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Completed

NCT Number: NCT01945554

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

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

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Key information

Conditions

Cervical Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Lumbar Disc Herniation Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flawil Hospital, Flawil, Canton of St. Gallen, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical nerve root infiltration

Procedure

4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.

Lumbar nerve root infiltration

Procedure

40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.

Mephamesone

Drug

0.5% bupivacaine (Bupivacain®)

Drug

Kenacort®

Drug

Primary outcomes

  1. Health-related quality of life (HRQoL)

    Time frame: 1 month

    (SF)-12 questionaire Change from Baseline SF-12 at 1 month

Secondary outcomes

  1. 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)

  2. Oswestry Disability Index (ODI)

    Time frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months

    Oswestry Disability Index (ODI)

  3. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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)

  9. 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.

  10. Health-related quality of life (HRQoL)

    Time frame: Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months

    (SF)-12 questionaire

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Holger Joswig

Other

Registry information

Acronym: InfStu

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2013
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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