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Completed

NCT Number: NCT03495076

Perceptual Distortions in Acute Neck Pain

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.

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Key information

Conditions

Neck Pain, Posterior Acute Pain Neck Pain Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Jerzy Kukuczka Academy of Physical Education

Katowice, 40-065, Poland

About this study

This project has following goals:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saline injection

Other

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 Injection

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Jerzy Kukuczka Academy of Physical Education in Katowice

Other

Collaborators

  • University of Luebeck

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2018
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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