Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction

NCT ID: NCT01104051

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2015-06-30

Brief Summary

Trial will enroll qualified subjects at a 2:1 ration to receive radiofrequency ablation or sham. At six weeks follow up they will be unblinded; sham subjects will then be given option to receive treatment.

Subjects will be followed after procedure for data collection for economic outcomes and efficacy of treatment.

Detailed Description

Patients presenting with low back pain associated with SIJD for longer than 6 months, and who have not had positive responsive to the conservative treatments:

• Pharmacologic Management
• Therapies; physical, acupuncture, massage etc…
• Other alternative treatments

Enrollment, Treatment/Sham Procedure, Follow-up at 3 weeks, 6 weeks with unblinding, 4, 6, 9 months. Un-blinding occurring at 6 weeks with crossover option to receive treatment. Total visits 7 with enrollment approximately over a period of 9 months. Trial extension optional for phone contact at year 1, 2. Sham subjects receiving treatment will be followed at months 6 weeks, 4, and 6 months with phone calls at year 1, 2.

Patients who complete at least 50% of their patient diaries, and miss no more 2 consecutive office visits. Data will be used if patients have remained enrolled thru 4 month visit.

Conditions

Sacroiliac Joint Dysfunction

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Radiofrequency Ablation

The treatment to be used in this trial is radiofrequency nerve ablation of lateral branches from S1 - S4 using radiofrequency treatments; Simplicity lll Electrode, a single RF electrode with a single percutaneous entry point.

No interventions assigned to this group

Sham

subjects to be blinded,to receive sham procedure; The treatment to be used in this trial is radiofrequency nerve ablation of lateral branches from S1 - S4 using radiofrequency treatments; Simplicity lll Electrode, a single RF electrode with a single percutaneous entry point.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 1. 18 years old, or older 2. Unilateral or Bilateral LBP or Buttocks Pain for greater than six months with a 3 day average VAS greater or equal to 4 on a 1-10 scale 3. Tenderness over the SI joint 4. 75% or greater relief of pain (with return to baseline) during the local anesthetic phase of two separate, one fluoroscopically guided intra-articular SI joint injection and one lateral branch block (see Appendix A) 5. Stable medications for pain for the last seven days 6. Have used at least 3 alternative treatments for pain without success (se 7. BMI less than 35.0

Exclusion Criteria

1. Focal Neurologic Signs

2. Any component of pain related to Lumbar Z-joints at L4-5 and/or L5-S1 as determined by one set of medial branch blocks

3. Previous radiofrequency procedure within the last 6 months

4. Moderate or greater spinal stenosis

5. Greater than Grade 2 listhesis

6. Foraminal Stenosis; marked to severe

7. Previous Lumbar Spine Surgery

8. Unstable Medical or Psychological Conditions as determined by the investigator

9. Concomitant cervical or thoracic pain greater than 2/10 on VAS

10. Workers compensation, disability or litigation

11. Pregnancy, breast feeding or planning on becoming pregnant during the trial

12. Subject unwillingness to complete study related activities

13. Current Smoker; unless quit greater than 6 months -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coastal Orthopedics & Sports Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Bundschu, MD

Role: PRINCIPAL_INVESTIGATOR

Coastal Orthopedics

Locations

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, United States

Countries

United States

Other Identifiers

RBSI001

Identifier Type: -

Identifier Source: org_study_id