Two Point Discrimination

NCT03686748 | Active Not Recruiting Early Phase 1

• 1 other identifier: CIN_TPD_001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ehlers-Danlos Syndrome (EDS); Complex Regional Pain Syndrome (CRPS); Amplified Musculoskeletal Pain Syndrome (AMPS); Low Back Pain; Fibromyalgia; Chronic Widespread Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (3)

• Change in spatial extent of pain from baseline visit to final visit

  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

  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

  pain-related disability as assessed by the Functional Disability Index

  baseline to final visit which is up to 5 weeks from baseline

Secondary Outcomes (1)

• Change in two point discrimination threshold from baseline visit to final visit

  baseline to final visit which is up to 5 weeks from baseline

Study Arms (3)

Two-point intervention

EXPERIMENTAL

Two point discrimination training.

Behavioral: Two-point discrimination training

One-point intervention

ACTIVE COMPARATOR

One point discrimination of size of probe

Behavioral: One-point discrimination training

Healthy Controls

NO INTERVENTION

Observational component of differences in discrimination between chronic pain patients and healthy controls.

Interventions

Two-point discrimination training BEHAVIORAL

Patients will undergo multiple sessions of two-point discrimination training.

Two-point intervention

One-point discrimination training BEHAVIORAL

Patients will undergo multiple sessions of one-point discrimination training.

One-point intervention

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (20)

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• Flor H, Denke C, Schaefer M, Grusser S. Effect of sensory discrimination training on cortical reorganisation and phantom limb pain. Lancet. 2001 Jun 2;357(9270):1763-4. doi: 10.1016/S0140-6736(00)04890-X.

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• Gardner EP, Martin JH, Jessell TM, Kandel ER, Schwartz JH (2000) Principles of neural science. New York: McGraw-Hill.

  BACKGROUND

• Groenewald CB, Essner BS, Wright D, Fesinmeyer MD, Palermo TM. The economic costs of chronic pain among a cohort of treatment-seeking adolescents in the United States. J Pain. 2014 Sep;15(9):925-33. doi: 10.1016/j.jpain.2014.06.002. Epub 2014 Jun 19.

  PMID: 24953887 BACKGROUND

• Hechler T, Wager J, Zernikow B. Chronic pain treatment in children and adolescents: less is good, more is sometimes better. BMC Pediatr. 2014 Oct 13;14:262. doi: 10.1186/1471-2431-14-262.

  PMID: 25308551 BACKGROUND

• Hestbaek L, Leboeuf-Yde C, Kyvik KO, Manniche C. The course of low back pain from adolescence to adulthood: eight-year follow-up of 9600 twins. Spine (Phila Pa 1976). 2006 Feb 15;31(4):468-72. doi: 10.1097/01.brs.0000199958.04073.d9.

  PMID: 16481960 BACKGROUND

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  PMID: 18088558 BACKGROUND

• King S, Chambers CT, Huguet A, MacNevin RC, McGrath PJ, Parker L, MacDonald AJ. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain. 2011 Dec;152(12):2729-2738. doi: 10.1016/j.pain.2011.07.016.

  PMID: 22078064 BACKGROUND

• Lotze M, Moseley GL. Role of distorted body image in pain. Curr Rheumatol Rep. 2007 Dec;9(6):488-96. doi: 10.1007/s11926-007-0079-x.

  PMID: 18177603 BACKGROUND

• Maihofner C, Handwerker HO, Neundorfer B, Birklein F. Patterns of cortical reorganization in complex regional pain syndrome. Neurology. 2003 Dec 23;61(12):1707-15. doi: 10.1212/01.wnl.0000098939.02752.8e.

  PMID: 14694034 BACKGROUND

• Maihofner C, Handwerker HO, Neundorfer B, Birklein F. Cortical reorganization during recovery from complex regional pain syndrome. Neurology. 2004 Aug 24;63(4):693-701. doi: 10.1212/01.wnl.0000134661.46658.b0.

  PMID: 15326245 BACKGROUND

• Moseley LG, Zalucki NM, Wiech K. Tactile discrimination, but not tactile stimulation alone, reduces chronic limb pain. Pain. 2008 Jul 31;137(3):600-608. doi: 10.1016/j.pain.2007.10.021. Epub 2007 Dec 3.

  PMID: 18054437 BACKGROUND

• O'Sullivan PB, Beales DJ, Smith AJ, Straker LM. Low back pain in 17 year olds has substantial impact and represents an important public health disorder: a cross-sectional study. BMC Public Health. 2012 Feb 5;12:100. doi: 10.1186/1471-2458-12-100.

  PMID: 22304903 BACKGROUND

• Price DD (1999) Psychological mechanisms of pain and analgesia, 0 Edition. Seattle: IASP Press.

  BACKGROUND

• Price DD, McHaffie JG, Larson MA. Spatial summation of heat-induced pain: influence of stimulus area and spatial separation of stimuli on perceived pain sensation intensity and unpleasantness. J Neurophysiol. 1989 Dec;62(6):1270-9. doi: 10.1152/jn.1989.62.6.1270.

  PMID: 2600624 BACKGROUND

• Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217-226. doi: 10.1016/0304-3959(94)90097-3.

  PMID: 8008411 BACKGROUND

• Quevedo AS, Coghill RC. Attentional modulation of spatial integration of pain: evidence for dynamic spatial tuning. J Neurosci. 2007 Oct 24;27(43):11635-40. doi: 10.1523/JNEUROSCI.3356-07.2007.

  PMID: 17959806 BACKGROUND

• Quevedo AS, Morch CD, Andersen OK, Coghill RC. Lateral inhibition during nociceptive processing. Pain. 2017 Jun;158(6):1046-1052. doi: 10.1097/j.pain.0000000000000876.

  PMID: 28195854 BACKGROUND

• Wand BM, Di Pietro F, George P, O'Connell NE. Tactile thresholds are preserved yet complex sensory function is impaired over the lumbar spine of chronic non-specific low back pain patients: a preliminary investigation. Physiotherapy. 2010 Dec;96(4):317-23. doi: 10.1016/j.physio.2010.02.005.

  PMID: 21056167 BACKGROUND

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Complex Regional Pain Syndromes; Chronic Pain; Low Back Pain; Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Robert C Coghill, Ph.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: Two group, single blind for chronic pain patients receiving intervention, additional basic science component with baseline comparisons between patients and healthy controls.

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: September 27, 2018
• Study Start: July 21, 2018
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): July 16, 2027
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)