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

NCT01104051 | Completed

• 1 other identifier: RBSI001
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Joint Dysfunction

Outcome Measures

Primary Outcomes (1)

• Reduction in pain

  • To evaluate the clinical efficacy of RF lesioning of sensory innervation of the sacroiliac region as a long term treatment for pain associated with SI joint dysfunction as measured by the reduction in VAS scale and the use of pain alleviating therapies

  6 months

Secondary Outcomes (1)

• Economic outcomes

  1 year

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \. 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

You may not qualify if:

• Focal Neurologic Signs
• 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
• Previous radiofrequency procedure within the last 6 months
• Moderate or greater spinal stenosis
• Greater than Grade 2 listhesis
• Foraminal Stenosis; marked to severe
• Previous Lumbar Spine Surgery
• Unstable Medical or Psychological Conditions as determined by the investigator
• Concomitant cervical or thoracic pain greater than 2/10 on VAS
• Workers compensation, disability or litigation
• Pregnancy, breast feeding or planning on becoming pregnant during the trial
• Subject unwillingness to complete study related activities
• Current Smoker; unless quit greater than 6 months -

Sponsors & Collaborators

• Coastal Orthopedics & Sports Medicine: lead

Study Sites (1)

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, 34209, United States

Location

Study Officials

• Richard Bundschu, MD

  Coastal Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

US (1)