Back to resultsEFFECT OF MYOFASCIAL RELEASE ON SCOLIOTIC CURVATURE AND PREMENSTRUAL SYMPTOMS IN FEMALES WITH DYSMENORRHEA
Primary Purpose
Scoliosis Idiopathic Adolescent, Dysmenorrhea, Premenstrual Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Myofascial release.
Traditional exercises for scoliosis treatment.
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis Idiopathic Adolescent focused on measuring Scoliosis , dysmenorrhea, Myofascial release, pre Menstrual symptoms
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Faculty of physical therapy cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control group
(Study group)
Arm Description
(Control group): will consist of 26 young females . They will receive traditional exercises for scoliosis.
(Study group): will consist of 26 young females. They will receive the same traditional scoliosis exercises in addition to myofascial release ( MFR ) .
Outcomes
Primary Outcome Measures
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
Assessment of menstrual symptoms by Menstrual distress questionnaire.
Menstrual Distress Questionnaire (MDQ): It will be used to assess menstrual symptoms of each female in both groups (A&B) at starting and after the end of the treatment course. The MEDI-Q investigated 25 items, covering the following areas: pain, discomfort, psychic or cognitive changes, gastrointestinal symptoms and changes in physiological functions. MEDI-Q Total Score and the three sub-scales, Menstrual Symptoms (MS), Menstrual Symptoms Distress (MSD) and Menstrual Specificity Index (MESI) were evaluated.
Assessment of quality of life by ISYQOL QUESTIONNAIRE (Italian Spine Youth Quality of Life (ISYQOL) Measuring Spine Related Quality of Life)
ISYQOL QUESTIONNAIRE(Italian Spine Youth Quality of Life (ISYQOL) Measuring Spine Related Quality of Life):The Italian Spine Youth Quality of Life questionnaire (ISYQOL) measures the health-related quality of life of adolescents with spinal deformities.ISYQOL consists of 20 items, each scored 0, 1 or 2. In accordance with the Rasch analysis technique, used to develop the questionnaire, the ordinal ISYQOL total score is converted to an interval measure (i.e., ISYQOL measure), which is expressed on a 0%- 100% scale (with 100% indicating high quality of life). Seven ISYQOL items assess the impact of bracing on quality of life and these are to be administered only to individuals who actually wear a brace. Thanks to the Rasch analysis approach, it is possible to compare the ISYQOL result of non-brace wearers (who answer only 13 of the 20 items) with that of brace wearers (who complete the entire questionnaire).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05817513
Brief Title
EFFECT OF MYOFASCIAL RELEASE ON SCOLIOTIC CURVATURE AND PREMENSTRUAL SYMPTOMS IN FEMALES WITH DYSMENORRHEA
Official Title
EFFECT OF MYOFASCIAL RELEASE ON SCOLIOTIC CURVATURE AND PREMENSTRUAL SYMPTOMS IN FEMALES WITH DYSMENORRHEA
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 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
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
Detailed Description
Adolescent idiopathic scoliosis (AIS) is a complex 3D structural disorder of the spine seen in children from 10 years old until skeletal maturity and confirmed by a Cobb angle of 10° or more and accompanied by vertebral rotation (Addai et al., 2020). It is the most common types of scoliosis and it is predominantly seen in girls at low curve magnitudes ( LeBauer et al., 2008).
A previous study reported the beneficial effect of myofascial release (MFR) on adults with idiopathic scoliosis (LeBauer et al., 2008). MFR showed a decrease in pain, improved posture, and advancement in quality of life, which may include physical, social, and pulmonary function (las Penas, 2005). HYPOTHESES:
There will be no effect of myofascial release on spinal curvatures, menstrual pain, and quality of life in young scoliotic females with primary dysmenorrhea .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic Adolescent, Dysmenorrhea, Premenstrual Syndrome, Quality of Life
Keywords
Scoliosis , dysmenorrhea, Myofascial release, pre Menstrual symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double masking
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm Description
(Control group): will consist of 26 young females . They will receive traditional exercises for scoliosis.
Arm Title
(Study group)
Arm Type
Experimental
Arm Description
(Study group): will consist of 26 young females. They will receive the same traditional scoliosis exercises in addition to myofascial release ( MFR ) .
Intervention Type
Other
Intervention Name(s)
Myofascial release.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional exercises for scoliosis treatment.
Intervention Description
The exercises are:
Pelvic tilt.
Arm and leg raises.
Cat-cow.
Bird dog.
Latismus dorsi stretch.
Abdominal press.
Practice a good posture.
Primary Outcome Measure Information:
Title
Assessment of trunk rotation and rib hump by Scoliometer.
Description
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
Time Frame
Eight weeks.
Title
Assessment of menstrual symptoms by Menstrual distress questionnaire.
Description
Menstrual Distress Questionnaire (MDQ): It will be used to assess menstrual symptoms of each female in both groups (A&B) at starting and after the end of the treatment course. The MEDI-Q investigated 25 items, covering the following areas: pain, discomfort, psychic or cognitive changes, gastrointestinal symptoms and changes in physiological functions. MEDI-Q Total Score and the three sub-scales, Menstrual Symptoms (MS), Menstrual Symptoms Distress (MSD) and Menstrual Specificity Index (MESI) were evaluated.
Time Frame
Eight weeks.
Title
Assessment of quality of life by ISYQOL QUESTIONNAIRE (Italian Spine Youth Quality of Life (ISYQOL) Measuring Spine Related Quality of Life)
Description
ISYQOL QUESTIONNAIRE(Italian Spine Youth Quality of Life (ISYQOL) Measuring Spine Related Quality of Life):The Italian Spine Youth Quality of Life questionnaire (ISYQOL) measures the health-related quality of life of adolescents with spinal deformities.ISYQOL consists of 20 items, each scored 0, 1 or 2. In accordance with the Rasch analysis technique, used to develop the questionnaire, the ordinal ISYQOL total score is converted to an interval measure (i.e., ISYQOL measure), which is expressed on a 0%- 100% scale (with 100% indicating high quality of life). Seven ISYQOL items assess the impact of bracing on quality of life and these are to be administered only to individuals who actually wear a brace. Thanks to the Rasch analysis approach, it is possible to compare the ISYQOL result of non-brace wearers (who answer only 13 of the 20 items) with that of brace wearers (who complete the entire questionnaire).
Time Frame
Eight weeks.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liza Ibrahim
Phone
+201226673900
Email
loza_ebrahim@yahoo.com
Facility Information:
Facility Name
Faculty of physical therapy cairo university
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cairo university
12. IPD Sharing Statement
Plan to Share IPD
No
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EFFECT OF MYOFASCIAL RELEASE ON SCOLIOTIC CURVATURE AND PREMENSTRUAL SYMPTOMS IN FEMALES WITH DYSMENORRHEA
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