NCT05817513

Brief Summary

PURPOSE: The purpose of this study is to determine the effect of myofascial release on spinal curvature, premenstrual symptoms, and quality of life in scoliotic females with dysmenorrhea

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

April 5, 2023

Last Update Submit

October 8, 2024

Conditions

Keywords

Scoliosis , dysmenorrhea, Myofascial release, pre Menstrual symptoms

Outcome Measures

Primary Outcomes (1)

  • Assessment of trunk rotation and rib hump by Scoliometer.

    Scoliometer will be used to measure trunk rotation and rib hump of each female in both groups (A\&B) at starting and after the end of the treatment course. The most common method to screen for significant scoliosis is the forward bend test, which is often combined with the use of a sociometer

    Eight weeks.

Secondary Outcomes (2)

  • Premenstrual symptoms were assessed using MSQ questionnaire.

    Eight weeks.

  • Assessment of quality of life by ISYQOL QUESTIONNAIRE (Italian Spine Youth Quality of Life (ISYQOL) Measuring Spine Related Quality of Life)

    Eight weeks.

Study Arms (2)

Control group

EXPERIMENTAL

(Control group): will consist of 26 young females . They will receive traditional exercises for scoliosis.

Other: Traditional exercises for scoliosis treatment.

(Study group)

EXPERIMENTAL

(Study group): will consist of 26 young females. They will receive the same traditional scoliosis exercises in addition to myofascial release ( MFR ) .

Other: Myofascial release.Other: Traditional exercises for scoliosis treatment.

Interventions

Myofascial release (MFR) is a therapeutic treatment that uses gentle pressure and stretching to facilitate the release of fascial restrictions caused by accidents, injury, stress, repetitive use, and traumatic or surgical scarring. The fascial restrictions are palpated by the practitioner and the techniques are applied directly to the skin of the patient without lotions or oils. The pressure is applied into the direction of the restriction just until resistance is felt or the tissue is perceived to stop moving. The pressure is sustained at this point of resistance, without sliding over the skin or forcing the tissue, for a minimum of 90-120s. As the tissue begins to release, the practitioner maintains the same amount of pressure and follows the release three dimensionally through multiple releases.

(Study group)

The exercises are: 1. Pelvic tilt. 2. Arm and leg raises. 3. Cat-cow. 4. Bird dog. 5. Latismus dorsi stretch. 6. Abdominal press. 7. Practice a good posture. 8. Stretching and scapular exercises.

(Study group)Control group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All young females have primary dysmenorrhea and idiopathic scoliosis.
  • They are diagnosed with idiopathic scoliosis; their trunk rotation and rib hump measured by scoliometer will be more than 5.
  • They will experience pain in abdominal region, back and/or referred to the thigh during menstruation.
  • They experience a regular menstrual cycle
  • Their age will range from 18 to 25 years old.
  • Body mass index (BMI) will range between 18.5 to 24.9 kg/m2.

You may not qualify if:

  • Females who have any pelvic diseases or secondary dysmenorrhea.
  • Females who had received any spinal surgeries.
  • Females with irregular menstrual cycles.
  • History of gynecological interventions and having received manipulative treatment within the 2 months before the beginning of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

DysmenorrheaPremenstrual SyndromeScoliosis

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups, one group will be treated by traditional exercises for scoliosis treatment and another group will be treated by Myofascial release and traditional exercises.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Liza Ibrahim saadallah ibrahim

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

April 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations