Core Stability vs. Traditional Physical Therapy: A Comparative Study on Alleviating Low Back Pain in Dysmenorrhea

NCT06807229 | Enrolling By Invitation

• 1 other identifier: AhmedM
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysmenorrhea; Low Back Pain

Keywords

Dysmenorrhea; Low back pain; core stability

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale (VAS)

  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.

  pre the intervention and immediately after the intervention

• Arabic oswestry disability index AODI assessment

  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

  pre the intervention and immediately after the intervention

• WaLIDD score

  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

  pre the intervention and immediately after the intervention

• Core stability endurance test

  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.

  pre the intervention and immediately after the intervention

Other Outcomes (3)

• age

  pre the intervention only

• weight

  pre the intervention only

• height

  pre the intervention only

Study Arms (2)

core stability exercise group

EXPERIMENTAL

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.

Device: Transcutaneous electrical nerve stimulation; Other: stretching exercises

traditional physical therapy

ACTIVE COMPARATOR

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

Device: Transcutaneous electrical nerve stimulation; Other: stretching exercises

Interventions

Transcutaneous electrical nerve stimulation DEVICE

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 at the first day of menstrual complaints without taking any analgesics. Patients lied in prone position with a thin pillow placed under their abdomen. Two electrodes were placed to the proximal margin of low back area, and two others were placed to the proximal of gluteal region laterally. The intensity of stimulation was increased up to the tolerated level without causing any contraction

Also known as: TENS, stretching exercises

core stability exercise group; traditional physical therapy

stretching exercises OTHER

The first stretching exercise: The subjects will be asked to stand and bend trunk forward from the hip joint so that the shoulders and back were positioned on a straight line and the upper body was placed parallel to the floor for 5 seconds repetition; 10 times. The second stretching exercise: The subjects will be requested to stand then raise 1 heel off the floor, then repeat the exercise with the other heel alternatively. The exercise will be performed 20 times. The third stretching exercise: The subjects will be asked to spread their feet shoulder width, place trunk and hands in forward stretching. The fourth stretching exercise: The subjects will be asked to spread her feet wider than shoulder width. Then the subject was asked to bend and touch left ankle with her right hand while putting her left hand in a stretched position above her head so that the head was in the middle and her head was turned and looked for her left hand, this exercise was repeated for the opposite foot with

Also known as: TENS

core stability exercise group; traditional physical therapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Females diagnosed with primary dysmenorrhea between age group 18-35 years and their VAS Score is 4 ≥, regular menstrual cycle, unmarried females, non-athlete.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Delta University for Science and Technology: lead
• Middle East University: collaborator

Study Sites (1)

delta university for science and technology, Al Manşūrah, gamasah 11152

Gamasah, Al Manşūrah, 11152, Egypt

Location

MeSH Terms

Conditions

Dysmenorrhea; Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. Randomization Informed consent will be attained from each individual after explanation of the aim as well as benefits of the study. Individuals were informed about the privacy of their information and their right to stop or withdraw at any time. They will be randomized using the randomization block method into two groups, study (n=35) and control (n=35) groups.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: October 29, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: February 4, 2025

Record last verified: 2024-10

Locations

EG (1)