Perceptual Distortions in Acute Neck Pain

August 7, 2018 updated by: Wacław Adamczyk, The Jerzy Kukuczka Academy of Physical Education in Katowice
Research has shown that chronic pain is related to variety of perceptual distortions. Little is known on how acute pain experience influences perception, especially precision of touch. This project is aiming to test the hypothesis of pain as a process of biological value leading to improvement in tactile acuity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project has following goals:

  1. To test the hypothesis of pain as a process of biological value leading to improvement in tactile acuity
  2. To investigate intra-rater reliability of tests measuring perceptual distortions in pain
  3. To investigate validity of novel tests measuring perceptual distortions in pain
  4. To explore the influence of acute neck pain on left/right recognition task
  5. To explore the effect of acute neck pain on body perception

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Poland
      • Katowice, Poland, 40-065
        • The Jerzy Kukuczka Academy of Physical Education

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Only participants without tactile dysfunction will be included.
  • Participants reporting availability during the days in which the research will be performed.

Exclusion Criteria:

  • current pain experience
  • episodes of neck
  • thoracic or lumbar pain lasting more than 24 hours within previous month
  • history of chronic pain, i.e. pain lasting more than three-month period
  • comorbidities affecting nervous system
  • cardio-vascular diseases
  • psychiatric illnesses
  • any disease requiring systematic drug consumption
  • diagnosed scoliosis.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saline injection
In the saline condition, acute neck pain will be induced via 0.5 ml hypertonic (5% NaCl) saline solution.
Other: Saline injection
In the saline injection condition, acute neck pain will be induced via 0.5 ml hypertonic (5% NaCl) saline bolus injection which is a commonly used model of acute pain. Saline will be injected into the right (or left) trapezius muscle at the level of C7 cervical level. Injections will be performed by a physician under ultrasound imaging guidance to ensure that each single injection will be equally placed at the same depth. The side for the pain induction will be randomised across subjects. The place of needle insertion and corresponding point on the opposite side of the body will be covered by placing a small piece of adhesive plaster to ensure blinding.
Other Names:
  • Pain induced by saline injection
Sham Comparator: Sham injection
In the sham injection condition, a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience.
Other: Sham injection
In the sham-injection condition (nocebo comparator), a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience. A pinprick sensation will be produced by a weighted stimulus applied perpendicularly to the skin without piercing the skin. A stimulus of 512 millinewtons (mN) will be used to produce a pinprick sensation and activation of cutaneous nociceptors. Adhesive tapes covering stimulation points will also be provided. The stimuli will be applied in exactly the same spot as the real injection in previous experimental condition.
Other Names:
  • Pain induced by sham injection
No Intervention: Control
Participants in the control condition will not receive any kind of pain or pinprick sensation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tactile acuity measured by two-point discrimination test (TPD).
Time Frame: TPD change from baseline at 30 seconds post-manipulation period (e.g. saline injection).
Mechanical callipers will be delicately applied to the spot just below the location where real or sham injection will be administered. Tactile stimuli will be applied until the very first blanching of the skin. Testing will be commenced with 0 mm between the two calliper's tips, and then the distance between them will be gradually increased until participants will able to verbally report that two points had been touched instead of one. Subsequently, the descending sequence will be applied until the perception of the two points disappeared.
TPD change from baseline at 30 seconds post-manipulation period (e.g. saline injection).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laterality judgements measured by left/right recognition application.
Time Frame: Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).
A set of images displaying human neck in different orientation in space will be show to participants. The goal of the task is to decide whether given picture depicts neck rotated to the left or right or flexed into left o right side. The accuracy and response time is measured.
Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).
Sensory dissociation measured by two-point estimation task (TPE).
Time Frame: Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).
One tactile stimulus will be applied until the very first blanching of the skin, with a 120 mm horizontal separation between the calipers' tips. Participants will be then asked to indicate with their calipers the distance they have perceived.
Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity measured behaviourally on a Numerical Rating Scale (NRS).
Time Frame: Pain intensity will be measured just after saline/sham injection and every 10 seconds after this time point up until 30 seconds.
The scale for pain intensity ratings will range from 0 = "no pain" to 10 = "the worst pain imaginable"
Pain intensity will be measured just after saline/sham injection and every 10 seconds after this time point up until 30 seconds.
Distribution of pain measured by estimating the diameter of the circle representing area affected by pain.
Time Frame: Pain distribution will be measured just after saline/sham injection and every 10 seconds after this time point up until 30 seconds.
Greater circle (diameter in cm) will refer to the greater distribution of pain (larger body surface affected).
Pain distribution will be measured just after saline/sham injection and every 10 seconds after this time point up until 30 seconds.
Fear of pain measured on a Numerical Rating Scale (NRS)
Time Frame: Fear of pain (state) measured only at baseline
Fear of pain will be rated on a scale ranging from 0 = "not at all" to 10 = "very much".
Fear of pain (state) measured only at baseline
Fear of Pain Questionnaire (FPQ-III).
Time Frame: Measured only at baseline.
FPQ-III consists of three subscales measuring: minor pain, severe pain, and medical pain. Each subscale contains 10 items. The total score has a range 30-150. A higher score indicates greater fear of pain.
Measured only at baseline.
Pain duration
Time Frame: One measurement collected immediately after pain alleviation. The time frame will vary from person to person, however it is expected to collect the data an average 10 minutes after the injection.
Pain duration measured by physician in seconds.
One measurement collected immediately after pain alleviation. The time frame will vary from person to person, however it is expected to collect the data an average 10 minutes after the injection.

Collaborators and Investigators

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

Sponsor

The Jerzy Kukuczka Academy of Physical Education in Katowice

Collaborators

University of Luebeck

Investigators

  • Study Director: Wacław M Adamczyk, MSc, The Jerzy Kukuczka Academy of Physical Education, Department of Physiotherapy

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)

April 20, 2018

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

July 20, 2018

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 11, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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