Trial Outcomes & Findings for Study Evaluating the Treatment of Occipital Neuralgia (NCT NCT01753765)
NCT ID: NCT01753765
Last Updated: 2024-01-24
Results Overview
Improvement of pain due to occipital neuralgia as measured on the Visual Analog Scale (VAS) for pain at Days 7 and 30 as compared to baseline (Day 0). 0= no pain, 10= worst pain imaginable. Higher scores equal worse outcome.
COMPLETED
NA
26 participants
Baseline to Day 7, Baseline to Day 30
2024-01-24
Participant Flow
Participant milestones
| Measure |
Treatment
Study treatment with Cryo-Touch III device at Day 0.
Device: Cryo-Touch III Study treatment at Day 0.: Device: Cryo-Touch III Study treatment at Day 0.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating the Treatment of Occipital Neuralgia
Baseline characteristics by cohort
| Measure |
Treatment
n=26 Participants
Study treatment with Cryo-Touch III device at Day 0.
Device: Cryo-Touch III Study treatment at Day 0.: Device: Cryo-Touch III Study treatment at Day 0.
|
|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Average baseline Pain Visual Analog Scale (VAS)
|
6.3 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 7, Baseline to Day 30Population: The variation in number analyzed at each timepoint from overall number of patients analyzed is due to the reflection of the actual number of participants with data collected at specified timepoint.
Improvement of pain due to occipital neuralgia as measured on the Visual Analog Scale (VAS) for pain at Days 7 and 30 as compared to baseline (Day 0). 0= no pain, 10= worst pain imaginable. Higher scores equal worse outcome.
Outcome measures
| Measure |
Treatment
n=26 Participants
Study treatment with Cryo-Touch III device at Day 0.
Device: Cryo-Touch III Study treatment at Day 0.: Device: Cryo-Touch III Study treatment at Day 0.
|
|---|---|
|
A Reduction in Either Pain Frequency or Severity Associated With Occipital Neuralgia.
Average Point Improvement Day 7
|
2.5 point improvement
Standard Deviation 2.5
|
|
A Reduction in Either Pain Frequency or Severity Associated With Occipital Neuralgia.
Average Point Improvement Day 30
|
2.7 point improvement
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Day 30, Day 56Treatment effect was based on Subject response when asked if the Subject had an effect from the treatment.
Outcome measures
| Measure |
Treatment
n=26 Participants
Study treatment with Cryo-Touch III device at Day 0.
Device: Cryo-Touch III Study treatment at Day 0.: Device: Cryo-Touch III Study treatment at Day 0.
|
|---|---|
|
Duration of Treatment
Day 30
|
13 Participants
|
|
Duration of Treatment
Day 56
|
9 Participants
|
Adverse Events
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=26 participants at risk
Study treatment with Cryo-Touch III device at Day 0.
Device: Cryo-Touch III Study treatment at Day 0.: Device: Cryo-Touch III Study treatment at Day 0.
|
|---|---|
|
Infections and infestations
Cold
|
3.8%
1/26 • Number of events 1 • Adverse events will be recorded from initiation of study treatment to Visit 5 Day 56- end of study
|
|
General disorders
Dizziness secondary to oral gabapentin medicine
|
3.8%
1/26 • Number of events 1 • Adverse events will be recorded from initiation of study treatment to Visit 5 Day 56- end of study
|
|
Injury, poisoning and procedural complications
Increased knee pain secondary to fall
|
3.8%
1/26 • Number of events 1 • Adverse events will be recorded from initiation of study treatment to Visit 5 Day 56- end of study
|
|
Infections and infestations
upper respiratory tract infection
|
3.8%
1/26 • Number of events 1 • Adverse events will be recorded from initiation of study treatment to Visit 5 Day 56- end of study
|
|
Injury, poisoning and procedural complications
pain in treatment area
|
3.8%
1/26 • Number of events 1 • Adverse events will be recorded from initiation of study treatment to Visit 5 Day 56- end of study
|
|
Injury, poisoning and procedural complications
increased pain in neck area
|
3.8%
1/26 • Number of events 1 • Adverse events will be recorded from initiation of study treatment to Visit 5 Day 56- end of study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60