Cervical Disc HerniationInfStuNCT01945554
The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
A study testing Cervical nerve root infiltration, Lumbar nerve root infiltration and Mephamesone in people with Cervical Disc Herniation and Lumbar Disc Herniation, run by Holger Joswig at 3 sites in Switzerland.
Trial summary
The purpose if this study is to assess the response to nerve root infiltration therapy in patients with cervical or lumbar disc herniations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Disc Herniation, Lumbar Disc Herniation
- What is being tested?
- Cervical nerve root infiltration, Lumbar nerve root infiltration and Mephamesone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Jul 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Flawil Hospital
Flawil, Canton of St. Gallen, 9230
Rorschach Hospital
Rorschach, Canton of St. Gallen, 9400
Cantonal Hospital St. Gallen
Sankt Gallen, 9007
About this study
The purpose if this study is to assess the response to nerve root infiltration therapy in patients with cervical or lumbar disc herniations.
Read the 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.
- Conditions
- Cervical Disc Herniation, Lumbar Disc Herniation
- Being tested
- Cervical nerve root infiltration, Lumbar nerve root infiltration, Mephamesone, 0.5% bupivacaine (Bupivacain®), Kenacort®
- Keywords
- infiltrative therapy, cervical disc herniation, lumbar disc herniation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical nerve root infiltrationProcedure or surgery
4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.
Lumbar nerve root infiltrationProcedure or surgery
40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.
MephamesoneDrug
0.5% bupivacaine (Bupivacain®)Drug
Kenacort®Drug
| Study group | Role | What they receive |
|---|---|---|
| Cervical disc herniation | Experimental | Patients with cervical disc herniation and compression of nerve roots C3-C8. Receives: Procedure: Cervical nerve root infiltration; Drug: Mephamesone; Drug: 0.5% bupivacaine (Bupivacain®) |
| Lumbar disc herniation | Experimental | Patients with lumbar disc herniation and compression of nerve roots L1-S1. Receives: Procedure: Lumbar nerve root infiltration; Drug: 0.5% bupivacaine (Bupivacain®); Drug: Kenacort® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQoL)
(SF)-12 questionaire Change from Baseline SF-12 at 1 month
Measured: 1 month
Secondary outcomes (12)
Neck Pain and Disability Scale (NPAD)
Neck Pain and Disability Scale (NPAD)
Measured: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Measured: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Percent change of pain (VAS)
Percent change of pain (VAS)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Frequency of opioid use (yes/no)
Frequency of opioid use (yes/no)
Measured: 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.
Measured: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Health-related quality of life (HRQoL)
(SF)-12 questionaire
Measured: 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
Measured: 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
Measured: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holger Joswig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Holger Joswig, Cantonal Hospital of St. Gallen
- Investigators
- Holger Joswig, M.D., Principal investigator, Cantonal Hospital St. Gallen, Dept. of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945554
- Sponsor's protocol ID
- EKSG 13/061
- Acronym
- InfStu
- Status last verified
- Jan 2018
- First submitted
- 10 Sep 2013
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
- ClinicalTrials.gov ID
- NCT01945554
- Acronym / sponsor ID
- InfStu / EKSG 13/061
- Conditions
- Cervical Disc Herniation, Lumbar Disc Herniation
- Keywords
- infiltrative therapy, cervical disc herniation, lumbar disc herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Holger JoswigUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical disc herniation | Experimental | Procedure: Cervical nerve root infiltration, Drug: Mephamesone, Drug: 0.5% bupivacaine (Bupivacain®)Patients with cervical disc herniation and compression of nerve roots C3-C8. |
| Lumbar disc herniation | Experimental | Procedure: Lumbar nerve root infiltration, Drug: 0.5% bupivacaine (Bupivacain®), Drug: Kenacort®Patients with lumbar disc herniation and compression of nerve roots L1-S1. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical nerve root infiltration4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered. | Procedure or surgery | Cervical disc herniation |
| Lumbar nerve root infiltration40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered. | Procedure or surgery | Lumbar disc herniation |
| Mephamesone | Drug | Cervical disc herniation |
| 0.5% bupivacaine (Bupivacain®) | Drug | Cervical disc herniation, Lumbar disc herniation |
| Kenacort® | Drug | Lumbar disc herniation |
Primary outcome
Health-related quality of life (HRQoL)
Time frame: 1 month
(SF)-12 questionaire Change from Baseline SF-12 at 1 month
12 secondary outcomes
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)
Time frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
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.
Time frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
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.
Time frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
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)
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.
Time frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Health-related quality of life (HRQoL)
Time frame: Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months
Reasons for 2nd infiltration / surgery
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months
Patient's satisfaction with therapy
Time frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Joswig, M.D. principal investigator
Cantonal Hospital St. Gallen, Dept. of Neurosurgery
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical nerve root infiltration, Lumbar nerve root infiltration and Mephamesone in people with Cervical Disc Herniation and Lumbar Disc Herniation, run by Holger Joswig at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQoL) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.