The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration (InfStu)

January 23, 2018 updated by: Holger Joswig
The purpose if this study is to assess the response to nerve root infiltration therapy in patients with cervical or lumbar disc herniations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Cantonal Hospital St. Gallen
    • Saint Gallen
      • Flawil, Saint Gallen, Switzerland, 9230
        • Flawil Hospital
      • Rorschach, Saint Gallen, Switzerland, 9400
        • Rorschach Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cervical disc herniation
Patients with cervical disc herniation and compression of nerve roots C3-C8.
Procedure: Cervical nerve root infiltration
4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.
Drug: Mephamesone
Drug: 0.5% bupivacaine (Bupivacain®)
EXPERIMENTAL: Lumbar disc herniation
Patients with lumbar disc herniation and compression of nerve roots L1-S1.
Drug: 0.5% bupivacaine (Bupivacain®)
Procedure: Lumbar nerve root infiltration
40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.
Drug: Kenacort®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life (HRQoL)
Time Frame: 1 month
(SF)-12 questionaire Change from Baseline SF-12 at 1 month
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neck Pain and Disability Scale (NPAD)
Time Frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Neck Pain and Disability Scale (NPAD)
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
Oswestry Disability Index (ODI)
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
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.
Time Frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
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.
Time Frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
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.
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.
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
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)
Time Frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
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.
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.
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
(SF)-12 questionaire
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
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
Time Frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months

Would you opt for an infiltration again (provided you had the same outcome as now)?

  • certainly yes
  • maybe yes
  • unsure
  • maybe no
  • certainly no
14 days, 1 month, 3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Holger Joswig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EKSG 13/061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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