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Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain (PROPEL)

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ClinicalTrials.gov Identifier: NCT03637998
Recruitment Status : Suspended (Due to COVID-19)
First Posted : August 20, 2018
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Wanli Xu, University of Connecticut

Brief Summary:
This pilot project will provide an understanding of the contextual variables responsible for chronic low back pain. These variables include, genetic variation, pain sensitivity, reactivity, pain catastrophizing, perceived stress and kinesiphobia. The purpose is to understand the initial efficacy of self-management (SM) strategies on each of these contextual variables, in an effort to inform a personalized approach to managing chronic low back pain and its effect on improved health outcomes.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Self-Management Behavioral: Problem-solving Pain to Enhance Living Well (PROPEL) Not Applicable

Detailed Description:

Chronic low back pain (cLBP) is the second most frequent chronic pain condition in the United States and results in billions of dollars each year in health care expenses, disability and lost productivity. A major factor that contributes to the refractory nature of cLBP is enhanced pain sensitivity, which is an altered state of pain processing that amplifies pain sensation and impairs descending pain inhibition. Enhanced pain sensitivity in patients who develop cLBP is associated with altered expression of pro-nociceptive and inflammatory genes. On the other hand, regular physical activity of at least moderate intensity for 150 or more minutes per week is recommended to reduce pain severity and improve function in individuals with cLBP. Therefore, a deeper mechanistic understanding of the effect of physical activity on the neurophysiologic and gene transcription alterations that characterize cLBP may inform more specific treatment options to optimize pain reduction and reduce the risk of pain chronicity.

The purpose of this longitudinal cohort pilot study is to examine the feasibility, acceptability, and preliminary efficacy of the Problem-solving Pain to Enhance Living Well (PROPEL) self-management (SM) intervention on cLBP. This pre-post intervention study will recruit 40 community dwelling adults (age 18 - 60 years old) with cLBP. They will receive electronic video modules focused on cLBP SM knowledge and weekly phone consultations to facilitate monitoring and problem-solving. All participants will be assessed for primary outcomes including cLBP SM behaviors, physical activity, pain severity and interferance, and pain sensitivity at baseline and every 2 weeks for 12 weeks. The study will examine differential neurophysiologic and gene expression profiles between participants with cLBP at 12-weeks post-intervention and correlate these outcome measures to total duration of physical activity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Physical Activity on the Neurophysiologic and Gene Expression Profiles of Chronic Low Back Pain: A Longitudinal Study Protocol
Actual Study Start Date : September 21, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: PROPEL
The Problem-solving Pain to Enhance Living Well (PROPEL) intervention entails each participant watching 10 video modules via REDCap. These modules include: (1) pain neurophysiology, (2) catastrophizing, (3) stress reactivity, (4) fear of movement, (5) progressive relaxation, (6) deep breathing, (7) guided imagery, (8) heat, ice and stretching, (9) strategies for physical activity self-activation and (10) problem-solving.
Behavioral: Problem-solving Pain to Enhance Living Well (PROPEL)
PROPEL incorporates evidence-based, standard of care methods to promote physical activity among individuals with pain, and tools to improve knowledge, skills and confidence to cope with cLBP. The focus is self-management of cLBP. All eligible participants will then undergo baseline data collection, which entails completion of study questionnaires, quantitative sensory testing (QST) and venipuncture for collection of a blood specimen. Participants will be provided with the information to access the PROPEL intervention. All participants will be asked to complete questionnaires at 2, 4, 6, 8, and 10 weeks following baseline testing. At 12 weeks, participants will be scheduled for a final data collection visit, which will follow the same procedures as the baseline visit.




Primary Outcome Measures :
  1. Change in physical activity [ Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 weeks ]
    Fitbit for activity tracker


Secondary Outcome Measures :
  1. Change in gene expression profiles [ Time Frame: Baseline and 12 weeks post-intervention ]
    RNA sequencing

  2. Change in pain sensitivity [ Time Frame: Baseline and 12 weeks post-intervention ]
    Quantitative sensory testing

  3. Relationship between pain self-management and pain severity [ Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 weeks ]
    Change over time through questionnaires

  4. Relationship between pain self-management and pain interferance [ Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 weeks ]
    Change over time through questionnaires

  5. Relationship between pain self-management and quality of life [ Time Frame: Baseline, 2, 4, 6, 8, 10 and 12 weeks ]
    Change over time through questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • be 18-60 years of age;
  • have nonspecific cLBP (≥4 on the numeric rating scale; NRS) present for at least 3 out of the last 6 months and ≥ half the days in the past 6 months;
  • comprehend English (due to lack of reliability and validity of study instruments and the intervention in non-English populations).
  • Have daily access to a computer, tablet or smartphone with access to internet
  • Have less than 150 minutes of moderate physical activity a week
  • Be willing to wear activity tracker for 12 weeks

Exclusion Criteria:

  • Chronic pain at another site or associated with a painful condition (eg., fibromyalgia, neuropathy, rheumatoid arthritis)
  • history of comorbidities that affect sensorimotor function (eg., multiple sclerosis, cancer, spinal cord injury, diabetes)
  • previous spinal surgery within last 1 year
  • presence of neurological deficits such as weakness in the lower extremities (motor strength 4/5 of quads, glutes, hamstrings, EHL)
  • bowel or bladder dysfunction such as difficulty voiding or incontinence
  • sciatica or (+) leg raise
  • positive Romberg test
  • being pregnant or within 3 months postpartum
  • history of psychological disorders (major depression, bipolar disorder, schizophrenia)
  • identification of any "red flag" condition in the volunteer's past medical history that suggests specific LBP as determined by Dr. Kim such as conditions or medications that can affect pain sensitivity
  • injury to non-dominant hand or presence of open skin lesions, disturbed sensation, carpal tunnel or rash

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637998


Locations
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United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
Sponsors and Collaborators
University of Connecticut
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Kyounghae Kim, PhD University of Connecticut
Study Director: Angela Starkweather, PhD University of Connecticut
Additional Information:
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Responsible Party: Wanli Xu, Assistant Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT03637998    
Other Study ID Numbers: H18-086
5P20NR016605 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

All of the individual participant data that are part of National Institute of Nursing Research (NINR) designated common data elements collected during the trial, after de-identification have been submitted to NIH repository at the Common Data Repository for Nursing Science (cdRNS). Data can be accessed by directly submitting requests at that website.

When will data be available (start and end dates)? Immediately. No end date.

With whom? Anyone who wishes to access the data and creates an account on cdRNS.nih.gov.

By what mechanism will data be made available? Data are available at cdRNS.nih.gov

Time Frame: Within 2 years
Access Criteria: Requests will be submitted through the cdRNS website
URL: https://cdrns.nih.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wanli Xu, University of Connecticut:
Gene expression
Quantitative Sensory Testing
Genotyping
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms