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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rehabilitation; Scoliosis Idiopathic; Idiopathic Scoliosis; C-shape
• Intervention / Treatment: Other: traction and mobilization; Other: active exercise therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: khalid safwat elsayed, assistant lecturer; Phone Number: 01222397882; Email: Khalidd843@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • May University in Cairo (MUC)
    • Contact: khalid safwat elsayed, assistant lecturer; Phone Number: 01222397882; Email: Khalidd843@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 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:

1. History of orthopaedic surgeries.
2. History of road traffic accidents (RTA).
3. Myopathy.
4. True leg length discrepancy.
5. Neuropathy.
6. Mental disorders.
7. Bone tumor.
8. Heart disease or circulatory problems.
9. Early osteoporosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: traction with mobilization; it consists of 35 patients and patients will receive traction with mobilization 3 sessions per week for 3 months with a total of 36 sessions. there will be a follow-up for 2 months with home program exercises and postural instructions only followed by the same pre and post-treatment assessment measures	Other: traction and mobilization; 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 Comparator: active exercise therapy); it consists of 35 patients and patients will active exercises 3 sessions per week for 3 months with a total of 36 sessions. there will be a follow-up for 2 months with home program exercises and postural instructions only followed by the same pre and post-treatment assessment measures	Other: active exercise therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of degree of spinal curvature	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	at baseline and after 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of the change of the weight, height and body mass index	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	at baseline and after 3 months
assessment of the change of the trunk flexion and extension ROM	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.	at baseline and after 3 months
assessment of the change of the trunk lateral flexion ROM	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.	at baseline and after 3 months
assessment of the change of the trunk rotation ROM	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.	at baseline and after 3 months
assessment of the change of the cervical flexion and extension ROM	To measure flexion, the patient should comfortably lower their chin towards their chest without bending their upper back or shoulders, maintaining straight-forward eyes.	at baseline and after 3 months
assessment of the change of the cervical lateral flexion ROM	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.	at baseline and after 3 months
assessment of the change of the cervical rotation ROM	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.	at baseline and after 3 months
assessment of the change of fingertips to floor distance	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.	at baseline and after 3 months
assessment of the change of the degree of spinal curvature	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.	at baseline and after 3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: August 17, 2024
• First Submitted That Met QC Criteria: August 17, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 17, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: khalid-005244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No