The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration

NCT ID: NCT01945554

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-03-31

Brief Summary

The purpose if this study is to assess the response to nerve root infiltration therapy in patients with cervical or lumbar disc herniations.

Detailed Description

This prospective, observational study examines the response to routine infiltration therapy in patients suffering from disc herniations of the spine. Using health-related quality of life questionnaires (SF-12 and Neck Pain and Disability Scale and Oswestry Disability Index) and the visual analogue scale the patients will be categorized into ultra-early-, early-, mid-term-, late-responders and non-responders. A two year follow-up of up to 250 patients is planned. With the anonymized participation of this study no patient will experience a change in his treatment plan. Valuable therapeutic management considerations might be drawn from the published results of this study for future patients.

Conditions

Cervical Disc Herniation; Lumbar Disc Herniation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cervical disc herniation

Patients with cervical disc herniation and compression of nerve roots C3-C8.

Group Type: EXPERIMENTAL

Cervical nerve root infiltration

Intervention Type: PROCEDURE

4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.

Mephamesone

Intervention Type: DRUG

0.5% bupivacaine (Bupivacain®)

Intervention Type: DRUG

Lumbar disc herniation

Patients with lumbar disc herniation and compression of nerve roots L1-S1.

Group Type: EXPERIMENTAL

Lumbar nerve root infiltration

Intervention Type: PROCEDURE

40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.

0.5% bupivacaine (Bupivacain®)

Intervention Type: DRUG

Kenacort®

Intervention Type: DRUG

Interventions

Cervical nerve root infiltration

4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.

Intervention Type: PROCEDURE

Lumbar nerve root infiltration

40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.

Intervention Type: PROCEDURE

Mephamesone

Intervention Type: DRUG

0.5% bupivacaine (Bupivacain®)

Intervention Type: DRUG

Kenacort®

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Symptomatic (pain) one-level cervical (C3-C8) or lumbar (L1-S1) radiculopathy with radiological evidence of discal nerve root compression
• Minimum VAS of 20/100
• Age between 18 - 70 years

Exclusion Criteria

• Multilevel disc herniations with multiple symptomatic nerve root compressions
• Higher motor deficits (Paresis M 0-3 of a peripheral muscle)
• Age < 18 or > 70 years
• Pregnancy
• Allergic reaction against steroids or local anaesthetic
• Bleeding disorder (Tc < 100.000/ul, Quick <50%, INR > 1.5, abnormal PTT)
• Known bleeding diathesis
• Continued anticoagulants (Warfarin = Marcoumar must be bridged with low- or high-molecular heparin; commonly, intake of Aspirin or Clopidogrel is no contraindication for infiltration therapy but is routinely paused when possible)
• Pseudoradicular pain (e.g. in facet arthrosis, iliosacral arthrosis...) - as evaluated to the best of the knowledge of the admitting physician and radiologist performing the infiltration
• Osseous spinal or foraminal stenosis
• Myelopathy
• Severe scoliosis
• Active neoplasm
• History of spinal infection / spondylodiscitis
• History of spinal surgery or previous infiltration therapy on the currently painful segment
• Rheumatic disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Holger Joswig

OTHER

Sponsor Role: lead

Responsible Party

Holger Joswig

Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Holger Joswig, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital St. Gallen, Dept. of Neurosurgery

Locations

Flawil Hospital

Flawil, Canton of St. Gallen, Switzerland

Rorschach Hospital

Rorschach, Canton of St. Gallen, Switzerland

Cantonal Hospital St. Gallen

Sankt Gallen, , Switzerland

Countries

Switzerland

Other Identifiers

EKSG 13/061

Identifier Type: -

Identifier Source: org_study_id