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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical disc herniation | Experimental | Patients with cervical disc herniation and compression of nerve roots C3-C8. |
|
| Lumbar disc herniation | Experimental | Patients with lumbar disc herniation and compression of nerve roots L1-S1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical nerve root infiltration | Procedure | 4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life (HRQoL) | (SF)-12 questionaire Change from Baseline SF-12 at 1 month | 1 month |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger Joswig, M.D. | Cantonal Hospital St. Gallen, Dept. of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flawil Hospital | Flawil | Canton of St. Gallen | 9230 | Switzerland | ||
| Rorschach Hospital |
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| Lumbar nerve root infiltration | Procedure | 40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered. |
|
| Mephamesone | Drug |
|
| 0.5% bupivacaine (Bupivacain®) | Drug |
|
| Kenacort® | Drug |
|
| 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)?
| 14 days, 1 month, 3 months, 6 months, 12 months, 24 months |
| Rorschach |
| Canton of St. Gallen |
| 9400 |
| Switzerland |
| Cantonal Hospital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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