Recruiting

Pain Neuroscience Education & tDCS

Sponsor:

High Point University

Code:

NCT05571215

Conditions

Chronic Low-back Pain

Catastrophizing Pain

Kinesiophobia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcranial Direct Current Stimulation

Pain Neuroscience Education

Study Details

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

Conditions

Chronic Low-back Pain

Catastrophizing Pain

Kinesiophobia

Study ID

NCT05571215

Start date

Jul 1, 2022

Status verified date

Oct, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combined tDCS and PNE

This is a single-arm pilot study used to evaluate the treatment effects of combining pain neuroscience education (PNE) and transcranial direct current stimulation (tDCS). All participants will receive the same Intervention, which includes five sessions of tDCS to the left dorsolateral prefrontal cortex (DLPFC) plus PNE over two weeks.

Interventions

Transcranial Direct Current Stimulation

Five sessions of tDCS will be performed following completions of baseline data collection. This will include 3 sessions during week one and 2 sessions in week 2. A tDCS unit (neuroConn Ilmenau, Germany) will be applied to the left DLPFC with participants in the sitting position for a 20 minutes of tDCS. An anodal 2.0 mA current will be applied to each participant, including a 30-second ramp up at the beginning of stimulation and a 30 second ramp down period and the end of stimulation. The left DLPFC (F3 from EEG 10/20 system) will be located using the Beam F3 measurement system. These parameters are consistent with those used in current literature on tDCS for pain. tDCS procedures will be performed by the PI (CA).

Pain Neuroscience Education

Immediately following completion of each tDCS intervention, participants will be given a one-on-one PNE session provided also by the PT (CA), who is a licensed healthcare provider with expertise in delivery of the content. This educational session will last about 30 minutes. Initial sessions will involve discussion and questioning of participants about their own understanding of their pain and this information will be used to subsequently individualize the forthcoming educational sessions. The educational sessions will follow the content of Explain Pain, a patient booklet, and will include information on the neurophysiology of pain, pain as typical process, the transition from acute to chronic pain, neuroplasticity, central sensitization, factors that promote pain chronicity. Information will be presented verbally along with visuals on paper.

Primary outcome measure

  • Change in Pain Catastrophizing Scale [ Time Frame: Completed prior to first intervention session and immediately following final intervention sessions ]
  • Change in Tampa Scale of Kinesiophobia [ Time Frame: Completed prior to first intervention session and immediately following final intervention sessions ]
  • Change in Stroop Color Word Test [ Time Frame: Completed prior to first intervention session and immediately following final intervention sessions ]
  • Change in Numeric Pain Rating Scale [ Time Frame: Completed prior to first intervention session and immediately following final intervention sessions ]

Central Contacts and Locations

Central contacts

Cory A Alcon, DPT

336-841-9723calcon@highpoint.edu

Locations

High Point University

Recruiting

High Point, North Carolina, United States, 27268

Contacts

Cory A Alcon, DPT

336-841-9723calcon@highpoint.edu

More Information

Sponsor

High Point University

Last update posted

Oct 7, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by High Point University on 2022-10-07.