Key words
chronic pelvic pain - myofascial trigger points - ischemic compression - low-level
laser therapy - pain management
Schlüsselwörter
Chronische Unterbauchschmerzen - chronische Beckenschmerzen - myofasziale Triggerpunkte
- ischämische Kompression - Low-Level-Lasertherapie - Schmerztherapie
Introduction
Chronic pelvic pain (CPP) is chronic or persistent pain perceived in structures
related to the pelvic region. CPP prevalence range between 5,7% and
26,6% in women. CPP is associated with symptoms suggestive of the lower
urinary tract, sexual, bowel, pelvic floor, or gynecological dysfunction. It is
often associated with negative emotional consequences and impaired quality of life
(QoL) [1].
Analgesics, hormone therapy, physiotherapy, psychological treatment, and surgical
methods are widely used in the treatment of CPP[1]. Medications provide pain and visceral management, surgery provides
correction of structure, but physiotheray approachs provides functional restoration.
Musculoskeletal pelvic pain is commonly originated myofascial, musculoskeletal,
neuromuscular structures[2]. CPP patients have
myofascial trigger points (MTrPs) located in the lower back, abdominal wall, and
pelvic girdle, which may be the primary source of pain[3]. These MTrPs are usually located in levator
ani, obturator internus, piriformis, gluteal muscles, quadratus lumborum and
abdominal wall muscles [4]. The MTrPs are
hyperirritable spots within a taut band, activated by repeated or chronic muscular
overload [5].
Ischemic compression (IC), in the other words trigger point compression, is an
effective method in the treatment of MTrPs in many musculoskeletal problems. IC
changes the circulatory perfusion of skin and is especially valuable in muscles that
are not suitable for stretch [6]. It is less
common to use pelvic floor rehabilitation [7],
urological CPP [8], interstitial cystitis and
painful bladder syndrome [9] and CPP [10] yet. Low-level laser therapy (LLLT) reduces
pain in MTrPs lead to musculoskeletal system disorders [11]
[12]
[13]
[14]. LLLT increases oxygen supply to hypoxic
cells in MTrPs areas by regulating microcirculation as well as it has analgesic,
biostimulation, and wound healing effects [15]. In the literature, it is seen that IC and LLLT are effective on MTrPs,
and IC is used in pelvic pain in a few studies. But the use of LLLT in pelvic pain
has not been found. It is a known fact that exercise is the basis for these MTrPs
treatments. Considering this knowledge, we hypothesized that both IC and LLLT
combined with exercise would be an effective method in the management of CPP.
The purpose of our study was to investigate the effectiveness of IC and LLLT methods
combined with exercise on the MTrPs in women with CPP in short and long term and
determine which method is more effective.
Materials and Methods
Participants
A single-blind pilot randomized clinical trial with the parallel design was
conducted in patients with CPP. Since the patients were enrolled in the
Department of Obstetrics and Gynecology (at Istanbul University), only women
patients were included. The patients were diagnosed by a gynecologist and then
referred to the clinical laboratory of physiotherapy and rehabilitation to
participate in the trial. The study was conducted from September 2017 to June
2019, in accordance with the Declaration of Helsinki.
To be eligible, participants had to be between 18–50 years of age, had
pain/discomfort in the lower abdominal and pelvic region lasting for 3
months in the last 6 months. Patients with MTrPs in at least two of the examined
muscles (rectus abdominis, piriformis, quadratus lumborum, gluteus
maximus-medius, adductor magnus, hamstring) were included to perform statistical
analysis.
The exclusion criteria were anticoagulation or bleeding disorders, neuropathy,
central nervous system disorders, advanced psychiatric disorders, significant
pelvic pathology or abnormality, severe prolapse, pregnancy, to have undergone
major surgery and pelvic surgery with general anesthesia in the last 3 months,
to have received treatment including electrotherapy and manual therapy for the
pelvic region in the last 6 months.
33 partients were assessed for eligibility and 28 of them met the criteria,
please refer to the Consort flow diagram ([Fig
1]). After being informed verbal and in writing, they signed the
consent form which was approved by the Clinical Research Ethics Committee at
Istanbul University (IRB:2017/1190). This study has been registered at
clinicaltrials.gov as clinical trial (NCT05546203).
Fig. 1 Design of the study (Consort flow diagram).
Sample size was determined using the Power and Sample Size Program. The minimal
clinically important difference of visual analog scale (VAS) as 33.9 mm
and the standard deviation of VAS as 24 mm [16], the 95% confidence interval
and 85% power were used to calculate the sample size. Sample size was
calculated as 10 for each group. The probability of falling from the study was
considered, 14 patients were included in each group.
Randomization and Blinding
After the baseline assessment, the participants were randomized to one of two
intervention groups (ratio 1:1) using “Research Randomizer” an
online randomization web service
(https://www.randomizer.org/). Simple randomization
procedures were performed, sequentially numbered index cards containing the
random assignments were prepared by an investigator (a student in the faculty)
with no clinical involvement in the study to ensure allocation concealment. The
index cards were folded and placed in sealed opaque envelopes. The first
physiotherapist opened each envelope and allocated the participants to the IC or
LLLT group according to the selected index card, then performed all
interventions. The evaluations were carried out by another physiotherapist who
did not know which participants belonged to each group (assessor-blinded).
Intervention
All participants received IC or LLLT treatments with the same standardized
exercise program at the clinic (2 times a week), consisting of 12 sessions of
approximately 50 min. Previously mentioned muscles of the patients were
examined by physiotherapist and MTrPs were determined.
IC was applied over the detected MTrPs and the participant was asked to describe
the pressure and pain she felt [17]. It
was started with moderate tolerable pressure (7/10) and then severity
was increased. The color of the thumb pulp was observed to control the pressure.
The pressure was continued for 90 sec. The patient’s pain
sensation continued to be questioned and the pressure was controlled to a level
at “comfortable pain” [6].
LLLT was applied for 90 sec at each MTrPs with a frequency of 2000 Hz
(3 J) using a GaAs diode laser instrument (Roland Serie Elettronica
Pagani, wavelength 904 nm, the frequency range of
5–7000 Hz and maximum peak power of 27, 50 or 2764 W)
[14]. The laser probe was held
perpendicular to the MTrPs in skin contact without pressure.
The standardized exercise program included stretching and pilates exercises for
core stabilization. All exercises were supervised by the same physiotherapist
whom certificated by The Australian Physiotherapy and Pilates Institute (APPI).
Pilates exercises were selected from APPI’s matwork exercises and
performed in accordance with APPI principles. Details of the exercises were
presented in Appendix 1. In addition, patients performed stretching exercises
for 5 days a week and pilates exercises for 3 days a week at home. They were
advised to continue home exercises at least one year.
Outcome measures
The primary (VAS and Pressure Pain Threshold (PPT)) and secondary outcomes
measures (ROM, pelvic floor symptom severity, QoL, anxiety/depression
and patient satisfaction) were obtained at baseline, at the end of treatment (6
weeks) and, follow up 1-year.
Pain intensity was assessed using the VAS, in which the patients were asked to
indicate their perceived pain during rest, activity and at night (0–10
numeric pain rating scale, with 0 as no pain and 10 as worst imaginable pain)
[18].
Handheld pressure algometer (Commander Algometer, J Tech Medical Industries,
Midvale, Utah; maximum output=111.6 N/cm2)
was used to measure PPT on the MTrPs determined by clinical examination. We
asked the subjects to say “stop” as soon as a discernible
sensation of pain was felt. When the subject lying on loose position, a
1-cm2 algometer probe was placed perpendicularly on the MTrPs,
and the pressure was increased gradually (1 lb/s). First painful
threshold was recorded, mean value of two measurements, with 3 minutes
interval, was used for analysis [19].
