Assessment of Chiropractic Treatment: Strength and Balance (ACT3)

Ian Coulter

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: Chiropractic manipulative therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02670148

2013-0159

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Chiropractic Care (CC)

Experimental group

Description:

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

Treatment:

Procedure: Chiropractic manipulative therapy

Waitlist control group (WC)

No Intervention group

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.