no Conditions
Conditions
Brief summary
Study comparing caudal prolotherapy to conventional steroid for chronic low back pain
Interventions
PROCEDUREEpidural Prolotherapy
caudal injection of 10mL 5% dextrose
PROCEDUREEpidural Steroid
caudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine
Sponsors
Naveed Natanzi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must satisfy diagnostic criteria for lumbar radicular pain at L4 nerve root level or below with consistent MRI or X ray findings. 2. Evidence of low back pain base upon one or more of the following: i. Lumbar back pain episodes lasting greater than 6 months and current pain level is greater than 6/10 on VAS. ii. Has received at lest 2 types of ancillary treatment (i.e. physical therapy, oral analgesia, acupuncture, etc.) 3. Men or women age greater than or equal to 18 years. 4. No significant alcohol use (7 or fewer drinks per week). 5. Patient has a history of at least 2 failed epidural CS injections.
Exclusion criteria
1. Treatment risk factors including one or more of the following: i. Unstable or symptomatic cardiac complaints ii. Unstable or symptomatic respiratory complaints iii. Unable to reliably comprehend the protocol or reliably record data 2. Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment. 3. History of Malignancy 4. Any medical (i.e. malignancy, infection, thrombo-embolic states, autoimmune disease, polyneuropathy) or psychosocial condition that in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief as measured by VAS pain scale. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Change in the frequency and amount of opioid use. | 1 year |
| Disability score as determined by Oswstery questionnaire. | 1 year |
Countries
United States
Contacts
Primary ContactNaveed M Natanzi, DO
Outcome results
None listed