Effectiveness of Inelastic LSO Versus Standard Medical Treatment for Back Pain Associated With Kyphosis (ARISE)

Aspen Medical Products

Status: Completed

Conditions: Back Pain; Kyphosis

Treatments: Other: Summit 456 TLSO

Study type: Interventional

Funder types: Other

Identifiers

NCT02180776

CPR-ORTHO01-2012

Details and patient eligibility

About

The objective of this study is to evaluate clinical effectiveness and the effect on quality of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic patients with moderate to severe back pain disability and to demonstrate the safety of the intervention through detailed reporting and analysis of adverse events.

Enrollment: 16 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate to complete disability (crippled) as defined by a score of 21% to 80% on the baseline evaluation of the Oswestry Back Pain Disability Questionnaire;
• Patients diagnosed with kyphosis and have a Cobb angle of at least 55 degrees;
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion criteria

• Patients under the age of 19;
• Pregnant patients or patients who are considering future pregnancies;
• Patients who were participating in any other investigational device or drug study or whose participation in a previous investigational study within 30 days of study entry may, in the opinion of the clinical investigator, impact analysis of this orthotic;
• Patients who, in the clinical judgment of the investigator, are not suitable for this study; Patients who, in the investigators opinion, are mentally or legally incapacitated preventing informed consent or unable to read or understand written material;
• Patients who are unable or unwilling to return to the study center for follow-up visits.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

Patients assigned to group A wore the Summit 456 TLSO (intervention) for four weeks in phase 1 of the study, followed by four weeks of observation (control) in phase 2.

Treatment:

Other: Summit 456 TLSO

Group B

Placebo Comparator group

Description:

Patients assigned to group B started four weeks of observation (control) in phase 1, followed by four weeks of summit 456 TLSO (intervention) in phase 2 of the study.

Treatment:

Other: Summit 456 TLSO