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

NYU Langone Health

Status: Completed

Conditions: Chronic Low-Back Pain

Treatments: Other: Limited Relationship; Other: Enhanced Relationship

Study type: Interventional

Funder types: Other

Identifiers

NCT05580380

22-00141

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Limited Patient-Clinician Relationship Group

Active Comparator group

Treatment:

Other: Limited Relationship

Enhanced Patient-Clinician Relationship Group

Experimental group

Treatment:

Other: Enhanced Relationship