Physiotherapy Scoliosis Specific Exercise Improves Truncal Shift in Idiopathic Scoliosis

March 9, 2023 updated by: Scoliosis SOS Ltd.

Physiotherapy Scoliosis Specific Exercise Improves Truncal Shift in Idiopathic Scoliosis: a 24 Month Follow up

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children
Patients under the age of 18
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.
Adults
Patients 18 years old and above
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Thoracic Apical Deviation
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Image Score
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scoliosis SOS Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Estimate)

March 10, 2023

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ScoliosisSOS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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