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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Disc Herniation, Lumbar Disc Herniation

Intervention / Treatment
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* Procedure: Cervical nerve root infiltration
* Procedure: Lumbar nerve root infiltration
* Drug: Mephamesone
* Drug: 0.5% bupivacaine (Bupivacain®)
* Drug: Kenacort®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical disc herniation<br>Patients with cervical disc herniation and compression of nerve roots C3-C8. | Procedure: Cervical nerve root infiltration<br>* 4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.<br>Drug: Mephamesone<br> <br> Drug: 0.5% bupivacaine (Bupivacain®)<br> <br> |
| Experimental: Lumbar disc herniation<br>Patients with lumbar disc herniation and compression of nerve roots L1-S1. | Procedure: Lumbar nerve root infiltration<br>* 40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.<br>Drug: 0.5% bupivacaine (Bupivacain®)<br> <br> Drug: Kenacort®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life (HRQoL) | (SF)-12 questionaire Change from Baseline SF-12 at 1 month | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Pain and Disability Scale (NPAD) | Neck Pain and Disability Scale (NPAD) | Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months | 
| Oswestry Disability Index (ODI) | Oswestry Disability Index (ODI) | Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months | 
| Percent change of pain (VAS) | Percent change of pain (VAS) | Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months | 
| Need for additional surgical therapy and time-to-surgery. | Need for additional surgical therapy and time-to-surgery. | 14 days, 1 month, 3 months, 6 months, 12 months, 24 months | 
| Need for hospitalization for disabling pain and time-to-hospitalization. | Need for hospitalization for disabling pain and time-to-hospitalization. | 14 days, 1 month, 3 months, 6 months, 12 months, 24 months | 
| Need for repeated infiltrations and time-to-infiltration between the study groups. | Need for repeated infiltrations and time-to-infiltration between the study groups. | 14 days, 1 month, 3 months, 6 months, 12 months, 24 months | 
| Absolute VAS pain reduction of a repeated boost-infiltration | Absolute VAS pain reduction of a repeated boost-infiltration | 14 days, 1 month, 3 months, 6 months, 12 months, 24 months | 
| Frequency of opioid use (yes/no) | Frequency of opioid use (yes/no) | 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. | 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 | 
| Health-related quality of life (HRQoL) | (SF)-12 questionaire | Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months | 
| Reasons for 2nd infiltration / surgery | Reasons may be either pain and/or sensory dysfunction and/or motor weakness | 1 month, 3 months, 6 months, 12 months, 24 months | 
| Patient's satisfaction with therapy | Would you opt for an infiltration again (provided you had the same outcome as now)? certainly yes maybe yes unsure maybe no certainly no | 14 days, 1 month, 3 months, 6 months, 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infiltrative therapy, cervical disc herniation, lumbar disc herniation