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Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation

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Johns Hopkins University

Status and phase

Terminated
Phase 4

Conditions

Neuritis
Radiofrequency Ablation

Treatments

Drug: Dexamethasone 4 mg/ml
Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03247413
IRB00113297

Details and patient eligibility

About

Chronic neck and back pain has become one of the leading causes of disability and loss of productivity. For many patients with facet or sacroiliac joint mediated pain who have responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe procedure with minimal risk of adverse events. However, with any procedure involving damage to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The investigators will test the hypothesis that dexamethasone injection delivered at the time of lesion effectively prevents the development of post-ablation neuritis through a placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic, lumbar, and sacroiliac joint radiofrequency denervations

Enrollment

63 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with a diagnosis of either cervical, thoracic, or lumbar facet or sacroiliac joint pain who have responded to medial branch blocks and are already scheduled for bilateral radiofrequency ablations
  • age greater than 18 years old
  • English speaking

Exclusion criteria

  • patient not previously scheduled for radiofrequency ablation of the cervical, thoracic, or lumbar facets, or sacroiliac joints
  • on anticoagulation
  • have a pacemaker
  • age less than 18 years old
  • non-English speaking

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

63 participants in 2 patient groups, including a placebo group

Dexamethasone
Experimental group
Description:
Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation
Treatment:
Drug: Dexamethasone 4 mg/ml
Placebo
Placebo Comparator group
Description:
Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation
Treatment:
Drug: Normal saline

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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