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Enhanced Patient-Clinician Relationship Group for Chronic Low Back Pain

New York University Department of Physical Therapy, Arthur J. Nelson Human Performance Laboratory, New York, NY
Chronic Low Back PainEnhanced Relationship - Other
Eligibility
18 - 45
All Sexes
What conditions do you have?
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Study Summary

This trial is examining how an enhanced patient-clinician relationship affects chronic low back pain and functional outcomes, and exploring racialized disparities in low back pain.

Eligible Conditions
  • Chronic Low Back Pain

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

14 Primary · 2 Secondary · Reporting Duration: Pre-Intervention (Day 1), Post-Intervention (Day 1)

Day 1
Average Trunk Extension Velocity
Average Trunk Flexion Velocity
Mean walking speed
Hypersensitivity
Peak Trunk Extension Velocity
Peak Trunk Flexion Velocity
Root mean square amplitude of electromyographic activity
Score on Experiences of Discrimination Scale (EDS)
Score on Tampa Scale of Kinesiophobias (TSK)
Time holding the horizontal position
Day 1
Change in Mean Walking Speed
Change in Number of lifts completed in 1 minute
Change in Trunk Flexion Range of Motion
Change in time holding the horizontal position
Pain
Visual Analogue Scale (VAS) for Pain

Trial Safety

Phase-Based Safety

1 of 3

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2
Antidepressant
2
LY3857210
2
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Limited Patient-Clinician Relationship Group
1 of 2
Enhanced Patient-Clinician Relationship Group
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Enhanced Patient-Clinician Relationship Group · No Placebo Group · N/A

Enhanced Patient-Clinician Relationship Group
Other
Experimental Group · 1 Intervention: Enhanced Relationship · Intervention Types: Other
Limited Patient-Clinician Relationship Group
Other
ActiveComparator Group · 1 Intervention: Limited Relationship · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: pre-intervention (day 1), post-intervention (day 1)

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,303 Previous Clinical Trials
757,763 Total Patients Enrolled
Angela Stolfi, PT, DPTPrincipal InvestigatorNYU Langone Health

Eligibility Criteria

Age 18 - 45 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have more pain in your back than in your legs.
You have been experiencing pain in your lower back for at least 3 months.
You have experienced lower back pain for over half of the days in the last 6 months.
You have pain in your lower back between your ribs and hips as reported by yourself.
References

Frequently Asked Questions

Is my eligibility for enrollment in this trial ascertained?

"Potential participants of this medical trial must be within the age range of 18 to 45 years old. The total number of enrollees is estimated to reach 100 individuals." - Anonymous Online Contributor

Unverified Answer

Is there a recruitment phase for this research endeavor?

"Data featured on clinicaltrials.gov confirms that this medical research is actively enrolling patients, with the initial posting of the trial occurring on April 1rst 2022 and a subsequent update recorded 18th October 2022." - Anonymous Online Contributor

Unverified Answer

Does this research endeavor accept participants younger than seventy-five years old?

"According to the enrollment requirements, 18 is the minimum age and 45 is the maximum age for participants in this trial." - Anonymous Online Contributor

Unverified Answer

How many applicants are being accepted into the trial?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical experiment, which was initially advertised on April 1st 2022, is actively recruiting participants. Approximately 100 subjects must be recruited from one specific healthcare facility." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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