Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace

• ClinicalTrials.gov Identifier: NCT02049931
• Recruitment Status: Completed
• First Posted: January 30, 2014
• Results First Posted: May 25, 2015
• Last Update Posted: August 7, 2018
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Jin S. Yeom, Seoul National University Hospital

Tracking Information

• First Submitted Date: January 28, 2014
• First Posted Date: January 30, 2014
• Results First Submitted Date: April 15, 2014
• Results First Posted Date: May 25, 2015
• Last Update Posted Date: August 7, 2018
• Study Start Date: December 2012
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 22, 2015)

Oswestry Disability Index (ODI) at 12 Weeks [ Time Frame: 12 weeks after injury ]

The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).

Original Primary Outcome Measures (submitted: January 28, 2014)

Improvement of Oswestry Disability Index (ODI) [ Time Frame: 12 weeks after injury ]

The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture.

Current Secondary Outcome Measures (submitted: August 5, 2018)

• Visual Analog Pain Scale (VAS) for Back Pain [ Time Frame: 2 weeks, 6 weeks, 12 weeks after injury ]
  The VAS for back pain comprised a 10-cm line with "none" (0) on one end and "disabled pain" (10) on the other. Participants were asked to place a mark on the 10-cm line, which represented his or her perceived level of back pain, and the measured distance (cm) from the mark to the zero point was considered the score.
• Oswestry Disability Index (ODI) [ Time Frame: at 2 weeks, 6 weeks, and 12 weeks after compression fracture. ]
  The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
• General Health Status [ Time Frame: at the initial enrollment and 12 weeks after compression fracture ]
  The general health status was assessed with use of the Short Form-36 Health Survey (SF-36) at the initial enrollment and 12 weeks after compression fracture.The raw scores for the eight subscales and the two summaries of the SF-36 (Physical Function,Role Physical, Bodily Pain, General Health, Vitality, Social Function, Role Emotion, and Mental Health, as well as the Physical Component Summary [PCS] and the Mental Component Summary [MCS]) were transformed into norm-based 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability, and the higher the score the less disability. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
• the Progression of Body Compression Ratio Over All Follow-up Assessments [ Time Frame: 2 weeks, 6 weeks, and 12 weeks after compression fracture ]
  The anterior body compression ratio was assessed by calculating the ratio between the vertical height of the most compressed anterior section of the injured vertebral body and the posterior vertebral body height at that level

Original Secondary Outcome Measures (submitted: January 28, 2014)

• Visual Analog Pain Scale (VAS) for back pain [ Time Frame: 2 weeks, 6 weeks, 12 weeks after injury ]
  The VAS for back pain comprised a 10-cm line with "none" (0) on one end and "disabled pain" (10) on the other. Participants were asked to place a mark on the 10-cm line, which represented his or her perceived level of back pain, and the measured distance (cm) from the mark to the zero point was considered the score.
• Oswestry Disability Index (ODI) [ Time Frame: at 2 weeks, 6 weeks, and 12 weeks after compression fracture. ]
• general health status [ Time Frame: at the initial enrollment and 12 weeks after compression fracture ]
  The general health status was assessed with use of the Short Form-36 (SF-36) at the initial enrollment and 12 weeks after compression fracture.
• the progression of body compression ratio over all follow-up assessments [ Time Frame: at the initial enrollment, 2 weeks, 6 weeks, and 12 weeks after compression fracture ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace
• Official Title: The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace
• Brief Summary: The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.
• Detailed Description: Bracing has been considered as a landmark step in conservative management for osteoporotic compression fractures. However, no prospective, randomized, and controlled clinical trials are available to document for the efficacy of wearing of the rigid or soft brace for the management of osteoporotic compression fracture. Therefore, the current trial was therefore designed to compare the outcome for improvement of disability and pain in patients with osteoporotic compression fracture using rigid, soft, or no brace.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Compression Fracture

Intervention

• Device: No brace treatment
  Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.
• Device: Rigid brace
  In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
• Device: Soft brace
  In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.

Study Arms

• Experimental: No brace group
  Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.
  Intervention: Device: No brace treatment
• Active Comparator: Rigid brace group
  Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
  Intervention: Device: Rigid brace
• Active Comparator: Soft brace group
  Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
  Intervention: Device: Soft brace

• Publications *: Kim HJ, Yi JM, Cho HG, Chang BS, Lee CK, Kim JH, Yeom JS. Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1959-66. doi: 10.2106/JBJS.N.00187.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 28, 2014): 60
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• the presence of acute back pain caused by a single level vertebral fracture within 3 days of minor trauma such as fall from height,
• compression fracture between T 7 and L3 including injuries of only anterior compartment of vertebral body without neurologic deficit.

Exclusion Criteria:

• the presence of more than two recent vertebral fractures,
• pathologic malignant compression fractures,
• neurologic complications,
• a history of previous injury or surgery to the fractured level,
• inability to complete the questionnaires about pain and disability.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02049931
• Other Study ID Numbers: Brace001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jin S. Yeom, Seoul National University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seoul National University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ho-Joong Kim, MD; Seoul National University Bundang Hospital

• PRS Account: Seoul National University Hospital
• Verification Date: August 2018