The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
- Conditions
- Cervical Disc HerniationLumbar Disc Herniation
- Interventions
- Procedure: Lumbar nerve root infiltrationProcedure: Cervical nerve root infiltrationDrug: Mephamesone
- Registration Number
- NCT01945554
- Lead Sponsor
- Holger Joswig
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cervical disc herniation Mephamesone Patients with cervical disc herniation and compression of nerve roots C3-C8. Lumbar disc herniation Lumbar nerve root infiltration Patients with lumbar disc herniation and compression of nerve roots L1-S1. Cervical disc herniation Cervical nerve root infiltration Patients with cervical disc herniation and compression of nerve roots C3-C8. Cervical disc herniation 0.5% bupivacaine (Bupivacain®) Patients with cervical disc herniation and compression of nerve roots C3-C8. Lumbar disc herniation 0.5% bupivacaine (Bupivacain®) Patients with lumbar disc herniation and compression of nerve roots L1-S1. Lumbar disc herniation Kenacort® Patients with lumbar disc herniation and compression of nerve roots L1-S1.
- Primary Outcome Measures
Name Time Method Health-related quality of life (HRQoL) 1 month (SF)-12 questionaire Change from Baseline SF-12 at 1 month
- Secondary Outcome Measures
Name Time Method Ability to return to work (0-100%) and time-to-return to work. Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months Ability to return to work (0-100%) and time-to-return to work.
Frequency of opioid use (yes/no) Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months Frequency of opioid use (yes/no)
Oswestry Disability Index (ODI) Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months Oswestry Disability Index (ODI)
Need for hospitalization for disabling pain and time-to-hospitalization. 14 days, 1 month, 3 months, 6 months, 12 months, 24 months Need for hospitalization for disabling pain and time-to-hospitalization.
Need for repeated infiltrations and time-to-infiltration between the study groups. 14 days, 1 month, 3 months, 6 months, 12 months, 24 months Need for repeated infiltrations and time-to-infiltration between the study groups.
Absolute VAS pain reduction of a repeated "boost"-infiltration 14 days, 1 month, 3 months, 6 months, 12 months, 24 months Absolute VAS pain reduction of a repeated "boost"-infiltration
Reasons for 2nd infiltration / surgery 1 month, 3 months, 6 months, 12 months, 24 months Reasons may be either pain and/or sensory dysfunction and/or motor weakness
Percent change of pain (VAS) Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months Percent change of pain (VAS)
Neck Pain and Disability Scale (NPAD) Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months Neck Pain and Disability Scale (NPAD)
Need for additional surgical therapy and time-to-surgery. 14 days, 1 month, 3 months, 6 months, 12 months, 24 months Need for additional surgical therapy and time-to-surgery.
Health-related quality of life (HRQoL) Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months (SF)-12 questionaire
Patient's satisfaction with therapy 14 days, 1 month, 3 months, 6 months, 12 months, 24 months Would you opt for an infiltration again (provided you had the same outcome as now)?
* certainly yes
* maybe yes
* unsure
* maybe no
* certainly no
Trial Locations
- Locations (3)
Cantonal Hospital St. Gallen
🇨🇭St. Gallen, Switzerland
Rorschach Hospital
🇨🇭Rorschach, Saint Gallen, Switzerland
Flawil Hospital
🇨🇭Flawil, Saint Gallen, Switzerland