Trial Outcomes & Findings for Assessment of Chiropractic Treatment Using Reaction and Response Times in Members of the Special Operation Forces (ACT2) (NCT NCT02168153)
NCT ID: NCT02168153
Last Updated: 2019-04-19
Results Overview
Handedness of the participants will be determined on the basis of self-report. The subject will react to the appearance of visual prompts on the screen by pressing a button with the thumb of their dominant hand. A set consists of 11 prompts shown in sequence with a time period between the response to one prompt and the appearance of the next prompt ranging from 0.5 to 4.0 seconds in random order. The outcome variable for this test, the mean reaction time, is the average of the length of time between the appearance of each prompt and the press of the button in response to that prompt.
COMPLETED
NA
120 participants
Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
2019-04-19
Participant Flow
Participants were primarily referred to the project manager from physical therapists and other healthcare providers. The remainder of the participants were recruited from informational presentations by the site project manager, informational emails, and the SOF newsletter.
Participant milestones
| Measure |
Chiropractic Manipulative Therapy
Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.
Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture.
|
Wait-List Control Group
Participants will complete questionnaires and biomechanical assessments
Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
57
|
60
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Chiropractic Treatment Using Reaction and Response Times in Members of the Special Operation Forces (ACT2)
Baseline characteristics by cohort
| Measure |
Chiropractic Manipulative Therapy
n=60 Participants
Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.
Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture.
|
Wait-List Control Group
n=60 Participants
Participants will complete questionnaires and biomechanical assessments
Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
33.2 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
33.0 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final VisitPopulation: Missing data for the simple hand reaction tests are due to a technical problem in early data collection. Once identified, the problem was corrected. Because data collected before the technical issue was corrected were unreliable and likely inaccurate, they were not included in the analysis for this measure.
Handedness of the participants will be determined on the basis of self-report. The subject will react to the appearance of visual prompts on the screen by pressing a button with the thumb of their dominant hand. A set consists of 11 prompts shown in sequence with a time period between the response to one prompt and the appearance of the next prompt ranging from 0.5 to 4.0 seconds in random order. The outcome variable for this test, the mean reaction time, is the average of the length of time between the appearance of each prompt and the press of the button in response to that prompt.
Outcome measures
| Measure |
Wait-List Control Group
n=40 Participants
Participants will complete questionnaires and biomechanical assessments
Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits.
|
Chiropractic Manipulative Therapy
n=37 Participants
Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.
Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture.
|
|---|---|---|
|
Simple Reaction Time With the Dominant Hand
Week 1-Study Visit 2
|
254.7 millisecond (ms)
Standard Deviation 46.4
|
258.7 millisecond (ms)
Standard Deviation 48.6
|
|
Simple Reaction Time With the Dominant Hand
Week 2-Final Visit
|
252.3 millisecond (ms)
Standard Deviation 49.3
|
252.6 millisecond (ms)
Standard Deviation 33.7
|
|
Simple Reaction Time With the Dominant Hand
Change from Visit 2 to Final Visit
|
-1.68 millisecond (ms)
Standard Deviation 53.56
|
-4.88 millisecond (ms)
Standard Deviation 42.57
|
PRIMARY outcome
Timeframe: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final VisitPopulation: Missing data for the simple foot reaction tests are due to a technical problem in early data collection. Once identified, the problem was corrected. Because data collected before the technical issue was corrected were unreliable and likely inaccurate, they were not included in the analysis for this measure.
This test will be done in a manner similar to that for the dominant hand except that the participants will press a pedal with their dominant foot.
Outcome measures
| Measure |
Wait-List Control Group
n=40 Participants
Participants will complete questionnaires and biomechanical assessments
Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits.
|
Chiropractic Manipulative Therapy
n=37 Participants
Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.
Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture.
|
|---|---|---|
|
Simple Reaction Time With the Dominant Foot
Change from Visit 2 to Final Visit
|
7.88 millisecond (ms)
Standard Deviation 42.83
|
8.65 millisecond (ms)
Standard Deviation 39.98
|
|
Simple Reaction Time With the Dominant Foot
Week 2-Final Visit
|
307.0 millisecond (ms)
Standard Deviation 49.3
|
300.6 millisecond (ms)
Standard Deviation 32.1
|
|
Simple Reaction Time With the Dominant Foot
Week 1-Study Visit 2
|
300.6 millisecond (ms)
Standard Deviation 41.8
|
291.9 millisecond (ms)
Standard Deviation 41.8
|
PRIMARY outcome
Timeframe: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final VisitPopulation: 3 participants in the Chiropractic group were lost to follow-up.
Prompts on the screen will occur with the same time interval (1 second) in between the press of a button or pedal in response to one prompt and the appearance of the next prompt. Each prompt could be for either hand or either foot and the position of the prompt on the computer screen will indicate which thumb or foot should be used. If the wrong button or pedal is pressed, the software still goes on to the next prompt, but keeps track of how many incorrect responses were made. A set consists of a sequence of 41 prompts. The outcome variable for this test, mean reaction time, is the average length of time between each prompt's appearance and the participant's response.
Outcome measures
| Measure |
Wait-List Control Group
n=60 Participants
Participants will complete questionnaires and biomechanical assessments
Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits.
|
Chiropractic Manipulative Therapy
n=57 Participants
Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.
Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture.
|
|---|---|---|
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Choice Reaction Time
Week 1-Study Visit 2
|
445.9 Millisecond (ms)
Standard Deviation 72.9
|
426.1 Millisecond (ms)
Standard Deviation 56.2
|
|
Choice Reaction Time
Week 2-Final Visit
|
436.4 Millisecond (ms)
Standard Deviation 67.9
|
421.7 Millisecond (ms)
Standard Deviation 55.7
|
|
Choice Reaction Time
Change from Visit 2 to Final Visit
|
-9.51 Millisecond (ms)
Standard Deviation 53.29
|
-6.42 Millisecond (ms)
Standard Deviation 44.06
|
PRIMARY outcome
Timeframe: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final VisitPopulation: 3 participants in the Chiropractic group were lost to follow-up.
Participants perform a computerized simple target acquisition task (a Fitts Law task) to investigate their response times using a mouse with their dominant hand. The participant will complete a block, a series of target selections on a computer monitor, by working through 32 trials. That is, 32 pairs of 'hits' - meaning the mouse was clicked when the cursor was inside each of two circles that appear on the screen. The measured outcome from this task will be the sum of the times required to complete each trial.
Outcome measures
| Measure |
Wait-List Control Group
n=60 Participants
Participants will complete questionnaires and biomechanical assessments
Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits.
|
Chiropractic Manipulative Therapy
n=57 Participants
Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.
Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture.
|
|---|---|---|
|
Response Time Involving the Dominant Hand (Fitts Law Test)
Week 1-Study Visit 2
|
67.1 millisecond (ms)
Standard Deviation 0.66
|
65.9 millisecond (ms)
Standard Deviation 0.40
|
|
Response Time Involving the Dominant Hand (Fitts Law Test)
Week 2-Final Visit
|
66.6 millisecond (ms)
Standard Deviation 0.32
|
66.3 millisecond (ms)
Standard Deviation 0.72
|
|
Response Time Involving the Dominant Hand (Fitts Law Test)
Change from Visit 2 to Final Visit
|
-0.548 millisecond (ms)
Standard Deviation 3.731
|
0.412 millisecond (ms)
Standard Deviation 3.710
|
PRIMARY outcome
Timeframe: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final VisitPopulation: 3 participants in the Chiropractic group were lost to follow-up.
Participants will stand in front of the t-wall which is a commercially available device with a 4 x 8 foot bank of square buttons that are each 8 cm per side. When test is begun, one of the buttons lights up. The participant hits that button with either hand. The light inside that button then goes out and another button lights up until that one is hit. This process continues for a random sequence of 100 buttons. When last button is hit, all the buttons light up momentarily to indicate that the test is over. The measured outcome from this test is the time from when the first button is hit to when the last of the random sequence of 100 buttons is hit.
Outcome measures
| Measure |
Wait-List Control Group
n=60 Participants
Participants will complete questionnaires and biomechanical assessments
Wait-list: Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits.
|
Chiropractic Manipulative Therapy
n=57 Participants
Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.
Chiropractic Manipulative Therapy: Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture.
|
|---|---|---|
|
Response Time Involving Whole Body Movement (T-wall)
Week 1-Study Visit 2
|
50.1 millisecond (ms)
Standard Deviation 4.2
|
49.1 millisecond (ms)
Standard Deviation 4.7
|
|
Response Time Involving Whole Body Movement (T-wall)
Week 2-Final Visit
|
48.5 millisecond (ms)
Standard Deviation 4.4
|
47.2 millisecond (ms)
Standard Deviation 4.2
|
|
Response Time Involving Whole Body Movement (T-wall)
Change from Visit 2 to Final Visit
|
-1.59 millisecond (ms)
Standard Deviation 2.1
|
-2.00 millisecond (ms)
Standard Deviation 2.40
|
Adverse Events
Chiropractic Manipulative Therapy
Wait-List Control Group
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