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

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: Completed
• Conditions: Lumbar Disc Herniation; Cervical Disc Herniation
• Intervention / Treatment: Procedure: Cervical nerve root infiltration; Drug: Mephamesone; Drug: 0.5% bupivacaine (Bupivacain®); Procedure: Lumbar nerve root infiltration; 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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Pain and Disability Scale (NPAD)	Neck Pain and Disability Scale (NPAD)	Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Oswestry Disability Index (ODI)	Oswestry Disability Index (ODI)	Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Percent change of pain (VAS)	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.	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.	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.	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	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)	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.	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)	(SF)-12 questionaire	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	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	14 days, 1 month, 3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Holger Joswig

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (ESTIMATE): September 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: lumbar disc herniation; cervical disc herniation; infiltrative therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: EKSG 13/061