Cervical and Lumbar pain treatment with local anesthesia versus corticosteroid injection

Selective local anesthesia versus a combined medication injection with corticosteroids in degenerartive spine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001146-29-ES

Enrollment

Unknown

Registered

2015-10-15

Start date

2016-01-12

Completion date

Unknown

Last updated

2017-05-22

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

Conditions

Degenerative spine pain when there are no indications for surgical treatment

Interventions

Trade Name: Procaina serra Product Name: Procaina Product Code: Procaina Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: PROCAINE CAS Number: 59-46-1 Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Inclusion: Patients of both sexes , regardless of age , profession without defined with musculoskeletal pain of cervical and / or lumbar do not meet the criteria for surgical intervention ( motor deficit or intractable pain ) . Anamnesis , physical examination and complementary imaging tests will be done. Espondiloartrósicos patients with degenerative changes ( herniated disc , stenosis of lateral recess stenosis channel , in conjunction foramen stenosis , spondylolisthesis ) not verify the exclusion criteria will be included. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: ? Exclusion: Patients taking antiplatelet or anticoagulated -tes . Patient refusal . Pre- allergy medication or ad- ministered in the study adverse reactions. Pain secondary to fractures in the acute phase (not consolidated ) , tumor or systemic disease process Refusal to sign informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the use of local selective anesthesia with procaine to reduce the associated pain to degenerative spine pathology ot same extent as the combined injection, having less side effects than the combined injection with corticosteroids.;Secondary Objective: To determine whether treatment with local infiltration : ? improves pain in patients with degenerative spine disease ? decreases the consumption of analgesic drugs orally. ? reduce disability associated with pain in cervical and lumbar regions. ? assess whether there is a correlation between the measured improvement in visual analogue pain scale and disability rates ODI and Oswestry . ? improving the overall health status perceived by the patient with this disease.;Primary end point(s): Selective local anesthetic procaine, reduces pain associated pathology dege-nerativa in the same column as the combined injection of corticosteroids, NSAIDs and mepiva-cocaine. The adverse reaction profile is more favorable for the injection of the local anesthetic agent procaine-psycho against the combined injection. The administration of both treatments produced improvement in disability-state and general health of patients;Timepoint(s) of evaluation of this end point: start, 3 months, 1 year	—

Measure

Time frame

Main Objective: To demonstrate the use of local selective anesthesia with procaine to reduce the associated pain to degenerative spine pathology ot same extent as the combined injection, having less side effects than the combined injection with corticosteroids.;Secondary Objective: To determine whether treatment with local infiltration : ? improves pain in patients with degenerative spine disease ? decreases the consumption of analgesic drugs orally. ? reduce disability associated with pain in cervical and lumbar regions. ? assess whether there is a correlation between the measured improvement in visual analogue pain scale and disability rates ODI and Oswestry . ? improving the overall health status perceived by the patient with this disease.;Primary end point(s): Selective local anesthetic procaine, reduces pain associated pathology dege-nerativa in the same column as the combined injection of corticosteroids, NSAIDs and mepiva-cocaine. The adverse reaction profile is more favorable for the injection of the local anesthetic agent procaine-psycho against the combined injection. The administration of both treatments produced improvement in disability-state and general health of patients;Timepoint(s) of evaluation of this end point: start, 3 months, 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): Patient satisfaction;Timepoint(s) of evaluation of this end point: 3 months, 1 year	—

Countries

Spain

Contacts

Public ContactHospital Gomez Ulla

Hospital Central de la Defensa

0034914222789

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026