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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-Back Pain
• Intervention / Treatment: Other: Limited Relationship; Other: Enhanced Relationship

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • New York University Department of Physical Therapy, Arthur J. Nelson Human Performance Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Limited Patient-Clinician Relationship Group	Other: Limited Relationship; In this group, participants will share information regarding their low back pain history to a clinician who is not providing eye-contact, has farther physical distance, and is not directly facing the participant. The clinician will not provide verbal affirmations or ask clarifying questions about the patient's low back pain history. Instead, more time will be spent on completion of documentation.
Experimental: Enhanced Patient-Clinician Relationship Group	Other: Enhanced Relationship; A condition in which the clinician is providing enhanced relatedness with consistent eye contact, closer physical distance, facing the patient, and providing non-verbal affirmations (i.e. nodding, smiling), as the participant shares their low back pain history. The clinician will provide empathic verbal affirmations and will ask clarifying questions about the patient's low back pain history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of lifts completed in 1 minute	To be measured during the 1-minute lift test, where the participant is asked to lift objects of a certain weight.	Pre-Intervention (Day 1), Post-Intervention (Day 1)
Change in time holding the horizontal position	To be collected during the Biering-Sorensen Test, which is a timed measure used to assess the endurance of the trunk extensor muscles.	Pre-Intervention (Day 1), Post-Intervention (Day 1)
Change in Trunk Flexion Range of Motion	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.	Pre-Intervention (Day 1), Post-Intervention (Day 1)
Change in Mean Walking Speed	To be measured/assessed during the 4-meter walking test.	Pre-Intervention (Day 1), Post-Intervention (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) for Pain	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.	Pre-Intervention (Day 1), Post-Intervention (Day 1)
Pain pressure threshold	Pain pressure threshold (the degree of pressure required to produce symptoms) will be assessed using a pressure algometer.	Pre-Intervention (Day 1), Post-Intervention (Day 1)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Angela Stolfi, PT, DPT, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Pain; Health Disparities; Back Pain; Biopsychosocial; Patient-Clinician Relationship
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 22-00141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasongle request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Angela.Stolfi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No