Cervical Disc Herniation, Lumbar Disc Herniation
Conditions
Keywords
infiltrative therapy, cervical disc herniation, lumbar disc herniation
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.
Interventions
PROCEDURECervical nerve root infiltration
4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.
PROCEDURELumbar nerve root infiltration
40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.
DRUGMephamesone
DRUG0.5% bupivacaine (Bupivacain®)
DRUGKenacort®
Sponsors
Holger Joswig
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life (HRQoL) | 1 month | (SF)-12 questionaire Change from Baseline SF-12 at 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Oswestry Disability Index (ODI) | Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months | Oswestry Disability Index (ODI) |
| Percent change of pain (VAS) | Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months | Percent change of pain (VAS) |
| 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. |
| 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. |
| 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. |
| 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) |
| 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. |
| Health-related quality of life (HRQoL) | Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months | (SF)-12 questionaire |
| 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 |
| 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 |
| 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 |
Countries
Switzerland
Outcome results
None listed