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Assessment of Chiropractic Treatment: Strength and Balance (ACT3)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chiropractic manipulative therapy
Sponsored by
Ian Coulter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chiropractic Manipulative Therapy, Low back pain, Trunk muscle strength, Balance, Active military personnel

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Naval Branch Health Clinic, NATTC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chiropractic Care (CC)

Waitlist control group (WC)

Arm Description

Participants in the CC group will receive evaluation and treatment (chiropractic manipulative therapy) from a doctor of chiropractic over a 4 week period.

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.

Outcomes

Primary Outcome Measures

Isometric muscle strength test using force transducer
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

One-Leg Standing Test (Stork test) via computer-activated timer
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.
Stopwatch-timed trunk muscle endurance assessment (Biering-Sorensen test)
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.

Full Information

First Posted
December 15, 2015
Last Updated
March 26, 2019
Sponsor
Ian Coulter
Collaborators
Palmer College of Chiropractic, Samueli Institute for Information Biology
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1. Study Identification

Unique Protocol Identification Number
NCT02670148
Brief Title
Assessment of Chiropractic Treatment: Strength and Balance
Acronym
ACT3
Official Title
Assessment of Chiropractic Treatment: Strength and Balance
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
February 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ian Coulter
Collaborators
Palmer College of Chiropractic, Samueli Institute for Information Biology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Chiropractic Manipulative Therapy, Low back pain, Trunk muscle strength, Balance, Active military personnel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chiropractic Care (CC)
Arm Type
Experimental
Arm Description
Participants in the CC group will receive evaluation and treatment (chiropractic manipulative therapy) from a doctor of chiropractic over a 4 week period.
Arm Title
Waitlist control group (WC)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Chiropractic manipulative therapy
Other Intervention Name(s)
Spinal manipulative therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Isometric muscle strength test using force transducer
Description
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.
Time Frame
Baseline and week 4
Secondary Outcome Measure Information:
Title
One-Leg Standing Test (Stork test) via computer-activated timer
Description
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.
Time Frame
Baseline and week 4
Title
Stopwatch-timed trunk muscle endurance assessment (Biering-Sorensen test)
Description
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.
Time Frame
Baseline and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age range 18 - ≤ 40, inclusive Able to provide written informed consent 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. Active duty status Exclusion Criteria: Any chiropractic care within 30 days of informed consent Any LBP confirmed or suspected to arise from a visceral source Spinal pathology or any other condition(s) contraindicating SM LBP for which specific treatments outside those available within study parameters are indicated Any spinal fracture within the past 6 months Any spinal surgery within the past 6 months LBP with positive neurologic signs indicating spinal nerve root compression, or LBP with presumptive or confirmed spinal nerve root compression Imaging evidence of neuroforaminal or spinal canal stenosis or the clinical presentation of neurogenic claudication Chronic pain syndrome diagnosis Diagnosis or suspected systemic inflammatory arthropathy of the spine Referral needed to evaluate or treat an urgent or emergent condition or to determine the status of a condition that pertains to eligibility Unable to safely perform strength, balance, or endurance tests, or the ability to assess health status Pregnant or planning to become pregnant within the next 6 weeks Knowledge of impending transfer or absence during study period 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) Unable or unwilling to comply with study protocols Patellar height is <15 inches or >25.5 inches
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Coulter, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Branch Health Clinic, NATTC
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32508
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30518400
Citation
Vining R, Minkalis A, Long CR, Corber L, Franklin C, Gudavalli MR, Xia T, Goertz CM. Assessment of chiropractic care on strength, balance, and endurance in active-duty U.S. military personnel with low back pain: a protocol for a randomized controlled trial. Trials. 2018 Dec 5;19(1):671. doi: 10.1186/s13063-018-3041-5.
Results Reference
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Assessment of Chiropractic Treatment: Strength and Balance

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