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

The Impact of Physical Activity on the Neurophysiologic and Gene Expression Profiles of Chronic Low Back Pain: A Longitudinal Study Protocol

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain; Self-Management
• Intervention / Treatment: Behavioral: Problem-solving Pain to Enhance Living Well (PROPEL)

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity	Fitbit for activity tracker	Baseline, 2, 4, 6, 8, 10 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gene expression profiles	RNA sequencing	Baseline and 12 weeks post-intervention
Change in pain sensitivity	Quantitative sensory testing	Baseline and 12 weeks post-intervention
Relationship between pain self-management and pain severity	Change over time through questionnaires	Baseline, 2, 4, 6, 8, 10 and 12 weeks
Relationship between pain self-management and pain interferance	Change over time through questionnaires	Baseline, 2, 4, 6, 8, 10 and 12 weeks
Relationship between pain self-management and quality of life	Change over time through questionnaires	Baseline, 2, 4, 6, 8, 10 and 12 weeks

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Study Director: Angela Starkweather, PhD, University of Connecticut; Principal Investigator: Wanli Xu, PhD, University of Connecticut

Publications and helpful links

Helpful Links

• Center for Accelerating Precision Pain Self-Management (CAPPS-M) Website

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quantitative Sensory Testing; Gene expression; Genotyping
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: H18-086; 5P20NR016605 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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

• IPD Sharing Time Frame: Within 2 years
• IPD Sharing Access Criteria: Requests will be submitted through the cdRNS website

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No