Chronic Low-Back PainNCT05580380
Addressing Health Disparities in Chronic Low Back Pain With Patient-Clinician Relatedness
A study testing Limited Relationship and Enhanced Relationship in people with Chronic Low-Back Pain, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Low-Back Pain
- What is being tested?
- Limited Relationship and Enhanced Relationship
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Department of Physical Therapy, Arthur J. Nelson Human Performance Laboratory
New York, New York, 10010
About this study
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
- Being tested
- Limited Relationship, Enhanced Relationship
- Keywords
- Patient-Clinician Relationship, Back Pain, Chronic Pain, Biopsychosocial, Health Disparities
- Medical subject headings
- Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limited RelationshipOther
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 RelationshipOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Limited Patient-Clinician Relationship Group | Active comparator | Not described Receives: Other: Limited Relationship |
| Enhanced Patient-Clinician Relationship Group | Experimental | Not described Receives: Other: Enhanced Relationship |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-Intervention (Day 1), Post-Intervention (Day 1)
Change in Mean Walking Speed
To be measured/assessed during the 4-meter walking test.
Measured: Pre-Intervention (Day 1), Post-Intervention (Day 1)
Secondary outcomes (2)
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.
Measured: Pre-Intervention (Day 1), Post-Intervention (Day 1)
Pain pressure threshold
Pain pressure threshold (the degree of pressure required to produce symptoms) will be assessed using a pressure algometer.
Measured: Pre-Intervention (Day 1), Post-Intervention (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Apr 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-Back PainStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Stolfi, PT, DPT, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580380
- Sponsor's protocol ID
- 22-00141
- Status last verified
- Jun 2023
- First submitted
- 12 Oct 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasongle request.
Publications
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.
PubMed 39584210
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Health Disparities in Chronic Low Back Pain With Patient-Clinician Relatedness
- ClinicalTrials.gov ID
- NCT05580380
- Acronym / sponsor ID
- 22-00141
- Conditions
- Chronic Low-Back Pain
- Keywords
- Patient-Clinician Relationship, Back Pain, Chronic Pain, Biopsychosocial, Health Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limited Patient-Clinician Relationship Group | Active comparator | Other: Limited Relationship |
| Enhanced Patient-Clinician Relationship Group | Experimental | Other: Enhanced Relationship |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limited RelationshipIn 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. | Other | Limited Patient-Clinician Relationship Group |
| Enhanced RelationshipA 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. | Other | Enhanced Patient-Clinician Relationship Group |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Visual Analogue Scale (VAS) for Pain
Time frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)
Pain pressure threshold
Time frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 39584210Vorensky 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasongle request.
Related trials for Chronic Low-Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Stolfi, PT, DPT principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limited Relationship and Enhanced Relationship in people with Chronic Low-Back Pain, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of lifts completed in 1 minute (time frame: Pre-Intervention (Day 1), Post-Intervention (Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05580380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.