A randomised sham controlled trial of vertebroplasty for painful chronic osteoporotic vertebral fractures

Phase 3

Completed

Conditions: osteoporotic vertebral fracture
vertebral compression fracture
10017322
10005944

Registration Number: NL-OMON47294

Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

•VCF on X-ray of the spine (minimal 15% loss of height)
•level of VCF Th5 or lower
•back pain <= 6 weeks at time of X-ray
•>= 50 years of age
•bone edema on MRI of the fractured vertebral body
•focal tenderness on VCF level
•decreased bone density T-scores <= -1

Exclusion Criteria

•severe cardio-pulmonary condition
•untreatable coagulopathy
•systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
•suspected alternative underlying disease (malignancy)
•radicular and/or cauda compression syndrome
•contra-indication for MRI

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome will be pain relief at 1 day, 1 week, and 1,3, 6 and 12 months.<br /><br>The questionnaire consist of the VAS score and questions about use of pain<br /><br>medication, pain location, and pain type. Other medical treatment and visits to<br /><br>alternative medical specialists, GP's and physical therapists are recorded and<br /><br>compared between groups. Patients are asked to fill out the VAS score and use<br /><br>of analgesics is recorded on a daily basis during the first month after<br /><br>randomization.<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Back pain related disability as measured with the Roland Morris Disability<br /><br>(RMD) Questionnaire. The RMD questionnaire is a disability questionnaire that<br /><br>measures the functional status of patients with back pain.<br /><br><br /><br>The Qualeffo is developed specifically for patients with osteoporosis. This<br /><br>questionnaire consists of 41 questions. Description: QOL as measured with the<br /><br>Questionnaire of the European Foundation for Osteoporosis (Qualeffo). The<br /><br>Qualeffo is developed specifically for patients with osteoporosis. This<br /><br>questionnaire consists of 41 questions about: pain, physical function, social<br /><br>function, general health perception, and mental function. The Qualeffo score<br /><br>ranges from 0 (best quality of life) to 100 (worst quality of life). This<br /><br>questionnaire will be completed at five measurement moments (before and at 1,<br /><br>3, 6 and 12 months after the procedure).<br /><br></p><br>