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Assessment of Chiropractic Treatment: Strength and Balance (ACT3)

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ClinicalTrials.gov Identifier: NCT02670148
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
Palmer College of Chiropractic
Samueli Institute for Information Biology
Information provided by (Responsible Party):
Ian Coulter, RAND

Brief Summary:
This study is a randomized controlled trial designed to compare the effects of 4 weeks of chiropractic care to a waitlist control group on measures of strength, balance, and endurance in military personnel experiencing non-surgical low back pain.

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Chiropractic manipulative therapy Not Applicable

Detailed Description:
This study will assess three functional outcomes (strength, balance and endurance) and patient-reported outcomes in participants with low back pain (LBP) treated with chiropractic care, providing evidence that may enhance our understanding of the relationship between functional outcomes and chiropractic care. The findings from this study may support the use of chiropractic care for military personnel as an effective, conservative treatment for low back pain that may also help preserve or improve functional outcomes and thus, allow active duty personnel to better perform the physical demands required of them.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Chiropractic Treatment: Strength and Balance
Study Start Date : April 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chiropractic Care (CC)
Participants in the CC group will receive evaluation and treatment (chiropractic manipulative therapy) from a doctor of chiropractic over a 4 week period.
Procedure: Chiropractic manipulative therapy
We will set an a priori treatment schedule of 8 visits at a frequency of 2 visits per week over a 4 week period. CC participants will receive chiropractic manipulative therapy (CMT). CMT procedures can be broadly divided into two types, thrust and non-thrust. Thrust CMT is a high-velocity low-amplitude procedure characterized by a single, short duration thrust (ranging from 100 to 500 ms) of low amplitude force applied to a target joint that often results in an audible sound, or cavitation. Non-thrust CMT employs low-velocity and often repeated joint movements of varying amplitude. In the event that no CMT treatment is clinically indicated, treatment will not be provided.
Other Name: Spinal manipulative therapy

No Intervention: Waitlist control group (WC)
Participants allocated to the waitlist control group will not receive any chiropractic treatment during the active study period. These individuals will be scheduled for one additional study visit following allocation. This final study visit will be scheduled 4 weeks after allocation (± 7 days). WC participants are not restricted from receiving any other healthcare during study participation. However, participants in the WC group will be asked not to receive any chiropractic care or spinal manipulation by any other provider during the 4 week intervention period. After WC participants complete the final study visit, they will be offered chiropractic care. This treatment will not be part of the study and no data will be collected at these visits.



Primary Outcome Measures :
  1. Isometric muscle strength test using force transducer [ Time Frame: Baseline and week 4 ]
    During the isometric muscle strength test, participants will first be placed in a safety harness and instructed into a proper lifting position. Participants will then be instructed to pull up (with gradually increasing effort levels) against a handle attached to a force transducer with a metallic chain. Participants will be instructed to immediately stop pulling on the handle if they experience any increased discomfort. The maximum pulling force recorded during the 3 tests will be used for data analysis, and these measurements will be taken at the first and last study visit. The outcome will be the change in strength following the 4-week intervention period.


Secondary Outcome Measures :
  1. One-Leg Standing Test (Stork test) via computer-activated timer [ Time Frame: Baseline and week 4 ]
    Participants will wear a safety harness and be instructed to remove their shoes, place their hands on their hips, and position their dominant foot against their supporting leg. The participant will then be asked to balance in the described position and raise their heel off the floor. A computer-activated timer connected to a sensor pad on the floor will start as the heel is raised. The timer will stop when the heel of the supporting foot or the other foot touches the floor. The longest holding time under conditions where the participant's eyes are open and closed will be used for data analysis. Measurements will be taken at the first and last study visit, and the outcome will be the change in balance following the intervention period.

  2. Stopwatch-timed trunk muscle endurance assessment (Biering-Sorensen test) [ Time Frame: Baseline and week 4 ]
    The test is performed with a participant lying prone on a padded table. The edge of the table is aligned with the top of the pelvis leaving the head, shoulders, and trunk extending over the edge, supported by the forearms resting on a padded cushion. The lower extremities are strapped to the table as firmly as comfort will allow. The participant is instructed to lift their arms off the support while maintaining a neutral trunk position and hold the posture for as long as possible. They are instructed to end the test if they experience pain or discomfort or are unable to maintain the posture. The length of time (in seconds) the participant holds the posture is recorded (using a hand-held stopwatch) as the test length. Measurements will be taken at the first and last study visit, and the outcome will be the change in endurance following the intervention period.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age range 18 - ≤ 40, inclusive
  2. Able to provide written informed consent
  3. Self-reported acute, subacute or chronic LBP at initial screen and baseline visit 1. Pain intensity of ≥ 2 on NRS within the past 24 hours.
  4. Active duty status

Exclusion Criteria:

  1. Any chiropractic care within 30 days of informed consent
  2. Any LBP confirmed or suspected to arise from a visceral source
  3. Spinal pathology or any other condition(s) contraindicating SM
  4. LBP for which specific treatments outside those available within study parameters are indicated
  5. Any spinal fracture within the past 6 months
  6. Any spinal surgery within the past 6 months
  7. LBP with positive neurologic signs indicating spinal nerve root compression, or LBP with presumptive or confirmed spinal nerve root compression
  8. Imaging evidence of neuroforaminal or spinal canal stenosis or the clinical presentation of neurogenic claudication
  9. Chronic pain syndrome diagnosis
  10. Diagnosis or suspected systemic inflammatory arthropathy of the spine
  11. Referral needed to evaluate or treat an urgent or emergent condition or to determine the status of a condition that pertains to eligibility
  12. Unable to safely perform strength, balance, or endurance tests, or the ability to assess health status
  13. Pregnant or planning to become pregnant within the next 6 weeks
  14. Knowledge of impending transfer or absence during study period
  15. Seeking or referred for Medical Evaluation Board / Physical Evaluation Board disability status (to ensure safety while performing study tests and to avoid confounding due to the potential for competing recovery goals)
  16. Unable or unwilling to comply with study protocols
  17. Patellar height is <15 inches or >25.5 inches

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670148


Contacts
Contact: Amy Minkalis, DC, MS, CCRP 563-884-5199 amy.minkalis@palmer.edu
Contact: Lara Hilton, MPH 310-393-0411 ext 7950 hilton@rand.org

Locations
United States, Florida
Naval Branch Health Clinic, NATTC Recruiting
Pensacola, Florida, United States, 32508
Contact: Crystal Franklin, MPH, CCRP    850-377-9183    crystal.franklin@palmer.edu   
Contact: Ethan Macarthur    850-452-8970 ext 131    ethan.j.macarthur.ctr@mail.mil   
Sponsors and Collaborators
Ian Coulter
Palmer College of Chiropractic
Samueli Institute for Information Biology
Investigators
Principal Investigator: Ian Coulter, PhD RAND

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ian Coulter, Principal Investigator, RAND
ClinicalTrials.gov Identifier: NCT02670148     History of Changes
Other Study ID Numbers: 2013-0159
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ian Coulter, RAND:
Chiropractic Manipulative Therapy
Low back pain
Trunk muscle strength
Balance
Active military personnel

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms