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Trial record 2 of 15 for:    Occipital Neuralgia

Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01670825
Recruitment Status : Completed
First Posted : August 22, 2012
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Occipital Neuralgia
Interventions Procedure: Pulsed radiofrequency
Drug: Corticosteroid injection
Drug: Local anethestic injection
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 42 39
Completed 42 39
Not Completed 0 0
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 42 39 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 39 participants 81 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 39 participants 81 participants
41.67  (10.72) 41.08  (13.61) 41.37  (12.16)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 39 participants 81 participants
Female
20
  47.6%
18
  46.2%
38
  46.9%
Male
22
  52.4%
21
  53.8%
43
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 39 participants 81 participants
United States 41 38 79
Germany 1 1 2
1.Primary Outcome
Title Change in Average Occipital Pain 6 Weeks After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 6 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 42 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.068  (2.431) 3.738  (2.415)
2.Primary Outcome
Title Change in Worst Occipital Pain 6 Weeks After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 6 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

Local anethestic injection

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

Local anethestic injection

Overall Number of Participants Analyzed 41 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.354  (3.165) 6.064  (3.226)
3.Primary Outcome
Title Change in Average Occipital Pain 6 Months After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 6 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 42 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.312  (2.232) 4.765  (1.998)
4.Primary Outcome
Title Change in Worst Occipital Pain 6 Months After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 6 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 42 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.705  (2.892) 7.541  (2.416)
5.Primary Outcome
Title Change in Average Occipital Pain 3 Months After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 3 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 40 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.791  (2.573) 4.441  (2.237)
6.Primary Outcome
Title Change in Worst Occipital Pain 3 Months After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 3 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 40 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.850  (3.292) 7.149  (2.967)
7.Primary Outcome
Title Change in Average Occipital Pain 2 Weeks After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 2 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 42 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.495  (2.094) 3.694  (2.221)
8.Primary Outcome
Title Change in Worst Occipital Pain 2 Weeks After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 2 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 42 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.726  (2.528) 5.846  (2.618)
9.Primary Outcome
Title Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 2 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 25 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.392  (2.106) 4.220  (2.496)
10.Primary Outcome
Title Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 2 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 25 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.540  (2.669) 6.650  (2.744)
11.Primary Outcome
Title Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 6 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 24 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.678  (2.448) 4.410  (2.544)
12.Primary Outcome
Title Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 6 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 24 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.583  (3.202) 6.825  (3.109)
13.Primary Outcome
Title Change in Overall Average Headache Pain 3 Months After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 3 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 24 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.000  (2.870) 4.694  (2.480)
14.Primary Outcome
Title Change in Overall Worst Headache Pain 3 Months After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 3 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 24 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.522  (3.232) 7.417  (2.952)
15.Primary Outcome
Title Change in Overall Average Headache Pain 6 Months After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 6 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 24 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.761  (3.096) 7.556  (2.623)
16.Primary Outcome
Title Change in Overall Worst Headache Pain 6 Months After the Start of Treatment
Hide Description 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.
Time Frame From baseline to 6 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 24 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.761  (3.096) 7.556  (2.623)
17.Secondary Outcome
Title Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.
Hide Description This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.
Time Frame From baseline to 6 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 40 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.025  (5.972) 8.132  (5.297)
18.Secondary Outcome
Title Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.
Hide Description This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.
Time Frame From baseline to 3 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.539  (6.043) 9.069  (5.955)
19.Secondary Outcome
Title Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.
Hide Description This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.
Time Frame From baseline to 6 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.256  (6.210) 9.431  (5.765)
20.Secondary Outcome
Title Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory
Hide Description This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.
Time Frame From baseline to 6 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 40 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.775  (11.079) 10.842  (9.945)
21.Secondary Outcome
Title Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory
Hide Description This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.
Time Frame From baseline to 3 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.333  (10.207) 11.972  (10.287)
22.Secondary Outcome
Title Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory
Hide Description This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.
Time Frame From baseline to 6 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.590  (10.684) 12.250  (10.103)
23.Secondary Outcome
Title Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.
Hide Description This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
Time Frame From baseline to 6 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 24 20
Mean (Standard Deviation)
Unit of Measure: days
1.708  (1.958) 1.810  (2.421)
24.Secondary Outcome
Title 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
Hide Description This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
Time Frame From baseline to 6 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 41 38
Mean (Standard Deviation)
Unit of Measure: days
1.436  (2.237) 1.436  (2.087)
25.Secondary Outcome
Title 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
Hide Description This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 3 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
Time Frame From baseline to 3 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 23 19
Mean (Standard Deviation)
Unit of Measure: days
2.087  (2.109) 2.263  (2.232)
26.Secondary Outcome
Title 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
Hide Description This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39 37
Mean (Standard Deviation)
Unit of Measure: days
1.846  (2.335) 1.919  (2.046)
27.Secondary Outcome
Title 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
Hide Description This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
Time Frame From baseline to 6 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 23 19
Mean (Standard Deviation)
Unit of Measure: days
2.044  (2.099) 2.368  (2.409)
28.Secondary Outcome
Title 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
Hide Description This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
Time Frame From baseline to 6 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39 37
Mean (Standard Deviation)
Unit of Measure: days
2.128  (2.308) 2.162  (2.154)
29.Secondary Outcome
Title Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale
Hide Description This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.
Time Frame From baseline to 6 weeks after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 40 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
60.087  (7.972) 59.553  (9.093)
30.Secondary Outcome
Title Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale
Hide Description This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.
Time Frame From baseline to 3 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
59.718  (9.761) 60.556  (10.814)
31.Secondary Outcome
Title Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale
Hide Description This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.
Time Frame From baseline to 6 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
59.641  (10.251) 61.389  (8.800)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Hide Arm/Group Description

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

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

All-Cause Mortality
Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/42 (7.14%)      6/39 (15.38%)    
Gastrointestinal disorders     
Vomiting/blurred vision  0/42 (0.00%)  0 1/39 (2.56%)  1
Musculoskeletal and connective tissue disorders     
Swelling at injection site [1]  1/42 (2.38%)  1 2/39 (5.13%)  2
Nervous system disorders     
Dizzines [2]  0/42 (0.00%)  0 1/39 (2.56%)  1
Worsening of headached [3]  1/42 (2.38%)  1 2/39 (5.13%)  2
Skin and subcutaneous tissue disorders     
Rash  1/42 (2.38%)  1 0/39 (0.00%)  0
[1]
2 people in the steroid group had swelling at the injection site
[2]
1 person in the steroid group experienced dizziness after the procedure.
[3]
2 people in the steroid group and 1 in the PRF group experienced worsening of headache after procedure.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pulsed Radiofrequency + Local Anesthetic Injection Corticosteroid Injection + Sham Pulsed Radiofrequency
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/39 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Cohen
Organization: Johns Hopkins Hospital
Phone: 410-955-1818
EMail: scohen40@jhmi.edu
Layout table for additonal information
Responsible Party: Steven P. Cohen, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01670825    
Other Study ID Numbers: 373481-3
First Submitted: August 19, 2012
First Posted: August 22, 2012
Results First Submitted: August 10, 2016
Results First Posted: March 1, 2017
Last Update Posted: March 1, 2017