Clinical trial NCT02643290: Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients
Official title: Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: Adult Scoliosis
Pain Management
Orthosis
Lead sponsor: Aspen Medical Products
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the study is to evaluate a new brace that has become available, the Peak Scoliosis Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic pain secondary to scoliosis.

20 adults with back pain secondary to Idiopathic Scoliosis will be recruited. The sample size was calculated considering the data collected during the development of the brace in the US. Patients will be evaluated at baseline immediately before starting with the brace and after 4 weeks and 6 months. The brace must be worn for at least 2-4 hours per day.

At each evaluation they will be asked to fill the questionnaires, to be used as outcome measure of the results.

Detailed description: Background: Some adult scoliosis patients suffer significant back pain and risk increased curvature leading to postural collapse. The main approach for these patients according to the current literature is the surgical one, however, surgery is not without complications, is not appropriate for all patients and certain patients do not choose to undergo surgery. Despite the fact that scoliosis has been estimated to affect up to 68% of the population over 60, there is scant literature about conservative treatments for adult scoliosis; a case report and a case series demonstrated the effectiveness of scoliosis specific exercise to stop progression, while another study reported the effectiveness of a soft brace in reducing pain at short time. Custom fabricated rigid torso braces, similar to those commonly used for children are sometimes used in adult patients, however, the goal of these braces is to correct and/or sustain the sagittal plane of patients, no data have been published on the efficacy of these braces in relief of pain, and such braces are typically not well tolerated by adults. Recently a new brace has become available, the Peak Scoliosis Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic pain secondary to scoliosis.

Aim: to test the efficacy of the Peak Scoliosis Brace in reducing pain in adult scoliosis patients.

Study design: prospective cohort study. Population: 20 adults with back pain secondary to Idiopathic Scoliosis. The sample size was calculated considering the data collected during the development of the brace in the US, and the first 2 patients fitted in Italy. Setting alpha at 0.05 and the power at 0.8, with a mean expected improvement of 2 point in the pain NRS, 16 patients would be necessary.

Considering the possibility of 25% drop out the investigators decided to recruit 20 subjects.

Statistical analysis: If data will be normally distributed, the investigators will use a paired t-test. Otherwise, non-parametric statistical tests will be applied.

Protocol: patients will be evaluated at baseline immediately before starting with the brace and after 4 weeks and 6 months. The brace must be worn for at least 2-4 hours per day. At each evaluation they will be asked to fill the NRS, Rolland Morris Questionnaire and COMI.

Eligibility criteria: Inclusion Criteria:

* Must have significant back pain from idiopathic or degenerative scoliosis
* Idiopathic or degenerative scoliosis with Cobb angle \> 30"
* Age \> 18 years

Exclusion Criteria:

* Prior back surgery
* Secondary scoliosis

Primary outcomes:
measure: Pain Relief
timeFrame: At start, 4 weeks, 6 months
Secondary outcomes:
measure: Pain Relief
timeFrame: At start, 4 weeks, 6 months
measure: Pain Relief
timeFrame: At start, 4 weeks, 6 months
measure: Pain Relief
timeFrame: At start, 4 weeks, 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Zaina F, Poggio M, Di Felice F, Donzelli S, Negrini S. Bracing adults with chronic low back pain secondary to severe scoliosis: six months results of a prospective pilot study. Eur Spine J. 2021 Oct;30(10):2962-2966. doi: 10.1007/s00586-021-06808-1. Epub 2021 Mar 17.