Two Point Discrimination (TPD)

January 29, 2020 updated by: Robert Coghill, Children's Hospital Medical Center, Cincinnati

Retuning the Nervous System in Youth With Chronic Pain

SPECIFIC AIMS

Pain in both youth and adults is a complex, subjective and personal experience, and remains poorly understood. One particularly perplexing dimension of some forms of pain is the tendency of pain to spread outside of an affected body site to adjacent location, and then to unaffected body sites. Such widespread pain may reflect an altered spatial tuning of somatosensory processing, such that lateral inhibition is diminished, thereby allowing pain to spread. To date, no therapies exist which are designed specifically to diminish or even reverse the spatial spread of pain. However, training in two-point discrimination holds the potential to retune spatial aspects of somatosensory processing and may represent a novel therapy for widespread pain. Thus, the present investigation will test the following aims:

Aim 1. Do youth with chronic pain have disrupted spatial tuning of somatosensory processing? Deficits in two point tactile discrimination have long been noted in adults with chronic pain, but such deficits remain poorly documented in pediatric chronic pain patients. In order to determine if such deficits exist, youth with both chronic pain and healthy youth will undergo assessment of two point discrimination thresholds.

Aim 2. Does two-point discrimination training result in diminished pain and disability in youth with somatic pain? After initial characterization of tactile discrimination thresholds, youth with chronic pain will participate in multiple sessions of either two-point discrimination training or a single-point spatially-directed attentional control condition. Training will involve up to 9 additional sessions. Efficacy of training will be assessed by 1) reductions in the spatial extent of pain, 2) reductions in pain intensity and unpleasantness, and 3) reductions in pain-related disability.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

STUDY DESIGN Prior to commencing this investigation, investigators will optimize the tactile discrimination threshold testing (i.e. as per baseline visit, below), and the training conditions, in up to ten participants (patients and/or healthy controls). This will serve as a pilot to refine operational aspects of study procedures before investigators commence the main investigation proposed herein. Following this, youth with either chronic pain (ages 10-17, n=40) or healthy youth (ages 10-17, n=20) will undergo assessments of two-point and single-point discrimination thresholds in an initial session (Aim 1). After this initial session, youth with chronic pain will participate in up to 9 additional sessions of attentional training (Aim 2). These chronic pain patients will be randomized to either two-point discrimination training (n=20) or a single-point spatially-directed attentional control condition (n=20). Participants will not be informed of which intervention they will receive (single-blind study). Psychological questionnaires will be completed in the first and last sessions in order to determine how these variables relate to tactile discrimination and response to training.

STUDY INTERVENTIONS 5.1 Two Point Discrimination Training: Two-point discrimination threshold (TPD) training may be performed 1) at spatial locations remote from pain, 2) at spatial locations adjacent to the region of pain, and/or 3) at spatial locations in the site of pain, if the participant will tolerate it. TPD is defined as the smallest distance between two points at which someone can recognize two points, and not one, touching their skin. As such this is a test of one's ability to identify separate stimulation of two discrete areas, and relies heavily on lateral inhibition. Highly precise mechanical calipers will be gently placed onto the skin and the distance between the prongs will be increased/decreased. After repeated decreases and increases in the distance between the prongs, the TPD will be deemed as the distance at which participants consistently report two points instead of one. One-point stimuli will be interleaved to serve as a control condition. Participants will be informed immediately of correct and incorrect responses as part of the discrimination training.

5.2 Control Stimulation: Participants will undergo a single-point discrimination training at the same sites as described above. Probes of different sizes will be used for this portion - a small diameter probe (~1-5 mm) and a large diameter probe (~6-50mm). The probes will be gently placed in contact with the participants' skin, and the participant will be instructed to respond if they were contacted with the small or large probe. Participants will be informed immediately of correct and incorrect responses as part of the discrimination training.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert C Coghill, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Chronic Pain Patients:

  • Somatically located chronic pain
  • amplified musculoskeletal pain syndrome
  • complex regional pain syndrome
  • low back pain
  • fibromyalgia
  • other forms of chronic, widespread pain
  • Male or female, 10-17 years
  • High fluency in written and oral English language

Control Participants:

  • Youth in good general health
  • Male or female, 10-17 years
  • High fluency in written and oral English language

Exclusion Criteria:

  • Present significant mental health disorder as defined by DSM V (e.g. psychosis, bipolar disorder, major depression),
  • alcohol or drug dependence
  • documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) of a magnitude that would interfere with adherence to study requirements or safe participation in the study
  • Primary complaint of migraine or visceral (abdominal) pain, with minimal somatic involvement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Two-point intervention
Two point discrimination training.
Behavioral: Two-point discrimination training
Patients will undergo multiple sessions of two-point discrimination training.
Active Comparator: One-point intervention
One point discrimination of size of probe
Behavioral: One-point discrimination training
Patients will undergo multiple sessions of one-point discrimination training.
No Intervention: Healthy Controls
Observational component of differences in discrimination between chronic pain patients and healthy controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in spatial extent of pain from baseline visit to final visit
Time Frame: baseline to final visit which is up to 5 weeks from baseline
total area of body affected by pain
baseline to final visit which is up to 5 weeks from baseline
Change in pain ratings from baseline visit to final visit
Time Frame: baseline to final visit which is up to 5 weeks from baseline
Ratings of current pain intensity on a non-numerical visual analog scale ranging from "not at all intense" to "most intense pain sensation imaginable" and of pain unpleasantness on a non-numerical visual analog scale ranging from "not at all unpleasant" to "most unpleasant pain imaginable".
baseline to final visit which is up to 5 weeks from baseline
Change in pain-related disability from baseline visit to final visit
Time Frame: baseline to final visit which is up to 5 weeks from baseline
pain-related disability as assessed by the Functional Disability Index
baseline to final visit which is up to 5 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in two point discrimination threshold from baseline visit to final visit
Time Frame: baseline to final visit which is up to 5 weeks from baseline
Calipers moving at fixed distances to determine threshold of two point detection
baseline to final visit which is up to 5 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Robert C Coghill, Ph.D., Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2018

Primary Completion (Anticipated)

July 17, 2021

Study Completion (Anticipated)

July 16, 2023

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIN_TPD_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected deidentified IPD that underlie results in a publication

IPD Sharing Time Frame

Immediately after publication with no end date.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal and who sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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