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

NCT ID: NCT02168153

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-06-30

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.

Conditions

Physiological Measurements of Response and Reaction Times

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chiropractic Manipulative Therapy

Participants will complete questionnaires and biomechanical assessments, and additionally receive CMT treatment.

Group Type: ACTIVE_COMPARATOR

Chiropractic Manipulative Therapy

Intervention Type: OTHER

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

Group Type: PLACEBO_COMPARATOR

Wait-list

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Chiropractic Care; Spinal Manipulation

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Palmer College of Chiropractic

OTHER

Sponsor Role: collaborator

Samueli Institute for Information Biology

OTHER

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Coulter, Ph.D

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

Blanchfield Army Community Hospital

Fort Campbell North, Kentucky, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27645465 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30606225 (View on PubMed)

Other Identifiers

2012-0352

Identifier Type: -

Identifier Source: org_study_id