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

Holger Joswig

Status: Completed

Conditions: Cervical Disc Herniation; Lumbar Disc Herniation

Treatments: Drug: Mephamesone; Procedure: Cervical nerve root infiltration; Procedure: Lumbar nerve root infiltration; Drug: Kenacort®; Drug: 0.5% bupivacaine (Bupivacain®)

Study type: Interventional

Funder types: Other

Identifiers

NCT01945554

EKSG 13/061

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Cervical disc herniation

Experimental group

Description:

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

Treatment:

Procedure: Cervical nerve root infiltration

Drug: Mephamesone

Drug: 0.5% bupivacaine (Bupivacain®)

Lumbar disc herniation

Experimental group

Description:

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

Treatment:

Procedure: Lumbar nerve root infiltration

Drug: Kenacort®

Drug: 0.5% bupivacaine (Bupivacain®)