions from randomized trials. Six relevant databases were searched for
studies on TENS and heat therapy for primary dysmenorrhea. Menstrual pain intensity and

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quality of life were the primary and secondary outcomes respectively. The search yielded 46
citations from which six studies on TENS and three studies on heat therapy were systematically
reviewed. On the PEDRO quality scale, the trials methodological quality was 4.8 out of 10 for

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TENS and 6.3 out of 10 for heat therapy. TENS and heat therapy both showed evidence of pain
reduction, but no study included quality of life as an outcome. Meta-analysis was not possible
due to substantial heterogeneity in included studies. TENS and heat therapy show potential as

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adjunct remedies in the management of primary dysmenorrhea, but rigorous high quality trials
are still needed to made conclusive recommendation.
Key words: TENS, primary dsymenorrhea, TENS therapy, heat therapy, ínfra-red therapy.

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BACKGROUND OF STUDY
Primary dysmenorrhea (pain during menses in absence of underlying pathology), constitutes a
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high health, social and economic burden. Absenteeism from school or work at least once sequel
to the symptoms of primary dysmenorrhea has been reported as between one third to half, with
5% to 14% of these absenteeism occurring frequently [1]. Non-steroidal anti-inflammatory
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medications (NSAID), and oral contraceptive pills are primary choice for routine relieve of pain
primary dysmenorrheal [2]. However, these have side-effects in some individuals [3], many
individual do not get pain relief from these choice interventions.
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Therefore effective alternative therapy for primary dysmenorrhea that have minimal side effect is
of potential value. Among these alternative are heat therapy and transcutenous electrical nerve
stimulation (TENS). TENs is belief to effect relief of primary dysmenorrheal pain by three
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mechanisms. First is by gating afferent ascending pain signal at the spinal cord[4]. The second is
the release of endogenous morphine for onward delivery through descending efferent fibre [5, 6].
Lastly, TENS is believed to reduces uterine muscle ischemia via enhanced corresponding skin
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perfusion brought about by local vasodilation in the same dermatome area after skin stimulation
with TENS[7].
TENS and heat interventions have been advocated as a major non-medical intervention for the
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relief of dysmenorrhoea [8, 9]. However, there is conflicting evidence regarding the main issue
of how the different interventions are beneficial. The major challengein translating research
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evidence to clinical guideline for regarding utilization of TENS and heat therapy for primary
dysmenorrheal has heterogeneity of the different protocols, doses and contradicting finding from
different trials. A systematic review is warranted to aggregate available research literature into a
high quality evidence translatable a clinical guideline for or against the routine use of heath and
TENStreatment as an adjust therapy for individuals with primaary dysmenorrhea. The objective
of this systematic review is to investigate the effect of heath and TENS in pain relief and quality
of life improvement in individuals with primary dysmenorrheal via review of RCTs.

METHODS
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RESEARCH DESIGN: This is a systematic review of outcome and quality of various trials on
TENS and heat therapy in pain relief and quality of life of females with primary dysmenorrhea.
SOURCE OF DATA: A comprehensive search strategy was conducted on Ovid Medline,
Science Direct, PEDro, CINAHL, PsyclINFO, and AMED were searched. The search was
performed using the following key indexing terms independently; ‘TENS’, ‘Electrical
stimulation’, ‘primary dsymenorrhea’, ‘TENS therapy’, ‘heat therapy’, ‘hot water bottle

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therapy’, ínfra-red therapy’, ‘physiotherapy’, ‘primary dsymenorrhea’ ‘quality of life’, ‘physical
intervention’. The literature was searched until October 2015.

SELETION CRITERIA

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Studies with the main focus on the efficacy, effectiveness, or effect of different heat
therapy and TENS modalities used for primary dysmenorrhea were included. Limiters peer
review journal or conference publications on human participants published in English language.

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All study abstract meeting these broad criteria were initially included. In the case that decision
could not be made based on the title and abstract of the paper, the authors were contacted for any
missing data in the included studies and the full text of the paper was included for further

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decision.
Subsequent inclusion, based on the inclusion criteria was then assessed independently by two
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review authors. When a difference of opinion occurred, consensus was reached on inclusion or
exclusion by discussion and reflection, or in consultation with a third review author.
The following inclusion criteria determined eligibility for the trial that was included in the
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review: primary dysmenorrhoea (pain affecting daily activity or with a high baseline score ≥3 on
VAS or equivalent tool); Primary dysmenorrhea in the majority (> 50%) of menstrual cycles;
Primary dysmenorrhea for at least one day of menses. Studies were excluded if participants had
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irregular or infrequent menstrual cycles (usually outside of the typical range of a 21 to 35 day
cycle); using an intra-uterine contraceptive device (IUD), report of usage oforal contraceptive
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pills (OCP).
Outcomes: The primary outcome was pain intensity. Secondary outcome was quality of life.
Any pain intensity outcome measure tool was included in as much as it can easily convert to 1-
10 on VAS. Only validated QoL outcome measurement tool was eligible.
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DATA EXTRACTION AND MANAGEMENT

Data extraction was independently completed by the last two review authors, later
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harmonized by discussion and reflection where there were differences between the two. Because
prior standardization of the data extraction procedures was required for consistency in method
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used by both review authors, a trial was conducted on two similar papers not related t the present
review topic. The result of the extraction was then discussed until procedure was clear. The first
author was consulted when there were agreement could not be reach between the last two authors
on data items. First author’s opinion stimulated further discussion to arrive at a consensus. This
data extraction method (double data extraction) has been shown to have a lower rate of error than
simple data extraction [10]. Pooling of data was undertaken were adequate homogeneity of
results existed. Discrepancies were resolved by discussion. For each included trial, data were
extracted regarding the participants (age range, eligibility criteria), the nature of the
interventions, and data relating to the outcomes of pain intensity and quality of life.
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DATA EXTRACTION FORM: This form consists of descriptive characteristics (see table 1)
and a quality appraisal tool (see table 3). Data was extracted based on the elements of this form
which are related to the research questions and aims of this systematic review.
QUALITY APPRAISAL: The quality of paper was assessed using the PEDro quality appraisal
tool. Answers to the quality appraisal items were defined as Yes, No, Not applicable or Unclear.
A score of one was given to each yes answer and zero to no, unclear and not applicable (N/A)

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answers. The overall score was reported as a tally of all yes answers out of 10 based on the
applicable answers for each study. Scores of individual item from the critical appraisal tool were
added to present a total score.

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ETHICAL APPROVAL
The present review utilized already published literature information as it primary data, and does
not require ethical approval.

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RESULTS
Flow of studies through the review
The initial searches identified 46 potential relevant papers. The flow of papers through the

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process of assessment of eligibility is represented with reasons for exclusion of papers at each
stage of the process (fig.1). Study authors were contacted when data were not reported in the
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format that allowed inclusion in the review. Where data could not be included in a suitable
format, the paper was excluded.
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Characteristics of included trials

In total, the 9 included studies contributed data on 423participants. The quality appraisal of the
included trials is presented in table 3 and table 4while the level/grade of evidence for each
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outcome is presented in table 1 and table 2 including trials with researches from 1990 to April
2015.
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Quality:The methodological quality of the included trials ranged from low to high, with a mean
PEDro score of 4.8 out of 10 for TENS interventions and 6.3 out of 10 for interventions on heat
therapy. Six trials were methodologically moderate-quality trials with scores ≥ 6. The individual
PEDro items satisfied by almost all the trials were random allocation, groups similar at baseline,
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<15% dropout rate and reporting of between group difference.

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Papers retrieved by search (n=46)

Not from a peer reviewed journal (n=6)

Duplicates (n=10)

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Excluded after screening title (n=7)

• Ineligible intervention (n=4)

• Studies on systematic reviews (n=3)

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Papers screened by abstract and

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evaluation of full text (23)

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Excluded after screening abstract (n=7)

•
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No pain intensity/quality of life outcome measure(n=2)
• Included participants with other complications eg
dsyperunia, chronic low back pain etc(n=3)
• Case reports and expert opinion(n=3)
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Excluded after screening full text (n=6)

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• Wrong language and translation (n=2)

• Ambiguity in data and result reporting (n=3)
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• Outcome measure of pain intensity not convertible to 0-10

scale(n=1)
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Studies included for systematic

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review (n=8)
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Figure 1; Flow of studies through the review

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Level/grade
The completeness of outcome data for each outcome was adequately described in all the included
studies in the meta-analysis. No other limitations, such as stopping early for benefit or use of
invalidated outcome measures, were identified in any of the included studies. The summary of
findings and evidence profile are presented in Table1 to table 4. The overall grade of the
evidence obtained for the outcome of exercise intervention trials was ‘moderate’ grades.

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Participants:The sample sizes contributed by the included trials ranged from 21 to 147. The
mean age of participants in the included trials ranged from 12 to 41 years.

Interventions

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For heat therapy interventions; Navvabi et al, [11] compared the effect of heat patch (7x12cm
patch) to an ibuprofen group, Kim et al, [12] compared the effect of heated red bean pillows to
pain killers (Tylenol), and Yu-Min Ke et al, [13] compared the effect of Far-infrared(FIR) belt

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(with 10weight% FIR ceramic powder) to a control that used belt without 10wt% FIR ceramic
powder.
For TENS interventions; Mannheimer et al, [14] compared the effect of conventional TENS

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and strong low rate acupuncture-like TENS to sham TENS, Hanfy and Adel El-Bigawy [15]
compared the effect of high frequency TENS to acupressure, Lewers et al, [16] compared the
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effect of acupuncture-like TENS to placebo pill, Kaplan et al, [17] and Tella et al, [18] both used
a pretest post test design to check the effect of high frequency TENS without a control group,
and Schiotz et al, [19] checked the effectiveness of TENS using an OVA TENS device.
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Outcome measures:All the trials included measured pain intensity/severity as outcome measure
with 5 trials using VAS, 2 trials using numeric pain rating scale, 2 trials using presenting pain
intensity of the Mcgill’s questionnaire, 1 trial used the menstrual distress questionnaire and the
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another used TENS analog pain rating scale.

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Excluded studies: Two trials were excluded; authors Wu et al, [20] did not respond to emails
sent to them for clarification and their studies were not included in the review.
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TABLE 1: DESCRIPTIVE CHARACTERISTICS OF STUDIES ON HEAT

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STUDY DESIGN PARTICIPANTS a INTERVENTION CONTROL OUTCOME

b MEASURES
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1) Navvabi et al RCT n = 147 (Exp = 72), Group I -> Heat No control Short form
[11] con =75) patch (7x12 and group MCGill pain
Age = 18-30 yrs patch questionnaire (0-
(SF-MPQ = not Group II -> 100)
reported Ibuprofen (400mg) (SF.MPQ) VAS
(0-5)
2) Kim et al Q-RCT Age = not reported Group I -> Heated No control VAS (for pain
[12] VAS red bean pillows group score (0-100)
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MDQ: Exp = 104.6 + Group II -> Pain MDQ (for

39.4 killers (Tylenol) dysmenorrhea
Cont = 111.9 + 34.5 (Acetaminophen severity)
ADL – not reported 500mg ADL
Pamobrome 25mg) questionnaire
3) Yu-Min ke RT n = 51 (Exp = 26), con (without % FIR Control belt VRS; 0-5 (none-
et al [13] = 25) ceramic powders) without 10w + very severe)

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Age = > 18yrs (19-35 Far-infrared (FIR) % FIR ceramic NRS: 0-10
yrs0 belt worn around the powders Abdominal
NRS -> not reported abdominal region for temperature

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Verbal rating scale -> 30 minutes (using fluke 1.25
not reported thermal imager)
Abdominal

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blood flow,
using Moor
<D12-IR laser
Doppler Imager

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DESCRIPTIVE CHARACTERISTICS OF STUDIES ON HEAT INTERVENTION

From table 1, three trials were included with RCT and Q-RCT as study designs [11-13]. Total of
242 participants were used with ages ≥ 18. The interventions involved use of heat patches, hot
water bottle and heated red bean pillows with VAS, Mcgill questionnaire, Menstrual distress
questionnaire and verbal rating scale as measures of pain outcome.
DESCRIPTIVE CHARACTERISTICS OF STUDIES ON TENS INTERVENTION

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As presented in table 2, seven trials met the inclusion criteria using RCT and pre-test post-test
design [14-20]. A total of 247 participants were used with age range of 19-41 years.
Conventional TENS, acupuncture-like TENS and OVA TENS device was used with VAS for

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measuring pain intensity outcome measure.

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TABLE 2: DESCRIPTIVE CHARACTERISTICS OF STUDIES ON TENS

INTERVENTION
STUDY DESIGN PARTICIPANTS INTERVENTION CONTROL OUTCOME
a MEASURES
b
c
1) Mannheimer RCT n = 27 (Grp 1-9, 2=9, Group I -> Sham TENS Pain Scale:
et al [14] 3=9) conventional TENS TENS analog

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Age = 19 – 27yrs Group II -> Strong pain rating scale
Pain rating scale: low rate 0-100
Acupuncture like DPR: duration

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TENS of pain relief
2) Hanfy and RCT n = 30 (Exp = 15, con TENS (High Freq Acupressure Pain relief scale
Adel = 15) TENS) (0-10 )

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El-Bigawy [15] Age = 17-23 Present pain
PPT: Exp = 3.73 intensity
(0.46), con = 3.80 scale(PPI)
(0.41)

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PRS: Exp = not
reported
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3) Lewers et al RCT n = 21 (Exp = 10, con Acupuncture like Placebo pill Pain rating
[16] = 11) TENS treatment index of McGill
Age = 20 – 38 yrs pain
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(25.9) Questionnaire
PRI = Exp = 24 VAS (0-10cm)
Con = 34
VAS = Exp = 4
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Con = 4.5
4) Kaplan et al Pre test n = 61 High TENS No control Pain scale (0-10)
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[17] Post test Age = not reported TENS Treatment group

Pain scale = not
reported
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5) Wu et al [20] RCT n = 66 con = 32 Al-Tens AL-TENS on McGill

Age = not reported Acupuncture-Like non acupoints Questionnaire
Tens Of Middle start form NRS
Frequency (100hz-
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10,00hz) At <14 And

Sp6 Acupoints
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6) Schiotz et al QRCT n =21 OVA TENS device No control Pain: VAS (0-
[19] Age = 12-41 (mean = group 10) cm
24) Change in use of
VAS = 6.87 (median 7, analgesic meds
range 2-10, SD 2.12)
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7) Tella et al Pre-test, n = 21 TENS (high No control VAS = (0-10)cm

[18] Post-test Age = 18-26yrs (mean frequency) group Cortisol &
design 23 + 2) 100Hz and 250ms of prolactin levels
Cortisol = 28.45 + pulse rate and pulse using ELISA
5.27ig/dl width respectively method/kit
Prolactin = 55.81+ for 30 minutes
31.86ng/mL

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VAS pain scale using
Wilcoxon signed
Ranks Test = 5.50 +

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1.73

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Table 3: PEDro quality appraisal of studies on TENS

Study Random Concealed Groups Participant Therapist Assessor <15% Intention Between Paint Total
Name of Allocation Allocation Similarat Blinding Blinding Blinding Droport to Treat Group Estimate 0-10

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Author Baseline Analysis Difference &
Variability
Reported

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1) Y Y N Y N N Y Y Y N 6
Mannheimer

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et al [14]
2) Hancy& Y N Y N N N Y Y Y Y 6
El-Tgamy

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[15]
3) Lawers et Y Y Y N N N Y Y Y Y 7

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al [16]
4) Kaplan et N N Y N N N Y N N N 2
al [17]

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5) Schiotz et Y N Y N N N Y Y Y N 5
al [19]

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6) Tella et al N N Y N N N Y N Y N 3
[18]

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Table 4: PEDro quality appraisal of studies on heat therapy
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Study Random Concealed Groups Participant Therapist Assessor <15% Intention Between Paint Total
Name of Allocation Allocation Similar Blinding Blinding Blinding Droport to Treat Group Estimate & 0-10
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Author at Analysis Difference Variability

Baseline Reported
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1) Y N Y N N N Y Y Y Y 6
NawabiRigi
et al [11]
2) Kim [12] N Y Y N N N Y Y Y Y 6
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3) Yu-min Y Y Y Y N N Y N Y Y 7
Ke et al [13]

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DISCUSSION
TENS INTERVENTION
Evidence from trials on TENS also had relatively positive effects in pain reduction. The different
trials used different types and intensities of TENS to infer their significance. One trial by
Lewerset al, [16] compared the effect of 30minutes acupuncture-like TENS (using four auricular
acupuncture points) with placebo pill and results revealed that pain relief was approximately the
same for the two groups over time. Another trial (Mannheimer et al, [14] compared the efficacy

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of conventional (high frequency)TENS and strong low rate (acupuncture-like) TENS to a control
group and revealed a statistically significant decrease in pain between the conventional and
control group as opposed to the acupuncture-like TENS group. Theafore outcomes were also in

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line with the results of two trials that also used conventional TENS though control groups were
absent [17, 18]. The absence of the control group excluded these studies from the meta-analysis.
Another study which also wasn’t included in the meta-analysis compared the effect of TENS

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against acupressure and indicated significant pain relief favoring especially the TENS group
[13]. These interventions show conventional TENS as a better option in dysmenorrheal pain
relief than other forms of TENS. This result corresponds with the finding of the systematic
review by Proctor et al, [21] which also recorded that high-frequency TENS was more effective

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for pain relief though with insufficient evidence to determine the effectiveness of low-frequency
TENS in reducing dysmenorrhea.
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INTERVENTIONS ON HEAT THERAPY
Trials on heat therapy showed individual improvement in pain levels. One trial used heated red
bean pillows in one group and pain killers in the second group with the study randomized by
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virtue of location in different campuses [12]. Both groups recorded a significant improvement in
alleviating menstrual discomfort but the inability of the study to confer a placebo effect without a
placebo group may indicate methodological limitations. The second trial with 147 participants
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compared the analgesic effect of heat patch containing iron chip and ibuprofen [11]. Same
reduction in pain was recorded in the different groups showing a comparable analgesic effect of
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heat patch and ibuprofen in relieve of dysmenorrhea. Further research in this area is needed to
narrow down the effect of various heating modalities to clinically worthwhile values in
comparison to other general interventions. The cost effectiveness of heat with its level of risk
may also be required.
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Although the analgesic effect of heat, TENS were mostly statistically significant, the evidence
for each intervention came with minor cautions. The estimates from the results were provided by
few trials and the differences in mean did not exclude the possibility that the effect was clinically
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trivial, though the quality of the trials was not particularly low except for trials on TENS that
have below moderate of 4.8 out of 10. However, these interventions have relatively low cost and
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risks, so it can be prescribed as a good form of intervention despite the uncertainties.

LIMITATIONS
This study had several limitations. The studies satisfying the inclusion criteria were clinically
and methodologically heterogenous with respect to the severity of pain, participants, the different
types and techniques of intervention used in similar trials, control groups employed and
outcomes examined. The follow-up length and timing of outcome assessment also varied, as did
the treatment schedule and frequency. These made it impossible for us to pool the data to
conduct a meta-analysis. In addition, a possible publication bias was not excluded clearly for this
review, as majority of trials reported were those found readily available from journals and

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authors; and also majority of those included indicated positive effects of the interventions in the
treatment of primary dysmenorrhea. Another possible limitation was the paucity of data on the
interventions with similar techniques in use of the various interventions. This made it impossible
to draw definite conclusions on interventions involving similar trials a meta-anaysis or sensitivity
analysis.
CONCLUSION

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This study involved three reviewers who independently and collaborately performed study
selection, quality assessment and data extraction and management. Several interventions
indicated statistical significance. Insights into effectiveness of each intervention were identified

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in each of the interventions in correlation to themselves and with each other. The systematic
review highlighted promising evidence in the form of studies done to establish the effectiveness
of some TENS and heat therapy interventions in the management of primary dysmenorrhea.

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However, the results were limited with methodological flaws. The review identified that both
TESN and heat therapy can significantly reduce the pain associated with dysmenorrheal but
more similar high quality and rigorous researches are needed to before high level of evidence
drawn though a meta-analysis . However, as the costs and risks of this intervention is low, it

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could be considered for clinical use.
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RECOMMENDATION
Further research is merited, as the quality of the trials and the reporting of the trials
methodologies reviewed in this study were averagely moderate; further higher quality trials are
needed to assess the effectiveness of these interventions for the treatment of menstrual pain. To
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improve the trial design quality, level of performance and degree of reporting of clinical trials,
future researchers should follow the basic guidelines for reporting clinical trials, such as PEDro
guideline CONSORT checklist which provide specific guidelines for the conduct and reporting
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clinical trials.
Further researches should also be conducted with patient blind and assessor blind against a sham
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control intervention in other to allow for placebo effect. They should also be of sufficient sample
size and employ validated outcome measures of clinical effectiveness. Quality of life of
participants should also be included as outcome of interest in future researches.
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