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Effect of Lumbar Proprioception Training on Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lumbar proprioception training
Hot packs
Pelvic rocking exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring lumbar proprioception training, pelvic rocking exercises, primary dysmenorrhea

Eligibility Criteria

18 Years - 22 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Doaa OsmanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Lumbar proprioception group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
September 11, 2023
Last Updated
October 2, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06051435
Brief Title
Effect of Lumbar Proprioception Training on Primary Dysmenorrhea
Official Title
Effect of Lumbar Proprioception Training on Primary Dysmenorrhea: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
lumbar proprioception training, pelvic rocking exercises, primary dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
They will receive hot packs and pelvic rocking exercises for one menstrual cycle.
Arm Title
Lumbar proprioception group
Arm Type
Experimental
Arm Description
They will receive the same lumbar proprioception training plus hot packs and pelvic rocking exercises for one menstrual cycle.
Intervention Type
Other
Intervention Name(s)
lumbar proprioception training
Other Intervention Name(s)
lumbar proprioception exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hot packs
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Pelvic rocking exercise
Intervention Description
Pelvic rocking exercise
Primary Outcome Measure Information:
Title
Measurement of lumbar proprioception
Description
It will be evaluated through Biodex system in both groups before and after treatment program through measuring the lumbar repositioning accuracy.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Calculation of score of WaLIDD Scale
Description
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).
Time Frame
4 weeks
Title
lumbar curvature angle
Description
it will be measured by Flexible ruler which is affected by the tilt of the pelvis, in both groups before and after treatment program.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females at period of Primary Dysmenorrhea.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
doaa osman, assis.prof.
Phone
5792245
Email
Doaa.osman@cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
doaa osman, assis. prof
Phone
5792245
Email
Doaa.osman@cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
doaa osman, assis.prof
Organizational Affiliation
study principle investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doaa Osman
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doaa Osman, Assis.prof
Phone
5792245
Email
Doaa.osman@cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Nehal G. Omran, Ass. lecturer
First Name & Middle Initial & Last Name & Degree
Amel M. Yousef, Professor
First Name & Middle Initial & Last Name & Degree
Hossam E. Kamel, Professor
First Name & Middle Initial & Last Name & Degree
Hamada Ahmed Hamada, Assis. Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Lumbar Proprioception Training on Primary Dysmenorrhea

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