The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
Overview
- Phase
- Not Applicable
- Intervention
- Kenacort®
- Conditions
- Cervical Disc Herniation
- Sponsor
- Holger Joswig
- Enrollment
- 250
- Locations
- 3
- Primary Endpoint
- Health-related quality of life (HRQoL)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Holger Joswig
Dr. med.
Cantonal Hospital of St. Gallen
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
Arms & Interventions
Lumbar disc herniation
Patients with lumbar disc herniation and compression of nerve roots L1-S1.
Intervention: Kenacort®
Cervical disc herniation
Patients with cervical disc herniation and compression of nerve roots C3-C8.
Intervention: Cervical nerve root infiltration
Cervical disc herniation
Patients with cervical disc herniation and compression of nerve roots C3-C8.
Intervention: Mephamesone
Cervical disc herniation
Patients with cervical disc herniation and compression of nerve roots C3-C8.
Intervention: 0.5% bupivacaine (Bupivacain®)
Lumbar disc herniation
Patients with lumbar disc herniation and compression of nerve roots L1-S1.
Intervention: Lumbar nerve root infiltration
Lumbar disc herniation
Patients with lumbar disc herniation and compression of nerve roots L1-S1.
Intervention: 0.5% bupivacaine (Bupivacain®)
Outcomes
Primary Outcomes
Health-related quality of life (HRQoL)
Time Frame: 1 month
(SF)-12 questionaire Change from Baseline SF-12 at 1 month
Secondary Outcomes
- 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)
- Frequency of opioid use (yes/no)(Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Oswestry Disability Index (ODI)(Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- 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.(14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Absolute VAS pain reduction of a repeated "boost"-infiltration(14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Reasons for 2nd infiltration / surgery(1 month, 3 months, 6 months, 12 months, 24 months)
- Percent change of pain (VAS)(Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Neck Pain and Disability Scale (NPAD)(Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Need for additional surgical therapy and time-to-surgery.(14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Health-related quality of life (HRQoL)(Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months)
- Patient's satisfaction with therapy(14 days, 1 month, 3 months, 6 months, 12 months, 24 months)