NCT06051435

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

September 11, 2023

Last Update Submit

April 17, 2025

Conditions

Keywords

lumbar proprioception trainingpelvic rocking exercisesprimary dysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Calculation of score of WaLIDD Scale

    4 weeks

  • lumbar curvature angle

    4 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Hot packsOther: Pelvic rocking exercise

Lumbar proprioception group

EXPERIMENTAL

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

Other: lumbar proprioception trainingOther: Hot packsOther: Pelvic rocking exercise

Interventions

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.

Also known as: lumbar proprioception exercises
Lumbar proprioception group

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

Control groupLumbar proprioception group

Pelvic rocking exercise

Control groupLumbar proprioception group

Eligibility Criteria

Age18 Years - 22 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doaa Osman

Giza, Egypt

Location

Study Officials

  • Amel Mohamed Yousef, PhD

    Professor, Cairo university

    STUDY CHAIR
  • Hamada Ahmed Hamada, PhD

    Assistant Professor, Cairo university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor Physical Therapy for Woman's Health Faculty of Physical Therapy Cairo University

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 22, 2023

Study Start

October 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 30, 2024

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations