Innovative Orthosis in Hyperkyphosis

Medipol Health Group

Status: Completed

Conditions: Postural Kyphosis; Hyperkyphosis

Treatments: Device: Cover spine orthosis (CSO); Device: Semi-rigid thoracolumbar orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06988046

E-30 10840098-772.02-6671

Details and patient eligibility

About

Thoracic hyperkyphosis is a common postural deformity; however, the optimal treatment strategy has yet to be clearly defined. This randomized controlled trial aimed to assess the effectiveness of an innovative three-dimensional printed Cover Spine Orthosis (CSO) in managing thoracic hyperkyphosis. Specifically, the study compared the effects of the CSO on kyphosis angle, quality of life (QoL), and user satisfaction with those of a semi-rigid thoracolumbar orthosis (SRTLO) that has established efficacy in the literature.

Full description

Postural kyphosis is associated with various clinical symptoms, including fatigue, pain, weakness of the back extensor muscles, depressive mood, and a reduction in quality of life (QoL). Previous research has consistently shown that spinal deformities negatively impact overall health, particularly diminishing individuals' QoL. Although conservative approaches are commonly recommended for managing postural kyphosis, a universally accepted treatment protocol has not yet been established. Current evidence suggests that interventions such as exercise, kinesio-taping, and orthotic use may be effective in decreasing the thoracic kyphosis angle (TKA). Among these, orthotic interventions have been widely employed to correct posture and reduce TKA. While various orthosis designs have been studied, and some have demonstrated significant outcomes, there is still no consensus on the most effective orthotic treatment. In light of existing literature and advancements in biomechanics and design technologies, a novel three-dimensional (3D) orthosis was developed to address these gaps. This study aimed primarily to assess the effectiveness of a custom-designed, 3D-printed Cover Spine Orthosis (CSO) in reducing TKA in individuals with postural kyphosis, in comparison to a semi-rigid thoracolumbar orthosis (SRTLO) previously validated in the literature. A secondary objective was to evaluate and compare the effects of both orthoses on quality of life and user satisfaction

Enrollment: 34 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals of both sexes (male and female)
• Aged between 20 and 60 years
• Presence of thoracic kyphosis angle (TKA) ≥ 40°

Exclusion criteria

• History of spinal surgery or traumatic injury
• Received physiotherapy treatment within the last six months
• Diagnosed with congenital spinal deformities or scoliosis
• Presence of acute musculoskeletal injury
• Inability to tolerate or adapt to orthotic application

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Cover spine orthosis group (CSO)

Experimental group

Description:

he Cover Spine Orthosis (CSO) is a novel therapeutic device specifically engineered to address excessive thoracic curvature in individuals diagnosed with hyperkyphosis. Utilizing three-dimensional (3D) printing technology, the orthosis is produced from thermoplastic polyurethane, a material known for its flexibility and durability. The CSO incorporates two primary corrective components positioned anteriorly and posteriorly. The anterior section functions to stabilize the thoracic region from the front, while the posterior section delivers a corrective force from the back, targeting spinal alignment. To ensure a secure and adaptive fit, elastic webbing with Velcro and loop fasteners is integrated on both sides of the shoulder and trunk. These connectors link the anterior and posterior components, maintaining optimal suspension of the orthosis on the user's body. Furthermore, the design features a broad contact area, which enhances postural control by distributing mechanical forces more

Treatment:

Device: Cover spine orthosis (CSO)

Semi-rigid thoracolumbar orthosis group (SRTLO)

Active Comparator group

Description:

The control group was fitted with a semi-rigid thoracolumbar orthosis (SRTLO), a device whose clinical efficacy has been previously validated. This orthosis includes paraspinal support bars, bilateral shoulder straps, and a Velcro-based fastening system. The paraspinal bars function to limit spinal flexion, thereby promoting an extended spinal posture. The shoulder straps are passed anteriorly over the shoulders, routed posteriorly through the axillary regions, crossed to the opposite side, and brought back to the front. Once appropriate tension is applied, the straps are secured using Velcro fasteners. Final stabilization is accomplished by anterior traction on the thoracic section straps to ensure optimal corrective force distribution.

Treatment:

Device: Semi-rigid thoracolumbar orthosis