Back to resultsThe Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis
Primary Purpose
Scoliosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise programme 1
exercise programme 2
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis focused on measuring Schroth, idiopathic scoliosis, pain, quality of life, body awareness
Eligibility Criteria
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
Sites / Locations
- Fizyo Omurga
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
experiment group
control group
Arm Description
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.
Traditional scoliosis exercises will be applied to the participants for 6 weeks. It consist of 6 different exercises
Outcomes
Primary Outcome Measures
Pain Level
Pain level will be assessed with VAS (visual analog scale) (min:0, max:10)
Pressure Pain Threshold
Pressure pain threshold with algometer (kg/cm^2).
Secondary Outcome Measures
Body awareness before and after treatment
body awareness assessment will be done with body awareness questionnaire (min:18, max:126 pts.)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04689295
Brief Title
The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis
Official Title
The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Schroth, idiopathic scoliosis, pain, quality of life, body awareness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experiment group
Arm Type
Other
Arm Description
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.
Arm Title
control group
Arm Type
Other
Arm Description
Traditional scoliosis exercises will be applied to the participants for 6 weeks. It consist of 6 different exercises
Intervention Type
Other
Intervention Name(s)
exercise programme 1
Intervention Description
Schroth three dimensional scoliosis therapy method
Intervention Type
Other
Intervention Name(s)
exercise programme 2
Intervention Description
Traditional scoliosis exercises
Primary Outcome Measure Information:
Title
Pain Level
Description
Pain level will be assessed with VAS (visual analog scale) (min:0, max:10)
Time Frame
6 weeks
Title
Pressure Pain Threshold
Description
Pressure pain threshold with algometer (kg/cm^2).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Body awareness before and after treatment
Description
body awareness assessment will be done with body awareness questionnaire (min:18, max:126 pts.)
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Quality of life before and after treatment
Description
quality of life assessment will be done with SRS-22 (scoliosis research society 22 form)(min:1, max:5 pts.)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatih çelik
Organizational Affiliation
physiotherapist
Official's Role
Study Director
Facility Information:
Facility Name
Fizyo Omurga
City
Konya
ZIP/Postal Code
42000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis
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