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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05817513
Other study ID # 012/004351
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date May 2023

Study information

Verified date April 2023
Source Cairo University
Contact Liza Ibrahim
Phone +201226673900
Email loza_ebrahim@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 2023
Est. primary completion date April 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: 1. All young females have primary dysmenorrhea and idiopathic scoliosis. 2. They are diagnosed with idiopathic scoliosis; their trunk rotation and rib hump measured by scoliometer will be more than 5. 3. They will experience pain in abdominal region, back and/or referred to the thigh during menstruation. 4. They experience a regular menstrual cycle 5. Their age will range from 18 to 25 years old. 6. Body mass index (BMI) will range between 18.5 to 24.9 kg/m2. Exclusion Criteria: 1. Females who have any pelvic diseases or secondary dysmenorrhea. 2. Females who had received any spinal surgeries. 3. Females with irregular menstrual cycles. 4. History of gynecological interventions and having received manipulative treatment within the 2 months before the beginning of the study.

Study Design


Intervention

Other:
Myofascial release.
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.
Traditional exercises for scoliosis treatment.
The exercises are: Pelvic tilt. Arm and leg raises. Cat-cow. Bird dog. Latismus dorsi stretch. Abdominal press. Practice a good posture.

Locations

Country Name City State
Egypt Faculty of physical therapy cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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. Eight weeks.
Primary 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). Eight weeks.
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