ScoliosisSQUADNCT02890654
Scoliosis and Quality of Life of Adolescents
An observational study of Scoliosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Around the scoliosis surgery, the pain (pre or post operative, physical, psychological, fantasy or real) is a major concern for adolescents and their families. She is also a key concern of caregivers, both its assessment and management is complex. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- First time measure, Second time measure and Third time measure
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Mar 2019
- Phase
- Observational
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Teenagers with diagnosis of idiopathic scoliosis
Who may be able to join
- Patients followed for idiopathic scoliosis with indication for surgery
- Patients monitored and operated at the Children Hospital of Toulouse
Who cannot join
- Opposition to the participation
- Spine deformations other than scoliosis
- Non idiopathic scoliosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Idiopathic Scoliosis Surgery in Adolescents ; Earnings a Multidisciplinary Management of Pain and Quality of Life
Around the scoliosis surgery, the pain (pre or post operative, physical, psychological, fantasy or real) is a major concern for adolescents and their families. She is also a key concern of caregivers, both its assessment and management is complex. this pain involved predominantly in the quality of life of these teenagers today who will become the adults of tomorrow.
To date in France, no study aims to describe and evaluate the effect of a multidisciplinary approach and its impact on the quality of life of these young people made.
Read more
The present study wish to prevent, anticipate and limit the short, medium and long-term morbidity. Focus will be on pain and its management, on preparing for surgery, hospitalization, follow-up after surgery, rehabilitation until recovery.
Help teens reclaim their bodies after the changes caused by the intervention is a major issue.
This study believe that support good quality, adapted to patient needs will limit operating and postoperative pain in the medium and long term.
Medical team developed special attention around the teenagers that are operated for scoliosis (teen groups and parent groups, interview before the operation and counseling, physiotherapy support ...).
The present study would systematize data collections in order to have a comprehensive and accurate assessment of the care.
The qualitative research will focus on the multidisciplinary care in an effort to evaluate the whole course of these teenagers, their experience and to identify efforts to put in place to optimize the current care.
- Conditions
- Scoliosis
- Being tested
- First time measure, Second time measure, Third time measure
- Keywords
- Teenagers, Multidisciplinary approach, Pain, Surgery
- Medical subject headings
- Scoliosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First time measureOther
- Initial Interview
- Initial Survey,
- Quality of life Scale
- Kinesitherapy Review
- Anxiety Scale
Second time measureOther
- Kinesitherapy review
- Second survey including numeric scale of pain
- Anxiety scale
- Scoliosis Research Society 22 quality of life scale
Third time measureOther
- Scoliosis Research Society 22 quality of life Scale
- Anxiety scale
- Numeric scale of pain
- Kinesitherapy review
| Study group | Role | What they receive |
|---|---|---|
| Teenagers with scoliosis | Patients will be evaluated at three times during the study :
* First time measure : 1 month before the scoliosis surgery
* Second time measure : 3 months after the scoliosis surgery
* Third time measure : 1 year after the scoliosis surgery Receives: Other: First time measure; Other: Second time measure; Other: Third time measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary
Measured: 1 Month before surgery
Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary
Measured: 3 Month after surgery
Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary
Measured: 6 months after the surgery
Secondary outcomes (9)
Comparison of pain before and after the surgery as assessed by visual scale of pain
Measured: 1 Month before surgery, 3 months and 6 months after the surgery
Comparison of pain before and after the surgery as assessed by visual scale of pain
Measured: 1 Month before surgery
Comparison of pain before and after the surgery as assessed by visual scale of pain
Measured: 3 Months after surgery
Comparison of anxiety before and after the surgery as assessed by anxiety scale
Measured: 6 months after the surgery
Patient global satisfaction before and after the surgery as assessed by oriented interviews
Measured: 1 Month before surgery
Patient global satisfaction before and after the surgery as assessed by oriented interviews
Measured: 6 months after surgery
Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back
Measured: 1 Month before surgery
Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back
Measured: 3 months after the surgery
Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2018
- Study completionMar 2019
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 University Hospital, ToulouseThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès SUC, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890654
- Sponsor's protocol ID
- RC31-15-7475
- Acronym
- SQUAD
- Status last verified
- Mar 2019
- First submitted
- 6 Jul 2016
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Scoliosis Surgery in Adolescents ; Earnings a Multidisciplinary Management of Pain and Quality of Life
- ClinicalTrials.gov ID
- NCT02890654
- Acronym / sponsor ID
- SQUAD / RC31-15-7475
- Conditions
- Scoliosis
- Keywords
- Teenagers, Multidisciplinary approach, Pain, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
Around the scoliosis surgery, the pain (pre or post operative, physical, psychological, fantasy or real) is a major concern for adolescents and their families. She is also a key concern of caregivers, both its assessment and management is complex. this pain involved predominantly in the quality of life of these teenagers today who will become the adults of tomorrow.
To date in France, no study aims to describe and evaluate the effect of a multidisciplinary approach and its impact on the quality of life of these young people made.
The present study wish to prevent, anticipate and limit the short, medium and long-term morbidity. Focus will be on pain and its management, on preparing for surgery, hospitalization, follow-up after surgery, rehabilitation until recovery.
Help teens reclaim their bodies after the changes caused by the intervention is a major issue.
This study believe that support good quality, adapted to patient needs will limit operating and postoperative pain in the medium and long term.
Medical team developed special attention around the teenagers that are operated for scoliosis (teen groups and parent groups, interview before the operation and counseling, physiotherapy support ...).
The present study would systematize data collections in order to have a comprehensive and accurate assessment of the care.
The qualitative research will focus on the multidisciplinary care in an effort to evaluate the whole course of these teenagers, their experience and to identify efforts to put in place to optimize the current care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teenagers with scoliosis | – | Other: First time measure, Other: Second time measure, Other: Third time measurePatients will be evaluated at three times during the study : * First time measure : 1 month before the scoliosis surgery * Second time measure : 3 months after the scoliosis surgery * Third time measure : 1 year after the scoliosis surgery |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Teenagers with diagnosis of idiopathic scoliosis
Key inclusion criteria (2 listed)
- Patients followed for idiopathic scoliosis with indication for surgery
- Patients monitored and operated at the Children Hospital of Toulouse
Key exclusion criteria (3 listed)
- Opposition to the participation
- Spine deformations other than scoliosis
- Non idiopathic scoliosis
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 |
|---|---|---|
| First time measure* Initial Interview * Initial Survey, * Quality of life Scale * Kinesitherapy Review * Anxiety Scale | Other | Teenagers with scoliosis |
| Second time measure* Kinesitherapy review * Second survey including numeric scale of pain * Anxiety scale * Scoliosis Research Society 22 quality of life scale | Other | Teenagers with scoliosis |
| Third time measure* Scoliosis Research Society 22 quality of life Scale * Anxiety scale * Numeric scale of pain * Kinesitherapy review | Other | Teenagers with scoliosis |
Primary outcome
Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary
Time frame: 1 Month before surgery
Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary
Time frame: 3 Month after surgery
Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary
Time frame: 6 months after the surgery
9 secondary outcomes
Comparison of pain before and after the surgery as assessed by visual scale of pain
Time frame: 1 Month before surgery, 3 months and 6 months after the surgery
Comparison of pain before and after the surgery as assessed by visual scale of pain
Time frame: 1 Month before surgery
Comparison of pain before and after the surgery as assessed by visual scale of pain
Time frame: 3 Months after surgery
Comparison of anxiety before and after the surgery as assessed by anxiety scale
Time frame: 6 months after the surgery
Patient global satisfaction before and after the surgery as assessed by oriented interviews
Time frame: 1 Month before surgery
Patient global satisfaction before and after the surgery as assessed by oriented interviews
Time frame: 6 months after surgery
Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back
Time frame: 1 Month before surgery
Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back
Time frame: 3 months after the surgery
Evaluation of scoliosis typography with kinesitherapy complete assessment using radiography of the back
Time frame: 6 months after the surgery
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 1 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
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Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
Agnès SUC, MD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by University Hospital, Toulouse at 1 site in France.
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 2 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 1 Apr 2019. 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 France. 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?
Comparison of quality of life before and after the surgery with Scoliosis Research Society 22 questionary (time frame: 1 Month before surgery). The study lists 3 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 1 Apr 2019.