Scoliosis Idiopathic AdolescentNCT05817513
Effect of Myofascial Release on Scoliotic Females With Dysmenorrhea.
A study testing Myofascial release. and Traditional exercises for scoliosis treatment. in people with Scoliosis Idiopathic Adolescent and Dysmenorrhea, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic Adolescent, Dysmenorrhea, Premenstrual Syndrome
- What is being tested?
- Myofascial release. and Traditional exercises for scoliosis treatment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Myofascial Release on Spinal Curvature, Pre Menstrual Symptoms and Quality of Life in Scoliotic Females With Dysmenorrhea.
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
Read the 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 .
- Being tested
- Myofascial release., Traditional exercises for scoliosis treatment.
- Keywords
- Scoliosis , dysmenorrhea, Myofascial release, pre Menstrual symptoms
- Medical subject headings
- Dysmenorrhea, Premenstrual Syndrome, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial release.Other
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.Other
The exercises are:
- Pelvic tilt.
- Arm and leg raises.
- Cat-cow.
- Bird dog.
- Latismus dorsi stretch.
- Abdominal press.
- Practice a good posture.
- Stretching and scapular exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | (Control group): will consist of 26 young females . They will receive traditional exercises for scoliosis. Receives: 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 ) . Receives: Other: Myofascial release.; Other: Traditional exercises for scoliosis treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Eight weeks.
Secondary outcomes (2)
Premenstrual symptoms were assessed using MSQ questionnaire.
Premenstrual symptoms were assessed using MSQ questionnaire a modified version of MOO's.
The symptoms commonly found are assessed on a four point scale with response ranging from 0 =no effect; 1 = mild, present; 2 = moderate; and 3 = severe disabling with regard to It evaluated behavioral changes; water and salt retention; depression. The MSQ also measured the occurrence and severity of two menstrual pain symptoms including cramp and backache experienced during the first 2 days of the subjects' last menstrual period.
Measured: Eight weeks.
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).
Measured: Eight weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic AdolescentStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liza ibrahim saadallah ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817513
- Sponsor's protocol ID
- 012/004351
- Status last verified
- Oct 2024
- First submitted
- 5 Apr 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofascial Release on Spinal Curvature, Pre Menstrual Symptoms and Quality of Life in Scoliotic Females With Dysmenorrhea.
- ClinicalTrials.gov ID
- NCT05817513
- Acronym / sponsor ID
- 012/004351
- Keywords
- Scoliosis , dysmenorrhea, Myofascial release, pre Menstrual symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Other: Traditional exercises for scoliosis treatment.(Control group): will consist of 26 young females . They will receive traditional exercises for scoliosis. |
| (Study group) | Experimental | Other: Myofascial release., Other: Traditional exercises for scoliosis treatment.(Study group): will consist of 26 young females. They will receive the same traditional scoliosis exercises in addition to myofascial release ( MFR ) . |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | (Study group) |
| Traditional exercises for scoliosis treatment.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. | Other | (Study group), Control group |
Primary outcome
Assessment of trunk rotation and rib hump by Scoliometer.
Time frame: Eight weeks.
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
2 secondary outcomes
Premenstrual symptoms were assessed using MSQ questionnaire.
Time frame: Eight weeks.
Assessment of quality of life by ISYQOL QUESTIONNAIRE (Italian Spine Youth Quality of Life (ISYQOL) Measuring Spine Related Quality of Life)
Time frame: Eight weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release. and Traditional exercises for scoliosis treatment. in people with Scoliosis Idiopathic Adolescent and Dysmenorrhea, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of trunk rotation and rib hump by Scoliometer. (time frame: Eight weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.