Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia

NCT01670825 | Completed Results

• 1 other identifier: 373481-3
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to determine whether pulsed radiofrequency or steroids are better for occipital neuralgia. Seventy-six patients with ON or migraine with tenderness over the occipital nerve who respond to occipital nerve blocks (hereafter included under the broad category "ON") will be randomized in a 1:1 ratio to receive either corticosteroid and local anesthetic injections (n=38) or local anesthetic and PRF of the occipital nerve(s) (n=38) for occipital neuralgia. Both patients and the treating \& evaluating physicians will be blinded. The first follow-up visit will be at 6 weeks. Patients who obtain significant pain relief will remain in the study. Those patients who fail to obtain any benefit will exit the study and be allowed to crossover to the other treatments or receive alternative care. The second follow-up will be at 3 months and the final follow-up will be at 6-months post-procedure.

Conditions

Occipital Neuralgia

Keywords

Occipital neuralgia; corticosteroid injection; pulsed radiofrequency

Outcome Measures

Primary Outcomes (16)

• Change in Average Occipital Pain 6 Weeks After the Start of Treatment

  The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 6 weeks after the start of treatment

• Change in Worst Occipital Pain 6 Weeks After the Start of Treatment

  The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 6 weeks after the start of treatment

• Change in Average Occipital Pain 6 Months After the Start of Treatment

  The change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 6 months after the start of treatment

• Change in Worst Occipital Pain 6 Months After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 6 months after the start of treatment

• Change in Average Occipital Pain 3 Months After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 3 months after the start of treatment

• Change in Worst Occipital Pain 3 Months After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 3 months after the start of treatment

• Change in Average Occipital Pain 2 Weeks After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 2 weeks after the start of treatment

• Change in Worst Occipital Pain 2 Weeks After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 2 weeks after the start of treatment

• Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 2 weeks after the start of treatment

• Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 2 weeks after the start of treatment

• Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 6 weeks after the start of treatment

• Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 6 weeks after the start of treatment

• Change in Overall Average Headache Pain 3 Months After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 3 months after the start of treatment

• Change in Overall Worst Headache Pain 3 Months After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 3 months after the start of treatment

• Change in Overall Average Headache Pain 6 Months After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 6 months after the start of treatment

• Change in Overall Worst Headache Pain 6 Months After the Start of Treatment

  This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  From baseline to 6 months after the start of treatment

Secondary Outcomes (15)

• Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.

  From baseline to 6 weeks after the start of treatment

• Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.

  From baseline to 3 months after the start of treatment

• Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.

  From baseline to 6 months after the start of treatment

• Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory

  From baseline to 6 weeks after the start of treatment

• Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory

  From baseline to 3 months after the start of treatment

Study Arms (2)

Pulsed radiofrequency + local anesthetic injection

EXPERIMENTAL

Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve

Procedure: Pulsed radiofrequency; Drug: Local anethestic injection

Corticosteroid injection + sham pulsed radiofrequency

ACTIVE COMPARATOR

Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus "sham" pulsed radiofrequency

Drug: Corticosteroid injection; Drug: Local anethestic injection

Interventions

Pulsed radiofrequency PROCEDURE

Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve

Pulsed radiofrequency + local anesthetic injection

Corticosteroid injection DRUG

Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve

Corticosteroid injection + sham pulsed radiofrequency

Local anethestic injection DRUG

Also known as: Local anethestic injection that both arms will receive

Corticosteroid injection + sham pulsed radiofrequency; Pulsed radiofrequency + local anesthetic injection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater or equal to 18 years
• Occipital neuralgia diagnosed based on history \& physical exam and diagnostic local anesthetic blocks, or migraine with occipital nerve(s) tenderness that responds to diagnostic blocks.
• a. Greater or equal to 50% relief based on diagnostic local anesthetic block of the greater and/ or lesser occipital nerves that lasts for at least 90 minutes with lidocaine or 3 hours with bupivacaine or ropivacaine 20
• Baseline Numerical Rating Scale average pain score \> 4/10
• Frequency of greater or equal to 4/10 pain for at least 10 days per month

You may not qualify if:

• Untreated coagulopathy
• Automatic implantable cardiac defibrillator or pacemaker that cannot be temporarily disabled for medical reasons
• Previous pulsed radiofrequency
• Other sources of headache, such as tension-type headache, cervicogenic headache, migraine headache without occipital neuralgia, and other causes (e.g. tumors, congenital abnormalities etc.). Those that can be confused with ON must be excluded based on history and exam (e.g. cervicogenic headaches), symptoms (tension-type headache), response to blocks (all of the above); and lab work (temporal arteritis, which would be confirmed by biopsy after an elevated erythrocyte sedimentation rate).
• Serious medical or uncontrolled or severe psychiatric -

Sponsors & Collaborators

• Johns Hopkins University: lead
• United States Naval Medical Center, San Diego: collaborator
• Landstuhl Regional Medical Center: collaborator
• Madigan Army Medical Center: collaborator
• United States Naval Medical Center, Portsmouth: collaborator

Study Sites (2)

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (4)

• Huang JH, Galvagno SM Jr, Hameed M, Wilkinson I, Erdek MA, Patel A, Buckenmaier C 3rd, Rosenberg J, Cohen SP. Occipital nerve pulsed radiofrequency treatment: a multi-center study evaluating predictors of outcome. Pain Med. 2012 Apr;13(4):489-97. doi: 10.1111/j.1526-4637.2012.01348.x. Epub 2012 Mar 5.

  PMID: 22390409 BACKGROUND

• Vanelderen P, Rouwette T, De Vooght P, Puylaert M, Heylen R, Vissers K, Van Zundert J. Pulsed radiofrequency for the treatment of occipital neuralgia: a prospective study with 6 months of follow-up. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):148-51. doi: 10.1097/aap.0b013e3181d24713.

  PMID: 20301822 BACKGROUND

• Choi HJ, Oh IH, Choi SK, Lim YJ. Clinical outcomes of pulsed radiofrequency neuromodulation for the treatment of occipital neuralgia. J Korean Neurosurg Soc. 2012 May;51(5):281-5. doi: 10.3340/jkns.2012.51.5.281. Epub 2012 May 31.

  PMID: 22792425 BACKGROUND

• Cohen SP, Peterlin BL, Fulton L, Neely ET, Kurihara C, Gupta A, Mali J, Fu DC, Jacobs MB, Plunkett AR, Verdun AJ, Stojanovic MP, Hanling S, Constantinescu O, White RL, McLean BC, Pasquina PF, Zhao Z. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness. Pain. 2015 Dec;156(12):2585-2594. doi: 10.1097/j.pain.0000000000000373.

  PMID: 26447705 DERIVED

MeSH Terms

Interventions

Pulsed Radiofrequency Treatment; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Steven Cohen
• Organization: Johns Hopkins Hospital

scohen40@jhmi.edu

410-955-1818

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2012
• First Posted: August 22, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 1, 2017
• Results First Posted: March 1, 2017

Record last verified: 2017-01

Locations

US (2)