Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures

Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00994032

Enrollment

120

Registered

2009-10-14

Start date

2006-03-31

Completion date

2011-06-01

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Osteoporosis, Spinal Fracture

Keywords

vertebroplasty, disability evaluation, outcome assessment, pain measurement

Brief summary

The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.

Detailed description

Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study. In our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.

Interventions

PROCEDUREpercutaneous injection of cement into the vertebral body

percutaneous injection of cement into the vertebral body

OTHERMedical treatment

standard antalgic medical treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5 * Fragility; i.e. fracture not in relation with significant trauma * Recent fracture, pain beginning not earlier than 1 year before inclusion

Exclusion criteria

* No vertebral edema on STIR MR images * Uncorrectable bleeding diatheses * Active infection * Substantial retropulsion of bony fragments * Non-osteoporotic fracture * Concomitant neoplasm

Design outcomes

Primary

Measure	Time frame
Impact into quality of life with the Qualeffo-41 test	Baseline, 2 weeks, 2 months, 6 months and 1 year

Secondary

Measure	Time frame
Analyze pain alleviation with the Analog Visual Scale	Baseline, 2 weeks, 2 months, 6 months and 1 year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026