Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction
| Status: | Completed |
|---|---|
| Conditions: | Back Pain, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2010 |
| End Date: | June 2015 |
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
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.
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.
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 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.
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 -
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