Back to resultsAddressing Health Disparities in Chronic Low Back Pain With Patient-Clinician Relatedness
Primary Purpose
Chronic Low-Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Limited Relationship
Enhanced Relationship
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Low-Back Pain focused on measuring Patient-Clinician Relationship, Back Pain, Chronic Pain, Biopsychosocial, Health Disparities
Eligibility Criteria
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.
Sites / Locations
- New York University Department of Physical Therapy, Arthur J. Nelson Human Performance Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Limited Patient-Clinician Relationship Group
Enhanced Patient-Clinician Relationship Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Change in Mean Walking Speed
To be measured/assessed during the 4-meter walking test.
Secondary Outcome Measures
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.
Pain pressure threshold
Pain pressure threshold (the degree of pressure required to produce symptoms) will be assessed using a pressure algometer.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05580380
Brief Title
Addressing Health Disparities in Chronic Low Back Pain With Patient-Clinician Relatedness
Official Title
Addressing Health Disparities in Chronic Low Back Pain With Patient-Clinician Relatedness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-Back Pain
Keywords
Patient-Clinician Relationship, Back Pain, Chronic Pain, Biopsychosocial, Health Disparities
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Limited Patient-Clinician Relationship Group
Arm Type
Active Comparator
Arm Title
Enhanced Patient-Clinician Relationship Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Limited Relationship
Intervention Description
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
Intervention Name(s)
Enhanced Relationship
Intervention Description
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 Outcome Measure Information:
Title
Change in Number of lifts completed in 1 minute
Description
To be measured during the 1-minute lift test, where the participant is asked to lift objects of a certain weight.
Time Frame
Pre-Intervention (Day 1), Post-Intervention (Day 1)
Title
Change in time holding the horizontal position
Description
To be collected during the Biering-Sorensen Test, which is a timed measure used to assess the endurance of the trunk extensor muscles.
Time Frame
Pre-Intervention (Day 1), Post-Intervention (Day 1)
Title
Change in Trunk Flexion Range of Motion
Description
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.
Time Frame
Pre-Intervention (Day 1), Post-Intervention (Day 1)
Title
Change in Mean Walking Speed
Description
To be measured/assessed during the 4-meter walking test.
Time Frame
Pre-Intervention (Day 1), Post-Intervention (Day 1)
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) for Pain
Description
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.
Time Frame
Pre-Intervention (Day 1), Post-Intervention (Day 1)
Title
Pain pressure threshold
Description
Pain pressure threshold (the degree of pressure required to produce symptoms) will be assessed using a pressure algometer.
Time Frame
Pre-Intervention (Day 1), Post-Intervention (Day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Stolfi, PT, DPT
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Department of Physical Therapy, Arthur J. Nelson Human Performance Laboratory
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Addressing Health Disparities in Chronic Low Back Pain With Patient-Clinician Relatedness
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