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Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression (PRISCOPRO)

Primary Purpose

Idiopathic Scoliosis

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
3D TLSO
Standard TLSO
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Scoliosis focused on measuring Idiopathic scoliosis, Randomized controlled trial, Brace, Orthosis

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cobb 25-40 degrees
  • Skeletally immature, Sanders score of 6 or less and Risser 2 or less.
  • Menarche status maximum one year in females
  • Aged 9-17 years
  • No previous brace treatment or surgery for scoliosis
  • Apex of the primary curve at T7 or caudal

Exclusion Criteria:

  • Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
  • Previous spine surgery

Sites / Locations

  • Linköping university hospital
  • Karolinska university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3D TLSO

Standard TLSO

Arm Description

A 3-dimensional Boston brace will be designed to the patient's individual type of scoliosis. In-brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time.

A standard Boston brace will be designed to the patient's individual type of scoliosis. In brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time.

Outcomes

Primary Outcome Measures

Curve progression
Increase in curve severity (Cobb angle) of more than 6 degrees on two consecutive radiographs after baseline

Secondary Outcome Measures

Clinical outcomes
Angle of trunk rotation in forward bending, assessed with scoliometer
Patient-reported outcome measures
Scoliosis Research Society-22r questionnaire
Patient-reported outcome measures
EQ5D questionnaire
Patient-reported outcome measures
Spinal Appearance Questionnaire (SAQ)
Patient-reported outcome measures
International Physical Activity Questionnaire (IPAQ)
Surgical rates
Number needing surgical intervention

Full Information

First Posted
March 13, 2021
Last Updated
October 13, 2023
Sponsor
Karolinska Institutet
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT04805437
Brief Title
Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression
Acronym
PRISCOPRO
Official Title
3D Designed Boston Brace Versus Standard Boston Brace in Halting Progression in Idiopathic Scoliosis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
April 2037 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.
Detailed Description
Bracing with a rigid TLSO is gold-standard treatment in terms of halting progression of idiopathic scoliosis in skeletally immature adolescents and children. The treatment is cumbersome and demanding for adolescents during a vulnerable stage in life, and may be associated with poor compliance. Furthermore, the treatment lasts in many cases for several years and has shown to have a negative psychological effect for patients. Since time in brace is of utmost importance for best possible outcome, the braces need to be tolerated by the patients. As of today, 3D designed braces have received much attention and are thought to increase comfortability and ultimately increase wearing time, leading to better outcomes. In a multicenter randomized controlled trial, we seek to compare standard Boston brace to a newly developed 3D designed Boston brace. Skeletally immature patients with idiopathic scoliosis will be randomized to receive either standard Boston brace or Boston 3D brace. All patients will be encouraged to be physically active for 60 minutes per day. Patients, outcome assessors and clinician in charge during follow-ups will be blinded for the type of brace the patients are being treated with. Thermal sensors will be installed in all braces to monitor compliance. Outcome include change in curve severity, quality of life and surgical rates. Patients will be evaluated with clinical and radiological follow-ups every six months until skeletal maturity and thereafter at 2, 5 and 10 years. Curve progression will not lead to change of brace. A total of 85 individuals are required in each group based on the hypothesis of a 2% failure rate in the 3D-brace group and 15% in the standard brace group with 5% significance level and 80% power and consideration for dropout of up to 20%. For individuals who are not willing to be randomized and participate in the study, standard Boston brace will be offered and these individuals will serve as an observational group with similar follow-ups and will be asked to answer same survey as the study populations will do.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis
Keywords
Idiopathic scoliosis, Randomized controlled trial, Brace, Orthosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Orthotist and research nurse will know what type of brace the participant receives, but will not tell the participant which type he/she has received. Investigators, care providers and outcome assessors will be blinded for type of brace.
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D TLSO
Arm Type
Experimental
Arm Description
A 3-dimensional Boston brace will be designed to the patient's individual type of scoliosis. In-brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time.
Arm Title
Standard TLSO
Arm Type
Active Comparator
Arm Description
A standard Boston brace will be designed to the patient's individual type of scoliosis. In brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time.
Intervention Type
Device
Intervention Name(s)
3D TLSO
Other Intervention Name(s)
Boston 3D brace
Intervention Description
Brace treatment with Boston 3D 20 hours a day until skeletal maturity.
Intervention Type
Device
Intervention Name(s)
Standard TLSO
Other Intervention Name(s)
Boston brace
Intervention Description
Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.
Primary Outcome Measure Information:
Title
Curve progression
Description
Increase in curve severity (Cobb angle) of more than 6 degrees on two consecutive radiographs after baseline
Time Frame
Measured at each six-month follow-up until skeletal maturity. Skeletal maturity defined as less than 1 cm body height increase in 6 months.
Secondary Outcome Measure Information:
Title
Clinical outcomes
Description
Angle of trunk rotation in forward bending, assessed with scoliometer
Time Frame
At each six-month follow-up and 2, 5, 10 years after skeletal maturity
Title
Patient-reported outcome measures
Description
Scoliosis Research Society-22r questionnaire
Time Frame
At each six-months follow-up and 2, 5, 10 years after skeletal maturity
Title
Patient-reported outcome measures
Description
EQ5D questionnaire
Time Frame
At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Title
Patient-reported outcome measures
Description
Spinal Appearance Questionnaire (SAQ)
Time Frame
At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Title
Patient-reported outcome measures
Description
International Physical Activity Questionnaire (IPAQ)
Time Frame
At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Title
Surgical rates
Description
Number needing surgical intervention
Time Frame
At each six-months follow-up and 2, 5, 10 years after skeletal maturity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cobb 25-40 degrees Skeletally immature, Sanders score of 6 or less and Risser 2 or less. Menarche status maximum one year in females Aged 9-17 years No previous brace treatment or surgery for scoliosis Apex of the primary curve at T7 or caudal Exclusion Criteria: Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis) Previous spine surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elias Diarbakerli, PT, PhD
Phone
+460851770000
Email
elias.diarbakerli@sll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Gerdhem, MD, PhD
Email
paul.gerdhem@uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias Diarbakerli, PT, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping university hospital
City
Linköping
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan Abbott, PT, PhD
Facility Name
Karolinska university hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elias Diarbakerli, PT, PhD
First Name & Middle Initial & Last Name & Degree
Paul Gerdhem, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD underlying published manuscripts will be accessible for other researchers.
IPD Sharing Time Frame
The study protocol will be submitted to a peer-reviewed journal.
IPD Sharing Access Criteria
The investigators in charge will be responsible for reviewing access requests. Crude data, randomization procedures and intervention details can be shared with other researchers upon request.
Citations:
PubMed Identifier
34370760
Citation
Diarbakerli E, Charalampidis A, Abbott A, Gerdhem P. PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace. PLoS One. 2021 Aug 9;16(8):e0255264. doi: 10.1371/journal.pone.0255264. eCollection 2021.
Results Reference
derived

Learn more about this trial

Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

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