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Completed

NCT Number: NCT05580380

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.

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Key information

Conditions

Chronic Low-back Pain Back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New York, 10010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Does not meet any of the above inclusion criteria.
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Number of lifts completed in 1 minute

    Time frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)

    To be measured during the 1-minute lift test, where the participant is asked to lift objects of a certain weight.

  2. Change in time holding the horizontal position

    Time frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)

    To be collected during the Biering-Sorensen Test, which is a timed measure used to assess the endurance of the trunk extensor muscles.

  3. Change in Trunk Flexion Range of Motion

    Time frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)

    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.

  4. Change in Mean Walking Speed

    Time frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)

    To be measured/assessed during the 4-meter walking test.

Secondary outcomes

  1. Visual Analogue Scale (VAS) for Pain

    Time frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)

    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.

  2. Pain pressure threshold

    Time frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)

    Pain pressure threshold (the degree of pressure required to produce symptoms) will be assessed using a pressure algometer.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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