NCT05764499

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

February 7, 2023

Last Update Submit

March 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Body Image Score

    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

Study Arms (2)

Children

Patients under the age of 18

Other: Physiotherapy Scoliosis Specific Exercise (PSSE)

Adults

Patients 18 years old and above

Other: Physiotherapy Scoliosis Specific Exercise (PSSE)

Interventions

Patients completed 120 hours of group based PSSE over a four week time frame. Monday - Friday, 10.00-17.00.

AdultsChildren

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants were all consecutive patients at the Scoliosis SOS Clinic in London, a private healthcare clinic specializing in non-invasive treatment for Scoliosis. All patients were routinely completing their treatment.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient who did not complete treatment or all measurements obtained. Patients who underwent surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scoliosis SOS Clinic

London, E1 8AN, United Kingdom

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

March 10, 2023

Study Start

April 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

No patient information or databases will be shared outside of the clinic

Locations