Clinical trial NCT01945554: The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
Official title: The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Disc Herniation
Lumbar Disc Herniation
Keywords: infiltrative therapy
cervical disc herniation
lumbar disc herniation
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: 1 month
Secondary outcomes:
measure: Neck Pain and Disability Scale (NPAD)
timeFrame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
measure: Oswestry Disability Index (ODI)
timeFrame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
measure: Percent change of pain (VAS)
timeFrame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
measure: Need for additional surgical therapy and time-to-surgery.
timeFrame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
measure: Need for hospitalization for disabling pain and time-to-hospitalization.
timeFrame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
measure: Need for repeated infiltrations and time-to-infiltration between the study groups.
timeFrame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
measure: Absolute VAS pain reduction of a repeated "boost"-infiltration
timeFrame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
measure: Frequency of opioid use (yes/no)
timeFrame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
measure: Ability to return to work (0-100%) and time-to-return to work.
timeFrame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
measure: Health-related quality of life (HRQoL)
timeFrame: Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months
measure: Reasons for 2nd infiltration / surgery
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months
measure: Patient's satisfaction with therapy
timeFrame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Flawil
country: Switzerland
facility: Flawil Hospital
state: Saint Gallen
city: Rorschach
country: Switzerland
facility: Rorschach Hospital
state: Saint Gallen
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen, Dept. of Neurosurgery
name: Holger Joswig, M.D.
role: PRINCIPAL_INVESTIGATOR
References: