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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06051435
Other study ID # P.T.REC/012/004410
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date December 1, 2023

Study information

Verified date February 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of this study will be to investigate the effect of lumbar proprioception training on primary dysmenorrhea.


Description:

Although previous studies reported the effect of physiotherapy practices through therapeutic exercises on primary dysmenorrhea as core muscles strengthening, core stability exercises, connective tissue massage and classical massage, relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga and Pilates. None of them have investigated the effect of lumbar proprioception training on primary dysmenorrhea. Therefore, this study will be the first one which aims to investigate the effect of lumbar proprioception training on primary dysmenorrhea. This trial will include 2 groups; group A composed of 20 females that will receive hot packs and pelvic rocking exercises for 4 weeks and group B also composed of 20 females that will receive hot packs and pelvic rocking exercises in addition to lumbar proprioception training for 4 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 22 Years
Eligibility Inclusion Criteria: - All females will have moderate to severe primary dysmenorrhea (as determined by WaLIDD Scale). - Their ages will range from 18 to 22 years old. - All females will be virginal and non-smokers. - Their BMI will be range from 20-25 kg/m2 - They have regular menstrual cycle with menstrual cycle length of 28-30 days. - They have persistent primary dysmenorrhea of more than 6 months Exclusion Criteria: - They shouldn't have musculoskeletal or neurological disorders, chronic LBP or sacroiliac dysfunction, diabetes, pelvic pathology or any gynecological disease. - They shouldn't experience a stressful event in the last 6 month. - Attending regular exercise training in the last 6 months. - Taking medications or vitamin and mineral supplements due to other medical conditions.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
lumbar proprioception training
a) Sensorimotor training: Sensorimotor training and reconditioning of proprioceptive senses have recently been found to be helpful in increasing motor performance and coordination, muscle strength, sensorimotor abilities, increasing intermuscular control, and improving one's response to sensory information and muscle tone. Reconditioning of proprioceptive senses and sensorimotor training increases one's muscle adjustment ability, maximizes the sensory input in different parts of the body and aids in improving one's motor adjustment ability (Hwang et al ., 2013). Position Exercise methods as Hollowing exercise: Participants will be asked to contract the abdominal muscles, raising the center of movement toward the navel in a quadruped position.
Hot packs
hot application in the form of hot packs on the lower abdomen and lower back for a total duration of 30 minutes, once per day, during the first two days of menstruation
Pelvic rocking exercise
Pelvic rocking exercise

Locations

Country Name City State
Egypt Doaa Osman Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of lumbar proprioception It will be evaluated through Biodex system in both groups before and after treatment program through measuring the lumbar repositioning accuracy. 4 weeks
Secondary Calculation of score of WaLIDD Scale It will be used to identify dysmenorrhea severity in both groups before and after treatment program through measuring combination of manifestations: subjective (intensity/Wong-Baker, work ability) and objective (days of pain, location) for both groups.The total score of 0 indicates without dysmenorrhea; 1-4 indicates mild dysmenorrhea, 5-7 indicates moderate dysmenorrhea, 8-12 indicates severe dysmenorrhea (Teherán et al., 2018). 4 weeks
Secondary lumbar curvature angle it will be measured by Flexible ruler which is affected by the tilt of the pelvis, in both groups before and after treatment program. 4 weeks
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