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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2017

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.

Interventions

  • Procedure: Cervical nerve root infiltration
    • 4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.
  • Procedure: Lumbar nerve root infiltration
    • 40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.
  • Drug: Mephamesone
  • Drug: 0.5% bupivacaine (Bupivacain®)
  • Drug: Kenacort®

Arms, Groups and Cohorts

  • Experimental: Cervical disc herniation
    • Patients with cervical disc herniation and compression of nerve roots C3-C8.
  • Experimental: Lumbar disc herniation
    • Patients with lumbar disc herniation and compression of nerve roots L1-S1.

Clinical Trial Outcome Measures

Primary Measures

  • Health-related quality of life (HRQoL)
    • Time Frame: 1 month
    • (SF)-12 questionaire Change from Baseline SF-12 at 1 month

Secondary Measures

  • 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)
  • Oswestry Disability Index (ODI)
    • Time Frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
    • Oswestry Disability Index (ODI)
  • 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)
  • 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.
  • 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.
  • 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.
  • 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
  • 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)
  • 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.
  • Health-related quality of life (HRQoL)
    • Time Frame: Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months
    • (SF)-12 questionaire
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Holger Joswig
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Holger Joswig, Dr. med. – Cantonal Hospital of St. Gallen
  • Overall Official(s)
    • Holger Joswig, M.D., Principal Investigator, Cantonal Hospital St. Gallen, Dept. of Neurosurgery

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.