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

NCT03637998 | Completed DMC

• 2 other identifiers: H18-0865P20NR016605
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain; Self-Management

Keywords

Gene expression; Quantitative Sensory Testing; Genotyping

Outcome Measures

Primary Outcomes (1)

• Change in physical activity

  Fitbit for activity tracker

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

Secondary Outcomes (5)

• Change in gene expression profiles

  Baseline and 12 weeks post-intervention

• Change in pain sensitivity

  Baseline and 12 weeks post-intervention

• Relationship between pain self-management and pain severity

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

• Relationship between pain self-management and pain interferance

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

• Relationship between pain self-management and quality of life

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

Study Arms (1)

PROPEL

EXPERIMENTAL

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)

Interventions

Problem-solving Pain to Enhance Living Well (PROPEL) BEHAVIORAL

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.

PROPEL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (1)

• 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.

  PMID: 37355622 DERIVED

Related Links

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

MeSH Terms

Interventions

Mometasone Furoate

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Wanli Xu, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

• Angela Starkweather, PhD

  University of Connecticut

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: September 21, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

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

Locations

US (1)