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
Unknown statusNot applicableNCT05571215
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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-behavior…
Study details
- Official title
- 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
- Conditions
- Chronic Low-back Pain
- Catastrophizing Pain
- Kinesiophobia
- Sponsor
- High Point University
- Start date
- 2022-07-01
- Primary completion
- 2023-12-31
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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) * Cancer * 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 * An electrical, magnetic, or mechanical implantation (e.g. cardiac pacemakers or intracerebral vascular * clip) * A metal implant in the head or neck areas * A history of seizures or unexplained loss of consciousness * An immediate family member with epilepsy * The use of seizure threshold lowering medicine * The current abuse of alcohol or drugs * A history of psychiatric illness requiring medication controls
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05571215