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

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.

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Key information

Conditions

Sacroiliac Joint Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, 34209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Primary outcomes

Reduction in pain

Time frame: 6 months
- 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 outcomes

Economic outcomes

Time frame: 1 year
- To evaluate the economic and cost benefits of radiofrequency as a treatment for chronic pain associated with SI joint pain.

Sponsors and collaborators

Lead sponsor

Coastal Orthopedics & Sports Medicine

Other

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Apr 15, 2010
Registry last updated: Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed