Effect of Lumbar Proprioception Training on Primary Dysmenorrhea

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06051435

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Dysmenorrhea	Other: lumbar proprioception training Other: Hot packs Other: Pelvic rocking exercise	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Lumbar Proprioception Training on Primary Dysmenorrhea: A Randomized Clinical Trial

Actual Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group They will receive hot packs and pelvic rocking exercises for one menstrual cycle.	Other: 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 Other: Pelvic rocking exercise Pelvic rocking exercise
Experimental: Lumbar proprioception group They will receive the same lumbar proprioception training plus hot packs and pelvic rocking exercises for one menstrual cycle.	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. Other Names: lumbar proprioception exercises Other: 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 Other: Pelvic rocking exercise Pelvic rocking exercise

Arm

Intervention/Treatment

Active Comparator: Control group

They will receive hot packs and pelvic rocking exercises for one menstrual cycle.

Other: 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

Other: Pelvic rocking exercise

Pelvic rocking exercise

Experimental: Lumbar proprioception group

They will receive the same lumbar proprioception training plus hot packs and pelvic rocking exercises for one menstrual cycle.

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.

Other Names:

lumbar proprioception exercises

Other: 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

Other: Pelvic rocking exercise

Pelvic rocking exercise

Outcome Measures

Primary Outcome Measures

Measurement of lumbar proprioception [4 weeks]
It will be evaluated through Biodex system in both groups before and after treatment program through measuring the lumbar repositioning accuracy.

Secondary Outcome Measures

Calculation of score of WaLIDD Scale [4 weeks]
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).
lumbar curvature angle [4 weeks]
it will be measured by Flexible ruler which is affected by the tilt of the pelvis, in both groups before and after treatment program.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 23 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Doaa Osman	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: doaa osman, assis.prof, study principle investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Doaa A. Osman, Assistant professor Physical Therapy for Woman's Health Faculty of Physical Therapy Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT06051435

Other Study ID Numbers:

P.T.REC/012/004410

First Posted:

Sep 22, 2023

Last Update Posted:

Sep 22, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Doaa A. Osman, Assistant professor Physical Therapy for Woman's Health Faculty of Physical Therapy Cairo University, Cairo University

lumbar proprioception training

pelvic rocking exercises

primary dysmenorrhea

Additional relevant MeSH terms:

Dysmenorrhea

Study Results

No Results Posted as of Sep 22, 2023