Clinical trial NCT05580380: Addressing Health Disparities in Chronic Low Back Pain With Patient-Clinician Relatedness
Official title: Addressing Health Disparities in Chronic Low Back Pain With Patient-Clinician Relatedness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-Back Pain
Keywords: Patient-Clinician Relationship
Back Pain
Chronic Pain
Biopsychosocial
Health Disparities
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Number of lifts completed in 1 minute
timeFrame: Pre-Intervention (Day 1), Post-Intervention (Day 1)
measure: Change in time holding the horizontal position
timeFrame: Pre-Intervention (Day 1), Post-Intervention (Day 1)
measure: Change in Trunk Flexion Range of Motion
timeFrame: Pre-Intervention (Day 1), Post-Intervention (Day 1)
measure: Change in Mean Walking Speed
timeFrame: Pre-Intervention (Day 1), Post-Intervention (Day 1)
Secondary outcomes:
measure: Visual Analogue Scale (VAS) for Pain
timeFrame: Pre-Intervention (Day 1), Post-Intervention (Day 1)
measure: Pain pressure threshold
timeFrame: Pre-Intervention (Day 1), Post-Intervention (Day 1)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Department of Physical Therapy, Arthur J. Nelson Human Performance Laboratory
state: New York
Study officials:
affiliation: NYU Langone Health
name: Angela Stolfi, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: