Trial Outcomes & Findings for Reciprocating Medical Devices - a Study of a New Safety Device (NCT NCT00651625)
NCT ID: NCT00651625
Last Updated: 2016-03-02
Results Overview
0-10 cm VAS pain scale at 2 weeks compared to 0-10 cm VAS pain scale at 0 weeks where 0= no pain, and 10 = the worst pain imaginable. The difference (2 week VAS-0 week VAS) is the primary outcome measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
437 participants
Primary outcome timeframe
2 weeks
Results posted on
2016-03-02
Participant Flow
dates from 2004 to August 2010, recruited from medical clinic
patients recruited immediately at point of contact
Participant milestones
| Measure |
1Conventional Syringe
The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
2RPD Syring
Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
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|---|---|---|
|
Overall Study
STARTED
|
219
|
218
|
|
Overall Study
COMPLETED
|
219
|
218
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reciprocating Medical Devices - a Study of a New Safety Device
Baseline characteristics by cohort
| Measure |
1Conventional Syringe
n=219 Participants
The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
2RPD Syring
n=218 Participants
Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
Total
n=437 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
219 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
437 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
175 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
219 participants
n=5 Participants
|
218 participants
n=7 Participants
|
437 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks0-10 cm VAS pain scale at 2 weeks compared to 0-10 cm VAS pain scale at 0 weeks where 0= no pain, and 10 = the worst pain imaginable. The difference (2 week VAS-0 week VAS) is the primary outcome measure.
Outcome measures
| Measure |
1Conventional Syringe
n=219 Participants
The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
2RPD Syringe
n=218 Participants
Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
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|---|---|---|
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Pain Using VAS (Visual Analogue Pain Scale)
|
5.2 cm
Standard Deviation 2.7
|
6.2 cm
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: during procedureAspirated fluid volume during procedure
Outcome measures
| Measure |
1Conventional Syringe
n=219 Participants
The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
2RPD Syringe
n=218 Participants
Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
|---|---|---|
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Aspirated Fluid Volume
|
7.2 ml
Standard Deviation 3.1
|
14.5 ml
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: during procedure, 2 weeks afterwards, and 6 months afterwardsOutcome measures
| Measure |
1Conventional Syringe
n=219 Participants
The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
2RPD Syringe
n=218 Participants
Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
|---|---|---|
|
Adverse Outcomes (Hemorrhage, Infection, Hematoma, Extravasation)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: during procedure0- 10 cm visual analogue satisfaction scale (VASS) 0-10 cm VASS at 2 weeks compared to 0-10 cm VASS pain scale at 0 weeks where 0= completely dissatisfied, and 10 = completely satsified. The difference (2 week VAS-0 week VAS) is the outcome measure
Outcome measures
| Measure |
1Conventional Syringe
n=219 Participants
The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
2RPD Syringe
n=218 Participants
Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
|---|---|---|
|
Physician Satisfaction
|
6.4 cm
Standard Deviation 2.1
|
8.5 cm
Standard Deviation 3.1
|
Adverse Events
1Conventional Syringe
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2RPD Syring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1Conventional Syringe
n=219 participants at risk
The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
|
2RPD Syring
n=218 participants at risk
Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
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|---|---|---|
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Investigations
|
0.00%
0/219 • 1 year
|
0.00%
0/218 • 1 year
|
Additional Information
Wilmer L. Sibbitt, MD, Principal Investigator
University of New Mexico
Phone: 505 272-4761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place