Trial Outcomes & Findings for The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain (NCT NCT01168986)
NCT ID: NCT01168986
Last Updated: 2016-06-20
Results Overview
a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
62 participants
Primary outcome timeframe
2 weeks
Results posted on
2016-06-20
Participant Flow
Participant milestones
| Measure |
Pulstar Multiple Impulse Therapy
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
|
Exercise
Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors
|
No Intervention
Participants receive/perform no intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
21
|
|
Overall Study
COMPLETED
|
18
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
Baseline characteristics by cohort
| Measure |
Pulstar Multiple Impulse Therapy
n=20 Participants
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
|
Exercise
n=21 Participants
Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors
|
No Intervention
n=21 Participants
Participants receive/perform no intervention
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.15 years
STANDARD_DEVIATION 12.32 • n=5 Participants
|
31.48 years
STANDARD_DEVIATION 10.95 • n=7 Participants
|
36.33 years
STANDARD_DEVIATION 14.12 • n=5 Participants
|
33.98 years
STANDARD_DEVIATION 12.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
62 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data
a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable
Outcome measures
| Measure |
Pulstar Multiple Impulse Therapy
n=18 Participants
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
|
Exercise
n=19 Participants
Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors
|
No Intervention
n=19 Participants
Participants receive/perform no intervention
|
|---|---|---|---|
|
2 Week Change in Pain Score on a Numeric Rating Scale
|
6.39 units on a scale
Standard Deviation 24.23
|
20.37 units on a scale
Standard Deviation 23.67
|
6.45 units on a scale
Standard Deviation 19.88
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data
A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability.
Outcome measures
| Measure |
Pulstar Multiple Impulse Therapy
n=18 Participants
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
|
Exercise
n=20 Participants
Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors
|
No Intervention
n=19 Participants
Participants receive/perform no intervention
|
|---|---|---|---|
|
2 Week Change in Disability on the Neck Disability Index
|
4.44 2 week change in units a scale
Standard Deviation 8.53
|
5.50 2 week change in units a scale
Standard Deviation 9.53
|
0.42 2 week change in units a scale
Standard Deviation 8.37
|
PRIMARY outcome
Timeframe: Immediate within session change pre to post interventionPopulation: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data
Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable.
Outcome measures
| Measure |
Pulstar Multiple Impulse Therapy
n=17 Participants
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
|
Exercise
n=19 Participants
Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors
|
No Intervention
n=18 Participants
Participants receive/perform no intervention
|
|---|---|---|---|
|
Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale
|
0.58 units on a scale
Standard Deviation 15.39
|
-0.76 units on a scale
Standard Deviation 16.66
|
1.62 units on a scale
Standard Deviation 10.83
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data
change in neck extension range of motion over a 2 week period
Outcome measures
| Measure |
Pulstar Multiple Impulse Therapy
n=18 Participants
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
|
Exercise
n=19 Participants
Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors
|
No Intervention
n=19 Participants
Participants receive/perform no intervention
|
|---|---|---|---|
|
Change From Baseline in Neck Extension Range of Motion at 2 Weeks
|
2.50 degrees
Standard Deviation 15.46
|
1.32 degrees
Standard Deviation 9.04
|
-1.84 degrees
Standard Deviation 6.06
|
Adverse Events
Pulstar Multiple Impulse Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place