Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06038214 |
| Other study ID # |
2022/3421 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2022 |
| Est. completion date |
December 20, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Inonu University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In fibromyalgia patients, exercise is needed to reduce symptoms and to prevent muscle
weakness with fatigue and pain. Core exercise retrains and strengthens deep postural spinal
muscles such as the multifidus and transverse abdominis by promoting neuromuscular control,
maintaining the dynamic stability of the spine and thus reducing pain. By performing core
exercises, the pelvic floor, which forms the lower base of the core, is strengthened.
Objective: It was planned to investigate the effects of core exercises on pelvic floor
dysfunction, sexual dysfunction, pain, sleep quality and quality of life in women with
fibromyalgia.
Materials and Methods: It was designed as randomized control. Sexually active women with
fibromyalgia syndrome between the ages of 18-65 will be included in the study. After the
patients are selected from the relevant stage with the improbable random sampling method, the
patients who accept to participate in the study and meet the inclusion criteria will be
assigned to one of the groups in which the core exercise or home program is applied.
Evaluations will be evaluated for each group before starting the exercise program and 1 day
after the last session, following the completion of 2 sessions per week for 8 weeks. Pain
Visual Analog Scale; fibromyalgia impact level Revised Fibromyalgia Impact Questionnaire
(FIQR); pelvic floor dysfunction Pelvic Floor Impact Questionnaire (PFIQ); sexual dysfunction
Female Sexual Function Scale; sleep quality: Pittsburgh Sleep Quality Index; short quality of
life It is planned to be evaluated with Form-36(SF-36). Conclusion: The effects of core
exercises on pelvic floor dysfunction, sexual dysfunction, pain, sleep quality and quality of
life will be evaluated and interpreted by comparing the evaluations before and after
treatment and between groups.
Description:
Fibromyalgia (FM) is a non-articular, chronic rheumatic disease of unknown etiology,
characterized by widespread musculoskeletal pain, sleep disturbance, mood changes, fatigue,
and the presence of multiple tender points. Diagnostic criteria were defined by the American
Rheumatism Association (ARA) in 1990. To diagnose FM, there should be widespread pain and
tenderness at 11 or more of 18 specific points (1).
Although the etiopathogenesis of FM is still unknown, triggering factors such as physical
trauma, surgical intervention, infections, acute or chronic emotional stress may play a role
(2). Various findings such as muscular symptoms accompanying chronic pain, cognitive
complaints, depression, insomnia and fatigue have been described in patients with FM (2).
chronic pain seen in FM; It creates physical and emotional stress such as sleep, fatigue and
cognitive symptoms. In addition, unwillingness to move or fear of movement may develop in
individuals due to chronic pain (2).
Various psychopathological disorders have been reported in FM. It is estimated that 1/3 of
his patients have minor depression or anxiety and anxiety state disorder. However, it is
unknown whether anxiety and depression in FM cause chronic pain or contribute to the severity
of symptoms (1). Despite various complaints of patients with fibromyalgia, the absence of a
significant disorder in physical examination and laboratory tests suggests that the symptoms
may be of psychological origin (2). Since the etiology of fibromyalgia syndrome is unknown,
pharmacological and non-pharmacological treatment methods should be used in patient-specific
combinations according to the prominent symptoms and their severity (2).
Sexuality is an important part of life and is associated with the well-being of the
individual. Sexuality covers many issues, starting with the self-image of the person and the
relationship with his partner (3). Sexual dysfunction is defined as the satisfaction of not
participating in sexual acts (3). The development of sexual dysfunction in women with
fibromyalgia is thought to be associated with many factors such as symptoms, pain, anxiety,
depression, and drug therapy (3).
Few studies have been done on the sexuality of women with fibromyalgia (4), and studies have
found a relationship between fibromyalgia and sexual dysfunction (4) In addition, considering
that women with fibromyalgia have an increase in pain, fatigue, and decrease in muscle
strength (5), Fusco et al. concluded that women with fibromyalgia exhibited weaker pelvic
floor muscles and also more frequent lower urinary tract symptoms compared to the healthy
control group (5). For this reason, a relationship between pelvic floor involvement and
impaired sexual function in women with fibromyalgia is considered (5).
It is reported that sleep quality is deteriorated by almost 80% of patients with fibromyalgia
(6). Epidemiological studies show that poor sleep quality is a risk factor for fibromyalgia.
Poor sleep is associated with symptom severity in patients with fibromyalgia (6). It has been
shown that improving sleep quality in exercise approaches as well as pharmacological
treatments can reduce pain in patients with fibromyalgia (6,7).
When looking at the quality of life, studies comparing the quality of life in FM patients
with healthy individuals of the same age show that FM has a negative effect, as symptoms
affect daily routine and physical activities, causing patients to enter a vicious circle(8).
Because fibromyalgia has a negative effect on fatigue, pain, anxiety, sleep disturbance
symptoms, and poor quality of life, the American Pain Society and the Association of
Scientific Medical Societies in Germany have recommended physical exercise, hydrotherapy,
massage, yoga and various treatment strategies besides medication use. It is recommended in
methods such as acupuncture (9).
The term core is used for the trunk or more specifically the lumbopelvic region of the body.
Stabilization of the lumbopelvic region is very important for upper and lower extremity
movements, supporting loads, protecting nerve roots and spinal cord. (10,11). core; It can be
thought of as a box formed by the abdominals in the front, the paraspinals and gluteals in
the back, the diaphragmatic roof above, and the pelvic floor muscles at the bottom. When the
stabilization system works effectively, optimal control and efficiency of the movement,
proper distribution of the force, adequate absorption of the ground effect force and
protection of the joints in the kinetic chain are ensured. (12,13). The stabilization system
consists of 3 sub-systems as neural, passive and active systems and are functionally
interconnected (11). The neural system receives stimuli from the muscle spindle, Golgi tendon
organ and spinal ligaments, adjusts the muscle strength, and determines the spinal stability
requirements. Stability can change abruptly depending on the external loads that the body can
carry along with postural adjustments. The neural system has to work synchronously with other
systems in order to perform the desired movement and to provide sufficient stability (11).
The passive system consists of spinal ligaments and facet joints and allows limited loading
of the lumbar vertebrae. For this reason, an active system is needed to load and support body
mass in resistant exercise-dynamic activities (11). The active system consists of muscles and
tendons. The active musculature, on the other hand, has been divided into two as "global" and
"local" according to their roles in core stabilization (11). The global group consists of
large superficial muscles. The muscles in the global musculature are the erector spina,
external oblique, and rectus abdominis (10). The local group is; It consists of deep and
small muscle groups. The local musculature consists of transversus abdominus, multifidi,
internal oblique, deep transversospinalis and pelvic floor muscles (10). For the continuity
of spinal function, the simultaneous function of the global and local groups is required
(13). Core muscles consist of 2 types of muscle fiber structures that contract slowly and
quickly. Slow-twitch fibers are mainly located in the local system known as the deep layer,
providing intersegmental movement control and posture changes. Fast-twitch fibers are found
in the superficial layer, that is, in the global musculature. These muscles are fibers with
large torque capability focused on speed, power, and greater range of motion (10-13). Pelvic
floor muscles form the base of the core muscles. The pelvic floor not only plays an important
role in muscle activation for lumbar stabilization, but also forms the basis of the abdominal
cavity. Pelvic floor muscles; During work that increases intra-abdominal pressure, it should
contract in order to maintain continence and contribute to the increase in pressure (14). It
has been reported that the contraction of the pelvic floor muscles can be strengthened by the
activation of the trunk stabilizing muscles. Therefore, trunk stabilization exercises are
thought to be an option to increase the effectiveness of pelvic floor muscle exercises (15).
Pelvic floor dysfunction is defined as the abnormal function of the pelvic floor and includes
conditions that may have significant adverse effects on a woman's quality of life, such as
urinary incontinence (stress, urge, and mixed), fecal incontinence, pelvic organ prolapse,
and sexual dysfunction (16).
Core exercise is recommended in the rehabilitation of chronic pain (17). Few studies on the
management of pain in fibromyalgia have focused on core exercise (18). The main purpose of
core exercise is to promote neuromuscular control and retrain and strengthen the deep
postural spinal muscles such as the multifidus and transversus abdominis, maintain the
dynamic stability of the spine and thus reduce pain (19,20). Core exercise alone reduced pain
and depression and improved health status, quality of life and sleep quality in women with
FM(19-22).
Core exercise focuses on activating the deep local musculature, regulating overactivity of
surface muscles, and restoring normal synergistic function between local and global
musculature, thereby reducing pain and improving function (19,21). Although the positive
effects of core exercise on chronic pain such as low back pain are well known (21), the
number of studies focusing on core exercise in axial pain, which is common in FM, is
insufficient. Only one study in the literature focused on investigating the effects of
specific core exercise on FM (18). Martinez-Rodriguez et al. (18) recently found that core
exercise plus lacto-vegetarian diet contributed to the reduction of pain and improvement of
body composition in FM. The current study reveals that core exercise alone is effective in
reducing pain and depression and improving health status, quality of life and sleep quality
in FM.
When we look at the literature, many studies have revealed that the symptoms of fibromyalgia
syndrome such as fatigue, depression, pain and sleep disturbance are also associated with
sexual dysfunction by affecting the pelvic floor (8). In line with this information, our aim
is to examine the effects of core exercises on pelvic floor dysfunction, sexual dysfunction,
pain, sleep quality and quality of life in women with fibromyalgia.
5.1. Type of study: Experimental randomized controlled trial 5.2. Place and time of the
research: İnönü University Turgut Özal Medical Center Department of Rheumatology
20.06.2022-20.12.2023 5.3. The universe and sample of the research: The population of the
study, which was planned as a randomized controlled study, consists of sexually active women
with fibromyalgia syndrome by the relevant specialist physician of İnönü University Turgut
Özal Medical Center Rheumatology Department. For the study, which is planned to be carried
out between 20.06.2022 and 20.12.2023, after the patients are selected from the relevant
stage with the improbable random sampling method, the patients who accept to participate in
the study and meet the inclusion criteria will be assigned to one of the groups in which core
exercise or home program is applied.
Inclusion criteria for the study:
Be between the ages of 18 and 60 with a previous diagnosis of fibromyalgia Symptoms last
longer than 3 months Being sedentary (not doing physical activity at least 3 days a week in
the last 3 months) being sexually active To voluntarily accept participation in an exercise
program 2 days a week for 8 weeks,
Exclusion criteria from the study:
Using psychotropic medication in the last 1 month Known central or peripheral nervous system
disease, progressive neurological damage, Presence of any cardiovascular pathology, Presence
of uncontrolled hypertension, Presence of any musculoskeletal system disease other than
fibromyalgia, Pregnancy, Presence of cognitive problems that will affect cooperation
Exclusion criteria:
Volunteer's request to leave Failure to continue training sessions
5.4. Study material: Evaluations will be evaluated for each group before starting the
exercise program and 1 day after the last session, following the completion of 2 sessions per
week for 8 weeks. Pain Visual Analog Scale; fibromyalgia impact level Revised Fibromyalgia
Impact Questionnaire (FIQR); pelvic floor dysfunction Pelvic Floor Impact Questionnaire (PFIQ
Pelvic Floor Impact Questionnaire); sexual dysfunction Female Sexual Function Scale; sleep
quality: Pittsburgh Sleep Quality Index; It is planned to evaluate the quality of life with
Short Form-36 (SF-36).
5.5. Data collection tools: Data Collection Inonu University Turgut Özal Medical Center
Rheumatology Department diagnosed with fibromyalgia by the relevant specialist, sexually
active women between the ages of 18-65 will be included in the study. Individuals will be
evaluated for compliance with the study content before the preliminary evaluation. After
eligibility is determined, individuals will be randomly assigned to groups. In the
randomization of the groups, the assignment will be made to the groups with the randomizer
program using the computer. Evaluations will be evaluated for each group at the same time of
the day before the exercise program starts and 1 day after the last session after completing
2 sessions a week for 8 weeks.
Evaluation form : Sociodemographic data of individuals will be questioned with an evaluation
form. Evaluation form; patient's name-surname, age, gender, height, weight, marital status
and duration of marriage, age at diagnosis and education level.
Pain: Regional neck and back pain at rest and during activity will be evaluated with the help
of the Visual Analogue Scale (VAS). The VAS is a 10 cm scale that rates 0 points as "no pain"
and 10 points as "worst pain imaginable".
Fibromyalgia Impact Level : Revised Fibromyalgia Impact Questionnaire (FIQR) will be used.
This scale; physically It measures 10 different features: function, well-being, not being
able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety
and depression. With the exception of the well-being trait, low scores indicate recovery or
less affliction. FEA is filled by the patient. The maximum possible score of each sub-title
is 10. Thus the total maximum score is 100. The average FM patient scores 50, while more
severely affected FM patients usually score above 70. Permission to use the survey has been
obtained.
Pelvic floor assessment: Pelvic Floor Impact Questionnaire (PFIQ Pelvic Floor Impact
Questionnaire) will be used for measurement. The PFIQ is a pelvic floor quality of life
questionnaire used to evaluate the effects of bowel, bladder, and/or pelvic symptoms on an
individual's activities of daily living, social relationships, and emotions. Each item
consists of 4 options (Never, Rarely, Moderately, Quite often) and is scored between 0 and 3.
The PFIQ scale also consists of 3 sub-dimensions. POPIQ-7 (Pelvic organ prolapse impact
questionnaire): In this sub-dimension consisting of 7 questions, it is questioned how the
pelvic organ prolapse affects the patient during travel, social activity and physical
activity and the effect of this situation on emotional health. CRAIQ-7 (Colo-rectal-anal
impact questionnaire): In this sub-dimension consisting of 7 questions, it is questioned how
intestinal complaints affect the patient during travel, social activity and physical activity
and the effect of this situation on emotional health. The mean scores of the items in each
sub-dimension are calculated and these scores are multiplied by (100/3) and PFIQ subscale
scores ranging from 0-100 are calculated. Then, the 3 subscale scores are summed to find the
PFIQ total score, which ranges from 0-300. A higher score indicates worse health. Permission
to use the survey has been obtained.
Sexual Dysfunction: It will be measured with the Female Sexual Dysfunction Scale. The scale
consists of 19 questions. Each The question has six options to answer, and each item is
scored from zero to five. In the structure of the scale; There are six sub-dimensions:
desire, arousal, lubrication, orgasm, satisfaction and pain. The person gets a score between
4 and 95 from the scale. Permission to use the survey has been obtained.
Sleep Quality: Pittsburgh It will be measured by the Sleep Quality Index. Defining good and
bad sleep and assesses sleep quality. It consists of a total of 24 questions, 19 of which are
self-evaluation and 5 of which are answered by the spouse or roommate of the person. The
questions are collected in 7 subscales. These are: subjective sleep quality, sleep latency,
sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and
daytime dysfunction. Each subscale is scored between 0-3 points. The total score is between
0-21. Questions asked to an individual's spouse or roommate are not included in the
calculation. Permission to use the survey has been obtained.
Quality of life: The Short Form-36 (SF-36) scale will be used. Assessing the SF-36 quality of
life developed for the purpose. A validity and reliability study was conducted in Turkey.
SF-36 is used to compare general and specific populations, to demonstrate the health benefits
of different treatments, and to monitor patients. The last 4 weeks are taken into account in
the evaluation of SF-36, which consists of a total of 36 items. It is stated that due to the
release of SF-36 v2.0, the use of v1.0 does not require permission.
5.6. Variables of the research While the dependent variables of our study were pelvic floor
dysfunction, sexual dysfunction, pain, sleep quality and quality of life, the independent
variables were age, gender, height, weight, marital status and duration of marriage, age at
diagnosis, and education level.
5.7. research plan The population of the study, which was planned as a randomized controlled
study, consists of sexually active women with fibromyalgia syndrome by the specialist
physician of the Inonu University Turgut Özal Medical Center Rheumatology Department. For the
study, which is planned to be carried out between 20.06.2022 and 20.12.2023, after the
patients are selected from the relevant stage with the improbable random sampling method, the
patients who accept to participate in the study and meet the inclusion criteria will be
assigned to one of the groups in which core exercise or home program is applied.
Treatment protocol:
The individuals included in the study will be divided into 2 groups.
- Group (experiment): Individuals in this group are planned to be included in the core
exercise program.
- Group (control): It is planned to receive a follow-up home program and information.
The core exercise group will be included in the exercise program under the supervision of a
physiotherapist, with 30 minutes each session, 2 days a week for 8 weeks. 30-minute exercise
sessions are planned as 5 minutes of warm-up, 20-minutes of core exercises and 5 minutes of
cool-down.
