Idiopathic Spinal DeformitiesNCT05120089
Muscle Energy Technique Versus Myofacial Release in Adolescents With Spinal Deformity
A study testing muscle energy technique and myofacial release (physiotherapy techniques) in people with Idiopathic Spinal Deformities, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Spinal deformity may not only alter the physical appearance, but may also have a psychological impact on the child, particularly in the adolescent to whom self- image is so important. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Spinal Deformities
- What is being tested?
- muscle energy technique and myofacial release (physiotherapy techniques)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Nov 2021to 31 Jan 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in this group will be healthy category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 5th to 85th percentiles . All children are normal \&perform all activities of daily living
- They were able to understand and follow verbal commands and instructions included in the testing procedures.
Who cannot join
- All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
- None of them had any surgical intervention .
- None of them had any history of other musculoskeletal deformities or neuromuscular disorders.
- hey had neither visual, auditory defect.
Trial locations and contacts
1 site in 1 country.
About this study
Spinal deformity may not only alter the physical appearance, but may also have a psychological impact on the child, particularly in the adolescent to whom self- image is so important.
This study will investigate the effect of muscle energy technique compared to myofacial release in the adolescent with spinal deformities( scoliosis and/ or kyphosis).
- Conditions
- Idiopathic Spinal Deformities
- Being tested
- muscle energy technique and myofacial release (physiotherapy techniques)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle energy technique and myofacial release (physiotherapy techniques)Other
Each technique will be applied for three month (3 session/week)
| Study group | Role | What they receive |
|---|---|---|
| muscle energy technique | Experimental | Muscle energy technique is an associate degree of osteopathic manipulation methodology. The muscles of patients were used, on request, to type a singular controlled position, in a very specific direction, and against a distinctly executed therapist-applied counterforce. Muscle energy technique could be a post-isometric relaxation, because it reduces the tone of a muscle or cluster of muscle after a brief period following an isometric contraction. The result of post-isometric relaxation is mediated by receptive input from Golgi connective tissue organ (GTO) that has associate degree repressive result on the antagonist muscles mediated by the muscle spindle receptive. The technique will be applied for three month (3 session/week) Receives: Other: muscle energy technique and myofacial release (physiotherapy techniques) |
| myofacial release | Experimental | The technique will be applied for three month (3 session/week). All participants underwent ipsilateral side bending in a side-lying position, with the goals being de-rotation and scoliosis reduction. Receives: Other: muscle energy technique and myofacial release (physiotherapy techniques) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cobb angle for spinal deformities (scoliosis and/or kyphosis)
It is defined as the greatest angle at a particular region of the vertebral column, when measured from the superior endplate of a superior vertebra to the inferior endplate of an inferior vertebra. However, the endplates are generally parallel for each vertebra, so not all sources include usage of a superior versus inferior endplate in the definition.
Measured: immediately before the beginning of the intervention procedures
cobb angle for spinal deformities (scoliosis and/or kyphosis)
It is defined as the greatest angle at a particular region of the vertebral column, when measured from the superior endplate of a superior vertebra to the inferior endplate of an inferior vertebra. However, the endplates are generally parallel for each vertebra, so not all sources include usage of a superior versus inferior endplate in the definition.
Measured: by the end of successful three month of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start17 Nov 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Spinal DeformitiesStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120089
- Sponsor's protocol ID
- muscle energy technique
- Status last verified
- Mar 2023
- First submitted
- 17 Sep 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Energy Technique Versus Myofacial Release in Adolescents With Spinal Deformity
- ClinicalTrials.gov ID
- NCT05120089
- Acronym / sponsor ID
- muscle energy technique
- Conditions
- Idiopathic Spinal Deformities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 15 Nov 2021 (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.
Spinal deformity may not only alter the physical appearance, but may also have a psychological impact on the child, particularly in the adolescent to whom self- image is so important.
This study will investigate the effect of muscle energy technique compared to myofacial release in the adolescent with spinal deformities( scoliosis and/ or kyphosis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| muscle energy technique | Experimental | Other: muscle energy technique and myofacial release (physiotherapy techniques)Muscle energy technique is an associate degree of osteopathic manipulation methodology. The muscles of patients were used, on request, to type a singular controlled position, in a very specific direction, and against a distinctly executed therapist-applied counterforce. Muscle energy technique could be a post-isometric relaxation, because it reduces the tone of a muscle or cluster of muscle after a brief period following an isometric contraction. The result of post-isometric relaxation is mediated by receptive input from Golgi connective tissue organ (GTO) that has associate degree repressive result on the antagonist muscles mediated by the muscle spindle receptive. The technique will be applied for three month (3 session/week) |
| myofacial release | Experimental | Other: muscle energy technique and myofacial release (physiotherapy techniques)The technique will be applied for three month (3 session/week). All participants underwent ipsilateral side bending in a side-lying position, with the goals being de-rotation and scoliosis reduction. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children in this group will be healthy category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 5th to 85th percentiles . All children are normal \&perform all activities of daily living
- They were able to understand and follow verbal commands and instructions included in the testing procedures.
Key exclusion criteria (4 listed)
- All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
- None of them had any surgical intervention .
- None of them had any history of other musculoskeletal deformities or neuromuscular disorders.
- hey had neither visual, auditory defect.
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 |
|---|---|---|
| muscle energy technique and myofacial release (physiotherapy techniques)Each technique will be applied for three month (3 session/week) | Other | muscle energy technique, myofacial release |
Primary outcome
cobb angle for spinal deformities (scoliosis and/or kyphosis)
Time frame: immediately before the beginning of the intervention procedures
It is defined as the greatest angle at a particular region of the vertebral column, when measured from the superior endplate of a superior vertebra to the inferior endplate of an inferior vertebra. However, the endplates are generally parallel for each vertebra, so not all sources include usage of a superior versus inferior endplate in the definition.
cobb angle for spinal deformities (scoliosis and/or kyphosis)
Time frame: by the end of successful three month of intervention
It is defined as the greatest angle at a particular region of the vertebral column, when measured from the superior endplate of a superior vertebra to the inferior endplate of an inferior vertebra. However, the endplates are generally parallel for each vertebra, so not all sources include usage of a superior versus inferior endplate in the definition.
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 17 Mar 2023.
- Individual participant dataSharing planned: Yes
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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 muscle energy technique and myofacial release (physiotherapy techniques) in people with Idiopathic Spinal Deformities, run by Delta University for Science and Technology 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 2 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 17 Mar 2023. 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?
cobb angle for spinal deformities (scoliosis and/or kyphosis) (time frame: immediately before the beginning of the intervention procedures). The study lists 2 primary outcomes in all. 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 17 Mar 2023.