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! 2014 Informa UK Ltd. DOI: 10.3109/09638288.2014.962108

RESEARCH PAPER

Vigorous exercises in the management of primary dysmenorrhea:


a feasibility study
Priya Kannan1, Leica S. Claydon2, Dawn Miller3, and Cathy M. Chapple1
1
Centre for Health, Activity and Rehabilitation Research, University of Otago, Dunedin, New Zealand, 2Faculty of Health, Social Care and Education,
Department of Allied Health and Medicine, Anglia Ruskin University, Chelmsford, UK, and 3Department of Women and Children’s Health, Dunedin
Disabil Rehabil Downloaded from informahealthcare.com by University of Otago on 09/22/14

School of Medicine, Dunedin, New Zealand

Abstract Keywords
Purpose: To examine the feasibility of using an exercise intervention for reducing menstrual Aerobic training, exercise, menstrual pain,
pain associated with primary dysmenorrhea (PD) and to obtain preliminary results to estimate physical activity, physiotherapy, primary
the sample size for a future randomized controlled trial (RCT). Methods: A quasi-experimental dysmenorrhea
design was applied. Ten women 18–45 years with PD were included. The participants
underwent vigorous aerobic training at the School of Physiotherapy on a treadmill three times History
a week for up to 4 weeks followed by aerobic training at home for up to 4 weeks. The feasibility
measures were adherence to the intervention programme and intervention prescription, Received 12 December 2013
retention and safety. The short form McGill pain questionnaire was used to measure pain at first Revised 31 August 2014
For personal use only.

(T1), second (T2) and third (T3) menstrual cycles following trial entry. Results: Overall adherence Accepted 2 September 2014
was 98%, with 100% adherence to clinic-based intervention and intervention prescription and Published online 22 September 2014
96% for home exercise programme. Retention rate was 100%. With respect to pain a large
effect size was identified at T2 and T3. No adverse events reported. Conclusions: Results
demonstrated that the intervention is applicable and feasible. In addition, the preliminary
results show evidence of positive changes after the intervention. The intervention programme’s
effectiveness will be studied further, in a future RCT.

ä Implications for Rehabilitation


 There is a lack of available evidence from randomized controlled trials regarding the use of
exercise in alleviating the symptoms associated with primary dysmenorrhea (PD).
 The preliminary results of this study shows that exercises may be effective in reducing the
pain associated with PD indicated by a large effect size.
 The preliminary findings from this study could also contribute significantly to PD
management and introduce new practice opportunities for physiotherapists working in
women’s health.

Introduction [5–7]. One study found that 51% of women had been absent from
school or work at least once and 8% had been absent with every
Dysmenorrhea associated with a normal ovulatory cycle and
menstrual period [8].
no identifiable pelvic disease, is termed primary dysmenorrhea
PD usually begins 6–12 months after menarche and is
(PD) [1]. The prevalence of PD is shown to be up to 90% in
characterized by spasmodic cramping pain in the lower abdomen
women aged 18–45 years [2]. About 90% of adolescent girls and
which can radiate to the lower back and anterior or medial thighs.
more than 50% of adult women worldwide report suffering from
The pain is attributed to excessive production of prostaglandins
PD, with 10–20% of them describing their suffering as severe and
(PGs) during menstruation which is hypothesized to cause
distressing [3]. Significant disability such as inability to sleep,
hyper contractility of the uterus, leading to uterine hypoxia and
limitations in activities, and a resulting decrease of quality of life
ischemia resulting in the pain and cramps of PD [9–11]. Non-
(QoL) have been reported in women with PD [3,4]. PD leaves
steroidal anti-inflammatory drugs (NSAIDs) are thought to
women incapacitated for 1–3 d each month and is reported to be
influence these mechanisms and are therefore frequently used to
the primary reason for recurrent absenteeism from school or work
manage PD [3,12]. However, conventional NSAIDs are associated
with the risk of significant clinical adverse effects, especially low
Address for correspondence: Priya Kannan, PhD candidate, Centre for gastrointestinal tolerability and disruption of platelet function,
Health, Activity and Rehabilitation Research, School of Physiotherapy,
University of Otago, Dunedin 9054, New Zealand. Tel: (+64) even with short-term use [13]. A systematic review currently
0211550880. E-mail: kanpr735@student.otago.ac.nz; website: http:// confirms that non-pharmacological interventions such as heat,
physio.otago.ac.nz/University of Otago TENS and yoga can significantly reduce the pain associated with
2 P. Kannan et al. Disabil Rehabil, Early Online: 1–6

PD, but that acupuncture and acupressure and spinal manipulation Intervention
are no better than placebo [14].
Participants underwent vigorous intensity aerobic training on a
Mosler in 1914 was the first to speculate that exercise relieves
treadmill at the School of Physiotherapy (SoP), Dunedin for
pelvic congestion by shunting uterine blood flow [15]. Other
30 min at 70–85% of their maximum heart rate (MHR). MHR was
proposed mechanisms include exercise-induced release of
calculated from an estimate of peak heart rate healthy women
endogenous opiates, specifically beta endorphins; vasodilatation;
should attain during exercise [21,22]. Treadmill exercise was
suppression of PGs; reduction in stress and elevation of mood
preceded by warm-up exercises for 10 min and followed by cool
[11,12]. Vigorous exercises are hypothesized to stimulate the
down exercises for 10 min, including stretching for mid- and
release of beta-endorphins which act as systemic analgesics in
lower- back muscles and abdominal strengthening. The interven-
reducing the menstrual pain associated with PD [16]. Though
tion at SoP was for 3 weeks for participants with 28 d cycle length
vigorous exercises are thought to be useful for PD, there is
and 4 weeks for participants with cycle lengths more than 28 d
limited empirical evidence to support their efficacy. Systematic
and less than 35 d. The intervention at SoP started after
reviews also report that there is a lack of evidence from RCT’s
completion of the first menstrual cycle, and ending before the
to support the use of exercise in the alleviation of symptoms
start of the second menstrual cycle. On completion of the
associated with PD [14,17]. Only a small, RCT has specifically
intervention at SoP, participants were then asked to complete a
evaluated the efficacy of a 12-week aerobic training pro-
home exercise programme, for up to 4 weeks between their
gramme on menstrual distress symptomatology [18]. The trial
second and third menstrual cycles. They were provided with a
reported significant reduction in the mean menstrual phase
booklet containing the stretching and strengthening exercises and
symptomatology in the group receiving intervention compared
Disabil Rehabil Downloaded from informahealthcare.com by University of Otago on 09/22/14

an exercise adherence diary.


with the control group but, the trial had some methodological
The intervention for the participants was provided by the
flaws such as lack of concealment of allocation, lack of blinding
primary investigator, a New Zealand registered physiotherapist,
and missing data for each main outcome. However, observational
with 3 years of specialist experience in the area of pain and
studies evaluating the efficacy of exercise are available with
women’s health. She has an undergraduate qualification in
contradicting results. One prospective observational study found
physiotherapy and is now undertaking a PhD at the School of
that physical activity was not associated with decreased dysmen-
Physiotherapy, University of Otago, New Zealand. The exercises
orrhea pain [19]. In contrast, another observational study found
and aerobic training were taught and supervised on a one-to-one
that vigorous exercisers experienced less PD symptoms compared
basis.
to their sedentary counterparts [20]. Owing to limited evidence
from RCT’s and conflicting results from observational studies,
there is a need to evaluate the efficacy of exercise in managing Procedures
For personal use only.

menstrual pain in women with PD in a randomized controlled Volunteers were given an appointment for screening for eligibility.
design. Therefore, the primary objective of this study was to Screening involves completing a self-reported questionnaire on
examine the feasibility of using the intervention for conducting a demographic details, pain history, general medical history,
future RCT to evaluate the efficacy of vigorous intensity aerobic gynaecological and menstrual history, obstetric history and
training on menstrual pain intensity. The secondary objective was participation in exercise. All eligible participants were provided
to obtain preliminary results that will be used to estimate the with an information sheet and consent forms. Those women who
sample size for the future RCT. gave written informed consent to participate were provided with
pain questionnaires and return envelopes and asked to complete
Methods the questionnaires on the day of maximum pain during their
Study design and recruitment first (T1) menstrual cycle before the start of intervention, second
(T2) menstrual cycle following intervention at SoP and third
Since the aim of this study is to inform the conduct of a future (T3) menstrual cycle following home exercise programme.
RCT, the feasibility issues were evaluated in a quasi-experimental,
one-way repeated measures design over time between March and
Feasibility measures
October 2013. Women were recruited from the Dunedin region of
New Zealand by advertising on the University of Otago campus The primary feasibility measures were (1) adherence to the
and in the community. The Southern Health and Disability Ethics clinic-based intervention programme recorded as percentage
Committee of New Zealand (Reference No. 13/STH/12) approved attendance, (2) adherence to home-based intervention programme
the research and all women gave informed written consent to monitored with the use of exercise diaries, (3) adherence to clinic-
participate. based intervention prescription, calculated as the percentage of
total minutes of walking/jogging within the target heart rate zone
Participants and total minutes of walking on treadmill, respectively [23],
(4) safety was measured by number of adverse events either
Study participants included 10 non-pregnant women with self- during the intervention at SoP and or during the home exercise
reported dysmenorrhea in the age group of 18–45 years. Women programme. This included changes in the menstrual cycle or
were considered eligible if they had regular menstrual cycles, and symptoms, in addition to sprains or strains from exercising,
menstrual pain scoring at least 4 on a 10-cm visual analogue scale (5) retention rates, calculated as the percentage of participants
(VAS) for at least two consecutive months. Exclusion criteria who completed the feasibility study, and (6) acceptability of
were: Women with secondary dysmenorrhea, women on a formal intervention obtained as feedback from participants.
exercise programme, women using intrauterine devices, women
on oral contraceptives and hormonal therapy and women with
Outcomes
menstrual cycle interval exceeding 34 d. Participants continued
taking pain medication (analgesics or NSAIDs) if required, and The outcomes were pain quality and intensity measured with
were requested to record the type and the amount of pain short form of McGill pain questionnaire (SF-MPQ) and pain
medication taken during the menstrual cycle after entering into medications. The time-points of measurements were at first
the study. menstrual cycle before the start of intervention (T1), second
DOI: 10.3109/09638288.2014.962108 Exercise for primary dysmenorrhea 3
menstrual cycle following intervention at SoP (T2) and third The flow of participants through the study is summarized
menstrual cycle following home exercise programme (T3). in Figure 1. Most participants were NZ European (5/10), and
(1) SF-MPQ is a self-reported measure of pain quality and were recruited from the University (8/10). The baseline charac-
intensity. It is a multi-dimensional measure of perceived pain teristics of the participants are presented in Table 1.
that evaluates the sensory, affective-emotional, evaluative and
temporal aspects of chronic pain and has three parts: the pain Adherence to the intervention programme
rating index (PRI), VAS and the present pain index (PPI) [24]. (clinic-based + home-based)
The SF-MPQ is reported to have adequate content validity
and reliability coefficient of 0.87 and good internal consistency Seven of the 10 (70%) had 18 sessions prescribed and 3/10 (30%)
(Cronbach’s a ¼ 0.92–0.93) on women with PD [25,26]. (2) Pain participants had 24 sessions prescribed each over the study
medications: The participants were asked to record type period. The mean number of intervention sessions prescribed over
and amount of pain medication taken during their participation the study period was 19.8 SD 2.8, and the mean number of
in the study. sessions attended by the participants was 19.4 SD 3.2. The mean
percentage of adherence to intervention sessions are summarized
in Table 2.
Data analysis
Statistical analysis was done using the Statistical Package for the Adherence to clinic-based and home-based intervention
Social Sciences (SPSS) version 20. A one-way repeated measure programme
analysis of variance (ANOVA) was used to compare the scores
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within the group at each time-point. As an index of post- All of the participants attended all of the clinic-based intervention
intervention change, effect sizes were computed based on the sessions prescribed and therefore the mean percentage of clinic-
difference between T1 and T2 and T1 and T3 means and the based intervention sessions completed was 100% (Table 2). The
pooled variance. mean percentage of home-based intervention sessions completed
was 96% (Table 2).
Results
Adherence to clinic-based intervention prescription
Participant characteristics and baseline data
The adherence to intensity and duration of the intervention at the
There were 14 women who volunteered to be in the study; SoP was 100%. All the participants were able to complete the
four women were excluded as they did not meet the inclusion aerobic training for the entire duration of 30 min within the target
criteria. The remaining 10 women were included in the study. heart rate zone.
For personal use only.

Figure 1. Flow diagram of the participants Assessed for eligibility (n=14)


through the study.

Excluded (n=4):
Age criteria not met (n=2) Enrolled (n=10)
Had irregular periods (n=2)

Baseline measurement (T1) First menstrual cycle

Intervention for up to 4 weeks at SoP

Measurement of outcomes (n=10)


Second menstrual cycle
(T2)

Home exercise for up to 4 weeks

Measurement of outcomes (n=10)


Third menstrual cycle
(T3)

Analyzed (n=10)
4 P. Kannan et al. Disabil Rehabil, Early Online: 1–6

Safety wrote ‘‘I intend to continue exercising as it is a good health


regime and I felt a difference in fitness levels and wellbeing’’.
No adverse events occurred during the intervention training at
SoP. No participant reported an adverse event to have occurred
Pain quality and intensity
while exercising at home.
With respect to quality of pain on PRI, and intensity of pain on
Retention of participants VAS and PPI there was a positive change in scores at T2 and T3.
The effect size for PRI, VAS and PPI between T1 and T2, and T1
All the participants who entered the study completed the study.
and T3 reflects a large difference. The effects of the intervention
There were no dropouts or loss to follow-up at any time-point.
are summarized in Table 3.
This represents a 100% retention rate.
Pain medications
Acceptability of intervention
Five participants reported they never took pain medications even
The intervention was acceptable to all the 10 participants and no
if the pain was unbearable, for the fear of the side effects
negative comments were made when feedback on the intervention
associated with NSAIDs. Of the remaining five participants who
and intensity of training was elicited. All 10 of them reported that
took pain medications, four participants took less pain medication
exercises were do-able in terms of intensity and duration. In
at T2 and/or T3 compared to T1 while one increased her pain
particular, one participant wrote ‘‘intensity and duration of the
medication at T3. The type and amount of pain medication
treadmill training was a good balance – pushed me but not too
consumed by five participants on the day of maximum pain are
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exhausting’’. Another participant wrote ‘‘the treadmill training


summarised in Table 4.
was do-able, not too much per week, and well-spaced out’’.
Regarding the commitment to home exercise programme all
Sample size for future trial
participants wrote that the home exercises were easy to keep up.
Three of the participants said they made it a point to walk back A two-sample normal approximation formula was used to
home from work instead of taking a bus or using their private determine the total sample size for a future RCT [27]. The
vehicle. For the question on their intention to exercise regularly sample size was estimated to be 70 (35 in each group), using the
even after the study ends, five participants wrote that they would variance for VAS scores between T1-T2 (Table 3), assuming 90%
continue to do the exercises. In particular one participant wrote power, two-tailed 0.05 level of significance, to detect a difference
‘‘the difference in my pain was so noticeable and therefore I will of 15 mm on the VAS for pain.
keep up to the exercise programme’’. Three participants wrote
For personal use only.

they will start going to the gym for exercises. One participant Discussion
The results from this study were encouraging with regard
Table 1. Baseline characteristics of participants. to adherence, safety and acceptability of the intervention tested.
This study focused on a heterogeneous sample of participants
Mean (SD, range) with regard to age (18–45), pain level, menstrual cycle length, and
(n ¼ 10) n (%) ethnicity.
Characteristics
Age (years) 33.0 (8.8, 21–44) Adherence, acceptability and safety
Mean pain on 0–10 cm 7.7 (1.4, 5–10)
VAS (SD, range) The study found high adherence rate to the clinic-based and
Mean age at menarche in 12.6 (0.5, 12–13) home-based exercise sessions, with a mean percentage of 98% of
years (SD, range) prescribed sessions attended by participants. These results support
Mean menstrual flow in days 4.7 (0.8, 3–6) the implementation of the programme on a larger scale.
(SD, range)
Mean interval between cycles in 28.6 (2.2, 25–32)
days (SD, range)
Marital status, married 5 (50) Table 2. The summary of adherence to intervention sessions.
Employed
Yes 5 (50) Mean number Mean number
No, student 4 (40) of sessions of sessions Mean
No, not student 1 (10) prescribed attended percentage
Pregnancies
0 2 (20) Over the study period 19.8 19.4 98%
1 2 (20) (n ¼ 10)
2 1 (10) Clinic-based (n ¼ 10) 9.9 9.9 100%
2+ 5 (50) Home-based (n ¼ 10) 9.9 9.5 96%

SD, standard deviation; %, percentage Min, minimum; Max, maximum.

Table 3. Means (SD) and effect sizes (Cohen’s d) for PRI, VAS, and PPI (n ¼ 10).

Mean (SD) Mean difference (SD) Effect size


T1 T2 T3 T1–T2 T1–T3 T1–T2 T1–T3
PRI 16.5 (3.4) 10.4 (5.0) 8.4 (5.4) 6.1 (4.9) 8.1 (4.9) 1.2 1.6
VAS 71.7 (16.4) 51.5 (18.1) 35.8 (19.3) 20.2 (13.7) 35.9 (19.7) 1.5 1.8
PPI 3.3 (1.1) 2.1 (1.1) 1.7 (0.9) 1.2 (1.2) 1.6 (1.0) 1.0 1.6

PRI, pain rating index; VAS, visual analogue scale; PPI, present pain index.
DOI: 10.3109/09638288.2014.962108 Exercise for primary dysmenorrhea 5
Table 4. Summary of analgesics used on the day of maximum pain. attributed to the intervention because this is an underpowered
non-randomized trial and some reduction in pain could have been
Time- Number of due to regression to the mean (RTM) and therefore the true
Participant point Medication pills (per day) efficacy of the interventions remains unknown. RTM is a
1 T1 Codeine (15 mg) 8 statistical phenomenon that can make natural variation in repeated
T2 Paracetamol (500 mg) 4 measurements look like real change [29]. It is suggested that the
T3 Paracetamol (500 mg) 4 problem of RTM could be minimized by random allocation to
2 T1 Ibuprofen (200 mg) 12 comparison groups and any difference in response between
T2 Ibuprofen (200 mg) 12
T3 Ibuprofen (200 mg) 8
the two groups will exclude RTM [30]. This indicates the need
3 T1 Aspirin (325 mg) 8 for an RCT.
T2 Aspirin (325 mg) 8
T3 Aspirin (325 mg) 4 Changes to the future RCT
4 T1 Naproxen sodium (275 mg) 3
T2 Naproxen sodium (275 mg) 3 Age criteria and baseline characteristics
T3 Naproxen sodium (275 mg) 2
5 T1 Paracetamol (500 mg) 4 The age criteria for inclusion will be reduced to 43 from 45
T2 Paracetamol (500 mg) 4 in order to exclude women in perimenopause transition stage.
T3 Paracetamol (500 mg) 8 The average age of menopause is reported to be 51 and the
perimenopause phase can begin 4–8 years prior to this [31].
NSAID, non-steroidal anti-inflammatory drug.
As smoking is considered to be a significant risk factor for
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PD [3] participants will be asked to report on their smoking


Environmental factors such as the exercise setting and its history for establishing baseline levels between groups for the
proximity to the workplace or home is generally accepted as a future RCT. We will also be using the international physical
positive indicator of good adherence [28]. High adherence rates activity questionnaire for establishing baseline physical activity
in the current study could be attributed to the fact that the study levels which was not done for the current study. In this study,
was conducted at the University campus, and the majority (8/10) we included participants with baseline pain scoring 4 or more on
of the study participants were from the University. An RCT by a 10-cm VAS but the Initiative on Methods, Measurement,
Israel et al. [18] to evaluate the efficacy of a 12-week aerobic and Pain Assessment in Clinical Trials (IMMPACT) 2010 [32]
training programme found 80% adherence to the intervention recommends all chronic pain clinical trials to include participants
programme. The possible reasons for the difference in adherence with self-reported baseline pain intensity levels of 4 on a 0–10
For personal use only.

