Transforaminal Epidural Steroid Injection With Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain Management

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Betamethasone; Betamethasone acetate phosphate; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Lidocaine; Pharmaceutical Solutions

Criteria

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