Physiological Measurements of Response and Reaction TimesNCT02168153

Assessment of Chiropractic Treatment Using Reaction and Response Times in Members of the Special Operation Forces (ACT2)

A study testing Chiropractic Manipulative Therapy and Wait-list in people with Physiological Measurements of Response and Reaction Times, run by RAND at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is a randomized controlled trial designed to evaluate changes in reaction times (RTs) and response times (RespTs) following chiropractic treatment compared to controls in the Special Forces Qualified (SFQ) population, including Special Operation Forces who are part of the 160th SOAR regiment on flight… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Physiological Measurements of Response and Reaction Times
What is being tested?: Chiropractic Manipulative Therapy and Wait-list
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age range at least 20 years of age
Written informed consent
Active duty SFQ personnel or Special Operation Forces who are part of the 160th SOAR regiment on flight status stationed at the Ft. Campbell, KY military site

Who cannot join

Pain Intensity (NIH's PROMIS- question #29) > 4 at the Initial Visit
Additional diagnostic procedure needed (e.g. x-ray)
Bone and joint pathology contraindications for CMT. Potential participants with recent spinal fracture, concurrent spinal or paraspinal tumor(s), spinal or paraspinal infection(s), inflammatory arthropathies and significant osteoporosis will be referred for appropriate care.
Other contraindications for CMT (i.e., unstable spinal segments, cauda equina syndrome)
Currently being treated for traumatic brain injury (TBI)
Reasonable chance that within 2-4 weeks of initial participation they may be unable to complete the study, i.e., deployment, receive orders for a distant duty assignment or training site or otherwise be absent from the current military site over the study participation period.
Received care from a Doctor of Chiropractic within the past 30 days.
Pregnant or planning to become pregnant within 4 weeks.

Trial locations and contacts

1 site in 1 country.

United States1 site

Blanchfield Army Community Hospital
Fort Campbell North, Kentucky, 42223

Other trials in United States

About this study

Read the detailed description

The Assessment of Chiropractic Treatment 2 (ACT2) assesses changes in reaction/response times following Chiropractic Manipulative Therapy (CMT) using a randomized controlled trial in members of SFQ or SOAR. This population is faced with simultaneous physiological and cognitive demands. The ability to give an accurate and appropriate motor response in a short time is required for successful completion of the types of missions they are expected to undertake.

It is possible that chiropractic care can improve performance in reaction and response times in populations that have low back pain and in populations that are asymptomatic. One possible theory for improvement, even in asymptomatic persons, is that they may have experienced an insult or stress to the body which is subclinical but alters their ability to function in an optimal manner. Thus a person may be asymptomatic and able to accomplish many activities in a normal manner, but when stressed to the limits of maximum capability, the effects of subclinical abnormalities may cause that person to function at a less than optimal level. If CMT is able to restore normal, more efficient mechanisms of functioning, it is therefore possible that the performance of challenging tasks could be improved.

Conditions: Physiological Measurements of Response and Reaction Times
Being tested: Chiropractic Manipulative Therapy, Wait-list
Keywords: Chiropractic Manipulative Therapy, Reaction Times, Response Times, Special Forces, Biomechanical Assessments

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chiropractic Manipulative TherapyOther
Also called Chiropractic Care, Spinal Manipulation
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-listOther
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.

Study groups in NCT02168153
Study group	Role	What they receive
Chiropractic Manipulative Therapy	Active comparator	Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment. Receives: Other: Chiropractic Manipulative Therapy
Wait-List Control Group	Placebo comparator	Participants will complete questionnaires and biomechanical assessments Receives: Other: Wait-list

What is being measured

The primary outcome is the main question the study is designed to answer.

Simple Reaction Time With the Dominant Hand
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.
Measured: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
Simple Reaction Time With the Dominant Foot
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.
Measured: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
Choice Reaction Time
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.
Measured: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
Response Time Involving the Dominant Hand (Fitts Law Test)
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.
Measured: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
Response Time Involving Whole Body Movement (T-wall)
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.
Measured: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Jun 2016

First posted20 Jun 2014 (estimated)
Study startAug 2014
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Physiological Measurements of Response and Reaction TimesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02168153
Sponsor's protocol ID: 2012-0352
Status last verified: Jan 2019
First submitted: 12 Jun 2014
Last updated: 19 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

DeVocht JW, Smith DL, Long CR, Corber L, Kane B, Jones TM, Goertz CM. The effect of chiropractic treatment on the reaction and response times of special operation forces military personnel: study protocol for a randomized controlled trial. Trials. 2016 Sep 20;17(1):457. doi: 10.1186/s13063-016-1580-1.
PubMed 27645465
DeVocht JW, Vining R, Smith DL, Long C, Jones T, Goertz C. Effect of chiropractic manipulative therapy on reaction time in special operations forces military personnel: a randomized controlled trial. Trials. 2019 Jan 3;20(1):5. doi: 10.1186/s13063-018-3133-2.
PubMed 30606225

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Chiropractic Treatment Using Reaction and Response Times in Members of the Special Operation Forces (ACT2)
ClinicalTrials.gov ID: NCT02168153
Acronym / sponsor ID: 2012-0352
Conditions: Physiological Measurements of Response and Reaction Times
Keywords: Chiropractic Manipulative Therapy, Reaction Times, Response Times, Special Forces, Biomechanical Assessments
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: Palmer College of Chiropractic, Samueli Institute for Information Biology
Study start: Aug 2014
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 20 Jun 2014 (estimated)
Results: Posted 19 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Chiropractic Manipulative Therapy	Active comparator	Other: Chiropractic Manipulative TherapyParticipants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.
Wait-List Control Group	Placebo comparator	Other: Wait-listParticipants will complete questionnaires and biomechanical assessments

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age range at least 20 years of age
Written informed consent
Active duty SFQ personnel or Special Operation Forces who are part of the 160th SOAR regiment on flight status stationed at the Ft. Campbell, KY military site

Key exclusion criteria (8 listed)

Pain Intensity (NIH's PROMIS- question #29) > 4 at the Initial Visit
Additional diagnostic procedure needed (e.g. x-ray)
Bone and joint pathology contraindications for CMT. Potential participants with recent spinal fracture, concurrent spinal or paraspinal tumor(s), spinal or paraspinal infection(s), inflammatory arthropathies and significant osteoporosis will be referred for appropriate care.
Other contraindications for CMT (i.e., unstable spinal segments, cauda equina syndrome)
Currently being treated for traumatic brain injury (TBI)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chiropractic Manipulative TherapyAlso: Chiropractic Care, Spinal ManipulationParticipants 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.	Other	Chiropractic Manipulative Therapy
Wait-listParticipants 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.	Other	Wait-List Control Group

Primary outcome

Simple Reaction Time With the Dominant Hand
Time frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
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.
Simple Reaction Time With the Dominant Foot
Time frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
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.
Choice Reaction Time
Time frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
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.
Response Time Involving the Dominant Hand (Fitts Law Test)
Time frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
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.
Response Time Involving Whole Body Movement (T-wall)
Time frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
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.

Results and safety

Results posted to the registry on 19 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chiropractic Manipulative Therapy	60	57
Wait-List Control Group	60	60

Primary outcome: Simple Reaction Time With the Dominant Hand

Time frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit. Mean (Standard Deviation). Unit: millisecond (ms)

Measure	Chiropractic Manipulative Therapy n = 37	Wait-List Control Group n = 40
Week 1-Study Visit 2	258.7 (48.6)	254.7 (46.4)
Week 2-Final Visit	252.6 (33.7)	252.3 (49.3)
Change from Visit 2 to Final Visit	-4.88 (42.57)	-1.68 (53.56)

Chiropractic Manipulative Therapy vs Wait-List Control Group: Mean Difference (Final Values): -3.49 (95% CI -25.75 to 18.77), p = 0.76, ANCOVA

Population analysed: 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.

Primary outcome: Simple Reaction Time With the Dominant Foot

Time frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit. Mean (Standard Deviation). Unit: millisecond (ms)

Measure	Chiropractic Manipulative Therapy n = 37	Wait-List Control Group n = 40
Week 1-Study Visit 2	291.9 (41.8)	300.6 (41.8)
Week 2-Final Visit	300.6 (32.1)	307.0 (49.3)
Change from Visit 2 to Final Visit	8.65 (39.98)	7.88 (42.83)

Chiropractic Manipulative Therapy vs Wait-List Control Group: Mean Difference (Final Values): 0.97 (95% CI -18.04 to 19.98), p = 0.92, ANCOVA

Population analysed: 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.

Primary outcome: Choice Reaction Time

Time frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit. Mean (Standard Deviation). Unit: Millisecond (ms)

Measure	Chiropractic Manipulative Therapy n = 57	Wait-List Control Group n = 60
Week 1-Study Visit 2	426.1 (56.2)	445.9 (72.9)
Week 2-Final Visit	421.7 (55.7)	436.4 (67.9)
Change from Visit 2 to Final Visit	-6.42 (44.06)	-9.51 (53.29)

Chiropractic Manipulative Therapy vs Wait-List Control Group: Mean Difference (Final Values): 3.49 (95% CI -14.4 to 21.39), p = 0.70, ANCOVA

Population analysed: 3 participants in the Chiropractic group were lost to follow-up.

Primary outcome: Response Time Involving the Dominant Hand (Fitts Law Test)

Time frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit. Mean (Standard Deviation). Unit: millisecond (ms)

Measure	Chiropractic Manipulative Therapy n = 57	Wait-List Control Group n = 60
Week 1-Study Visit 2	65.9 (0.40)	67.1 (0.66)
Week 2-Final Visit	66.3 (0.72)	66.6 (0.32)
Change from Visit 2 to Final Visit	0.412 (3.710)	-0.548 (3.731)

Chiropractic Manipulative Therapy vs Wait-List Control Group: Mean Difference (Final Values): 0.988 (95% CI -0.373 to 2.349), p = 0.15, ANCOVA

Population analysed: 3 participants in the Chiropractic group were lost to follow-up.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chiropractic Manipulative Therapy	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Wait-List Control Group	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27645465DeVocht JW, Smith DL, Long CR, Corber L, Kane B, Jones TM, Goertz CM. The effect of chiropractic treatment on the reaction and response times of special operation forces military personnel: study protocol for a randomized controlled trial. Trials. 2016 Sep 20;17(1):457. doi: 10.1186/s13063-016-1580-1.
Background: PubMed 30606225DeVocht JW, Vining R, Smith DL, Long C, Jones T, Goertz C. Effect of chiropractic manipulative therapy on reaction time in special operations forces military personnel: a randomized controlled trial. Trials. 2019 Jan 3;20(1):5. doi: 10.1186/s13063-018-3133-2.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ian Coulter, Ph.D principal investigator

RAND

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Chiropractic Manipulative Therapy and Wait-list in people with Physiological Measurements of Response and Reaction Times, run by RAND at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Simple Reaction Time With the Dominant Hand (time frame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02168153, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.