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NCT Number: NCT06563141

A Suggested Rehabilitation Protocol for the Treatment of C-shape Scoliosis

This study aims to compare the effectiveness of mechanical traction and 3D apical vertebral mobilization and active exercises on Cobb's angle, spinal ROM, and function in patients with C-shaped scoliosis.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

May University in Cairo (MUC)

Cairo, Egypt

Location status: Recruiting

Location contact

khalid safwat elsayed, assistant lecturer

CONTACT

[email protected]

01222397882

About this study

Scoliosis is a skeletal issue causing asymmetries, leading to functional disruptions. Common symptoms include uneven eye tilt, drop asloped shoulder, and muscle imbalances. These changes can affect the patient's physical appearance and psychological state. Current treatments have shown suboptimal results due to the lack of accepted scientific theories for idiopathic scoliosis. Therefore, a new therapeutic approach is needed to provide novel insights and improve treatment outcomes. This underscores the need for a more comprehensive approach to scoliosis treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult individuals aged 18 to 30 years (after complete ossification and before the start of the ageing process and joint changes) as mentioned in studies.
  • Thoracolumbar scoliosis with Cobb angle between 10 to 30 degrees because a curve below 10 degrees has no effect and above 30 is indicated for surgery.

Exclusion criteria

  • History of orthopaedic surgeries.
  • History of road traffic accidents (RTA).
  • Myopathy.
  • True leg length discrepancy.
  • Neuropathy.
  • Mental disorders.
  • Bone tumor.
  • Heart disease or circulatory problems.
  • Early osteoporosis.

Treatment and study plan

traction and mobilization

Other

The patient undergoes a 15-minute infrared therapy session, followed by flexibility and stretching exercises targeting the trunk and four extremities muscles. Land manipulation techniques are used for cervical, dorsal, and lumbar spine to assess and treat spinal dysfunctions. Deep breathing exercises with rib mobilization are also performed to promote respiratory function and thoracic flexibility. The session aims to improve overall health.

active exercise therapy

Other

Patients with adolescent idiopathic scoliosis will receive exercise programs from seven major schools under SOSORT, focusing on realigning the spine, rib cage, shoulders, and pelvis to normal anatomical postures.

Primary outcomes

  1. assessment of degree of spinal curvature

    Time frame: at baseline and after 3 months

    it will be assessed using the scoliometer which is typically consists of a level or inclinometer attached to a base. The scoliometer is placed along the spine, and the angle of deviation from the vertical is measured to assess the severity of the curvature

Secondary outcomes

  1. assessment of the change of the weight, height and body mass index

    Time frame: at baseline and after 3 months

    This scale (DT-150, Shanghai, China) Figure (3) will be used for the measurement of height and weight for each participant and the results will be used for the calculation of the Body Mass Index

  2. assessment of the change of the trunk flexion and extension ROM

    Time frame: at baseline and after 3 months

    To measure flexion, the patient should bend forward at the waist comfortably without knees, and the examiner should stabilize the goniometer's stationary arm on the midline of the spine.

  3. assessment of the change of the trunk lateral flexion ROM

    Time frame: at baseline and after 3 months

    To measure lateral flexion, the patient should lean comfortably sideways without bending forward or rotating the trunk, while the goniometer's stationary arm should be stabilized at the appropriate level.

  4. assessment of the change of the trunk rotation ROM

    Time frame: at baseline and after 3 months

    To measure rotation, the patient rotates their trunk comfortably without moving their hips or feet. The goniometer is placed parallel to the ground, using the scapula's spine as a reference point. The stationary arm remains parallel to the starting position.

  5. assessment of the change of the cervical flexion and extension ROM

    Time frame: at baseline and after 3 months

    To measure flexion, the patient should comfortably lower their chin towards their chest without bending their upper back or shoulders, maintaining straight-forward eyes.

  6. assessment of the change of the cervical lateral flexion ROM

    Time frame: at baseline and after 3 months

    To measure lateral flexion, the patient should tilt their head sideways comfortably without rotating their head or shoulders, keeping their chin level during the movement.

  7. assessment of the change of the cervical rotation ROM

    Time frame: at baseline and after 3 months

    To measure rotation, the patient should comfortably turn their head left or right without tilting their head or shoulders, maintaining straight eyes during the movement.

  8. assessment of the change of fingertips to floor distance

    Time frame: at baseline and after 3 months

    The finger-to-floor distance test is a quick and convenient method to assess hamstring and lower back flexibility. It involves standing up straight, bending forward, lowering hands, reaching the endpoint, and measuring the distance between fingers and the floor.

  9. assessment of the change of the degree of spinal curvature

    Time frame: at baseline and after 3 months

    To measure the Cobb angle on an X-ray, identify the vertebrae with the most tilted endplates, draw lines along the spine's curvature, draw perpendicular lines intersecting at a right angle, and measure the Cobb angle, which represents the degree of spinal curvature.

Study contacts

Contact information is provided by the study sponsor or research team.

khalid safwat elsayed, assistant lecturer

CONTACT

[email protected]

01222397882

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Suggested Rehabilitation Protocol for the Treatment of C-shape Scoliosis: a Randomized Control Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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