Contemporary Clinical Trials 42 (2015) 8189

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Contemporary Clinical Trials

journal homepage: www.elsevier.com/locate/conclintrial

Menstrual pain and quality of life in women with primary

dysmenorrhea: Rationale, design, and interventions of a
randomized controlled trial of effects of a treadmill-based
exercise intervention
Priya Kannan a,, Cathy M Chapple a, Dawn Miller b, Leica S Claydon c, G David Baxter a
a
Centre for Health, Activity and Rehabilitation Research, University of Otago, New Zealand
b
Department of Women's and Children's Health, Dunedin School of Medicine, New Zealand
c
Department of Allied and Public Health, Anglia Ruskin University, Chelmsford, UK

a r t i c l e i n f o a b s t r a c t

Article history: Dysmenorrhea in the absence of pelvic abnormality is termed primary dysmenorrhea (PD). The
Received 8 January 2015 health burden and social and economic costs of PD are high as it is reported to be the leading cause
Received in revised form 23 March 2015 of recurrent absenteeism from school or work in adolescent girls and young adults. The belief that
Accepted 24 March 2015 exercise works for relieving symptoms in women with PD is based on anecdotal evidence and
Available online 31 March 2015
non-experimental studies. There is very limited evidence from randomized controlled trials
(RCTs) to support the use of exercise to reduce the intensity of menstrual pain. The objective of
Keywords: this study is to evaluate the effectiveness of exercise to reduce intensity of pain and improve
Dysmenorrhea quality of life in women with PD. We describe the study design of a single-blind (assessor),
Exercise
prospective, two-arm RCT, and the participant characteristics of the 70 women recruited in the
Menstrual pain
age-group 18 to 43 years. The primary outcome of the study is pain intensity. The secondary
Primary dysmenorrhea
Randomized controlled trial outcomes of the study are quality of life, functional limitation, sleep, global improvement with
Treadmill treatment, and protocol adherence. The outcomes assessments are done at first menstrual period
(baseline, Week 0), 2nd menstrual period (Week 4) and at two additional time points (Week 16
and Week 28) during the trial.
The results of the study will provide physiotherapists, medical practitioners, and researchers as
well as the women who have PD with new insights, knowledge, and evidence about the use of
exercise to manage pain in women with PD.
2015 Elsevier Inc. All rights reserved.

1. Introduction
The word dysmenorrhea translates as difficult menstrua-
tion [1]. Dysmenorrhea in adolescent and young women, usually
associated with a normal ovulatory cycle [2,3] and no identifiable
pelvic disease, is termed primary dysmenorrhea [PD] [4]. PD is an
extremely common problem, with a prevalence ranging from
Trial Registration: This study has been registered in the Australia New
Zealand Clinical Trials Registry (Ref: ACTRN12613001195741).
Corresponding author at: School of Physiotherapy, University of Otago,
Dunedin 9054, New Zealand. Tel.: +64 211550880.
E-mail address: kanpr735@student.otago.ac.nz (P. Kannan).URL:
http://www.physio.otago.ac.nz/UniversityofOtago (P. Kannan).
60% to 93%, depending upon the population and study [3,5]. A
New Zealand prevalence study of 2,261 women in 2001 reported
that the 3-month prevalence of dysmenorrhea was 55.2% and
the 12-month prevalence 66.5% [6]. The initial onset of PD is
usually within 6 to 12 months after menarche [7,8] and is
commonly described as cramping, aching, or dull pain in the
midline supra-pubic region, with or without radiation into the
lower back, abdomen, medial thigh, or upper legs [9,10]. PD may
begin a few hours before or after the onset of menstrual bleeding,
lasts for about 48 to 72 h, and is most severe during the first or
second day of menstruation [9,10]. Other associated symptoms
include nausea, vomiting, loss of appetite, headaches, dizziness,
diarrhea, sleeplessness, depression, irritability, and in severe

http://dx.doi.org/10.1016/j.cct.2015.03.010
1551-7144/ 2015 Elsevier Inc. All rights reserved.
82 P. Kannan et al. / Contemporary Clinical Trials 42 (2015) 8189
cases, syncope or fainting [4,11]. A key differentiating factor
in secondary dysmenorrhea is the onset and the presence
of symptoms of pain that persist beyond the normal menstrual
period. Secondary dysmenorrhea occurs any time after
menarche and can arise as a new symptom in women in their
30s or 40s [7]. Chronic pelvic or lower abdominal pain that
could begin 12 weeks before the onset of menstruation that is
relieved after the onset of menstruation is usually associated
with an underlying organic pathology such as endometriosis
[10,12]. The onset, location, duration, and characteristics of
pain plus any aggravating or relieving factors are helpful in
differentiating primary and secondary dysmenorrhea [2,13].
There are a number of hypotheses proposed for the
effectiveness of exercise for relieving menstrual pain. Mosler
in 1914 was the first to speculate that exercise relieves pelvic
congestion by shunting uterine blood flow [14]. Other proposed
mechanisms include exercise-induced release of endogenous
opiates, specifically beta-endorphins, vasodilatation, suppres-
sion of prostaglandins, reduction in stress, and elevation of
mood: mechanisms that decrease pain or uterine contractions
thereby relieving menstrual discomfort [11,12]. Particularly
vigorous-intensity exercises are believed to stimulate the
release of beta-endorphins, which act as systemic analgesics
in reducing the menstrual pain associated with PD [15]. Aerobic
exercise during the luteal phase is thought to be beneficial for
PD [16], but no recommendations have been made for stopping
exercises during menstruation. However, previous studies on
exercise for PD restricted women from exercising during
menstruation [17,18].
According to the American College of Sports Medicine
(ACSM, 1978) guidelines for exercise prescription, vigorous-
intensity aerobic exercise is 60%90% of maximum heart rate
(MHR) completed 35 times per week in bouts of 1560 min per
session [19]. Methods of quantifying the relative intensity of
exercise include metabolic equivalents (METs), heart rate, or
heart rate reserve. METs are considered a useful, convenient, and
standardized way to describe the absolute intensity of a variety
of exercises [20]. Vigorous exercise is defined as requiring 6
METS, including activities such as walking at a very brisk pace,
jogging, and running [20,21].
Though vigorous-intensity exercises are believed to be
useful for PD, there is limited empirical evidence to support
their efficacy, with most studies being observational. A
recent systematic review [22] that evaluated the efficacy of
physiotherapy interventions for PD identified a single RCT
on exercise [18]; however, the RCT was not eligible for the
review as pain was not an outcome measure in the study. A
review in 2008 [11] and a Cochrane systematic review of RCTs
in 2010 [23] on exercise for PD identified only a single RCT on
exercise for PD [18], with major methodological flaws. The
potential benefits of vigorous exercise to manage associated
symptoms of PD, and the lack of high quality studies, were
the drivers to design this experimental study, which aims to
evaluate the effectiveness of an exercise intervention to reduce
the pain and associated symptoms of menstruation in women
with PD.
1.1. Operational denition of primary dysmenorrhea
Primary dysmenorrhea is painful menstruation that pre-
sents within six to 12 months after menarche [7,8], when
ovulation becomes regular, and in the absence of pelvic
pathology. It is characterized by cramping, aching, or dull pain
in the supra-pubic region with or without radiation into lower
back, abdomen, medial thigh and/or upper leg and occurs just
before or during menstruation with pain lasting from 48 to 72 h
[7,10,12,24,25].
2. Methods
2.1. Objective and Study design
The study is a single-blind (assessor), prospective, two-arm,
RCT, being conducted at the Otago School of Physiotherapy,
Dunedin, New Zealand. The objective of the study is to evaluate
the effects of an exercise intervention to reduce pain intensity
and improve quality of life in women with PD. The study
duration is 29 weeks inclusive of baseline (Week 0) and final
follow-up (Week 28) assessments. Participant recruitment
took place between 19 March 2014 and 23 July 2014. The study
was approved by the Health and Disability Ethics Committee of
New Zealand (Ref: 13/STH/206).
2.2. Sample size
The required sample size is calculated based on results of our
previous feasibility study to explore the use of a treadmill-based
exercise intervention for alleviating menstrual pain associated
with PD [26]. A sample size of 70 participants (35 in intervention
group and 35 in usual care control group) was estimated for an
overall two-tailed 0.05 level of significance with 90% power, and
standard deviations consistent with those observed in the
feasibility study [26], to detect effect sizes of 15 mm on the
visual analogue scale (VAS). The estimated sample size accom-
modated a dropout rate of 15%.
2.3. Study population and recruitment strategy
The study recruited a multiethnic group of women by
public and University campus advertising. Advertising was by
posting study flyers around the University of Otago, Dunedin
campus, waiting rooms of the Women's and Children's Health
clinic, Dunedin Hospital, General Practitioners, Dunedin Family
Planning Clinic and physiotherapy clinics, sports centers and
clubs, child care centers, community churches, and super
markets. The advertisement flyers contained simple inclusion
and exclusion information as well as contact details of the
Clinical Research Administrator (CRA).
The study recruited women who fulfilled the following
inclusion criteria: Non-pregnant in the age-group 18 to 43 years
with general good health and having PD, not on a formal
exercise program, women with regular menstrual periods
and having no pelvic abnormality, PD with pain scoring 4 on
a 010 numeric rating scale (NRS) for at least two consecutive
months. The exclusion criteria were as follows: women with
secondary dysmenorrhea, women having intra uterine devices,
women on oral contraceptive pills (OCPs), and hormonal
therapy and women with menstrual cycle interval exceeding
34 days.
 P. Kannan et al. / Contemporary Clinical Trials 42 (2015) 8189 83

2.4. Screening process and procedures
Potential participants followed a two-step screening pro-
cess. Interested women who contacted the CRA were subjected
to telephone screening to determine if they met the eligibility
criteria regarding age, use of OCPs/intrauterine device, preg-
nancy status, and regularity of menstrual periods. The second
step of the screening process was conducted during the visit to
School of Physiotherapy (SoP). Following the written informed
consent, participants completed a screening questionnaire on
demographic details, pain history including the onset, duration
and location of pain, use of analgesics and presence/absence
of pain relief with analgesics, general medical history, and
menstrual history, general obstetric, and gynecological history.
Information on onset, pain history, and relief obtained with
analgesics were used as indicators to confirm PD [7].
On completion of the screening questionnaire, participants
completed the short form of international physical activity
questionnaire (IPAQ) to establish their baseline physical activity
levels. All participants were then provided with self-reported
outcome questionnaires and return envelopes and requested to
complete these questionnaires on the day of maximum pain
during the first (baseline, Week 0) and second menstrual
periods (Week 4) and during menstrual periods at the end of
3 months (Week 16) and 6 months (Week 28) following trial
entry. No restrictions were placed on the use and amount of
analgesics for all participants. The schedule of study visits and
the assessments are summarized in Table 1. Participants were
then directed to the CRA for randomization to study groups.
2.5. Randomization
The CRA randomized participants into one of two groups
by asking them to select any one of seventy (35 intervention
and 35 usual control) identical opaque sealed envelopes.
Every participant had an equal chance of going into either
group. The envelopes contained a group name, either the
intervention or the usual care control group. The CRA assigned
a non-sequential personal identification number (PIN) to each
participant. Each participant was then informed by phone of
their group allocation by the CRA after the completed first
menstrual period (baseline) questionnaire was received from
the participant.
2.6. Blinding
The CRA randomized the participants and scheduled ap-
pointments for the exercise intervention for all intervention
group participants. The exercise intervention was conducted
by the primary investigator (PI). The PI is blinded to the
outcome assessments as they are all self-reported and sent by
post, addressed to the CRA. A research assistant (RA) prompts
return of questionnaires, and enters data on an Excel spread
sheet. The PIN numbers replaced the participants name on the
outcomes assessment forms and data spread sheet. The PI will
be blinded to group allocation during data analysis, with the
two groups being assigned a code. The group code will be
broken after the analysis is completed.
2.7. Study interventions
2.7.1. Exercise intervention
The exercise intervention is for 7 months beginning with
one month training period at the SoP followed by a home
exercise program for 6 months. The exercise intervention is
done in 3 week blocks between menstrual periods with no
exercises during the week of expected menstruation. The
training period at SoP started after completion of the first
menstrual period, and ending before the start of the second
menstrual period. During the training period, participants
underwent vigorous aerobic training on a treadmill for
30 min at 70%85% of their MHR. Treadmill training was
preceded by warm-up exercises for 10 min and followed by
cool down exercises for 10 min, including stretching for mid
and lower back muscles, pelvic region, and strengthening of
abdominal and gluteal muscles. MHR was calculated using a
formula developed by Gulati et al. (2010) for estimating the
peak heart rate for healthy women [27,28]. The heart rate was
monitored with the polar fitness heart rate monitor. Partici-
pants also wore a pedometer to record the distance covered on
treadmill.

Table 1
Study visits and assessments.

Type of visit Time from randomization in weeks

Screening Week 0 Week 1 Weeks 23 Week 4 Weeks 515 Week 16 Weeks 1727 Week 28

Informed consent X
Demographics X
Eligibility checklist X
Physical activity (IPAQ) X
Pain (Sf-MPQ) X X X X
Quality of life (SF-12) X X X X
Functional limitation (BPI-sf) X X X X
Sleep (WHIIRS) X X X X
Global improvement with treatment (PGIC) X X X
Readiness for physical activity (PAR-Q) X
Attendance X X
Adherence diary X X
Adverse events X X X X

IPAQ: International Physical Activity Questionnaire; Sf-MPQ: Short Form McGill Pain Questionnaire; SF-12: 12-Item Short Form Health Survey; BPI-sf: Brief Pain
Inventory Short Form; WHIIRS: Women's Health Initiative Insomnia Rating Scale; PGIC: patient global impression of change; PAR-Q: Physical Activity Readiness
Questionnaire.
84 P. Kannan et al. / Contemporary Clinical Trials 42 (2015) 8189
While participants were on the treadmill, the Borg's rate of
perceived exertion (RPE) scale between 6 and 20 was used to
regulate the exercise intensity on the treadmill. RPE is an
excellent tool to regulate and monitor intensity of aerobic
training [29]. Borg's RPE scale is one of the most widely used
valuable and reliable scales for quantifying and monitoring
exercise tolerance [2931]. Based on the participants' feedback,
the intensity of exercise was adjusted by speeding up or
slowing down the treadmill in order to maintain their level of
exertion between RPE 14 to 16, which is considered as vigorous
intensity [32]. Heart rate was monitored while on treadmill to
ensure it does not exceed an intensity of 85% of age-adjusted
MHR. Heart rate was recorded every 10 min while participants
were on the treadmill.
On completion of the 3-week training period at SoP,
participants were then asked to complete a home exercise
program, based on the trial intervention, for 6 months. They
were provided with a booklet containing the stretching and
strengthening exercises and an adherence diary with the average
distance covered on the treadmill at SoP. The participants were
requested to adhere to the intensity and distance of aerobic
training.
2.7.2. Usual care control
Usual care is operationally defined as any medical interven-
tion available for PD, including non-steroidal anti-inflammatory
drugs. It is recommended that in RCTs, usual care should be
defined by the best current method available [33]. In current
practice, the only treatment that is found to be of definitive
benefit for PD is analgesia [34]. A usual care arm is thought to
improve the relevance, external validity, and the practicality of
the study [35].
2.8. Outcome measures
Outcomes included in the study are predominantly self-
reported to assess the effect of exercise intervention on bio-
psycho-social domains [36]. These domains also largely adhere
to the Initiative on Methods, Measurement, and Pain Assess-
ment in Clinical Trials (IMMPACT) recommendations for
chronic pain clinical trials [37]. The measures were chosen for
their psychometric properties and appropriateness to PD or
women's health.
2.8.1. Primary outcome measure
Pain is measured with the short form of McGill pain
questionnaire (Sf-MPQ). The Sf-MPQ is a multidimensional
measure of perceived pain that evaluates the sensory, affective-
emotional, evaluative, and temporal aspects of chronic pain and
has three parts: the pain rating index (PRI), VAS, and the present
pain index (PPI) [38]. The PRI is comprised of 2 subscales: (1)
sensory subscale with 11 words and (2) affective subscale with 4
words, which are rated on an intensity scale as 0 = none, 1 =
mild, 2 = moderate, or 3 = severe. The total PRI index score is
obtained by summing the item scores (range 045) [39]. The
VAS is a 100 mm horizontal scale anchored with no pain on the
left and worst imaginable pain on the right. The PPI is scored on
a six-point scale as 0 = no pain, 1 = mild, 2 = discomforting,
3 = distressing, 4 = horrible, and 5 = excruciating. A higher
score on the SF-MPQ indicates worse pain [39].
2.8.2. Secondary outcome measures
Quality of life is measured with the 12-Item short form health
survey (SF-12) [40]. The SF-12 is a multipurpose short form
generic measure of health status which has been commonly used
to measure health related quality of life (HRQOL) in women with
endometriosis [41]. The SF-12 consists of 12 items assessing
physical and mental health in eight dimensions. These are
physical functioning, role limitation due to physical problems,
bodily pain, general health, vitality (energy /fatigue), social
functioning, role limitations due to emotional problems, and
mental health (psychological distress or well-being) [40]. SF12
yields two different global scores, the physical component
summary (PCS) and the mental component summary (MCS);
with higher scores indicating better health.
Physical functioning is measured with the short form of the
brief pain inventory (BPI-sf). The BPI-sf is used to assess the
severity of pain and impact of pain on daily functions [42]. The
BPI-sf includes three pain severity items (worst pain, average
pain, and present pain), and also pain in the last 24 h or last
week, seven interference items (how pain interferes with
general activity, mood, walking ability, normal work, relations
with others, enjoyment of life, and sleep), specifications of the
treatments, or medications being currently taken and percent-
age of pain relief from medications in the past 24 h. The pain
severity and pain interference domains are assessed on a 010
NRS anchored at zero for no pain and 10 for pain as bad as
you can imagine for severity and does not interfere to
completely interferes for interference. The four severity items
and 7 interference items can be averaged to form two composite
scores, the pain severity index, and the pain interference
index [43].
Sleep is measured with the women's health initiative
insomnia rating scale (WHIIRS), a self-report measure that
indicates how often they experience certain sleep difficulties
over the past month. This five-item scale was developed
for evaluating insomnia symptoms [4446]. Questions one
through four is answered using a five-point, Likert-type scale in
which 0 indicates the problem has not been experienced in the
past 4 weeks, while four denotes a problem that occurs at least
five times a week. Question five rates quality of sleep on a
typical night. The total scores of the WHIIRS are obtained by
summing the item scores (range 020) with higher scores
denoting higher insomnia symptoms.
Participant ratings of global improvement and satisfaction
with treatment is measured with patient global impression of
change (PGIC) [47]. This measure is a single item rating by
participants of their improvement with treatment on a 7-point
scale that ranges from very much improved to very much
worse with no change as the mid-point. Higher scores
indicate better improvement with treatment.
Protocol adherence to exercise sessions at SoP is assessed
through attendance at every session for each intervention
group participant. The adherence to the home exercise program
is assessed with the use of an exercise adherence diary that
is provided for all participants in the intervention group. A
priori, an acceptable adherence rate of 80% was determined,
i.e., completion of 7 of the 9 exercise sessions at the SoP and 43
of the 54 home exercise sessions.
To optimize adherence to exercise session at SoP the
CRA contacted any participant who missed any exercise
sessions and re-booked those participants for make-up
 P. Kannan et al. / Contemporary Clinical Trials 42 (2015) 8189
sessions. To optimize adherence to home exercise sessions,
the CRA reviews the adherence diaries monthly and reports to
the PI, names of participants who completed less than 7
sessions a month. The PI makes telephone calls to those
participants to discuss the reasons for not completing the
exercises as prescribed and measures to overcome the barriers
for exercise if any. The PI also makes follow-up telephone
calls to all intervention group participants' once a month
to provide general encouragement to continue with the
home exercise program and to remind them to complete the
adherence diary.
2.9. Adverse events
To determine safety or possible risk of exercising, each
participant in the intervention group was screened by the PI
using the Physical Activity Readiness Questionnaire (PAR-Q)
before starting the exercise program. The PAR-Q is recom-
mended as a minimum standard for screening participants
before beginning with an exercise program [48]. If participants
answered yes to any one of the questions in the PAR-Q, they
were then requested to clarify with their medical practitioner if
it was safe for them to be physically active with their current
state of health. Participants were monitored while on treadmill
at SoP for adverse events and were requested to record and
report the occurrence of adverse events while involved in
home exercise program.
2.10. Data analysis plan
The RA will double enter raw data onto an Excel spread
sheet with PIN numbers (in place of names to ensure blinding),
