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
Primary Purpose
Chronic Low-back Pain, Catastrophizing Pain, Kinesiophobia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Pain Neuroscience Education
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain
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)
- 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
Sites / Locations
- High Point UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combined tDCS and PNE
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Pain Catastrophizing Scale
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 Tampa Scale of Kinesiophobia
. 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 Stroop Color Word Test
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.
Change in Numeric Pain Rating Scale
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.
Secondary Outcome Measures
Change in Comprehensive Trail Making
The Trail making A and B is used to assess participants ability to sustain focus and shift between sets of different stimuli. Part A: Consists of 25 circles numbered from 1 to 25 randomly distributed over a page of letter size paper. The participant is required to connect the circles with a pencil as quickly as possible in numerical sequence beginning with the number 1. Part B: Consists of 25 circles numbered 1 to 13 and lettered A to L, randomly distributed over a page of paper. The participant is required to connect the circles with a pencil as quickly as possible, but alternating between numbers and letters and taking both series in ascending sequence (i.e. 1, A, 2, B, 3, C…)
Change in Coding Test
Change in Pressure Pain Thresholds
: PPTs will be measured using a pressure algometer (Wagner Instruments, Greenwich, CT) by a research team member. The algometer will be pressed at a steady rate into the most tender point of low back. Participants will indicate when the applied pressure becomes painful (i.e., pain threshold). Three trials will be performed and the last two measurements will be averaged and used for statistical analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05571215
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
High Point University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Catastrophizing Pain, Kinesiophobia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study - intervention group only
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined tDCS and PNE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Pain Neuroscience Education
Intervention Description
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 Information:
Title
Change in Pain Catastrophizing Scale
Description
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.
Time Frame
Completed prior to first intervention session and immediately following final intervention sessions
Title
Change in Tampa Scale of Kinesiophobia
Description
. 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.
Time Frame
Completed prior to first intervention session and immediately following final intervention sessions
Title
Change in Stroop Color Word Test
Description
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.
Time Frame
Completed prior to first intervention session and immediately following final intervention sessions
Title
Change in Numeric Pain Rating Scale
Description
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.
Time Frame
Completed prior to first intervention session and immediately following final intervention sessions
Secondary Outcome Measure Information:
Title
Change in Comprehensive Trail Making
Description
The Trail making A and B is used to assess participants ability to sustain focus and shift between sets of different stimuli. Part A: Consists of 25 circles numbered from 1 to 25 randomly distributed over a page of letter size paper. The participant is required to connect the circles with a pencil as quickly as possible in numerical sequence beginning with the number 1. Part B: Consists of 25 circles numbered 1 to 13 and lettered A to L, randomly distributed over a page of paper. The participant is required to connect the circles with a pencil as quickly as possible, but alternating between numbers and letters and taking both series in ascending sequence (i.e. 1, A, 2, B, 3, C…)
Time Frame
Completed prior to first intervention session and immediately following final intervention sessions
Title
Change in Coding Test
Time Frame
Completed prior to first intervention session and immediately following final intervention sessions
Title
Change in Pressure Pain Thresholds
Description
: PPTs will be measured using a pressure algometer (Wagner Instruments, Greenwich, CT) by a research team member. The algometer will be pressed at a steady rate into the most tender point of low back. Participants will indicate when the applied pressure becomes painful (i.e., pain threshold). Three trials will be performed and the last two measurements will be averaged and used for statistical analysis.
Time Frame
Completed prior to first intervention session and immediately following final intervention sessions
Other Pre-specified Outcome Measures:
Title
Functional MRI
Time Frame
Completed with 1-2 weeks prior to intervention protocol and within 1 week of completion of the protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cory A Alcon, DPT
Phone
336-841-9723
Email
calcon@highpoint.edu
Facility Information:
Facility Name
High Point University
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27268
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cory A Alcon, DPT
Phone
336-841-9723
Email
calcon@highpoint.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
We'll reach out to this number within 24 hrs