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

Sacroiliac Joint Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104051
• Other study ID #: RBSI001
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: July 27, 2015
• Start date: April 2010
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Coastal Orthopedics & Sports Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 -

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Joint Diseases
• Low Back Pain
• Sacroiliac Joint Dysfunction

Locations

Country	Name	City	State
United States	Coastal Orthopedics & Sports Medicine	Bradenton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Coastal Orthopedics & Sports Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Economic outcomes	• To evaluate the economic and cost benefits of radiofrequency as a treatment for chronic pain associated with SI joint pain.	1 year	No