MedPath

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

Not Applicable
Completed
Conditions
Chronic Low-Back Pain
Interventions
Other: Enhanced Relationship
Other: Limited Relationship
Registration Number
NCT05580380
Lead Sponsor
NYU Langone Health
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
56
Inclusion Criteria
  1. Self-reported low back pain located between the 12th rib and the gluteal fold.
  2. Low back pain lasting at least 3-months.
  3. Low back pain for more than half of the days in the past 6-months.
  4. Age 18-45 years old.
  5. Reports at least 3 out of 10 average pain over the past week on the numerical pain rating scale.
  6. Reports having more back pain when compared to leg pain.
Exclusion Criteria
  1. Does not meet any of the above inclusion criteria.
  2. If there is a reported low back procedure scheduled within the upcoming 8-weeks including an epidural injection or spinal surgery.
  3. If low back pain care (i.e. physicians visits, physical therapy) is being received through Worker's Compensation or No Fault insurance.
  4. Dizziness, vestibular, or visual difficulties that cause balance problems over the past 2-weeks.
  5. 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.
  6. Individuals who are pregnant or breastfeeding.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Enhanced Patient-Clinician Relationship GroupEnhanced Relationship-
Limited Patient-Clinician Relationship GroupLimited Relationship-
Primary Outcome Measures
NameTimeMethod
Change in time holding the horizontal positionPre-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 MotionPre-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 SpeedPre-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 minutePre-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 Outcome Measures
NameTimeMethod
Visual Analogue Scale (VAS) for PainPre-Intervention (Day 1), Post-Intervention (Day 1)

VAS will be used to report pain at rest. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

Pain pressure thresholdPre-Intervention (Day 1), Post-Intervention (Day 1)

Pain pressure threshold (the degree of pressure required to produce symptoms) will be assessed using a pressure algometer.

Trial Locations

Locations (1)

New York University Department of Physical Therapy, Arthur J. Nelson Human Performance Laboratory

🇺🇸

New York, New York, United States

© Copyright 2025. All Rights Reserved by MedPath