Trial record 18 of 151 for:    Pinched Nerve

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Cantonal Hospital of St. Gallen
Sponsor:
Information provided by (Responsible Party):
Holger Joswig, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01945554
First received: September 10, 2013
Last updated: April 27, 2014
Last verified: April 2014
  Purpose

The purpose if this study is to assess the response to nerve root infiltration therapy in patients with cervical or lumbar disc herniations.


Condition Intervention
Cervial Disc Herniation
Lumbar Disc Herniation
Procedure: Cervical nerve root infiltration
Procedure: Lumbar nerve root infiltration
Drug: Mephamesone
Drug: 0.5% bupivacaine (Bupivacain®)
Drug: Kenacort®

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Health-related quality of life (HRQoL) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    (SF)-12 questionaire Change from Baseline SF-12 at 1 month


Secondary Outcome Measures:
  • Neck Pain and Disability Scale (NPAD) [ Time Frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Neck Pain and Disability Scale (NPAD)

  • Oswestry Disability Index (ODI) [ Time Frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Oswestry Disability Index (ODI)

  • Percent change of pain (VAS) [ Time Frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Percent change of pain (VAS)

  • Need for additional surgical therapy and time-to-surgery. [ Time Frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Need for additional surgical therapy and time-to-surgery.

  • Need for hospitalization for disabling pain and time-to-hospitalization. [ Time Frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Need for hospitalization for disabling pain and time-to-hospitalization.

  • 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 ] [ Designated as safety issue: No ]
    Need for repeated infiltrations and time-to-infiltration between the study groups.

  • Absolute VAS pain reduction of a repeated "boost"-infiltration [ Time Frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Absolute VAS pain reduction of a repeated "boost"-infiltration

  • Frequency of opioid use (yes/no) [ Time Frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Frequency of opioid use (yes/no)

  • 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 ] [ Designated as safety issue: No ]
    Ability to return to work (0-100%) and time-to-return to work.

  • Health-related quality of life (HRQoL) [ Time Frame: Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    (SF)-12 questionaire

  • Reasons for 2nd infiltration / surgery [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Reasons may be either pain and/or sensory dysfunction and/or motor weakness

  • Patient's satisfaction with therapy [ Time Frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

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

    • certainly yes
    • maybe yes
    • unsure
    • maybe no
    • certainly no


Estimated Enrollment: 250
Study Start Date: July 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Lumbar nerve root infiltration
40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.
Drug: 0.5% bupivacaine (Bupivacain®) Drug: Kenacort®

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945554

Contacts
Contact: Holger Joswig, M.D. +4171494 ext 1111 Holger.Joswig@kssg.ch
Contact: Martin N Stienen, M.D. +4171494 ext 1111 Martin.Stienen@kssg.ch

Locations
Switzerland
Flawil Hospital Recruiting
Flawil, St. Gallen, Switzerland, 9230
Rorschach Hospital Recruiting
Rorschach, St. Gallen, Switzerland, 9400
Cantonal Hospital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Holger Joswig
Investigators
Principal Investigator: Holger Joswig, M.D. Cantonal Hospital St. Gallen, Dept. of Neurosurgery
  More Information

Additional Information:
No publications provided

Responsible Party: Holger Joswig, Dr. med., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01945554     History of Changes
Other Study ID Numbers: EKSG 13/061
Study First Received: September 10, 2013
Last Updated: April 27, 2014
Health Authority: Ethikkommission des Kantons St. Gallen (Ethics Committee of the Canton of St. Gallen) Switzerland:

Keywords provided by Cantonal Hospital of St. Gallen:
infiltrative therapy
cervical disc herniation
lumbar disc herniation

Additional relevant MeSH terms:
Hernia
Intervertebral Disc Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Bupivacaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014