The purpose of this study is to evaluate the quality and effect of scoliosis brace treatment, by means of correlating body brace interface pressure and scoliosis correction in combination with quality of life questionnaires.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
One interface pressure measurement session
two successive quality of life questionnaires
Secondary outcome
Optimalisation scoliosis brace treatment.
Background summary
Idiopathic scoliosis is a relatively common deformation starting with or just
before the growth spurt. Brace treatment is used to prevent progression and if
possible correction of the scoliosis. In order to achieve a good result the
brace should be worn for 23 hours, and during the whole growth period. Patients
are predominantly girls in the age between 8 to 16 year old. The long treatment
in combination with the difficult age of the patients makes sufficient
compliance a challenge.
Study objective
The purpose of this study is to evaluate the quality and effect of scoliosis
brace treatment, by means of correlating body brace interface pressure and
scoliosis correction in combination with quality of life questionnaires.
Study design
Single centre, single measurement, non-randomised observational study.
Study burden and risks
One non invasive, risk less interface pressure measurement session lasting for
30 minutes, subsequently after the regular scoliosis outpatient clinic visit.
During this session, the patient has to assume different postures, mimicking
daily activity. Two quality of life questionnaires are send to the patient with
a three month interval, completing these questionnaires will take approximately
15 minutes. The total extra time is 60 minutes. The correction of the scoliosis
is measured on the regular control X-rays.
Postbus 5800
6202 AZ Maastricht
Nederland
Postbus 5800
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Patients with idiopathic scoliosis, who are indicated for a scoliosis brace.
Cobbs angle between 20o - 40o at start of treatment.
Male and female patients
Patients who read and understand the METC approved patient information
Patients who are willing to participate and have written permission from their parents / guardians.
Exclusion criteria
Patients requiring surgical treatment. (Cobbs angle >40o)
Patients with other back problems
Patients with spine operations in the past
Patients with neurological signs
Patients willing, but without parental / guardian permission
Patients without a working knowledge of Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20510.068.07 |
| Other | NTR (TC = 1247) |