Lumbar spine active ROM from full extension to full flexion, and hip active ROM
on flexion, extension and mediolateral rotation was measured [20] using a digital goniometer (Baseline
Evaluation Instrument, Fabrication Enterprises, Inc.). Average of 3 repetitions
was recorded for analysis.
The Pelvic Floor Bother Questionnaire (PFBQ) was used to identify the presence
and degree of bother related to common pelvic floor problems. It had excellent
test–retest reliability (0.998, p<0.0001)[21].
Urogenital Distress Inventory (UDI-6) was used to assess urinary symptoms related
QoL. It consists of 6 questions covering three domains: stress urinary
incontinence, detrusor overactivity, bladder outlet obstruction. It had high
internal consistency (Cronbach’s alpha: 0.74) and test-retest
reliability (Spearman’s rho:0.99, p<0.001)[22]. Additionally Short Form Health
Survey-36 (SF-36) was used to assess the general QoL. It consists of 36 items, 8
sub-scales: physical and social functioning, role limitations due to physical
health and emotional problems, emotional well-being, pain, energy-fatigue,
general health status [23]
[24]. It has recently been shown to be
highly reliable (Cronbach alpha value of the subscales varied in the range
0.792–0.992) in chronic pain [25].
The Hospital Anxiety and Depression Scale (HADS) [26] was used to identify the anxiety disorders and depression among
patients. It has anxiety and depression subscale, both containing seven items.
It had high internal consistency (Cronbach’s alpha coefficient: 0.8525
for anxiety subscale and 0.7784 for depression subscale) [27].
Patient Global Impression of Improvement (PGII) used to assess patient
satisfaction. It consists of 7-point question (1=very much better,
7=very much worse) asking the patient’s level of recovery after
treatment. PGII have a significant correlation with incontinence episode
frequency, stress pad test, and incontinence-related quality of life [28].
Data analysis
The data were evaluated using the Statistical Package for the Social Sciences
21.0 program for Windows and by analyzing descriptive statistics (frequency,
mean, and standard deviation). Before the statistical analysis, “The
Kolmogorov-Simirnov Test” was used to assess the distribution of the
data. Our data were found to be normally distributed and thus a parametric test
was used. Statistical significance was set for all tests at p<0.05.
Baseline demographic data were compared between treatment groups using analysis
of “The Independent Sample T Test” and the “Chi-square
Test” to assess the adequacy of the randomization. Comparisons of score
changes measuring improvements were carried out using the “Paired Sample
T Test” with time (baseline to 6 weeks and baseline to 1-year follow-up)
as the within-subject variable. The effects of treatment were analyzed using a
2-by-2 and 2-by-3 mixed-model repeated-measures ANOVA with treatment group
(Groups 1–2) as the between-subject factor and time (baseline, after 6
weeks and 1-year follow-up) as the within-subject factor. A Chi-square test was
used to analyze patient satisfaction. Effect sizes were determined dividing the
changes in mean baseline and follow-up scores by the baseline standard
deviation. The effect sizes of 0.2, 0.5, and 0.8 were considered small,
moderate, and large, respectively [29].
Results
Total of 28 patients were included in the study; 14 were randomized to per
intervention groups; seven participants discontinued treatment; therefore, 21
patients were analyzed at the end of the treatment, please refer to the Consort flow
diagram ([Fig. 1]). The mean age and body
mass index of patients in Group 1/Group 2 were
38.91(9.78)/33.7(9.03) years and 25.47(3.36)/24.1(2.72)
kg/m2, respectively. All baseline demographics, are presented
in [Table 1], were similar between groups
(p>0.05).
Table 1 Baseline Demographics of Groups.
|
Group 1 (n=11)
|
Group 2 (n=10)
|
pa
|
|
Mean±SD
|
Mean±SD
|
|
Age (year)
|
38.91±9.78
|
33.7±9.03
|
0.22
|
|
BMI (kg/m
2
)
|
25.47±3.36
|
24.1±2.72
|
0.32
|
|
Marital Status
|
n (%)
|
n (%)
|
p
b
|
|
Married
|
10 (90.9)
|
9 (90)
|
0.94
|
|
Single
|
1 (9.1)
|
1 (10)
|
|
Employment
|
|
Homemaker
|
10 (90.9)
|
7 (70)
|
0.22
|
|
Employed
|
1 (9.1)
|
3 (30)
|
|
Menopause
|
|
No
|
8 (72.7)
|
9 (90)
|
0.31
|
|
Yes
|
3 (27.3)
|
1 (10)
|
|
Number of deliveries
|
|
None
|
3 (27.3)
|
3 (30)
|
0.73
|
|
One
|
1 (9.1)
|
2 (20)
|
|
Two and more
|
7 (63.6)
|
5 (50)
|
|
Misscary-abortion
|
|
None
|
7 (63.6)
|
6 (60)
|
0.36
|
|
One
|
1 (9.1)
|
3 (30)
|
|
Two and more
|
3 (27.3)
|
1 (10)
|
|
Abdominal surgeries
|
|
None
|
8 (72.7)
|
8 (80)
|
0.86
|
|
One
|
1 (9.1)
|
1 (10)
|
|
Two and more
|
2 (18.2)
|
1 (10)
|
Abbreviations: BMI, Body Mass Index; SD, Standard Deviation,
p
a
,Independent Sample T Test;
p
b
, Chi Square Test.
Following the 6 weeks of treatment, significant differences were observed within both
group subject in pain (VAS, PPT), ROM, pelvic floor symptom severity (PFBQ), QoL
(UDI-6, physical functioning, emotional wellbeing, pain and vitality subgroups) and
anxiety-depression (p<0.05). This significant improvement within both group
subject in VAS, PFBQ, UDI-6, and pain subgroup of SF-36, continued after 1-year
follow up (p<0.05) ([Tables 2]
[3]).
Table 2 Comparison of Pain and Range of Motion within group
and between groups.
|
Assessment
|
Group
|
Baseline
|
After 6 weeks
|
Efect Size
|
Paired Sample T Test
|
ANOVA 2×2
|
1 year follow up
|
Efect Size
|
Paired Sample T Test
|
ANOVA 2×3
|
|
Visual Analog Scale (VAS)
|
|
Mean±SD
|
Mean±SD
|
Within-group score change Mean±SD
|
|
p whitin group
|
p between group
|
Mean±SD
|
Within-group score change Mean±SD
|
|
P whitin group
|
P between group
|
|
VAS-rest
|
Group 1
|
5.45±2.15
|
3.09±1.75
|
2.36±1.12
|
1.09
|
0.001
|
0.59
|
2.64±2.11
|
2.81±2.71
|
1.30
|
0.006
|
0.36
|
|
Group 2
|
5.2±1.47
|
4.1±1.1
|
1.1±0.73
|
0.74
|
0.001
|
3.80±1.93
|
1.4±1.34
|
0.95
|
0.01
|
|
VAS-activity
|
Group 1
|
7.18±2.27
|
5.0±2.19
|
2.18±1.25
|
0.96
|
0.001
|
0.15
|
4.36±2.15
|
2.81±1.99
|
1.23
|
0.001
|
0.09
|
|
Group 2
|
8.2±1.47
|
6.3±1.16
|
1.9±.99
|
1.29
|
0.001
|
6.00±1.76
|
2.20±0.91
|
1.49
|
0.001
|
|
VAS-night
|
Group 1
|
3.36±2.5
|
1.45±1.63
|
1.9±1.3
|
0.76
|
0.001
|
0.38
|
1.55±1.57
|
1.81±2.35
|
0.72
|
0.02
|
0.38
|
|
Group 2
|
3.1±1.52
|
2.6±1.26
|
0.5±0.7
|
0.32
|
0.05
|
2.40±1.0
|
0.70±1.56
|
0.46
|
0.19
|
|
Pressure Pain Treshold (PPT)
|
|
Rektus Abdominus -R
|
Group 1
|
3.0±1.17
|
5.3±3.46
|
2.24±3.05
|
1.91
|
0.03
|
0.01
|
3.2±0.95
|
0.13±1.69
|
0.11
|
0.79
|
0.006
|
|
Group 2
|
2.0±0.8
|
2.48±0.86
|
0.48±1.1
|
0.6
|
0.21
|
2.42±0.64
|
0.42±0.55
|
0.51
|
0.04
|
|
Rektus Abdominus-L
|
Group 1
|
3.24±1.02
|
5.64±4.15
|
2.4±4.26
|
2.35
|
0.09
|
0.01
|
3.83±2.77
|
0.59±3.32
|
0.57
|
0.93
|
0.01
|
|
Group 2
|
2.23±0.81
|
2.76±1.15
|
0.53±1.25
|
0.65
|
0.21
|
2.48±0.7
|
0.25±0.77
|
0.30
|
0.37
|
|
Quadratus Lumborum-R
|
Group 1
|
3.02±0.66
|
7.03±4.13
|
4.01±3.95
|
6.07
|
0.02
|
0.006
|
6.65±4.45
|
3.6±4.33
|
5.45
|
0.05
|
0.004
|
|
Group 2
|
1.87±0.5
|
3.05±0.62
|
1.17±0.24
|
2.34
|
0.001
|
2.35±0.55
|
0.47±0.26
|
0.94
|
0.001
|
|
Quadratus Lumborum-L
|
Group 1
|
2.9±0.92
|
5.5±3.71
|
2.6±3.79
|
2.82
|
0.03
|
0.03
|
4.6±2.96
|
1.7±2.95
|
1.27
|
0.12
|
0.01
|
|
Group 2
|
1.97±0.45
|
2.8±0.83
|
0.82±0.64
|
1.82
|
0.02
|
2.37±0.55
|
0.4±0.36
|
0.88
|
0.02
|
|
Gluteus Maksimus-R
|
Group 1
|
2.7±0.88
|
4.72±3.31
|
2.16±2.93
|
2.45
|
0.02
|
0.23
|
6.11±4.61
|
3.41±4.29
|
3.87
|
0.1
|
0.09
|
|
Group 2
|
2.14±0.72
|
3.25±0.6
|
1.11±0.39
|
1.54
|
0.01
|
2.6±0.81
|
0.45±0.49
|
0.62
|
0.52
|
|
Gluteus Maksimus- L
|
Group 1
|
2.5±0.6
|
4.71±3.65
|
2.21±3.86
|
3.68
|
0.04
|
0.2
|
6.03±4.68
|
3.53±4.87
|
5.8
|
0.13
|
0.09
|
|
Group 2
|
2.05±0.66
|
3.2±0.84
|
1.14±0.59
|
1.72
|
0.01
|
2.64±0.95
|
0.58±0.43
|
0.87
|
0.01
|
|
Range of Motion
|
|
Lumbal spine flexion
|
Group 1
|
78.81±7.69
|
79.45±8.05
|
0.63±0.8
|
0.08
|
0.03
|
0.82
|
79.0±7.83
|
0.18±0.4
|
0.02
|
0.16
|
0.81
|
|
Group 2
|
79.6±7.53
|
80.2±7.68
|
0.6±0.96
|
0.07
|
0.09
|
79.9±7.56
|
0.3±0.67
|
0.03
|
0.19
|
|
Lumbal spine extention
|
Group 1
|
18.36±5.12
|
20.09±4.92
|
1.72±0.78
|
0.33
|
0.001
|
0.68
|
19.45±4.84
|
1.09±0.94
|
0.21
|
0.003
|
0.66
|
|
Group 2
|
18.2±4.84
|
18.5±4.74
|
0.3±0.48
|
0.06
|
0.09
|
18.4±4.81
|
0.2±0.42
|
0.04
|
0.16
|
|
Hip flexion-R
|
Group 1
|
108.36±8.38
|
108.72±8.25
|
0.36±0.5
|
0.04
|
0.04
|
0.61
|
108.45±8.46
|
0.45±0.68
|
0.05
|
0.34
|
0.62
|
|
Group 2
|
106.5±8.07
|
106.9±8.13
|
0.4±0.51
|
0.04
|
0.04
|
106.8±8.14
|
0.7±0.48
|
0.08
|
0.08
|
|
Hip flexion-L
|
Group 1
|
108.36±8.6
|
108.72±8.48
|
0.36±0.5
|
0.04
|
0.04
|
0.61
|
108.81±8.45
|
0.09±0.3
|
0.01
|
0.05
|
0.62
|
|
Group 2
|
106.4±8.16
|
107.0±7.91
|
0.6±0.51
|
0.07
|
0.01
|
107.1±7.89
|
0.3±0.48
|
0.03
|
0.001
|
Abbreviations:R, Right; L,Left; SD, Standard Deviation.
Table 3 Comparison of Pelvic Floor Function, Anxiety,
Depression and Quality of Life within the group and between
groups.
|
Assessment
|
Group
|
Baseline
|
After 6 weeks
|
Efect Size
|
Paired Sample T Test
|
ANOVA 2×2
|
1 year follow up
|
Efect Size
|
Paired Sample T Test
|
ANOVA 2×3
|
|
|
Mean±SD
|
Mean±SD
|
Within-group score change Mean±SD
|
|
p whitin group
|
p between group
|
Mean±SD
|
Within-group score change Mean±SD
|
|
P whitin group
|
P between group
|
|
PFBQ
|
Group 1
|
35.3±21.95
|
25.2±17.72
|
10.09±6.21
|
0.45
|
0.001
|
0.09
|
26.2±14.24
|
9.09±13.37
|
0.41
|
0.04
|
0.08
|
|
Group 2
|
21.96±7.29
|
15.5±5.41
|
6.46±2.67
|
0.88
|
0.001
|
17.92±6.83
|
4.04±2.15
|
0.55
|
0.00
|
|
UDI-6
|
Group 1
|
28.74±11.25
|
16.25±6.58
|
12.49±5.89
|
1.11
|
0.001
|
0.004
|
18.14±9.9
|
10.6±8.2
|
0.94
|
0.002
|
0.007
|
|
Group 2
|
14.98±5.96
|
9.14±4.72
|
5.84±2.16
|
0.97
|
0.001
|
11.22±4.83
|
3.76±3.06
|
0.63
|
0.004
|
|
Short Form 36
|
|
Physical functioning
|
Group 1
|
64.54±24.43
|
74.54±17.09
|
10.0±11.83
|
0.40
|
0.02
|
0.64
|
64.09±23.11
|
0.45±25.24
|
0.01
|
0.95
|
0.8
|
|
Group 2
|
65.5±12.34
|
73.5±8.18
|
8.0±7.14
|
0.64
|
0.01
|
69.0±11.0
|
3.5±12.25
|
0.28
|
0.39
|
|
Physical role limitations
|
Group 1
|
20.45±29.19
|
38.63±34.21
|
18.18±25.22
|
0.62
|
0.04
|
0.54
|
50.45±41.56
|
30.0±47.16
|
1.02
|
0.61
|
0.29
|
|
Group 2
|
20.0±32.91
|
22.5±32.16
|
2.5±7.9
|
0.07
|
0.34
|
27.0±26.26
|
7.0±19.03
|
0.21
|
0.27
|
|
Bodily Pain
|
Group 1
|
32.5±20.4
|
57.63±17.07
|
25.13±14.2
|
1.23
|
0.001
|
0.48
|
56.81±25.59
|
24.31±20.0
|
1.19
|
0.02
|
0.42
|
|
Group 2
|
34.5±16.32
|
45.0±18.55
|
10.5±7.52
|
0.64
|
0.001
|
47.5±23.00
|
13.0±16.19
|
0.79
|
0.03
|
|
Social functioning
|
Group 1
|
54.54±26.96
|
60.9±25.67
|
6.36±9.44
|
0.23
|
0.05
|
0.98
|
60.0±29.77
|
5.45±14.82
|
0.2
|
0.25
|
0.94
|
|
Group 2
|
55.0±14.67
|
60.0±16.45
|
5.0±8.74
|
0.34
|
0.1
|
58.5±13.95
|
3.5±9.36
|
0.23
|
0.26
|
|
Emotional wellbeing
|
Group 1
|
44.54±11.73
|
52.18±13.57
|
7.63±8.28
|
0.07
|
0.01
|
0.22
|
52.81±15.07
|
8.27±15.55
|
0.01
|
0.1
|
0.29
|
|
Group 2
|
53.6±14.5
|
57.6±14.87
|
4.0±3.77
|
0.27
|
0.01
|
