- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04689295
The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis
May 26, 2022 updated by: Fatih Çelik, Hacettepe University
This study was aimed to compare the effect of Schroth therapy method, which is a 3-dimensional scoliosis exercise method, and traditional exercises on pain, body awareness and quality of life in young individuals with idiopathic scoliosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
38 individuals aged between 10-18 with the diagnosis of idiopathic scoliosis will be participated in the study.
Individuals (study group) underwent 1 hour exercise program 3 times a week for 6 weeks, and the individuals (control group) undervent a traditional exercise program once a week under supervision of physiotherapist for 6 weeks.
During the rest of the week, same exercise program was given as a home program for at least half an hour a day and individuals will followed up.
Individuals' subjective pain intensity will be assessed with Visual Analogue Scale (VAS), pressure pain threshold by algometer, body awareness by Turkish version of Body Awareness Questionnaire and quality of life by Turkish version of Scoliosis Research Society (SRS)-22 scale.
Measurements will be performed before and after the 6-week exercise program.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
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
-
-
-
Konya, Turkey, 42000
- Fizyo Omurga
-
-
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
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having been diagnosed with idiopathic scoliosis by a specialist physician,
- Between the ages of 10-18,
- Primary curvature between 20-40 degrees according to the Cobb method,
- Having C or S type of scoliosis,
- Having back / low-back pain due to scoliosis,
- Those who have not received any previous exercise therapy for scoliosis,
- Volunteering to participate in the study,
- Having the cognitive capacity to cooperate with the directions of the physiotherapist,
- Has not suffered any injuries to the musculoskeletal system in the last 6 months,
- No neurological, orthopedic or cardiopulmonary disorders other than scoliosis diagnosis,
- Young individuals who have not undergone any surgery related to the diagnosis of scoliosis
Exclusion Criteria:
- Previous spinal surgery,
- Any disease other than idiopathic scoliosis,
- Individuals who cannot adapt to the directions of the physiotherapist and cannot fulfill the requirements of the exercise program
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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: experiment group
Three dimensional scoliosis therapy method (Schroth) will be applied to the participants for 6 weeks.
It consist of 15 different exercises combined with rotational breathing exercise.
|
Schroth three dimensional scoliosis therapy method
|
Other: control group
Traditional scoliosis exercises will be applied to the participants for 6 weeks.
It consist of 6 different exercises
|
Traditional scoliosis exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Level
Time Frame: 6 weeks
|
Pain level will be assessed with VAS (visual analog scale) (min:0, max:10)
|
6 weeks
|
Pressure Pain Threshold
Time Frame: 6 weeks
|
Pressure pain threshold with algometer (kg/cm^2).
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body awareness before and after treatment
Time Frame: 6 weeks
|
body awareness assessment will be done with body awareness questionnaire (min:18, max:126 pts.)
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life before and after treatment
Time Frame: 6 weeks
|
quality of life assessment will be done with SRS-22 (scoliosis research society 22 form)(min:1, max:5 pts.)
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: fatih çelik, Physiotherapist
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)
July 1, 2019
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
October 15, 2021
Study Registration Dates
First Submitted
December 2, 2020
First Submitted That Met QC Criteria
December 29, 2020
First Posted (Actual)
December 30, 2020
Study Record Updates
Last Update Posted (Actual)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 26, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/0041
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
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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