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Clinical Trials/NCT05571215
NCT05571215
Recruiting
Not Applicable

The Effect of Combining Pain Neuroscience Education and Transcranial Direct Current Stimulation on Pain Catastrophizing, Kinesiophobia, and Pain in Patients With Chronic Low Back Pain

High Point University1 site in 1 country40 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low-back Pain
Sponsor
High Point University
Enrollment
40
Locations
1
Primary Endpoint
Change in Tampa Scale of Kinesiophobia
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Recent literature has shown that individuals with persistent chronic pain often exhibit altered cognitive, affective, and sensorimotor behaviors despite a full recovery of peripheral structural injury. Clinically this can be observed via altered pain behaviors (e.g., pain catastrophizing and kinesiophobia) and increased sensitivity to pressure stimuli, each of which are predictive of poorer outcomes. These alterations are believed to have arisen from maladaptive reorganization of brain networks, including cognitive-evaluative and affective networks. Structurally, decreased gray matter in the dorsolateral prefrontal cortex (DLFPC), a key area in the cognitive-affective processing of pain, has been found in those suffering from chronic musculoskeletal pain. The changes are shown to be reversible when the pain is successfully treated and uniquely connected to cognitive-affective behaviors in that as catastrophizing or fear decreases, DLPFC density increases.

Pain science education (PNE), a cognitive-behavioral intervention, has shown promising effects, especially on cognitive- affective behaviors. Non-invasive brain stimulation, such as transcranial direct current stimulation (tDCS), has also been shown to reduce pain and pain-associated behavioral changes in chronic pain. However, the combined effects of these two interventions have not been investigated. It remains unclear if priming the cognitive-affective circuitry that is conceptualized to support PNE with tDCS will augment the behavioral effect of PNE. Therefore, the primary objective of this pilot study is to examine the effects of combining PNE and tDCS on pain catastrophizing, kinesiophobia, and hypersensitivity to pressure stimuli in patients with chronic low back pain (CLBP). We will also examine the influence of PNE and tDCS on cortical network patterns in a subgroup of participants. The results of this pilot study could support the use of tDCS as a priming agent to increase the effect of cognitive-behavioral interventions such as PNE. With success, this intervention could be safely and easily replicated in the clinical setting and provide a novel approach to treating chronic pain more effectively. In addition, the outcomes can further the understanding of more precisely matching specific cortical targets with the desired behavioral therapy

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cory Alcon

Assistant Professor

High Point University

Eligibility Criteria

Inclusion Criteria

  • Reports chronic low back pain defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months
  • Age: 18-65 years
  • Score \>30 on Pain Catastrophizing Scale

Exclusion Criteria

  • History of previous lower back surgery
  • Systemic joint disease (e.g. rheumatoid arthritis)
  • Evidence of red flags (e.g. fracture, infection, tumor, cauda equina syndrome)
  • Neurological disorders
  • Neuropathy
  • Raynaud's disease
  • Pregnancy
  • An inability to maintain the testing and treatment positions (i.e. sitting for \>30 minutes).
  • Exclusion criteria for the tDCS include:
  • A history of significant head trauma

Outcomes

Primary Outcomes

Change in Tampa Scale of Kinesiophobia

Time Frame: Completed prior to first intervention session and immediately following final intervention sessions

. The 17-item TSK (17-68) will be used to determine each participant's level of fear of movement. A higher score indicates higher level of kinesiophobia.

Change in Numeric Pain Rating Scale

Time Frame: Completed prior to first intervention session and immediately following final intervention sessions

The NPRS (0-10) will be recorded by the participants rating their current pain on the day of assessment, 0 being no pain and 10 being the worst imaginable pain.

Change in Pain Catastrophizing Scale

Time Frame: Completed prior to first intervention session and immediately following final intervention sessions

The 13-item PCS (0-52) will be used to determine each participant's pain catastrophizing level. Pain catastrophizing is characterized by the tendency to magnify pain stimulus and to feel helpless in the presence of pain. A higher score indicates higher pain catastrophizing level.

Change in Stroop Color Word Test

Time Frame: Completed prior to first intervention session and immediately following final intervention sessions

The Stroop Color and Word Test (SCWT) will be used to assess participants ability to inhibit cognitive interference. Cognitive interference occurs when the processing of one stimulus influences the ability to process another feature of the same stimulus.

Secondary Outcomes

  • Change in Coding Test(Completed prior to first intervention session and immediately following final intervention sessions)
  • Change in Comprehensive Trail Making(Completed prior to first intervention session and immediately following final intervention sessions)
  • Change in Pressure Pain Thresholds(Completed prior to first intervention session and immediately following final intervention sessions)

Study Sites (1)

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