rates could have been the access to the study setting or the numeric rating scale (NRS). Therefore, for our future RCT we will
duration of the intervention programme. be using the NRS instead of the VAS.
The study also found that participants had good acceptance
towards the intervention and intensity of training. Lack of Intervention and outcomes measures
motivation is the most commonly identified personal character-
istic directly related to decreased adherence to and increased In this study, there was an inequality in the frequency of
dropout from exercise programmes [28]. All our 10 participants intervention for participants with different menstrual cycle
were very motivated and were able to complete 30 min of lengths provided at SoP. Therefore, to make the frequency of
walking/jogging on the treadmill at an intensity calculated for intervention homogeneous for all participants in the future RCT
their age and this indicates that the intervention protocol is we decided to keep the intervention frequency as 3 weeks for all
achievable. This suggests adherence rates to intervention pre- participants in the experimental group, irrespective of their
scription should be high in the future RCT. In terms of safety, we menstrual cycle length.
noticed that no participant experienced adverse events to the Women with PD experience cyclic pelvic pain that nega-
intervention programme. This provides support for the assertion tively impacts their QoL [33]. It is recommended that women’s
that vigorous physical activity is safe for women with PD. health care providers should not discount the possibility of
improving a woman’s quality of life by reducing or relieving
Recruitment and retention menstrual discomfort [7]. As measurement of QoL is considered
a vital part of assessing the effect of treatment in clinical trials,
There was a good response to advertisement flyers and the we therefore will include health-related quality of life (HRQoL)
required number of participants was recruited in less than 4 as an outcome measure in our future trial. Several intervention
weeks. We hope to recruit three participants each week for the studies have used generic SF-36 health survey to evaluate the
future RCT which makes it 6 months for the estimated sample outcomes of treatment on women with PD [34–36]. For our
size. The University was a good source for recruiting participants future RCT, we will therefore be using the SF-12 health survey
and will be targeted for recruitment in the future RCT. With which is a validated alternative to the SF36 [37,38]. Apart from
regards to retention, there were no dropouts or lost to follow-up in negatively affecting QoL, PD can cause significant activity
the study. A previous RCT [18] on 12-week aerobic training for limitation and can leave women incapacitated for 1–3 d every
PD had a lost to follow-up of 39% in the experimental group and month. [7,39]. This indicates a need to evaluate physical
17% in the control group. The authors of that trial report, the functioning in women with PD. An instrument for measuring
dropouts were due to illness and injuries which were not caused physical functioning will therefore be included for our future
by trial intervention. Though this study had no dropouts, to RCT. There is also a need to measure quality of sleep because
accommodate for any such reasons we plan to keep the drop-out sleep and chronic pain are interrelated [40]. Disturbed sleep is a
rate at 15% for the future RCT. consequence of pain, and sleep disruption may also contribute
directly to hyperalgesia [41]. Baker et al. reported that women
Changes in pain quality and intensity
with the pain of PD have more disturbed sleep and less efficient
The preliminary results of our feasibility study showed large sleep during menstruation compared with the controls [4].
effect size in PRI, VAS and PPI scores between T1 and T2, and T1 Additionally the IMMPACT 2005 [42] guidelines recommend
and T3. This improvement in pain levels cannot be completely that clinical trials studying chronic pain should measure sleep.
6 P. Kannan et al. Disabil Rehabil, Early Online: 1–6

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26. Chen HM, Chen CH. Effects of acupressure on menstrual distress in
Department of Women’s and Children’s Health, Dunedin School
adolescent girls: a comparison between Hegu-Sanyinjiao matched
of Medicine, University of Otago, Dunedin, New Zealand. The points and Hegu, Zusanli single point. J Clin Nurs 2010;19:
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