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

Sponsor:	Coastal Orthopedics & Sports Medicine
Information provided by (Responsible Party):	Coastal Orthopedics & Sports Medicine
ClinicalTrials.gov Identifier:	NCT01104051

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:

MedlinePlus related topics: Back Pain Joint Disorders

U.S. FDA Resources

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
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (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:

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 -

Contacts and Locations

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

Locations

United States, Florida
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States, 34209

Sponsors and Collaborators

Coastal Orthopedics & Sports Medicine

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:	September 21, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Back Pain
Joint Diseases
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 09, 2012