and the analysis of data will be done by the PI. Statistical
analysis will be performed in accordance with intention to treat
principle. Analysis will be done using the software package for
the social sciences (SPSS), version 22.0 (Armonk, NY). Missing
values will be replaced with the group mean.
Demographics and menstrual data were summarized with
descriptive statistics such as frequencies, percentages, and
means. Normality tests such as KolmogorovSmirnov will be
used to determine whether the data is normally distributed
[49]. Categorical variables will be described as numbers and
percentage and analyzed using the chi-square test. Normally
distributed continuous variables will be presented as mean
and standard deviation and compared with Student's t-test.
Non-normally distributed variables will be presented as
median and interquartile ranges and analyzed using the
MannWhitney U-test. If parametric assumptions are satisfied,
the mean scores of the exercise intervention and usual care
control groups between baseline (Week 0) and Week 4, Week
16, and Week 28 will be compared using repeated measures
analysis of covariance (ANCOVA) with the baseline (Week
0) score as the covariate. If a significant interaction effect of
treatment group by time will be found, pairwise comparisons
between the groups at the discrete time points of end of
intervention at SoP (Week 4) and follow-up time points
(Weeks 16 and 28) will be followed up with Bonferroni or
Sidak corrections [50]. A two-sided significance level of 0.05
will be used.
85
2.11. Current status of trial
Participant's recruitment, enrolment, and exercise inter-
vention training at SoP are completed. Home exercise program
and follow-up assessments (Weeks 16 and 28) are underway.
Final follow-up assessments are expected to be returned by
March 2015. Data analysis will be done after all the completed
assessment forms are obtained.
3. Results
3.1. Recruitment, randomization, and participant characteristics
Seventy-nine women volunteered to be in the study; six
women were excluded following the initial telephone screen-
ing process, and three women were excluded during the
screening process at SoP as they did not meet the eligibility
criteria. The remaining 70 women were randomized to either
the intervention group (n = 35) or usual care control group
(n = 35). No participants were compensated on the basis of
analgesic use for participating. The recruitment, enrollment,
and randomization scheme of the study is presented in Fig. 1.
Participants recruited in the study belonged to multiethnic
groups and the majority of the participants recruited were
students from the University. The information relating to
demographics and characteristics of participants in the inter-
vention and control groups, collected at the time of screening at
SoP, is summarized in Table 2.
4. Discussion
4.1. Study strengths and limitations
To our knowledge this is the first RCT primarily designed to
evaluate the effects of an exercise intervention on menstrual
pain and quality of life in women with PD. A previous trial [18]
also investigated the effects of an aerobic exercise program on
PD but, the trial evaluated the effects of the intervention on
cardiovascular fitness and menstrual symptoms. Pain was not
evaluated as a separate outcome measure but as a component
of a menstrual symptoms questionnaire and the effect of
intervention on pain was reported as a composite score. A
primary research question that informed the design of the
current study was to evaluate the effectiveness of aerobic
training combined with stretching and strengthening exercises
in reducing menstrual pain and improving quality of life in
women with PD. The study is adequately powered to allow for a
dropout rate of 15%. The methodological procedures and the
feasibility of providing the intervention has been piloted [26].
Safe assumptions about effect sizes and variability and rates of
recruitment and retention have been made in accordance with
the Medical Research Council guidelines on the development,
evaluation, and implementation of interventions to improve
health [36]. A wide range of outcome measures are included
in the study to assess the effect of the intervention on bio-
psycho-social domains including physical, emotional, psycho-
logical, and social factors [36]. Another strength is the study
included participants from a wide age range and therefore the
results could be generalized to a wider age-group. The long-
term follow-up period included in the study may be useful
86 P. Kannan et al. / Contemporary Clinical Trials 42 (2015) 8189

Volunteers with PD (n= 79)

Excluded by telephone screening (n=6)

Use of OCP (n=2)

Use of IUD (n=3)
Irregular periods (n=1)

Volunteers completed screening

questionnaire (n=73)

Excluded (n=3)

Pain <4 NRS (n=2)

Marathon training (n=1)

Randomized (n=70)

Intervention group Usual care control

(n=35) group (n=35)

First menstrual period (baseline, Week 0)

Intervention group: Control group:

Data for analysis (n=XXX) Data for analysis (n=XXX)

Second menstrual period (Week 4)

Intervention group: Control group:

Data for analysis (n=XXX) Data for analysis (n=XXX)

Menstrual period at the end of 3 months follow-up

(Week 16)

Intervention group: Control group:

Lost to follow-up (n=XXX) Lost to follow-up (n=XXX)

Menstrual period at the end of 6 months follow-up

(Week 28)

Intervention group: Lost to Control group:

follow-up (n=XXX) Lost to follow-up (n=XXX)

Fig. 1. Recruitment, enrollment, and randomization scheme of study.

in determining if any changes observed in outcomes persist
long-term.
All the outcome measures used in the study are self-report,
but this is not considered a limitation of the study because all
the outcome measures are based on the IMMPACT recommen-
dations for clinical trials of chronic pain treatments [37].
Furthermore, self-report measures are considered the gold
standard in assessing pain outcomes because they reflect the
inherently subjective nature of pain [37]. A possible disadvan-
tage of using self-report measures is lower response rates [51],
and should this be the case in the current study, the impact of
results will be acknowledged and discussed. However, re-
sponse rates in the pilot study [26] were good, suggesting
the methods employed may promote good response rates
for the current study. Lack of stratification of participants, is a
limitation of the study as stratification is considered a way of
 P. Kannan et al. / Contemporary Clinical Trials 42 (2015) 8189 87

Table 2
Demographics and characteristics of study participants at baseline assessment.

Characteristics Exercise intervention group (n = 35) Usual care control group (n = 35) Test for difference

Mean age (SD, range) 29.26 (7.03, 2142) 28.96 (6.27, 2142) p = 0.85a
Ethnicity, n (%)
NZ Europeans 15 (42.3) 13 (34.7) p = 0.07b
Asians 17 (50.0) 17 (50.0)
Africans 3 (7.7)
Pacic Islander 4 (11.5)
Maori 1 (3.8)

Mean pain on 010 cm NRS (SD, range)

Period 1 6.50 (1.36, 49) 6.53 (1.33, 49) p = 0.93a
Period 2 6.8 (1.31, 59) 6.61 (1.09, 59) p = 0.53a

Use of analgesics, n (%)

Yes 12 (33.9) 13 (37.1) p = 0.80b
No 23 (66.1) 22 (62.9)
Mean age at menarche in years (SD, range) 12.5 (0.50, 1213) 12.4 (0.50, 1213) p = 0.41a
Mean menstrual ow in days (SD, range) 4.88 (1.14, 36) 5.07 (0.79, 36) p = 0.50a
Length of menstrual cycle in days (SD, range) 28.1 (1.62, 2532) 28.46 (1.20, 2630) p = 0.30a

Marital status, n (%)

Married 12 (34.6) 13 (38.4) p = 0.80b
Never married 22 (61.6) 22 (61.6)
De facto relationship 1 (3.8)

Employment status, n (%)

Employed 11 (30.8) 11 (30.8) p N 0.99b
Not employed (student) 23 (65.4) 24 (69.2)
Not employed (not student) 1 (3.8)

Pregnancies, n (%)
0 24 (67.2) 24 (67.2) p = 0.76b
1 5 (14.5) 3 (9.7)
2 5 (14.5) 7 (19.3)
2+ 1 (3.8) 1 (3.8)

Smoking status n (%)

Current 11 (30.8) 10 (27.8) p N 0.99b
Former 4 (11.5) 5 (14.5)
Never 20 (57.7) 20 (57.7)

NRS: numeric rating scale; SD: standard deviation.

a
t-test.
b
Chi-square.
A relationship as a couple living together on a genuine domestic basis.

minimizing sampling error [52]. Despite there being an over-
representation of student participants in the study sample,
this should not affect generalizability of results, as the age range
of the students falls within the most prevalent age range
for PD. There was also a good representation of participants in
all age ranges, as well as an equal percentage of participants
recruited from non-university settings in both groups (40%).
Inadequate monitoring of the adherence to the home exercise
program and adherence to intensity of exercise is another
limitation of the study. There is a lack of gold standards for
measuring adherence and therefore measurement of adherence
to exercise remains challenging [53]. Self-reported methods
such as interviews or questionnaires, an exercise diary, are
commonly used to measure adherence [54]. Objective mea-
sures could be used to monitor adherence to the home exercise
program.
5. Conclusion
PD is a problem for many women and therefore is an
important public health, occupational health, and family practice
health problem. Potentially findings from this study will provide
the women who suffer with PD and the health professionals who
care for them with new evidence and therefore improved
understanding about the effectiveness of exercise in managing
pain in women with PD. Physiotherapists' skills in managing
chronic painful conditions, in promoting exercise for healthy
lifestyles, and in the management of women's health, mean
they are well positioned to provide an effective intervention for
PD. Exercise is a low cost intervention that can be taught and
tailored to an individual. If benefit is proven, it can be continued
independently and indefinitely for long-term management
of PD.
Sources of funding
Funding for the study was obtained as a grant from the
Department of Women's and Children's Health, Dunedin
School of Medicine, New Zealand; Physiotherapy New Zealand
Scholarship trust fund; and School of Physiotherapy research
budget.
88 P. Kannan et al. / Contemporary Clinical Trials 42 (2015) 8189
Conict of interest
The authors report no conflicts of interest. The funding
sources had no role in the conduct of research or preparation of
article.
Acknowledgments
The authors gratefully acknowledge all our participants for
their kind support toward our study. We also thank the
research staff, research assistant, and technical staff of School
of Physiotherapy, University of Otago, and Department of
Women's and Children's Health for their assistance with the
project. We also acknowledge our funders.
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