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
NCT05571215, Not applicable, Unknown, High Point University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| 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 | ClinicalTrials.gov |
| NCT number | NCT05571215 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | High Point University | ClinicalTrials.gov |
| Conditions | Chronic Low-back Pain, Catastrophizing Pain, Kinesiophobia | ClinicalTrials.gov |
| Interventions | Transcranial Direct Current Stimulation, Pain Neuroscience Education | ClinicalTrials.gov |
| First posted | 2022-10-07 | ClinicalTrials.gov |
| Last updated | 2022-10-07 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Pain Catastrophizing Scale | 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. | ClinicalTrials.gov |
| Primary | Change in Tampa Scale of Kinesiophobia | 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. | ClinicalTrials.gov |
| Primary | Change in Stroop Color Word Test | 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. | ClinicalTrials.gov |
| Primary | Change in Numeric Pain Rating Scale | 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. | ClinicalTrials.gov |
| Secondary | Change in Comprehensive Trail Making | Completed prior to first intervention session and immediately following final intervention sessions | 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…) | ClinicalTrials.gov |
| Secondary | Change in Coding Test | Completed prior to first intervention session and immediately following final intervention sessions | ClinicalTrials.gov | |
| Secondary | Change in Pressure Pain Thresholds | Completed prior to first intervention session and immediately following final intervention sessions | : 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. | ClinicalTrials.gov |
| Other | Functional MRI | Completed with 1-2 weeks prior to intervention protocol and within 1 week of completion of the protocol | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 39400579 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)