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

NCT ID: NCT02180776

Last Updated: 2014-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-03-31

Brief Summary

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.

Conditions

Kyphosis; Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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.

Group Type: ACTIVE_COMPARATOR

Summit 456 TLSO

Intervention Type: OTHER

Thoracolumbarsacral orthosis

Group B

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.

Group Type: PLACEBO_COMPARATOR

Summit 456 TLSO

Intervention Type: OTHER

Thoracolumbarsacral orthosis

Interventions

Summit 456 TLSO

Thoracolumbarsacral orthosis

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aspen Medical Products

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel J Schaffer, MD

Role: PRINCIPAL_INVESTIGATOR

Southeastern Integrated Medical

Other Identifiers

CPR-ORTHO01-2012

Identifier Type: -

Identifier Source: org_study_id