Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Two Point Discrimination (TPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686748
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Coghill, Children's Hospital Medical Center, Cincinnati

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ehlers-Danlos Syndrome (EDS) Complex Regional Pain Syndrome (CRPS) Amplified Musculoskeletal Pain Syndrome (AMPS) Low Back Pain Fibromyalgia Chronic Widespread Pain Behavioral: Two-point discrimination training Behavioral: One-point discrimination training Early Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two group, single blind for chronic pain patients receiving intervention, additional basic science component with baseline comparisons between patients and healthy controls.
Masking: Single (Participant)
Masking Description:

Participant in the Chronic Pain Group are initially blinded to the intervention they will be receiving in the study.

Healthy participants under go all assessments in the study.

Primary Purpose: Treatment
Official Title: Retuning the Nervous System in Youth With Chronic Pain
Actual Study Start Date : July 21, 2018
Estimated Primary Completion Date : July 17, 2021
Estimated Study Completion Date : July 16, 2023


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.



Primary Outcome Measures :
  1. 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

  2. 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".

  3. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686748


Contacts
Layout table for location contacts
Contact: Geraldine C Schulze 513-978-3007 geraldine.schulze@cchmc.org
Contact: Eric Leon eric.leon@cchmc.org

Locations
Layout table for location information
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Geraldine C Schulze, BS    513-517-0593    Geraldine.Schulze@cchmc.org   
Contact: Eric Leon, BA    513-517-0594    Eric.Leon@cchmc.org   
Principal Investigator: Robert C Coghill, PHD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Layout table for investigator information
Principal Investigator: Robert C Coghill, Ph.D. Children's Hospital Medical Center, Cincinnati
  Study Documents (Full-Text)

Documents provided by Robert Coghill, Children's Hospital Medical Center, Cincinnati:
Informed Consent Form: Healthy Control  [PDF] October 8, 2017
Study Protocol  [PDF] November 16, 2017


Publications:
Gardner EP, Martin JH, Jessell TM, Kandel ER, Schwartz JH (2000) Principles of neural science. New York: McGraw-Hill.
Price DD (1999) Psychological mechanisms of pain and analgesia, 0 Edition. Seattle: IASP Press.

Layout table for additonal information
Responsible Party: Robert Coghill, Director of Research, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03686748     History of Changes
Other Study ID Numbers: CIN_TPD_001
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected deidentified IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Immediately after publication with no end date.
Access Criteria: Researchers who provide a methodologically sound proposal and who sign a data sharing agreement.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Coghill, Children's Hospital Medical Center, Cincinnati:
Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Musculoskeletal Pain
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Ehlers-Danlos Syndrome
Syndrome
Low Back Pain
Somatoform Disorders
Disease
Pathologic Processes
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders
Autonomic Nervous System Diseases
Peripheral Nervous System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic