Assessment of Chiropractic Treatment: Strength and Balance

NCT ID: NCT02670148

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-02-14

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chiropractic manipulative therapy

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Spinal manipulative therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Palmer College of Chiropractic

OTHER

Sponsor Role: collaborator

Samueli Institute for Information Biology

OTHER

Sponsor Role: collaborator

Ian Coulter

OTHER

Sponsor Role: lead

Responsible Party

Ian Coulter

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ian Coulter, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

Naval Branch Health Clinic, NATTC

Pensacola, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30518400 (View on PubMed)

Other Identifiers

2013-0159

Identifier Type: -

Identifier Source: org_study_id