Back to resultsThe Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration (InfStu)
Primary Purpose
Cervical Disc Herniation, Lumbar Disc Herniation
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cervical nerve root infiltration
Lumbar nerve root infiltration
Mephamesone
0.5% bupivacaine (Bupivacain®)
Kenacort®
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Disc Herniation focused on measuring infiltrative therapy, cervical disc herniation, lumbar disc herniation
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
Sites / Locations
- Flawil Hospital
- Rorschach Hospital
- Cantonal Hospital St. Gallen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cervical disc herniation
Lumbar disc herniation
Arm Description
Patients with cervical disc herniation and compression of nerve roots C3-C8.
Patients with lumbar disc herniation and compression of nerve roots L1-S1.
Outcomes
Primary Outcome Measures
Health-related quality of life (HRQoL)
(SF)-12 questionaire Change from Baseline SF-12 at 1 month
Secondary Outcome Measures
Neck Pain and Disability Scale (NPAD)
Neck Pain and Disability Scale (NPAD)
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Percent change of pain (VAS)
Percent change of pain (VAS)
Need for additional surgical therapy and time-to-surgery.
Need for additional surgical therapy and time-to-surgery.
Need for hospitalization for disabling pain and time-to-hospitalization.
Need for hospitalization for disabling pain and time-to-hospitalization.
Need for repeated infiltrations and time-to-infiltration between the study groups.
Need for repeated infiltrations and time-to-infiltration between the study groups.
Absolute VAS pain reduction of a repeated "boost"-infiltration
Absolute VAS pain reduction of a repeated "boost"-infiltration
Frequency of opioid use (yes/no)
Frequency of opioid use (yes/no)
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.
Health-related quality of life (HRQoL)
(SF)-12 questionaire
Reasons for 2nd infiltration / surgery
Reasons may be either pain and/or sensory dysfunction and/or motor weakness
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01945554
Brief Title
The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
Acronym
InfStu
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Holger Joswig
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Herniation, Lumbar Disc Herniation
Keywords
infiltrative therapy, cervical disc herniation, lumbar disc herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cervical disc herniation
Arm Type
Experimental
Arm Description
Patients with cervical disc herniation and compression of nerve roots C3-C8.
Arm Title
Lumbar disc herniation
Arm Type
Experimental
Arm Description
Patients with lumbar disc herniation and compression of nerve roots L1-S1.
Intervention Type
Procedure
Intervention Name(s)
Cervical nerve root infiltration
Intervention Description
4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.
Intervention Type
Procedure
Intervention Name(s)
Lumbar nerve root infiltration
Intervention Description
40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.
Intervention Type
Drug
Intervention Name(s)
Mephamesone
Intervention Type
Drug
Intervention Name(s)
0.5% bupivacaine (Bupivacain®)
Intervention Type
Drug
Intervention Name(s)
Kenacort®
Primary Outcome Measure Information:
Title
Health-related quality of life (HRQoL)
Description
(SF)-12 questionaire Change from Baseline SF-12 at 1 month
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Neck Pain and Disability Scale (NPAD)
Description
Neck Pain and Disability Scale (NPAD)
Time Frame
Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Title
Oswestry Disability Index (ODI)
Description
Oswestry Disability Index (ODI)
Time Frame
Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Title
Percent change of pain (VAS)
Description
Percent change of pain (VAS)
Time Frame
Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Title
Need for additional surgical therapy and time-to-surgery.
Description
Need for additional surgical therapy and time-to-surgery.
Time Frame
14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Title
Need for hospitalization for disabling pain and time-to-hospitalization.
Description
Need for hospitalization for disabling pain and time-to-hospitalization.
Time Frame
14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Title
Need for repeated infiltrations and time-to-infiltration between the study groups.
Description
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
Title
Absolute VAS pain reduction of a repeated "boost"-infiltration
Description
Absolute VAS pain reduction of a repeated "boost"-infiltration
Time Frame
14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Title
Frequency of opioid use (yes/no)
Description
Frequency of opioid use (yes/no)
Time Frame
Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Title
Ability to return to work (0-100%) and time-to-return to work.
Description
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
Title
Health-related quality of life (HRQoL)
Description
(SF)-12 questionaire
Time Frame
Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months
Title
Reasons for 2nd infiltration / surgery
Description
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
Title
Patient's satisfaction with therapy
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Joswig, M.D.
Organizational Affiliation
Cantonal Hospital St. Gallen, Dept. of Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flawil Hospital
City
Flawil
State/Province
Saint Gallen
ZIP/Postal Code
9230
Country
Switzerland
Facility Name
Rorschach Hospital
City
Rorschach
State/Province
Saint Gallen
ZIP/Postal Code
9400
Country
Switzerland
Facility Name
Cantonal Hospital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
We'll reach out to this number within 24 hrs