56.3±14.1
|
2.7±5.31
|
0.18
|
0.14
|
|
Emotional role limitations
|
Group 1
|
42.39±36.76
|
54.5±34.22
|
12.11±22.46
|
0.32
|
0.1
|
0.83
|
55.91±36.57
|
13.52±34.6
|
0.36
|
0.22
|
0.68
|
|
Group 2
|
49.99±36.0
|
40.99±33.26
|
9.0±28.46
|
0.25
|
0.34
|
45.0±29.62
|
4.99±32.6
|
0.13
|
0.64
|
|
Vitality
|
Group 1
|
41.36±17.76
|
52.72±14.55
|
11.36±5.95
|
0.63
|
0.001
|
0.87
|
50.9±14.8
|
9.54±19.93
|
0.53
|
0.14
|
0.94
|
|
Group 2
|
45.25±19.09
|
51.25±18.97
|
6.0±5.67
|
0.31
|
0.01
|
50.25±18.27
|
5.0±5.27
|
0.26
|
0.01
|
|
General health
|
Group 1
|
35.45±17.95
|
37.27±18.75
|
1.81±3.37
|
0.1
|
0.1
|
0.8
|
39.81±13.31
|
4.36±19.6
|
0.24
|
0.47
|
0.76
|
|
Group 2
|
38.0±17.02
|
38.5±16.67
|
0.5±1.58
|
0.02
|
0.34
|
42.0±17.82
|
4.0±11.49
|
0.23
|
0.3
|
|
Anxiety
|
Group 1
|
9.9±3.2
|
7.45±2.94
|
2.45±2.06
|
0.76
|
0.001
|
0.81
|
9.09±2.94
|
0.81±3.57
|
0.25
|
0.46
|
0.59
|
|
Group 2
|
9.5±1.5
|
7.4±0.84
|
2.1±0.87
|
1.4
|
0.001
|
8.2±1.31
|
1.3±.82
|
0.86
|
0.001
|
|
Depression
|
Group 1
|
7.72±3.84
|
5.54±3.44
|
2.18±1.72
|
0.56
|
0.001
|
0.60
|
7.27±3.58
|
0.45±3.32
|
0.11
|
0.66
|
0.42
|
|
Group 2
|
6.4±2.45
|
5.5±1.71
|
0.9±0.87
|
0.36
|
0.01
|
5.8±1.98
|
0.6±0.69
|
0.24
|
0.02
|
Abbreviations: UDI-6. Urogenital Distress Inventory-6; PFBQ. Pelvic Floor
Bother Questionnaire; SD: Standard Deviation.
In comparison between groups, Group 1 have more significant improvement than Group
2
in terms of UDI-6 after 6 weeks of treatment (p<0,05) ([Tables 2]
[3]).
There were no significant differences between the groups in terms of patient
satisfaction (p>0.05). Overall, 7(63.6%) in Group 1 and
4(40%) in Group 2 reported “much better” or “very
much better” improvement after 6 weeks and
5(46%)/1(10%) after 1-year follow up.
Discussion
Our results indicated that providing either IC or LLLT in addition to exercise
therapy presented benefits in terms of pain, ROM, symptom severity, QoL,
anxiety-depression and patient satisfaction. Improvement in pain, symptom severity
and symptom related QoL continued until 1-year follow up in both groups. Also, IC
more effective in symptom related QoL parameters than LLLT.
Pain was our primary outcome measurement parameter, which was mainly responsible for
the negative impact of quality of life and psychological status. In this study, both
IC and LLLT methods showed a good effect on pain after treatment consistently with
previous studies [6]
[11]
[30]
in literature. Additionally, we analyzed the 1-year effect and this improvement in
pain was continued to 1-year.
Montenegro et al. administered IC on the MTrPs during one weekly session for four
weeks in 30 women with CPP [10]. Although a
considerable improvement of PPT was observed immediately after the IC, this
improvement was not maintained until 12 weeks follow-up. In the literature, LLLT is
used for various musculoskeletal problems, but not the pelvic region. Manca et al.
applied LLLT for 2 weeks on MTrPs in the upper trapeze and reported a significant
improvement in PPT after 2 weeks and 12 weeks [31]. Hakgüder et al. applied LLLT with stretching exercises to
the neck/upper back muscles for 10 consecutive days, reported effect on the
PPT after 3 weeks [30]. At our study both IC
and LLLT showed a significant improvement in PPT at 6th week.
MTrPs on the pelvic floor and abdominal wall may cause bladder symptoms and pelvic
floor dysfunction by the mechanism of referred pain [7]. By applying manual therapy to these MTrPs, significant improvement
was observed in urgency-frequency and sexual function scale scores in various
studies [8]
[9]. At another study, by the IC of internal pelvic floor muscles,
recovery was seen in severity of urgency, frequency problems, and interstitial
cystitis [7]. Similarly, in this study there
was an improvement in pelvic floor symptom severity in both groups.
At previous studies, 10 sessions of LLLT were found effective in improving the QoL
in
myofascial pain syndrome [30], manual therapy
that applied to women with interstitial cystitis and painful bladder syndrome showed
improvement in physical and mental health [9].
In this study, there were improvements in symptoms related QoL, physical health,
mental health, pain, and vitality parameters of QoL scale. Additioally, improvement
in symptoms related QoL continued up to 1-year. This long-term effect may be due to
the core stabilization exercises that provide coactivation of the pelvic floor
muscles [32].
In a study HADS used to evaluate only the initial status of patients [10]. We used the same scale; at the end of our
treatment, anxiety and depression values were improved as secondary to recovery in
pain and pelvic floor symptom severity. Depression level improved in a study
performed with LLLT [12] like us. Anxiety and
depression evaluations were not given much attention in MTrPs research. We consider
that the level of anxiety and depression are a part of recovery therefore to assess
it is necessary. Another important indicator of recovery is also patient
satisfaction. It has even been included in some studies as a primary outcome measure
[8]
[9]. Studies on patients with urological CPP [8], interstitial cystitis and painful bladder
syndrome receiving myofascial manual physiotherapy [9], and patients with myofascial pelvic pain receiving self-myofascial
release combined with biofeedback and electrical stimulation [33] showed high satisfaction rate. Likewise,
this study showed high satisfaction rate in both groups.
There were some limitations in our study. The fact that we received patients from
only one institution, affects the generalizability of the results. It was intended
to be a pilot for a future study, so its sample size is relatively small, which
might lead to Type II errors; therefore, its findings should be interpreted with
caution. In this study, adherence with home exercise could not be evaluated with a
tool. Different results can be obtained by evaluating compliance with home exercise
with a reliable method.
To our knowledge, this study differs between the MTrPs studies in the literature in
terms of comparing a phototherapy with a manual method. In the future, studies that
perform various MTrPs therapy with a higher number of patients with CPP create more
evidence and contribute to a consensus.
As a conclusion, it appears to be beneficial to adding a MTrPs therapy combined with
exercise to the treatment of CPP patients. Both IC and LLLT methods have shown
efficacy and can be used safely in CPP patients. Because it is more effective on
symptom related QoL, the IC method may be preferred for primary use.
