Conservative Management for Adolescent Idiopathic Scoliosis
ConditionScoliosis; Adolescence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorUmm Al-Qura University
About this trial
Idiopathic scoliosis is a living problem that resists correction. The underlying cause of the such disorder is unknown but directed more toward muscular disorders. However recent clinical observation showed a possible neuromuscular compromise early in those patients. The main purpose of this study is to develop a treatment procedure to correct the degree of bony curvature in patients with Idiopathic scoliosis through developing a neuromuscular corrective approach that might be a more effective conservative treatment protocol for such disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents of both sexes with an age range between 10-17 years.
They were diagnosed with Adolescent idiopathic scoliosis by an orthopedic specialist, confirmed through (loaded) X- rays.
They have mild non-structural scoliosis with Cobb's angle measurement of between 10 and 25 degrees
They have Single major thoracolumbar curve located between T6-7 to L1-2, apex at T12 or L1.
Disqualifiers
Adolescents with cerebral palsy or other degenerative neurological disorders;
Participants with nutritional disorders e.g. diabetes or vascular disorders.
Participants with a scoliotic curve with angle > 25° will be excluded.
Participants will be excluded from this study if they have inflexible spinal deformities interfering with spinal mobility,
Trial design
Design model
Parallel
Treatments tested in this trial
Scoliosis-Specific Exercise Program
Other interventionAdolescents in the control group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve. This exercise program will include frontal plane active or passive correction exercises for scoliotic posture. The exercise program for every participant will be three sessions per week for 12 successive weeks. Every treatment session was applied for one hour.The exercise program for every participant will be three sessions per week for 12 successive weeks. Every treatment session was applied for one hour. The exercise program for every participant will be three sessions per week for 12 successive weeks. Every treatment session was applied for one hour.
Soft orthoses with external strapping.
Other interventionAdolescents in the experimental group will receive a scoliosis-specific exercises program which will be prescribed to control the progression of the scoliotic curve in addition to wearing the soft orthoses with external strapping. The wearing schedule of the soft orthosis with the external strapping for every participant in this group will be 12 hours daily for 12 successive weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Experimental GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in the scoliotic cobb's angle (°)
X-ray imaging will be measured by a radiologist
Time frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]2
Changes in the Pelvic Obliquity (mm)
The following device (DIERS Formetric 3D/4D spine \& posture analysis system) will be used to examine the changes in the spinal vertebral parameters in different planes (sagittal, coronal and transverse). This device supplies a thorough report about the alignment of the whole spine in one assessment session.
Time frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]3
Change in the vertebral rotation (Angle)
The following device (DIERS Formetric 3D/4D spine \& posture analysis system) will be used to examine the changes in the spinal vertebral parameters in different planes (sagittal, coronal and transverse). This device supplies a thorough report about the alignment of the whole spine in one assessment session.
Time frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]4
Change in the Coronal imbalance (mm)
The following device (DIERS Formetric 3D/4D spine \& posture analysis system) will be used to examine the changes in the spinal vertebral parameters in different planes (sagittal, coronal and transverse). This device supplies a thorough report about the alignment of the whole spine in one assessment session.
Time frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]Sponsors and contacts
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Source ClinicalTrials.gov