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

NCT02180776 | Completed

• 1 other identifier: CPR-ORTHO01-2012
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups

  4 weeks

Secondary Outcomes (1)

• Measured amount of opioid medication consumed in the intervention group versus control group

  Baseline and weeks 2,3,4,8,12,16,20 and 24

Other Outcomes (4)

• ODI scores between the intervention group versus control group

  Weeks 8, 12, 16, 20 and 24

• SF-26v2 Survey scores in the intervention versus the control group

  Baseline and weeks 4, 8, 12 and 24.

• Cost and return on investment of the LSO intervention

  24 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Other: Summit 456 TLSO

Group B

PLACEBO COMPARATOR

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.

Other: Summit 456 TLSO

Interventions

Summit 456 TLSO OTHER

Thoracolumbarsacral orthosis

Group A; Group B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aspen Medical Products: lead

MeSH Terms

Conditions

Kyphosis; Back Pain

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel J Schaffer, MD

  Southeastern Integrated Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: July 3, 2014
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 3, 2014

Record last verified: 2014-07