Clinical trial NCT02670148: Assessment of Chiropractic Treatment: Strength and Balance
Official title: Assessment of Chiropractic Treatment: Strength and Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Chiropractic Manipulative Therapy
Low back pain
Trunk muscle strength
Balance
Active military personnel
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Palmer College of Chiropractic
name: Samueli Institute for Information Biology
First posted: 2016-02-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Isometric muscle strength test using force transducer
timeFrame: Baseline and week 4
Secondary outcomes:
measure: One-Leg Standing Test (Stork test) via computer-activated timer
timeFrame: Baseline and week 4
measure: Stopwatch-timed trunk muscle endurance assessment (Biering-Sorensen test)
timeFrame: Baseline and week 4
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Naval Branch Health Clinic, NATTC
state: Florida
Study officials:
affiliation: RAND
name: Ian Coulter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.