The Effects of Pain and the Memory of Pain on Autonomic and Neuromuscular Function

NCT02269384 | Unknown

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

Brief Summary

The prevalence of chronic pain has been estimated at 30% in the US and these values may under report the true prevalence of people who experience long term pain as additional research has shown that 73% will have a reoccurrence of symptoms within 12 months of the original injury indicating that while the pain and symptoms may resolve, additional impairments or issues may underlie the symptoms. Biopsychosocial factors such as depression, post traumatic stress, anxiety, pain catastrophizing, and negative emotions have been closely linked to pain and can influence a patient's pain perceptions. Along these lines, the memory of past experiences and trauma potentially play a large role in these biopsychosocial responses. Research is evolving and a strong correlation has been established between chronic pain and prior history of trauma or abuse and also non-traumatic incidents such as motor vehicle accidents and injuries/surgical procedures. This has led to speculation and research that explores how a variety of life events may become stimulants for long-term alterations in the processing and manifestation of pain and how they may have an enduring impact on physical health outcomes. The proposed research will add to the body of knowledge underlying the association between pain, memory, autonomic system, and neuromuscular function. The goal of this project is to study the relationship between pain memory systems, specifically acute pain, short-term memory of pain, and long term pain memory, and their effects upon neuromuscular and autonomic system responses in the body.

Conditions

Pain

Keywords

Pain; Memory; Pressure Pain Threshold; Electromyography; Heart Rate Variability

Outcome Measures

Primary Outcomes (4)

• Change in surface electromyography (sEMG) from baseline to either during or immediately post intervention or condition

  Surface electrodes will be placed upon the tibialis anterior muscle to monitor muscle activity during testing.

  Data will be collected in one, one hour session. During the session, sEMG will be collected during or immediately following intervention or condition.

• Change in hand held dynamometric (HHD) measures from baseline to either during or immediately post intervention or condition

  A Hoggan Scientific Microfet 2 Handheld Muscle Tester will be placed upon the lateral aspect of the fifth metatarsal bone of the foot and a plantar and eversion directed force will be applied until the muscle can no longer resist the force applied (break test).

  Data will be collected in one, one hour session. During the session, HHD will be collected during or immediately following intervention or condition

• Change in pressure pain threshold (PPT) from baseline to either during or immediately post intervention or condition

  The force required to elicit the pain response will be applied and monitored by a Wagner Force Ten™ FDX Digital Force Gauge Pain Algometer.

  Data will be collected in one, one hour session. During the session, PPT will be collected during or immediately following intervention or condition

• Change in heart rate variability (HRV) from baseline to either during or immediately post intervention or condition

  The HRV Live heart rate variability monitoring systems will be utilized and recording sensors will be placed upon the wrist of both arms to monitor cardiovagal responses during testing.

  Data will be collected in one, one hour session. Continuous monitoring of HRV will occur during each intervention or condition and significant data points will be marked for future analysis.

Secondary Outcomes (1)

• Change in verbal numeric pain scale (NPS) rating from baseline to immediately post intervention or condition

  Data will be collected in one, one hour session. During the session, NPS will be collected immediately following intervention or condition.

Study Arms (2)

No History of Significant Injury

SHAM COMPARATOR

Experimental Noxious Stimulus, Memory of Experimental Noxious Stimulus, Memory of Prior Significant Injury, Mental Challenge Test

Procedure: Experimental Noxious Stimulus; Behavioral: Memory of Experimental Noxious Stimulus; Behavioral: Memory of Prior Significant Injury; Procedure: Mental Challenge Test

History of Significant Injury

ACTIVE COMPARATOR

Experimental Noxious Stimulus, Memory of Experimental Noxious Stimulus, Memory of Prior Significant Injury, Mental Challenge Test

Procedure: Experimental Noxious Stimulus; Behavioral: Memory of Experimental Noxious Stimulus; Behavioral: Memory of Prior Significant Injury; Procedure: Mental Challenge Test

Interventions

Experimental Noxious Stimulus PROCEDURE

Localized manual pressure will be placed up predetermined points on the lower extremity until maximum pain tolerance levels are reached.

Also known as: Acute Pain Stimulus

History of Significant Injury; No History of Significant Injury

Memory of Experimental Noxious Stimulus BEHAVIORAL

Subjects will be asked to visualize previously experience experimental noxious stimulus

History of Significant Injury; No History of Significant Injury

Memory of Prior Significant Injury BEHAVIORAL

Subjects will visual prior significant injury or a predetermined lower extremity region in control subjects.

History of Significant Injury; No History of Significant Injury

Mental Challenge Test PROCEDURE

Subjects will count backwards from 100 by specified amounts as rapidly as possible

History of Significant Injury; No History of Significant Injury

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who have experienced a significant injury in the lower extremity (i.e. fracture, ligament strain, surgery, trauma) that resulted in a significant loss of function for greater then three weeks time period will be included in the study.
• Significant loss of function will be defined as not being able to walk or being required to use crutches for the three weeks and trauma shall be defined as physical, emotional, or social distress or suffering that also coincided with injury to the lower extremity.
• Individuals with a history of significant injury to the lower extremity will be age and gender matched with individuals who have no history of traumatic injury.

You may not qualify if:

• Acute injuries in the lower extremity occurring less than six weeks prior,
• any heart conditions, any open wounds in their lower extremities,
• severe hypertension greater than 180/110,
• poor sensation in the lower extremities, or
• cognitive impairments that prevent following the instructions of the study, and
• chronic pain greater then 3/10 in any region of the body.

Sponsors & Collaborators

• Mount St. Mary's College, Los Angeles, CA: lead

Study Sites (1)

Mount St. Mary's College

Los Angeles, California, 90007, United States

Location

Related Publications (1)

• Sueki DG, Dunleavy K, Puentedura EJ, Heard L, Van der Heide P, Cheng MS. Differing Effects of Nociception and Pain Memory on Isometric Muscle Strength in Participants With and Without a History of Injury: A Quasi-Experimental Study. Am J Phys Med Rehabil. 2023 Sep 1;102(9):787-794. doi: 10.1097/PHM.0000000000002205. Epub 2023 Feb 3.

  PMID: 36753453 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• M. Samuel Cheng, DSc

  Nova Southeastern University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2014
• First Posted: October 21, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

US (1)