The Effect of Schroth Method on Pain, Body Awareness and... | NCT04689295

Studies
The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis

NCT04689295

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

Jul 23, 2024Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Scoliosis

Interventions

exercise programme 1
exercise programme 2

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

May 15, 2021Actual

First Submitted Date

Dec 2, 2020

First Submission Date that Met QC Criteria

Dec 29, 2020

First Posted Date

Dec 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2024

Last Update Posted Date

Jul 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experiment group	Other	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.	Other: exercise programme 1
control group	Other	Traditional scoliosis exercises will be applied to the participants for 6 weeks. It consist of 6 different exercises	Other: exercise programme 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise programme 1	Other	Schroth three dimensional scoliosis therapy method	experiment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Level	Pain level will be assessed with VAS (visual analog scale) (min:0, max:10)	6 weeks
Pressure Pain Threshold	Pressure pain threshold with algometer (kg/cm^2).	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Body awareness before and after treatment	body awareness assessment will be done with body awareness questionnaire (min:18, max:126 pts.)	6 weeks

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
fatih çelik	physiotherapist	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Fizyo Omurga		Konya		42000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012600	Scoliosis
D010146	Pain

Ancestor Terms

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided