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Perceptual Distortions in Acute Neck Pain

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ClinicalTrials.gov Identifier: NCT03495076
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
University of Luebeck
Information provided by (Responsible Party):
Wacław Adamczyk, The Jerzy Kukuczka Academy of Physical Education in Katowice

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neck Pain, Posterior Pain, Acute Other: Saline injection Other: Sham injection Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Within-group designed study. All participants will be assessed in three different experimental conditions (control, saline injection, sham injection). The order of conditions will be counterbalanced across participants and randomly chosen.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Participants will not be informed about the hypotheses tested and will not be informed about the sham-injection condition. The fact that they received only one injection during the study period will be uncovered at the end of the project.

Examiner will be blinded towards conditions sequence. Between pre-test and post-test examiner will not be present in the research room to provide blinding towards the manipulation provided (control, saline injection, sham injection).

Primary Purpose: Basic Science
Official Title: Perceptual Distortions in Acute Neck Pain
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Pain induced by sham injection

No Intervention: Control
Participants in the control condition will not receive any kind of pain or pinprick sensation.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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"

  2. 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).

  3. 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".

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03495076


Locations
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Poland
The Jerzy Kukuczka Academy of Physical Education
Katowice, Poland, 40-065
Sponsors and Collaborators
The Jerzy Kukuczka Academy of Physical Education in Katowice
University of Luebeck
Investigators
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Study Director: Wacław M Adamczyk, MSc The Jerzy Kukuczka Academy of Physical Education, Department of Physiotherapy
Publications:
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Responsible Party: Wacław Adamczyk, Principal Investigator, main director of the project, The Jerzy Kukuczka Academy of Physical Education in Katowice
ClinicalTrials.gov Identifier: NCT03495076    
Other Study ID Numbers: 1/2018
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wacław Adamczyk, The Jerzy Kukuczka Academy of Physical Education in Katowice:
Tactile acuity
Tactile dysfunction
Sensory dissociation
Two-point discrimination
Perception
Additional relevant MeSH terms:
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Neck Pain
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms