Clinical trial NCT05819034: Conservative Management for Adolescent Idiopathic Scoliosis
Official title: Orthotic Management for Controlling Scoliotic Curve Progression in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scoliosis; Adolescence
Keywords: Adolescents Idiopathic Scoliosis
Physical Therapy
Orthosis
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Scoliosis is one of the most common spinal deformities occurring in school-going children during the growth spurts of adolescents. It is an abnormal curvature of the spine. Failure of early management of idiopathic scoliosis could lead to multiple problems related to postural malalignment, pulmonary and physical dysfunctions, and surgical interventions. These problems could lead to health-related quality-of-life issues such as psychological and social problems that are represented in social isolation, depression, loss of self-confidence, limited job opportunities, and hospital stays \& days off school and university as a result of undergoing corrective surgeries. Treatment methods for adolescent idiopathic Scoliosis (AIS) vary between surgical intervention and conservative treatment, in mild and moderate cases. Conservative treatment includes physical therapy in addition to rigid splints and braces, which may cause pain, tightness, restriction of movement, and a bad psychological status for adolescents which may lead them to the irregular wearing of these splints and braces. A type of soft, lightweight, breathable orthosis which is TheraTogs orthotic undergarment with the strapping system has been fabricated to provide gentle, passive compression to correct spinal deformities. Therefore, the objective of this study is to evaluate the effectiveness of TheraTogs orthotic undergarment with the strapping system on controlling and modulating the degree of scoliosis in Saudi adolescents with idiopathic scoliosis.

Eligibility criteria: The inclusion criteria will be:

* 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.
* They have good health conditions except for scoliosis.
* They can understand and communicate with no mental abnormalities.

The exclusion criteria will be:

* 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,
* Participants who were subjected to any corrective surgery to their spine within the previous two years.
* Participants will be also excluded if their skin were sensitive or inflamed to any materials used.
* Participants who have seizures, perceptual disorders, visual problems, and auditory deficits
* Participants who have leg length discrepancy
* Participants who have scoliosis developed as a consequence of traumatic scoliosis.

Primary outcomes:
measure: Change in the scoliotic cobb's angle (°)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
measure: Changes in the Pelvic Obliquity (mm)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
measure: Change in the vertebral rotation (Angle)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
measure: Change in the Coronal imbalance (mm)
timeFrame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Secondary outcomes:
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Umm Al Qura University
Study officials:
affiliation: Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University
name: Ehab M Abd El Kafy, PhD
role: PRINCIPAL_INVESTIGATOR
References: