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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.
40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.
Flawil Hospital
Flawil, Canton of St. Gallen, Switzerland
Rorschach Hospital
Rorschach, Canton of St. Gallen, Switzerland
Cantonal Hospital St. Gallen
Sankt Gallen, Switzerland
Health-related quality of life (HRQoL)
(SF)-12 questionaire Change from Baseline SF-12 at 1 month
Time frame: 1 month
Neck Pain and Disability Scale (NPAD)
Neck Pain and Disability Scale (NPAD)
Time frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Time frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Percent change of pain (VAS)
Percent change of pain (VAS)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Absolute VAS pain reduction of a repeated "boost"-infiltration
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Absolute VAS pain reduction of a repeated "boost"-infiltration
Time frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Frequency of opioid use (yes/no)
Frequency of opioid use (yes/no)
Time frame: 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.
Time frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Health-related quality of life (HRQoL)
(SF)-12 questionaire
Time frame: 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
Time frame: 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
Time frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months