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

Chronic Low-Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05580380
• Other study ID #: 22-00141
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: June 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University Department of Physical Therapy, Arthur J. Nelson Human Performance Laboratory	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Change in Mean Walking Speed	To be measured/assessed during the 4-meter walking test.	Pre-Intervention (Day 1), Post-Intervention (Day 1)
Secondary	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)
Secondary	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)