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
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Procedure: Chiropractic manipulative therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Amy Minkalis, DC, MS, CCRPfirstname.lastname@example.org|
|Contact: Lara Hilton, MPH||310-393-0411 ext email@example.com|
|United States, Florida|
|Naval Branch Health Clinic, NATTC||Recruiting|
|Pensacola, Florida, United States, 32508|
|Contact: Crystal Franklin, MPH, CCRP 850-377-9183 firstname.lastname@example.org|
|Contact: Ethan Macarthur 850-452-8970 ext 131 email@example.com|
|Principal Investigator:||Ian Coulter, PhD||RAND|