NCT04689295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

December 2, 2020

Last Update Submit

July 22, 2024

Conditions

Keywords

Schrothidiopathic scoliosispainquality of lifebody awareness

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Body awareness before and after treatment

    6 weeks

Other Outcomes (1)

  • Quality of life before and after treatment

    6 weeks

Study Arms (2)

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

Schroth three dimensional scoliosis therapy method

experiment group

Traditional scoliosis exercises

control group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fizyo Omurga

Konya, 42000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ScoliosisPain

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • fatih çelik

    physiotherapist

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 30, 2020

Study Start

July 1, 2019

Primary Completion

April 30, 2021

Study Completion

May 15, 2021

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations