Core Stability vs. Traditional Physical Therapy: A Comparative Study on Alleviating Low Back Pain in Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Dysmenorrhea is a menstrual disorder defined by the presence of painful cramps of uterine origin that occur during menstruation. It is one of the most common causes of pelvic pain and short-term absenteeism from school or work, among young and adult women [1].
The prevalence of Primary dysmenorrhea is highest in the 16-25-year age group but is greatly underestimated as many women consider pain a normal part of the menstrual cycle and do not seek medical treatment, despite the considerable distress they experience. A previous systematic review on the impact of dysmenorrhea in adolescents reported that the prevalence is high and that it imposes a significant negative impact on academic performance [2], restrictions on daily activities and sports or social and sexual relationships [3].
Primary dysmenorrhea occurs in the absence of pelvic pathology, it is mediated by elevated prostaglandin and leukotriene levels, inflammation causing uterine contractility and cramping pain. Secondary dysmenorrhea is due to pelvic pathology or a recognized medical condition and accounts for about 10% of cases of dysmenorrhea. The most common etiology of secondary dysmenorrhea is endometriosis, other etiologies include congenital or acquired obstructive and nonobstructive anatomic abnormalities (e.g., müllerian malformations, uterine leiomyomas, adenomyosis), pelvic masses, and infection [4].
It has been demonstrated that prostaglandins are overproduced in dysmenorrhea. Prostaglandins cause narrowing of the blood vessels supplying the uterus, abnormal contractile activity of the uterus, which leads to ischemia, hypoxia of the uterus and increased sensitivity of the nerve endings [5].
The treatment approach is mainly directed toward relieving the pain through physiological mechanisms that underlie menstrual pain (production of prostaglandins). The treatment is also aimed toward the improvement of the function, leading to fewer days lost at work, school or extracurricular activities [6]. There are different approaches to the treatment of primary dysmenorrhea. The drug approach is achieved through prostaglandins inhibitors, which are non-steroidal anti-inflammatory drugs (NSAIDs) and hormonal drugs such as contraceptives. Many NSAIDs which non-specifically inhibit both COX-1 and COX-2 enzymes (e.g., ibuprofen) are the most common initial therapy for dysmenorrhea [7]. Likewise, oral contraceptives are not free from side effects either, related as they are to the frequency of bleeding, weight gain, or the patient's basal risk of venous thromboembolism [1].
All this shows us that there is a need for emphasis on alternative methods of conservative treatment as a non-pharmacological and non-invasive therapy, safe and easy to use for obtaining relief from dysmenorrhea symptoms, including acupuncture and acupressure, biofeedback, heat treatments, transcutaneous electrical nerve stimulation (TENS), exercises and relaxation techniques [8]. On the other hand, these physiotherapeutic treatments, being supported by clinical trial data, could be a very useful treatment alternative for women with primary dysmenorrhea, particularly those who are not eligible for pharmacological therapy, since physiotherapy has no side effects according to the analyzed studies [9]. Exercise is an activity performed to develop or maintain fitness which requires physical exertion, is one of the non-pharmacological and effective ways of treating dysmenorrhea. Many reviews have evaluated the efficacy of exercise or individual physiotherapy interventions for primary dysmenorrhea [10].
Alternative or non-pharmacological treatments include TENS, exercise, acupuncture, acupressure, massage therapy, heat pads. The reduction of pain maybe due to the effect's hormonal changes in the uterine tissue or due to an increase in the endorphin levels [11].
Core muscle strengthening focuses on isolated muscle group conditioning which will strengthen the small intrinsic musculature around the lumbar spine and provide lumbar stability. When these muscles are strong, they become capable of handling normal biomechanical forces even the stress of menstrual cramps which a women's body undergoes during the menstrual cycle (12).
Core stability exercise has been known as a beneficial intervention in the management of several medical problems. Core stability exercises strengthen and coordinate the muscles around the abdominal, lumbar, and pelvic regions. Because it has been suggested that the core stability exercises mainly affect the lumbosacral muscles and increase blood supply in lumbosacral structures.
It was proved in some studies that core stability exercises can improve pain and function for primary dysmenorrhea in young and adult women. (13,14) but the number of studies about this were limited with many limitations so, we hypothesized that the core stability exercises might be effective in reducing primary dysmenorrhea symptoms.
So, this study was designed to compare among the effect
详细描述
Core Stability vs. Traditional Therapy: A Comparative Study on Alleviating Low Back Pain in Dysmenorrhea Dysmenorrhea is a menstrual disorder defined by the presence of painful cramps of uterine origin that occur during menstruation. It is one of the most common causes of pelvic pain and short-term absenteeism from school or work, among young and adult women [1].
The prevalence of Primary dysmenorrhea is highest in the 16-25-year age group but is greatly underestimated as many women consider pain a normal part of the menstrual cycle and do not seek medical treatment, despite the considerable distress they experience. A previous systematic review on the impact of dysmenorrhea in adolescents reported that the prevalence is high and that it imposes a significant negative impact on academic performance [2], restrictions on daily activities and sports or social and sexual relationships [3].
Primary dysmenorrhea occurs in the absence of pelvic pathology, it is mediated by elevated prostaglandin and leukotriene levels, inflammation causing uterine contractility and cramping pain. Secondary dysmenorrhea is due to pelvic pathology or a recognized medical condition and accounts for about 10% of cases of dysmenorrhea. The most common etiology of secondary dysmenorrhea is endometriosis, other etiologies include congenital or acquired obstructive and nonobstructive anatomic abnormalities (e.g., müllerian malformations, uterine leiomyomas, adenomyosis), pelvic masses, and infection [4].
It has been demonstrated that prostaglandins are overproduced in dysmenorrhea. Prostaglandins cause narrowing of the blood vessels supplying the uterus, abnormal contractile activity of the uterus, which leads to ischemia, hypoxia of the uterus and increased sensitivity of the nerve endings [5].
The treatment approach is mainly directed toward relieving the pain through physiological mechanisms that underlie menstrual pain (production of prostaglandins). The treatment is also aimed toward the improvement of the function, leading to fewer days lost at work, school or extracurricular activities [6]. There are different approaches to the treatment of primary dysmenorrhea. The drug approach is achieved through prostaglandins inhibitors, which are non-steroidal anti-inflammatory drugs (NSAIDs) and hormonal drugs such as contraceptives. Many NSAIDs which non-specifically inhibit both COX-1 and COX-2 enzymes (e.g., ibuprofen) are the most common initial therapy for dysmenorrhea [7]. Likewise, oral contraceptives are not free from side effects either, related as they are to the frequency of bleeding, weight gain, or the patient's basal risk of venous thromboembolism [1].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
A convenient sample of 80 participants will be screened for study eligibility. The sample size was calculated utilizing G*Power based on a prior study with an effect size of 0.8. to detect a true difference in means with 80% power and a 5% significance level. An estimated sample size of 70 patients will be randomly allocated to a software application. Group A will receive core stability exercises combined traditional physical therapy (stretching exercises and TENS). The 2nd group (group B) will receive traditional physical therapy (stretching exercises and TENS) only.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females diagnosed with primary dysmenorrhea between age group 18-35 years and their VAS Score is 4 ≥, regular menstrual cycle, unmarried females, non-athlete.
排除标准
- •history of pelvic inflammatory disease, endometriosis, any pathology, compulsory use of special drugs, had symptoms such as (tingling, itching, discharge), Irregular menstruation cycle, use of painkillers during the study period, any musculoskeletal problems causing inability to perform core strengthening exercises, mental, psychological problems
研究组 & 干预措施
core stability exercise group
Subjects in this group will be handled with core stability exercises that targeted deep abdominal muscles. This included a series of exercises as well as a baseline therapeutic management of ultrasonic as well as TENS. A physiotherapist supervised these exercises.
For four weeks, all groups did core stability exercises for 30 minutes three times per week. Isometric contraction was sustained for 7-8 seconds for every exercise. Each exercise was repeated ten times, with a three-second rest break among repetitions. Patients were given a 1-minute break between exercises. (13) Based on the patient's success, the intensity of the individual training steadily increased with decreasing therapist support. Patients were told to contract their abdominal muscles and hold the contraction while continuing to breathe normally during each repetition of each exercise. (22) Each patient followed a customized exercise program designed by their therapist and kept track of their progress in a diary.
干预措施: Transcutaneous electrical nerve stimulation (Device)
core stability exercise group
Subjects in this group will be handled with core stability exercises that targeted deep abdominal muscles. This included a series of exercises as well as a baseline therapeutic management of ultrasonic as well as TENS. A physiotherapist supervised these exercises.
For four weeks, all groups did core stability exercises for 30 minutes three times per week. Isometric contraction was sustained for 7-8 seconds for every exercise. Each exercise was repeated ten times, with a three-second rest break among repetitions. Patients were given a 1-minute break between exercises. (13) Based on the patient's success, the intensity of the individual training steadily increased with decreasing therapist support. Patients were told to contract their abdominal muscles and hold the contraction while continuing to breathe normally during each repetition of each exercise. (22) Each patient followed a customized exercise program designed by their therapist and kept track of their progress in a diary.
干预措施: stretching exercises (Other)
traditional physical therapy
Stretching exercises Information will be given to participants of group (A) to do 4 stretching exercises for 8 weeks at home (3 days per week and 3 times per day for 10 minutes). They were asked to avoid performing stretching exercises during the period cycle. They will be given a questionnaire prior to the stretching exercises and completed it after 4 weeks of stretching exercises Transcutaneous electrical nerve stimulation (TENS) We will apply high frequency TENS for low back pain relief as it showed effectiveness more than low frequency TENS in pain relief (21). The recommendation is to apply the TENS at the highest tolerable intensity (22). While adjusting the current amplitude in a continuous manner so that its presence will be noticeable throughout the treatment. We applied a TENS device (ENRAF NONIUS Model, four electrodes) with a frequency of 0- 100/HZ and 90-100 pulse /seconds was applied for 20 minutes, to increase circulation and to have pain relief
干预措施: stretching exercises (Other)
traditional physical therapy
Stretching exercises Information will be given to participants of group (A) to do 4 stretching exercises for 8 weeks at home (3 days per week and 3 times per day for 10 minutes). They were asked to avoid performing stretching exercises during the period cycle. They will be given a questionnaire prior to the stretching exercises and completed it after 4 weeks of stretching exercises Transcutaneous electrical nerve stimulation (TENS) We will apply high frequency TENS for low back pain relief as it showed effectiveness more than low frequency TENS in pain relief (21). The recommendation is to apply the TENS at the highest tolerable intensity (22). While adjusting the current amplitude in a continuous manner so that its presence will be noticeable throughout the treatment. We applied a TENS device (ENRAF NONIUS Model, four electrodes) with a frequency of 0- 100/HZ and 90-100 pulse /seconds was applied for 20 minutes, to increase circulation and to have pain relief
干预措施: Transcutaneous electrical nerve stimulation (Device)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: pre the intervention and immediately after the intervention
The Visual Analogue Scale (VAS), a reliable and effective measure of pain intensity that is sensitive to variations in pain caused by clinical conditions, was used to assess the severity of the pain. At the scale's left end, a zero means there is no pain, and a 10 means the most agonizing suffering possible. A minor improvement with a change of 1.1-1.2 cm is clinically meaningful.
Arabic oswestry disability index AODI assessment
时间窗: pre the intervention and immediately after the intervention
Patients will complete a questionnaire, which indicates a percentage score of level of function in daily living activities in pre-sessions and after end of sessions. This questionnaire examines levels of function every day in ten daily living activities. The categories will be scored from zero to five (10 categories). If all 10 sectors are finished the result is calculated as follows: if 20 the total result out of 50 total possible, score x 100 = 40%. (14) We recorded the results of this scale before and after the study
WaLIDD score
时间窗: pre the intervention and immediately after the intervention
It is a scale-type survey and abbreviation of (working ability, location, intensity, days of pain, dysmenorrhea), score: 0 without dysmenorrhea, 1-4 mild dysmenorrhea, 5-7 moderate dysmenorrhea, 8-12 severe dysmenorrhea. Wong-Baker scale was reclassified to adjust a four-level scale. We recorded the results of this scale before and after the study
Core stability endurance test
时间窗: pre the intervention and immediately after the intervention
They are three core endurance tests generated by McGgill. (19) they are trunk flexor test, trunk extensor test and side bridge test. The trunk flexor test was performed while the body was 60° in flexion, knees and hip were 90° in flexion. The arms were joined diagonally on the chest. Participants were wanted to protect this position as long as it is possible. The test was terminated when the individual could not maintain this position. The trunk extensor test was performed on the treatment table in a prone position. Pelvis, hip and knees were fixed to the treatment table up to spina iliaca anterior superior level. The body and upper extremities were supported with a chair at the same height as the surface of the table. Then the chair was removed and the individual tried to keep the horizontal body position as long as possible while crossing the arms on the chest.
次要结局
未报告次要终点