Conservative Management for Adolescent Idiopathic Scoliosis

Umm Al-Qura University

Status: Enrolling

Conditions: Scoliosis; Adolescence

Treatments: Other: Soft orthoses with external strapping.; Other: Scoliosis-Specific Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05819034

DSR02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Adolescents in the control group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve

Treatment:

Other: Scoliosis-Specific Exercise Program

Experimental Group

Experimental group

Description:

Adolescents in the experimental group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve in addition to wearing the soft orthoses with external strapping.

Treatment:

Other: Scoliosis-Specific Exercise Program

Other: Soft orthoses with external strapping.