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

Lumbar Disc Herniation Clinical Trial

— InfStu  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945554
• Other study ID #: EKSG 13/061
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: January 23, 2018
• Start date: July 2013
• Est. completion date: March 2017

Study information

• Verified date: January 2018
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Herniation
• Hernia
• Lumbar Disc Herniation

Intervention

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

Drug:
• Mephamesone

• 0.5% bupivacaine (Bupivacain®)

• Kenacort®

Locations

Country	Name	City	State
Switzerland	Flawil Hospital	Flawil	Saint Gallen
Switzerland	Rorschach Hospital	Rorschach	Saint Gallen
Switzerland	Cantonal Hospital St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Holger Joswig

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life (HRQoL)	(SF)-12 questionaire Change from Baseline SF-12 at 1 month	1 month
Secondary	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
Secondary	Oswestry Disability Index (ODI)	Oswestry Disability Index (ODI)	Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Secondary	Percent change of pain (VAS)	Percent change of pain (VAS)	Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health-related quality of life (HRQoL)	(SF)-12 questionaire	Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months
Secondary	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
Secondary	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

External Links

•   Study synopsis