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Clinical Trials/NCT05580380
NCT05580380
Completed
Not Applicable

Addressing Health Disparities in Chronic Low Back Pain With Patient-Clinician Relatedness

NYU Langone Health1 site in 1 country56 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low-Back Pain
Sponsor
NYU Langone Health
Enrollment
56
Locations
1
Primary Endpoint
Change in time holding the horizontal position
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The primary objective of the current research is to assess the effect of an enhanced patient-clinician relationship when compared to a limited patient-clinician relationship on measures of chronic low back pain and objective functional measures.

The second objective is to examine racialized disparities in chronic low back pain among individuals who identify as non-Hispanic Black and non-Hispanic White using a qualitative approach.

Lastly, the study team will explore relationships between psychosocial components of low back pain, pain and functional outcomes, and patient-clinician relationship measures.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
February 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Self-reported low back pain located between the 12th rib and the gluteal fold.
  • Low back pain lasting at least 3-months.
  • Low back pain for more than half of the days in the past 6-months.
  • Age 18-45 years old.
  • Reports at least 3 out of 10 average pain over the past week on the numerical pain rating scale.
  • Reports having more back pain when compared to leg pain.

Exclusion Criteria

  • Does not meet any of the above inclusion criteria.
  • If there is a reported low back procedure scheduled within the upcoming 8-weeks including an epidural injection or spinal surgery.
  • If low back pain care (i.e. physicians visits, physical therapy) is being received through Worker's Compensation or No Fault insurance.
  • Dizziness, vestibular, or visual difficulties that cause balance problems over the past 2-weeks.
  • Any lower or upper extremity surgery within the past year or any prior history of spine surgery, spinal fracture, or malignancy in the spine will not be included in the study.
  • Individuals who are pregnant or breastfeeding.

Outcomes

Primary Outcomes

Change in time holding the horizontal position

Time Frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)

To be collected during the Biering-Sorensen Test, which is a timed measure used to assess the endurance of the trunk extensor muscles.

Change in Trunk Flexion Range of Motion

Time Frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)

To be measured during the Fingertip-to-floor (FTF) Test, where the participant is asked to bed forward and attempt to reach the floor with their fingertips.

Change in Mean Walking Speed

Time Frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)

To be measured/assessed during the 4-meter walking test.

Change in Number of lifts completed in 1 minute

Time Frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)

To be measured during the 1-minute lift test, where the participant is asked to lift objects of a certain weight.

Secondary Outcomes

  • Visual Analogue Scale (VAS) for Pain(Pre-Intervention (Day 1), Post-Intervention (Day 1))
  • Pain pressure threshold(Pre-Intervention (Day 1), Post-Intervention (Day 1))

Study Sites (1)

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