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

NCT ID: NCT05580380

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-02-01

Brief Summary

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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

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Conditions

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Chronic Low-Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Limited Patient-Clinician Relationship Group

Group Type ACTIVE_COMPARATOR

Limited Relationship

Intervention Type 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.

Enhanced Patient-Clinician Relationship Group

Group Type EXPERIMENTAL

Enhanced Relationship

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Stolfi, PT, DPT

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39584210 (View on PubMed)

Other Identifiers

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22-00141

Identifier Type: -

Identifier Source: org_study_id

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