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

NCT05580380 | Completed

• 1 other identifier: 22-00141
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-Back Pain

Keywords

Patient-Clinician Relationship; Back Pain; Chronic Pain; Biopsychosocial; Health Disparities

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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 Arms (2)

Limited Patient-Clinician Relationship Group

ACTIVE COMPARATOR

Other: Limited Relationship

Enhanced Patient-Clinician Relationship Group

EXPERIMENTAL

Other: Enhanced Relationship

Interventions

Limited Relationship OTHER

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.

Limited Patient-Clinician Relationship Group

Enhanced Relationship OTHER

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.

Enhanced Patient-Clinician Relationship Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

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

New York, New York, 10010, United States

Location

Related Publications (1)

• Vorensky M, Squires A, Jones S, Sajnani N, Castillo E, Rao S. Impact of Patient-Clinician Relationships on Pain and Objective Functional Measures for Individuals with Chronic Low Back Pain: An Experimental Study. J Health Care Poor Underserved. 2024;35(4):1229-1257. doi: 10.1353/hpu.2024.a943987.

  PMID: 39584210 DERIVED

MeSH Terms

Conditions

Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela Stolfi, PT, DPT

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: April 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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
• 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

Locations

US (1)