ScoliosisNCT04689295
The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis
A study testing exercise programme 1 and exercise programme 2 in people with Scoliosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- exercise programme 1 and exercise programme 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 15 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Scoliosis
- Being tested
- exercise programme 1, exercise programme 2
- Keywords
- Schroth, idiopathic scoliosis, pain, quality of life, body awareness
- Medical subject headings
- Scoliosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise programme 1Other
Schroth three dimensional scoliosis therapy method
exercise programme 2Other
Traditional scoliosis exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: exercise programme 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Pain level will be assessed with VAS (visual analog scale) (min:0, max:10)
Measured: 6 weeks
Pressure Pain Threshold
Pressure pain threshold with algometer (kg/cm^2).
Measured: 6 weeks
Secondary outcomes (1)
Body awareness before and after treatment
body awareness assessment will be done with body awareness questionnaire (min:18, max:126 pts.)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jul 2019
- Primary completion30 Apr 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Çelik, Hacettepe University
- Investigators
- fatih çelik, Study director, physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689295
- Sponsor's protocol ID
- 2019/0041
- Status last verified
- Jul 2024
- First submitted
- 2 Dec 2020
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04689295
- Acronym / sponsor ID
- 2019/0041
- Conditions
- Scoliosis
- Keywords
- Schroth, idiopathic scoliosis, pain, quality of life, body awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Other | Other: exercise programme 1Three 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. |
| control group | Other | Other: exercise programme 2Traditional scoliosis exercises will be applied to the participants for 6 weeks. It consist of 6 different exercises |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise programme 1Schroth three dimensional scoliosis therapy method | Other | experiment group |
| exercise programme 2Traditional scoliosis exercises | Other | control group |
Primary outcome
Pain Level
Time frame: 6 weeks
Pain level will be assessed with VAS (visual analog scale) (min:0, max:10)
Pressure Pain Threshold
Time frame: 6 weeks
Pressure pain threshold with algometer (kg/cm^2).
1 secondary outcome
Body awareness before and after treatment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fatih çelik study director
physiotherapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise programme 1 and exercise programme 2 in people with Scoliosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.