Overview

This trial is active, not recruiting.

Conditions cervical disc herniation, lumbar disc herniation
Treatments cervical nerve root infiltration, lumbar nerve root infiltration, mephamesone, 0.5% bupivacaine (bupivacain®), kenacort®
Sponsor Holger Joswig
Start date July 2013
End date December 2016
Trial size 250 participants
Trial identifier NCT01945554, EKSG 13/061

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients with cervical disc herniation and compression of nerve roots C3-C8.
cervical nerve root infiltration
4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.
mephamesone
0.5% bupivacaine (bupivacain®)
(Experimental)
Patients with lumbar disc herniation and compression of nerve roots L1-S1.
lumbar nerve root infiltration
40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.
0.5% bupivacaine (bupivacain®)
kenacort®

Primary Outcomes

Measure
Health-related quality of life (HRQoL)
time frame: 1 month

Secondary Outcomes

Measure
Neck Pain and Disability Scale (NPAD)
time frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Oswestry Disability Index (ODI)
time frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Percent change of pain (VAS)
time frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
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 hospitalization for disabling pain and time-to-hospitalization.
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.
time frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Absolute VAS pain reduction of a repeated "boost"-infiltration
time frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Frequency of opioid use (yes/no)
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.
time frame: Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months
Health-related quality of life (HRQoL)
time frame: Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months
Reasons for 2nd infiltration / surgery
time frame: 1 month, 3 months, 6 months, 12 months, 24 months
Patient's satisfaction with therapy
time frame: 14 days, 1 month, 3 months, 6 months, 12 months, 24 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
Principal investigator Holger Joswig, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Cantonal Hospital of St. Gallen.