Assessment of Chiropractic Treatment: Strength and Balance

NCT02670148 | Completed DMC

• 1 other identifier: 2013-0159
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Chiropractic Manipulative Therapy; Low back pain; Trunk muscle strength; Balance; Active military personnel

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and week 4

Secondary Outcomes (2)

• One-Leg Standing Test (Stork test) via computer-activated timer

  Baseline and week 4

• Stopwatch-timed trunk muscle endurance assessment (Biering-Sorensen test)

  Baseline and week 4

Study Arms (2)

Chiropractic Care (CC)

EXPERIMENTAL

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

Waitlist control group (WC)

NO INTERVENTION

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.

Interventions

Chiropractic manipulative therapy PROCEDURE

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.

Also known as: Spinal manipulative therapy

Chiropractic Care (CC)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ian Coulter: lead
• Palmer College of Chiropractic: collaborator
• Samueli Institute for Information Biology: collaborator

Study Sites (1)

Naval Branch Health Clinic, NATTC

Pensacola, Florida, 32508, United States

Location

Related Publications (1)

• 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.

  PMID: 30518400 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian Coulter, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: February 1, 2016
• Study Start: April 1, 2016
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: March 28, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)