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Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia

This study has been completed.
Sponsor:
Collaborators:
United States Naval Medical Center, San Diego
Landstuhl Regional Medical Center
Madigan Army Medical Center
United States Naval Medical Center, Portsmouth
Information provided by (Responsible Party):
Steven P. Cohen, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01670825
First received: August 19, 2012
Last updated: January 10, 2017
Last verified: January 2017
Results First Received: August 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Occipital Neuralgia
Interventions: Procedure: Pulsed radiofrequency
Drug: Corticosteroid injection
Drug: Local anethestic injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pulsed Radiofrequency + Local Anesthetic Injection

Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve

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

Corticosteroid Injection + Sham Pulsed Radiofrequency

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

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


Participant Flow:   Overall Study
    Pulsed Radiofrequency + Local Anesthetic Injection   Corticosteroid Injection + Sham Pulsed Radiofrequency
STARTED   42   39 
COMPLETED   42   39 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pulsed Radiofrequency + Local Anesthetic Injection

Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve

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

Corticosteroid Injection + Sham Pulsed Radiofrequency

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

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

Total Total of all reporting groups

Baseline Measures
   Pulsed Radiofrequency + Local Anesthetic Injection   Corticosteroid Injection + Sham Pulsed Radiofrequency   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   39   81 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      42 100.0%      39 100.0%      81 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.67  (10.72)   41.08  (13.61)   41.37  (12.16) 
Gender 
[Units: Participants]
Count of Participants
     
Female      20  47.6%      18  46.2%      38  46.9% 
Male      22  52.4%      21  53.8%      43  53.1% 
Region of Enrollment 
[Units: Participants]
     
United States   41   38   79 
Germany   1   1   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Average Occipital Pain 6 Weeks After the Start of Treatment   [ Time Frame: From baseline to 6 weeks after the start of treatment ]

2.  Primary:   Change in Worst Occipital Pain 6 Weeks After the Start of Treatment   [ Time Frame: From baseline to 6 weeks after the start of treatment ]

3.  Primary:   Change in Average Occipital Pain 6 Months After the Start of Treatment   [ Time Frame: From baseline to 6 months after the start of treatment ]

4.  Primary:   Change in Worst Occipital Pain 6 Months After the Start of Treatment   [ Time Frame: From baseline to 6 months after the start of treatment ]

5.  Primary:   Change in Average Occipital Pain 3 Months After the Start of Treatment   [ Time Frame: From baseline to 3 months after the start of treatment ]

6.  Primary:   Change in Worst Occipital Pain 3 Months After the Start of Treatment   [ Time Frame: From baseline to 3 months after the start of treatment ]

7.  Primary:   Change in Average Occipital Pain 2 Weeks After the Start of Treatment   [ Time Frame: From baseline to 2 weeks after the start of treatment ]

8.  Primary:   Change in Worst Occipital Pain 2 Weeks After the Start of Treatment   [ Time Frame: From baseline to 2 weeks after the start of treatment ]

9.  Primary:   Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment   [ Time Frame: From baseline to 2 weeks after the start of treatment ]

10.  Primary:   Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment   [ Time Frame: From baseline to 2 weeks after the start of treatment ]

11.  Primary:   Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment   [ Time Frame: From baseline to 6 weeks after the start of treatment ]

12.  Primary:   Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment   [ Time Frame: From baseline to 6 weeks after the start of treatment ]

13.  Primary:   Change in Overall Average Headache Pain 3 Months After the Start of Treatment   [ Time Frame: From baseline to 3 months after the start of treatment ]

14.  Primary:   Change in Overall Worst Headache Pain 3 Months After the Start of Treatment   [ Time Frame: From baseline to 3 months after the start of treatment ]

15.  Primary:   Change in Overall Average Headache Pain 6 Months After the Start of Treatment   [ Time Frame: From baseline to 6 months after the start of treatment ]

16.  Primary:   Change in Overall Worst Headache Pain 6 Months After the Start of Treatment   [ Time Frame: From baseline to 6 months after the start of treatment ]

17.  Secondary:   Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.   [ Time Frame: From baseline to 6 weeks after the start of treatment ]

18.  Secondary:   Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.   [ Time Frame: From baseline to 3 months after the start of treatment ]

19.  Secondary:   Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.   [ Time Frame: From baseline to 6 months after the start of treatment ]

20.  Secondary:   Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory   [ Time Frame: From baseline to 6 weeks after the start of treatment ]

21.  Secondary:   Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory   [ Time Frame: From baseline to 3 months after the start of treatment ]

22.  Secondary:   Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory   [ Time Frame: From baseline to 6 months after the start of treatment ]

23.  Secondary:   Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.   [ Time Frame: From baseline to 6 weeks after the start of treatment ]

24.  Secondary:   Severe Headache Frequency for Occipital Neuralgia Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit   [ Time Frame: From baseline to 6 weeks after the start of treatment ]

25.  Secondary:   Severe Headache Frequency for Migraine Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit   [ Time Frame: From baseline to 3 months after the start of treatment ]

26.  Secondary:   Severe Headache Frequency for Occipital Neuralgia Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit   [ Time Frame: 3 months ]

27.  Secondary:   Severe Headache Frequency for Migraine Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit   [ Time Frame: From baseline to 6 months after the start of treatment ]

28.  Secondary:   Severe Headache Frequency for Occipital Neuralgia Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit   [ Time Frame: From baseline to 6 months after the start of treatment ]

29.  Secondary:   Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale   [ Time Frame: From baseline to 6 weeks after the start of treatment ]

30.  Secondary:   Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale   [ Time Frame: From baseline to 3 months after the start of treatment ]

31.  Secondary:   Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale   [ Time Frame: From baseline to 6 months after the start of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Steven Cohen
Organization: Johns Hopkins Hospital
phone: 410-955-1818
e-mail: scohen40@jhmi.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven P. Cohen, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01670825     History of Changes
Other Study ID Numbers: 373481-3
Study First Received: August 19, 2012
Results First Received: August 10, 2016
Last Updated: January 10, 2017