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Chronic Low Back PainPROPELNCT03637998

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

A study testing Problem-solving Pain to Enhance Living Well (PROPEL) in people with Chronic Low Back Pain and Self-Management, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chronic Low Back Pain, Self-Management
What is being tested?
Problem-solving Pain to Enhance Living Well (PROPEL)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
21 Sep 2018to 31 Dec 2021
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Connecticut

    Storrs, Connecticut, 06269

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Problem-solving Pain to Enhance Living Well (PROPEL)
Keywords
Gene expression, Quantitative Sensory Testing, Genotyping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Problem-solving Pain to Enhance Living Well (PROPEL)Behavioural

    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.

Study groups in NCT03637998
Study groupRoleWhat they receive
PROPELExperimentalThe 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.
Receives: Behavioral: Problem-solving Pain to Enhance Living Well (PROPEL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical activity

    Fitbit for activity tracker

    Measured: Baseline, 2, 4, 6, 8, 10 and 12 weeks

Secondary outcomes (5)

  1. Change in gene expression profiles

    RNA sequencing

    Measured: Baseline and 12 weeks post-intervention

  2. Change in pain sensitivity

    Quantitative sensory testing

    Measured: Baseline and 12 weeks post-intervention

  3. Relationship between pain self-management and pain severity

    Change over time through questionnaires

    Measured: Baseline, 2, 4, 6, 8, 10 and 12 weeks

  4. Relationship between pain self-management and pain interferance

    Change over time through questionnaires

    Measured: Baseline, 2, 4, 6, 8, 10 and 12 weeks

  5. Relationship between pain self-management and quality of life

    Change over time through questionnaires

    Measured: Baseline, 2, 4, 6, 8, 10 and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2018
  2. Study start21 Sep 2018
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03637998
Sponsor's protocol ID
H18-086
Other IDs
5P20NR016605
Acronym
PROPEL
Status last verified
Nov 2023
First submitted
16 Aug 2018
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Xu W, Zhang Y, Wang Z, Dorsey SG, Starkweather A, Kim K. Pain self-management plus activity tracking and nurse-led support in adults with chronic low back pain: feasibility and acceptability of the problem-solving pain to enhance living well (PROPEL) intervention. BMC Nurs. 2023 Jun 25;22(1):217. doi: 10.1186/s12912-023-01365-y.

    PubMed 37355622

Questions about this trial

What is this clinical trial studying?

A study testing Problem-solving Pain to Enhance Living Well (PROPEL) in people with Chronic Low Back Pain and Self-Management, run by University of Connecticut 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 11 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 28 Nov 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 physical activity (time frame: Baseline, 2, 4, 6, 8, 10 and 12 weeks). 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 NCT03637998, 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 28 Nov 2023.

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