Trial Outcomes & Findings for Pathophysiology of Post Amputation Pain (NCT NCT01632709)
NCT ID: NCT01632709
Last Updated: 2015-07-21
Results Overview
Pain rating before and after injection on a 0-10 NRS pain scale (0=no pain, 10= worst pain imaginable)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
Pain rating before and at 15 minutes and 1 hour post injection
Results posted on
2015-07-21
Participant Flow
Subjects were not assigned to an arm until Visit 2 (randomization).
Participant milestones
| Measure |
Sympathetic Nerve Block of Bupivacaine
|
Dry Needling at Sympathetic Ganglion
|
Neuroma Injection of Bupivacaine
|
Dry Needling at the Neuroma
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
5
|
4
|
|
Overall Study
Completed Visit 2 (Received Injection)
|
4
|
2
|
5
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pathophysiology of Post Amputation Pain
Baseline characteristics by cohort
| Measure |
Sympathetic Nerve Block of Bupivacaine
n=4 Participants
|
Dry Needling at Sympathetic Ganglion
n=2 Participants
|
Neuroma Injection of Bupivacaine
n=5 Participants
|
Dry Needling at the Neuroma
n=3 Participants
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
55 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 7 • n=4 Participants
|
53.4 years
STANDARD_DEVIATION 13.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pain rating before and at 15 minutes and 1 hour post injectionPopulation: all available data was analyzed (some subjects did not complete all outcomes)
Pain rating before and after injection on a 0-10 NRS pain scale (0=no pain, 10= worst pain imaginable)
Outcome measures
| Measure |
Sympathetic Nerve Block of Bupivacaine
n=3 Participants
Bupivacaine: one injection of 10ml of .25%
|
Dry Needling
n=2 Participants
Placebo: Dry needling
|
Neuroma Injection of Bupivacaine
n=5 Participants
Bupivacaine: one injection of 10ml of .25%
|
Dry Needling at the Neuroma
n=3 Participants
Placebo: Dry needling
|
|---|---|---|---|---|
|
Change in Pain
NRS-Phantom Limb Pain (15 minutes post)
|
-0.3 units on a scale
Standard Deviation 2.3
|
-2 units on a scale
Standard Deviation 0
|
-1 units on a scale
Standard Deviation 2.3
|
1.3 units on a scale
Standard Deviation 0.6
|
|
Change in Pain
NRS-Phantom Limb Pain (1 hour post)
|
-3.5 units on a scale
Standard Deviation 0.7
|
-1 units on a scale
Standard Deviation 1.4
|
-0.3 units on a scale
Standard Deviation 0.6
|
0 units on a scale
Standard Deviation 0
|
|
Change in Pain
NRS-Residual Limb Pain (15 minutes post)
|
-1.7 units on a scale
Standard Deviation 1.5
|
-1 units on a scale
Standard Deviation 1.4
|
-2.2 units on a scale
Standard Deviation 3.5
|
0.7 units on a scale
Standard Deviation 0.6
|
|
Change in Pain
NRS-Residual Limb Pain (1 hour post)
|
-2 units on a scale
Standard Deviation 2.8
|
-0.5 units on a scale
Standard Deviation 0.7
|
0.3 units on a scale
Standard Deviation 1.5
|
3 units on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: PDI collected pre injection and 1 week post injectionPopulation: all available data was analyzed (some subjects did not complete all outcomes)
The PDI is a seven-item validated instrument that assesses perceived disability in 7 key life areas. The Pain Disability Scale is a scale from 0-70 where 0= no disability and 70=the most disability
Outcome measures
| Measure |
Sympathetic Nerve Block of Bupivacaine
n=2 Participants
Bupivacaine: one injection of 10ml of .25%
|
Dry Needling
n=2 Participants
Placebo: Dry needling
|
Neuroma Injection of Bupivacaine
n=5 Participants
Bupivacaine: one injection of 10ml of .25%
|
Dry Needling at the Neuroma
n=3 Participants
Placebo: Dry needling
|
|---|---|---|---|---|
|
Change in Perceived Disability (PDI)
|
-16.5 units on a scale
Standard Deviation 10.6
|
-21.5 units on a scale
Standard Deviation 24.7
|
-5.2 units on a scale
Standard Deviation 12.7
|
13.0 units on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: PASS collected pre injection and 1 week post injectionPopulation: all available data was analyzed (some subjects did not complete all outcomes)
The Pain Anxitey Symptoms Scale (PASS) is a validated instrument that assesses anxiety in.The PASS is a scale from 0-100 where 0= no anxiety and 100=the most anxiety
Outcome measures
| Measure |
Sympathetic Nerve Block of Bupivacaine
n=2 Participants
Bupivacaine: one injection of 10ml of .25%
|
Dry Needling
n=2 Participants
Placebo: Dry needling
|
Neuroma Injection of Bupivacaine
n=5 Participants
Bupivacaine: one injection of 10ml of .25%
|
Dry Needling at the Neuroma
n=3 Participants
Placebo: Dry needling
|
|---|---|---|---|---|
|
Change in Perceived Anxiety (PASS)
|
-3.0 units on a scale
Standard Deviation 8.5
|
-36.5 units on a scale
Standard Deviation 5.0
|
-1.0 units on a scale
Standard Deviation 17.4
|
11.3 units on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: CES-D 10 collected pre injection and 1 week post injectionPopulation: all available data was analyzed (some subjects did not complete all outcomes)
The Center for Epidemiologic Studies Short Depression Scale (CES-D 10) is a validated instrument that assesses depression. The CES-D 10 is a scale from 0-30 where 0= no depression and 30=the most depression
Outcome measures
| Measure |
Sympathetic Nerve Block of Bupivacaine
n=2 Participants
Bupivacaine: one injection of 10ml of .25%
|
Dry Needling
n=2 Participants
Placebo: Dry needling
|
Neuroma Injection of Bupivacaine
n=5 Participants
Bupivacaine: one injection of 10ml of .25%
|
Dry Needling at the Neuroma
n=3 Participants
Placebo: Dry needling
|
|---|---|---|---|---|
|
Change in Depression (CES-D 10)
|
-2.0 units on a scale
Standard Deviation 2.8
|
-4.0 units on a scale
Standard Deviation 2.8
|
-2.0 units on a scale
Standard Deviation 6.5
|
3.3 units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: VAS collected pre injection and 1 week post injectionPopulation: all available data was analyzed (some subjects did not complete all outcomes)
The Pain Visual Analogue Scale (VAS) is a scale from 0-100 where 0= no pain and 100=the worst pain
Outcome measures
| Measure |
Sympathetic Nerve Block of Bupivacaine
n=2 Participants
Bupivacaine: one injection of 10ml of .25%
|
Dry Needling
n=2 Participants
Placebo: Dry needling
|
Neuroma Injection of Bupivacaine
n=5 Participants
Bupivacaine: one injection of 10ml of .25%
|
Dry Needling at the Neuroma
n=3 Participants
Placebo: Dry needling
|
|---|---|---|---|---|
|
Pain Visual Analogue Scale (VAS)
Change in VAS- Phantom Limb Pain
|
-8.5 units on a scale
Standard Deviation 36.1
|
-8.0 units on a scale
Standard Deviation 8.5
|
-4.4 units on a scale
Standard Deviation 42.6
|
10.8 units on a scale
Standard Deviation 14.8
|
|
Pain Visual Analogue Scale (VAS)
Change in VAS-Residual Limb Pain
|
3.0 units on a scale
Standard Deviation 18.4
|
-10.8 units on a scale
Standard Deviation 7.4
|
-9.5 units on a scale
Standard Deviation 20.6
|
5 units on a scale
Standard Deviation 22.6
|
Adverse Events
Placebo/Sham Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Center for Pain Studies
Rehabilitation Institute of Chicago
Phone: 312.238.5654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place