Multicenter, randomized, double-blind, controlled clinical trial to evaluate the safety and efficacy of PRGF-Endoret® infiltrations in the treatment of low back pain

Conditions

Low back pain

Brief summary

Evaluation of the Oswestry scale at 6 months follow-up.

Detailed description

Percentage of treatment failures at 1, 3, and 12 months follow-up (following the definition in 8.7)., Assessment of the Oswestry scale at 1, 3, and 12 months of follow-up., Evaluation of the COMI scale at 1, 3, 6, and 12 months of follow-up., Evaluation of the SF-12 scale at 1, 3, 6, and 12 months of follow-up., Radiological imaging (MRI) results. Differences at 12 months with respect to baseline determinations of the: Pfirrmann, Size of the disc herniation, Intervertebral space height (endplate to endplate) and Disc volume grade., Incidence and type of adverse events., Cost-utility analysis., Hematological characterization of blood and PRGF., Biochemical characterization of PRGF.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGCelestone Cronodose suspensión inyectable

DRUGPlasma rich in growth factors

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Evaluation of the Oswestry scale at 6 months follow-up.	—

Secondary

Measure	Time frame
Percentage of treatment failures at 1, 3, and 12 months follow-up (following the definition in 8.7)., Assessment of the Oswestry scale at 1, 3, and 12 months of follow-up., Evaluation of the COMI scale at 1, 3, 6, and 12 months of follow-up., Evaluation of the SF-12 scale at 1, 3, 6, and 12 months of follow-up., Radiological imaging (MRI) results. Differences at 12 months with respect to baseline determinations of the: Pfirrmann, Size of the disc herniation, Intervertebral space height (endplate to endplate) and Disc volume grade., Incidence and type of adverse events., Cost-utility analysis., Hematological characterization of blood and PRGF., Biochemical characterization of PRGF.	—

Measure

Time frame

Percentage of treatment failures at 1, 3, and 12 months follow-up (following the definition in 8.7)., Assessment of the Oswestry scale at 1, 3, and 12 months of follow-up., Evaluation of the COMI scale at 1, 3, 6, and 12 months of follow-up., Evaluation of the SF-12 scale at 1, 3, 6, and 12 months of follow-up., Radiological imaging (MRI) results. Differences at 12 months with respect to baseline determinations of the: Pfirrmann, Size of the disc herniation, Intervertebral space height (endplate to endplate) and Disc volume grade., Incidence and type of adverse events., Cost-utility analysis., Hematological characterization of blood and PRGF., Biochemical characterization of PRGF.

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Countries

Spain

Outcome results

None listed