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Completed

NCT Number: NCT02180776

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Summit 456 TLSO

Other

Thoracolumbarsacral orthosis

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

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

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

Other outcomes

  1. ODI scores between the intervention group versus control group

    Time frame: Weeks 8, 12, 16, 20 and 24

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

    Time frame: Baseline and weeks 4, 8, 12 and 24.

  3. Cost and return on investment of the LSO intervention

    Time frame: 24 weeks

  4. Number of adverse events associated with the LSO intervention

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

Sponsors and collaborators

Lead sponsor

Aspen Medical Products

Other

Registry information

Official study title

A Randomized Crossover Pilot Study To Determine Clinical Effectiveness and Patient Wellness of Inelastic Lumbosacral Orthoses Versus Standard Medical Treatment in Patients With Back Pain AssociatEd With Kyphosis (The ARISE Study)

Acronym: ARISE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 3, 2014
Registry last updated
Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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