Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03637998
Study type Interventional
Source University of Connecticut
Contact
Status Completed
Phase N/A
Start date September 21, 2018
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT03243084 - Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy N/A
Suspended NCT04735185 - Stem Cells vs. Steroids for Discogenic Back Pain N/A
Completed NCT03162952 - RAND Center of Excellence for the Study of Appropriateness of Care in CAM
Completed NCT03240146 - Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain N/A
Completed NCT05282589 - Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients N/A
Recruiting NCT02289170 - Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100) N/A
Active, not recruiting NCT01944163 - The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain N/A
Completed NCT02231554 - Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial N/A
Recruiting NCT02063503 - Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients N/A
Completed NCT01704677 - Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT01177280 - Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes N/A
Completed NCT01490905 - A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain Phase 4
Completed NCT01177241 - Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids N/A
Completed NCT01177254 - Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions N/A
Completed NCT00984815 - Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment Phase 3
Completed NCT00763321 - Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) Phase 3
Completed NCT00767806 - A Study for Patient With Chronic Low Back Pain Phase 3
Completed NCT00761150 - Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) Phase 3
Completed NCT00613106 - Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216) Phase 3