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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04689295
Other study ID # 2019/0041
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date October 15, 2021

Study information

Verified date May 2022
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 15, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
exercise programme 1
Schroth three dimensional scoliosis therapy method
exercise programme 2
Traditional scoliosis exercises

Locations

Country Name City State
Turkey Fizyo Omurga Konya

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of life before and after treatment quality of life assessment will be done with SRS-22 (scoliosis research society 22 form)(min:1, max:5 pts.) 6 weeks
Primary Pain Level Pain level will be assessed with VAS (visual analog scale) (min:0, max:10) 6 weeks
Primary Pressure Pain Threshold Pressure pain threshold with algometer (kg/cm^2). 6 weeks
Secondary Body awareness before and after treatment body awareness assessment will be done with body awareness questionnaire (min:18, max:126 pts.) 6 weeks
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