Trial Outcomes & Findings for Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia (NCT NCT01670825)
NCT ID: NCT01670825
Last Updated: 2017-03-01
Results Overview
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.
COMPLETED
NA
81 participants
From baseline to 6 weeks after the start of treatment
2017-03-01
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
39
|
|
Overall Study
COMPLETED
|
42
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia
Baseline characteristics by cohort
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=42 Participants
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
n=39 Participants
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
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
81 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
41.67 years
STANDARD_DEVIATION 10.72 • n=39 Participants
|
41.08 years
STANDARD_DEVIATION 13.61 • n=41 Participants
|
41.37 years
STANDARD_DEVIATION 12.16 • n=35 Participants
|
|
Gender
Female
|
20 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
Gender
Male
|
22 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=39 Participants
|
38 participants
n=41 Participants
|
79 participants
n=35 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=39 Participants
|
1 participants
n=41 Participants
|
2 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From baseline to 6 weeks after the start of treatmentThe 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=42 Participants
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
n=39 Participants
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
|
|---|---|---|
|
Change in Average Occipital Pain 6 Weeks After the Start of Treatment
|
3.068 units on a scale
Standard Deviation 2.431
|
3.738 units on a scale
Standard Deviation 2.415
|
PRIMARY outcome
Timeframe: From baseline to 6 weeks after the start of treatmentThe 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=41 Participants
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
n=39 Participants
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
|
|---|---|---|
|
Change in Worst Occipital Pain 6 Weeks After the Start of Treatment
|
5.354 units on a scale
Standard Deviation 3.165
|
6.064 units on a scale
Standard Deviation 3.226
|
PRIMARY outcome
Timeframe: From baseline to 6 months after the start of treatmentThe 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=42 Participants
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
n=39 Participants
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
|
|---|---|---|
|
Change in Average Occipital Pain 6 Months After the Start of Treatment
|
4.312 units on a scale
Standard Deviation 2.232
|
4.765 units on a scale
Standard Deviation 1.998
|
PRIMARY outcome
Timeframe: From baseline to 6 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=42 Participants
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
n=39 Participants
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
|
|---|---|---|
|
Change in Worst Occipital Pain 6 Months After the Start of Treatment
|
6.705 units on a scale
Standard Deviation 2.892
|
7.541 units on a scale
Standard Deviation 2.416
|
PRIMARY outcome
Timeframe: From baseline to 3 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=40 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Change in Average Occipital Pain 3 Months After the Start of Treatment
|
3.791 units on a scale
Standard Deviation 2.573
|
4.441 units on a scale
Standard Deviation 2.237
|
PRIMARY outcome
Timeframe: From baseline to 3 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=40 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Change in Worst Occipital Pain 3 Months After the Start of Treatment
|
5.850 units on a scale
Standard Deviation 3.292
|
7.149 units on a scale
Standard Deviation 2.967
|
PRIMARY outcome
Timeframe: From baseline to 2 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=42 Participants
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
n=39 Participants
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
|
|---|---|---|
|
Change in Average Occipital Pain 2 Weeks After the Start of Treatment
|
2.495 units on a scale
Standard Deviation 2.094
|
3.694 units on a scale
Standard Deviation 2.221
|
PRIMARY outcome
Timeframe: From baseline to 2 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=42 Participants
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
n=39 Participants
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
|
|---|---|---|
|
Change in Worst Occipital Pain 2 Weeks After the Start of Treatment
|
4.726 units on a scale
Standard Deviation 2.528
|
5.846 units on a scale
Standard Deviation 2.618
|
PRIMARY outcome
Timeframe: From baseline to 2 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=25 Participants
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
n=20 Participants
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
|
|---|---|---|
|
Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment
|
3.392 units on a scale
Standard Deviation 2.106
|
4.220 units on a scale
Standard Deviation 2.496
|
PRIMARY outcome
Timeframe: From baseline to 2 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=25 Participants
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
n=20 Participants
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
|
|---|---|---|
|
Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment
|
5.540 units on a scale
Standard Deviation 2.669
|
6.650 units on a scale
Standard Deviation 2.744
|
PRIMARY outcome
Timeframe: From baseline to 6 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=24 Participants
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
n=20 Participants
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
|
|---|---|---|
|
Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment
|
3.678 units on a scale
Standard Deviation 2.448
|
4.410 units on a scale
Standard Deviation 2.544
|
PRIMARY outcome
Timeframe: From baseline to 6 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=24 Participants
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
n=20 Participants
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
|
|---|---|---|
|
Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment
|
6.583 units on a scale
Standard Deviation 3.202
|
6.825 units on a scale
Standard Deviation 3.109
|
PRIMARY outcome
Timeframe: From baseline to 3 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=24 Participants
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
n=18 Participants
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
|
|---|---|---|
|
Change in Overall Average Headache Pain 3 Months After the Start of Treatment
|
4.000 units on a scale
Standard Deviation 2.870
|
4.694 units on a scale
Standard Deviation 2.480
|
PRIMARY outcome
Timeframe: From baseline to 3 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=24 Participants
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
n=18 Participants
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
|
|---|---|---|
|
Change in Overall Worst Headache Pain 3 Months After the Start of Treatment
|
6.522 units on a scale
Standard Deviation 3.232
|
7.417 units on a scale
Standard Deviation 2.952
|
PRIMARY outcome
Timeframe: From baseline to 6 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=24 Participants
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
n=18 Participants
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
|
|---|---|---|
|
Change in Overall Average Headache Pain 6 Months After the Start of Treatment
|
6.761 units on a scale
Standard Deviation 3.096
|
7.556 units on a scale
Standard Deviation 2.623
|
PRIMARY outcome
Timeframe: From baseline to 6 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=24 Participants
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
n=18 Participants
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
|
|---|---|---|
|
Change in Overall Worst Headache Pain 6 Months After the Start of Treatment
|
6.761 units on a scale
Standard Deviation 3.096
|
7.556 units on a scale
Standard Deviation 2.623
|
SECONDARY outcome
Timeframe: From baseline to 6 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=40 Participants
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
n=38 Participants
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
|
|---|---|---|
|
Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.
|
10.025 units on a scale
Standard Deviation 5.972
|
8.132 units on a scale
Standard Deviation 5.297
|
SECONDARY outcome
Timeframe: From baseline to 3 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=39 Participants
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
n=36 Participants
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
|
|---|---|---|
|
Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.
|
9.539 units on a scale
Standard Deviation 6.043
|
9.069 units on a scale
Standard Deviation 5.955
|
SECONDARY outcome
Timeframe: From baseline to 6 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=39 Participants
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
n=36 Participants
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
|
|---|---|---|
|
Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.
|
9.256 units on a scale
Standard Deviation 6.210
|
9.431 units on a scale
Standard Deviation 5.765
|
SECONDARY outcome
Timeframe: From baseline to 6 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=40 Participants
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
n=38 Participants
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
|
|---|---|---|
|
Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory
|
12.775 units on a scale
Standard Deviation 11.079
|
10.842 units on a scale
Standard Deviation 9.945
|
SECONDARY outcome
Timeframe: From baseline to 3 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=39 Participants
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
n=36 Participants
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
|
|---|---|---|
|
Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory
|
11.333 units on a scale
Standard Deviation 10.207
|
11.972 units on a scale
Standard Deviation 10.287
|
SECONDARY outcome
Timeframe: From baseline to 6 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=39 Participants
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
n=36 Participants
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
|
|---|---|---|
|
Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory
|
12.590 units on a scale
Standard Deviation 10.684
|
12.250 units on a scale
Standard Deviation 10.103
|
SECONDARY outcome
Timeframe: From baseline to 6 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=24 Participants
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
n=20 Participants
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
|
|---|---|---|
|
Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.
|
1.708 days
Standard Deviation 1.958
|
1.810 days
Standard Deviation 2.421
|
SECONDARY outcome
Timeframe: From baseline to 6 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=41 Participants
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
n=38 Participants
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
|
|---|---|---|
|
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
|
1.436 days
Standard Deviation 2.237
|
1.436 days
Standard Deviation 2.087
|
SECONDARY outcome
Timeframe: From baseline to 3 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=23 Participants
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
n=19 Participants
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
|
|---|---|---|
|
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
|
2.087 days
Standard Deviation 2.109
|
2.263 days
Standard Deviation 2.232
|
SECONDARY outcome
Timeframe: 3 monthsThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=39 Participants
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
n=37 Participants
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
|
|---|---|---|
|
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
|
1.846 days
Standard Deviation 2.335
|
1.919 days
Standard Deviation 2.046
|
SECONDARY outcome
Timeframe: From baseline to 6 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=23 Participants
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
n=19 Participants
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
|
|---|---|---|
|
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
|
2.044 days
Standard Deviation 2.099
|
2.368 days
Standard Deviation 2.409
|
SECONDARY outcome
Timeframe: From baseline to 6 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=39 Participants
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
n=37 Participants
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
|
|---|---|---|
|
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
|
2.128 days
Standard Deviation 2.308
|
2.162 days
Standard Deviation 2.154
|
SECONDARY outcome
Timeframe: From baseline to 6 weeks after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=40 Participants
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
n=38 Participants
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
|
|---|---|---|
|
Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale
|
60.087 units on a scale
Standard Deviation 7.972
|
59.553 units on a scale
Standard Deviation 9.093
|
SECONDARY outcome
Timeframe: From baseline to 3 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=39 Participants
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
n=36 Participants
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
|
|---|---|---|
|
Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale
|
59.718 units on a scale
Standard Deviation 9.761
|
60.556 units on a scale
Standard Deviation 10.814
|
SECONDARY outcome
Timeframe: From baseline to 6 months after the start of treatmentThis 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.
Outcome measures
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=39 Participants
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
n=36 Participants
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
|
|---|---|---|
|
Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale
|
59.641 units on a scale
Standard Deviation 10.251
|
61.389 units on a scale
Standard Deviation 8.800
|
Adverse Events
Pulsed Radiofrequency + Local Anesthetic Injection
Corticosteroid Injection + Sham Pulsed Radiofrequency
Serious adverse events
| Measure |
Pulsed Radiofrequency + Local Anesthetic Injection
n=42 participants at risk
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
n=39 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Dizzines
|
0.00%
0/42
|
2.6%
1/39 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Swelling at injection site
|
2.4%
1/42 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
|
Nervous system disorders
Worsening of headached
|
2.4%
1/42 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting/blurred vision
|
0.00%
0/42
|
2.6%
1/39 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/42 • Number of events 1
|
0.00%
0/39
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place