Study Stopped
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Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy vs Decompression Catheter in Lumbar Disc Herniation
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to learn which of three minimally invasive procedures is the most effective for treatment of contained lumbar disc herniation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2006
CompletedFirst Posted
Study publicly available on registry
March 10, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMay 3, 2022
May 1, 2022
1.1 years
March 8, 2006
May 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months
baseline 1, 3, 6, 9, 12 months
Secondary Outcomes (5)
Oswestry results
baseline 1, 3, 6, 9, 12 months
Quality of Life SF-36
baseline 1, 3, 6, 9, 12 months
Return to work evaluation
1 month
Depression score
BASELINE
Opioid use
1, 3, 6, 9, 12 months
Study Arms (4)
Nucleoplasty
ACTIVE COMPARATORProcedure/Surgery: Nucleoplasty
Percutaneous decompression
ACTIVE COMPARATORProcedure/Surgery: Percutaneous decompression
Electrothermal disc decompression (IDET)
ACTIVE COMPARATORProcedure/Surgery: Intervertebral electrothermal disc decompression (IDET)
Behavioral:Conservative treatment
EXPERIMENTALConservative treatment with oral medications, physical therapy, epidural steroid injections
Interventions
Eligibility Criteria
You may qualify if:
- History of concordant radicular leg pain unresponsive to conservative treatment for longer than 3 months
- Leg pain must be greater than back pain
- Contained disc herniation as evidenced by MRI
- No evidence of psychological issues by exam or history
You may not qualify if:
- A score of greater than 10 on Beck Depression Inventory (BDI)
- Patients with pending workers compensation claim or litigation
- Pregnancy
- Tumor
- Systemic infection or localized infection at the anticipated entry needle site
- Traumatic spinal fracture
- History of coagulopathy
- Unexplained bleeding
- Progressive neurological deficits
- History of opioid abuse or patients currently on long acting opioids
- Patients presenting with moderate or severe lumbar central or lateral canal stenosis, free disc fragments or degenerative disc disease as described on MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonardo Kapural, MD, OhD
Cleveland Clinic Foundation, Pain Management Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2006
First Posted
March 10, 2006
Study Start
July 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
May 3, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share