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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Coastal Orthopedics & Sports Medicine
Sponsor:
Information provided by (Responsible Party):
Coastal Orthopedics & Sports Medicine
ClinicalTrials.gov Identifier:
NCT01104051
First received: April 13, 2010
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition
Sacroiliac Joint Dysfunction

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: A Prospective, Single Center, Double Blind, Randomized, Sham Controlled, Crossover Study to Evaluate the Clinical Efficacy of Radiofrequency Nerve Ablation Using Simplicity III Versus Sham for the Treatment of Chronic Low Back Pain Associated With Sacroiliac Joint Dysfunction

Resource links provided by NLM:


Further study details as provided by Coastal Orthopedics & Sports Medicine:

Primary Outcome Measures:
  • Reduction in pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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


Secondary Outcome Measures:
  • Economic outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • To evaluate the economic and cost benefits of radiofrequency as a treatment for chronic pain associated with SI joint pain.


Estimated Enrollment: 39
Study Start Date: April 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104051

Contacts
Contact: Heather Gillen 941-782-1353 hgillen@coastalorthopedics.com
Contact: Lois Davis, BSN, MA 941-782-1353 ldavis@coastalorthopedics.com

Locations
United States, Florida
Coastal Orthopedics & Sports Medicine Recruiting
Bradenton, Florida, United States, 34209
Contact: Heather L Gillen    941-782-1353    hgillen@coastalorthopedics.com   
Contact: Lois A Davis, BSN, MA    9417821353    ldavis@coastalorthopedics.com   
Principal Investigator: Richard Bundschu, MD         
Sponsors and Collaborators
Coastal Orthopedics & Sports Medicine
Investigators
Principal Investigator: Richard Bundschu, MD Coastal Orthopedics
  More Information

No publications provided

Responsible Party: Coastal Orthopedics & Sports Medicine
ClinicalTrials.gov Identifier: NCT01104051     History of Changes
Other Study ID Numbers: RBSI001
Study First Received: April 13, 2010
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Low Back Pain
Joint Diseases
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 01, 2014