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

NCT02930057 | Unknown Phase 4

• 1 other identifier: 3301-16-SMC
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Radicular; Neuropathic, Lumbar, Lumbosacral; Low Back Pain; Back Pain With Radiation

Keywords

lumbar dorsal root ganglion; transforaminal epidural steroid injection; chronic lumbosacral radicular pain; pulsed radiofrequency treatment; betamethasone; dorsal root ganglion

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• adverse events

  immediately and for up to 72 hours after the treatment

Study Arms (2)

Celestone

EXPERIMENTAL

all patients of the experimental Celestone group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of Celestone® Chronodose® around each dorsal root ganglion immediately after the radiofrequency treatment has been performed.

Drug: Celestone; Procedure: pulsed radiofrequency treatment

Control

OTHER

all patients of the control group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of normal saline around each dorsal root ganglion immediately after the radiofrequency treatment will be performed.

Procedure: pulsed radiofrequency treatment; Drug: Control

Interventions

Celestone DRUG

all of the patients of the experimental Celestone group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of Celestone® Chronodose® around each dorsal root ganglion immediately after the radiofrequency treatment has been performed

Celestone

pulsed radiofrequency treatment PROCEDURE

all of the patients who will participate in the study will receive pulsed radiofrequency treatment adjacent to lumbosacral dorsal root ganglion(s).

Celestone; Control

Control DRUG

all of the patients of the control group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of normal saline around each dorsal root ganglion immediately after the radiofrequency treatment will be performed.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Related Publications (25)

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MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Betamethasone; Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• Vadim Tashlikov, M.D.

  Sheba Medical Center Hospital, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vadim Tashlikov, M.D.

CONTACT

0504820159; vtashl@gmail.com

Dmitry Shklovsky, M.D.

CONTACT

0524774479; dm86sh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Doctor

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 11, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: October 17, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share