Low Back Pain Clinical Trial
Official title:
Transforaminal Epidural Steroid Injection in Conjunction With Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for the Management of Chronic Lumbosacral Radicular Pain: a Randomized, Double-blind Trial
The purpose of this study is to examine the potential changes in levels of pain, quality of
life (QoL) and activities of daily living (ADL) observed when transforaminal epidural
steroid injection is administered in conjunction with pulsed radiofrequency treatment of the
lumbar dorsal root ganglion during the initial 3 months follow-up period. Safety (monitoring
side effects) of the treatment is determined.
The study hypothesis is that the application of transforaminal epidural steroid injection
(TFESI) in conjunction with pulsed radiofrequency treatment (PRF) treatment of the lumbar
dorsal root ganglion would increase the treatment response of PRF and thereby provide a
measurable difference in the pain scores, quality of life and activities of daily living for
the patients suffering from chronic lumbosacral radicular pain.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | October 2018 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - men and women - age =18 years old, - pain intensity=4 out of 10 on the numerical rating scale (NRS), - chronic lumbosacral radicular pain lasting =12 weeks, - dominant leg pain with less intense back pain, - the previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications. - segmental pain of a radicular nature originating from the lumbar segments and with a shooting or lancinating quality corresponding to a dermatome suggestive of the involved nerve root. - availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features. Exclusion Criteria: - patient refusal to participate in the study, - age <18 years, - pregnant or nursing - pain <4-points on NRS, - acute pain of onset lasting<12 weeks, - progressive motor weakness in the affected leg, - allergies to local anesthetics, contrast dyes or steroids - significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging - presence of cancer accounting for back pain - patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment - steroid injection within the previous 12 weeks, - systemic infection, - injection site infection, - unstable medical or psychiatric condition |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain scores | Changes in pain scores, as reported by the patients via the NRS scores, will be analyzed before the procedure and at 1, 2 and 3 months after the treatment | before the procedure and at 1, 2 and 3 months after the treatment | Yes |
Primary | quality of life and activities of daily living | The potential changes in quality of life and activities of daily living will be measured by validated Roland Disability Questionnaire or Oswestry Disability Index scores | before the procedure and at 1, 2 and 3 months after the treatment | Yes |
Secondary | adverse events | immediately and for up to 72 hours after the treatment | Yes |
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