Clinical trial NCT02168153: Assessment of Chiropractic Treatment Using Reaction and Response Times in Members of the Special Operation Forces (ACT2)
Official title: Assessment of Chiropractic Treatment Using Reaction and Response Times in Members of the Special Operation Forces (ACT2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Measurements of Response and Reaction Times
Keywords: Chiropractic Manipulative Therapy
Reaction Times
Response Times
Special Forces
Biomechanical Assessments
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Palmer College of Chiropractic
name: Samueli Institute for Information Biology
First posted: 2014-06-20
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 status.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Simple Reaction Time With the Dominant Hand
timeFrame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
measure: Simple Reaction Time With the Dominant Foot
timeFrame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
measure: Choice Reaction Time
timeFrame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
measure: Response Time Involving the Dominant Hand (Fitts Law Test)
timeFrame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
measure: Response Time Involving Whole Body Movement (T-wall)
timeFrame: Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Campbell North
country: United States
facility: Blanchfield Army Community Hospital
state: Kentucky
Study officials:
affiliation: RAND
name: Ian Coulter, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.