Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05764499
Other study ID # ScoliosisSOS1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date December 31, 2021

Study information

Verified date March 2023
Source Scoliosis SOS Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Introduction: Truncal shift caused by scoliosis can be measured with a Formetric Scanner using the Maximal Thoracic Apical Deviation (MTAD) measurement. It is a well-documented complaint with regards to body-image in patients with idiopathic scoliosis (IS). Furthermore, thoracic apical deviation is an important measure in pre-operative assessment and post-operative outcomes. Objective: The aim of this retrospective cohort study was to determine the long-term effects of an intensive course of Physiotherapy Scoliosis Specific Exercise (PSSE) on MTAD in patients with IS. Methods: Consecutive IS patients with a single right-sided thoracic curvature who completed an intensive 4-week course of PSSE were recruited. Data was collected between April 2019 and December 2021. All patients were routinely scanned using a Formetric Scanner pre-, immediately post-, 12- and 24-months post-treatment. MTAD, measured in millimetres, was documented. Adults (>17 years old) (group 1) and children (group 2) were analysed separately.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who completed the group treatment program in its entirety. Patients who have measurements obtained from all necessary time points. Patient who have Scoliosis and who have a primary thoracic curvature. Exclusion Criteria: - Patient who did not complete treatment or all measurements obtained. Patients who underwent surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physiotherapy Scoliosis Specific Exercise (PSSE)
Patients completed 120 hours of group based PSSE over a four week time frame. Monday - Friday, 10.00-17.00.

Locations

Country Name City State
United Kingdom Scoliosis SOS Clinic London

Sponsors (1)

Lead Sponsor Collaborator
Scoliosis SOS Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal Thoracic Apical Deviation Maximal Apical Deviation measurement in mm, obtained from the DIERS 4D Formetric Scanner Pre-Treatment (Day 1 of treatment), Day 20 of treatment after study completion, an average of four weeks later, 12 months after Post-Treatment, and 24 months after Post-Treatment
Secondary Body Image Score Average Body Image Score. Average score from 5 categories, scored from 1-10. Pre-Treatment (Day 1 of treatment), Day 20 of treatment after study completion, an average of four weeks later, 12 months after Post-Treatment, and 24 months after Post-Treatment
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Recruiting NCT05944393 - Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery N/A
Recruiting NCT05888038 - Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair N/A
Completed NCT02558985 - Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
Completed NCT02413788 - Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis N/A
Completed NCT02531945 - Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years N/A
Completed NCT02890654 - Scoliosis and Quality of Life of Adolescents
Terminated NCT02134704 - MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis N/A
Completed NCT02609009 - Back Pain and Spinal Manipulation in Adolescent Scoliosis N/A
Completed NCT02285621 - Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis N/A
Withdrawn NCT00768313 - Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis. Phase 4
Completed NCT00155545 - Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients Phase 1
Completed NCT00154505 - Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons Phase 1
Completed NCT00320619 - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery N/A
Completed NCT00273598 - Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis Phase 2
Completed NCT03135665 - Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure N/A
Completed NCT06428864 - Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
Recruiting NCT04423146 - Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
Completed NCT03814239 - Blood and Fluid Management During Scoliosis Surgery
Withdrawn NCT02058238 - ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity