Perceptual Distortions in Acute Neck Pain

NCT03495076 | Completed

• 1 other identifier: 1/2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain, Posterior; Pain, Acute

Keywords

Tactile acuity; Tactile dysfunction; Sensory dissociation; Two-point discrimination; Perception

Outcome Measures

Primary Outcomes (1)

• Tactile acuity measured by two-point discrimination test (TPD).

  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 Outcomes (2)

• Laterality judgements measured by left/right recognition application.

  Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).

• Sensory dissociation measured by two-point estimation task (TPE).

  Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).

Other Outcomes (5)

• Pain intensity measured behaviourally on a Numerical Rating Scale (NRS).

  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.

  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)

  Fear of pain (state) measured only at baseline

Study Arms (3)

Saline injection

EXPERIMENTAL

In the saline condition, acute neck pain will be induced via 0.5 ml hypertonic (5% NaCl) saline solution.

Other: Saline injection

Sham injection

SHAM COMPARATOR

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

Control

NO INTERVENTION

Participants in the control condition will not receive any kind of pain or pinprick sensation.

Interventions

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.

Also known as: Pain induced by saline injection

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.

Also known as: Pain induced by sham injection

Sham injection

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Jerzy Kukuczka Academy of Physical Education in Katowice: lead
• University of Luebeck: collaborator

Study Sites (1)

The Jerzy Kukuczka Academy of Physical Education

Katowice, 40-065, Poland

Location

Related Publications (5)

• Adamczyk WM, Saulicz O, Saulicz E, Luedtke K. Tactile acuity (dys)function in acute nociceptive low back pain: a double-blind experiment. Pain. 2018 Mar;159(3):427-436. doi: 10.1097/j.pain.0000000000001110.

  PMID: 29140929 BACKGROUND

• Adamczyk WM, Luedtke K, Saulicz O, Saulicz E. Sensory dissociation in chronic low back pain: Two case reports. Physiother Theory Pract. 2018 Aug;34(8):643-651. doi: 10.1080/09593985.2017.1423431. Epub 2018 Jan 11.

  PMID: 29324082 BACKGROUND

• Adamczyk W, Luedtke K, Saulicz E. Lumbar Tactile Acuity in Patients With Low Back Pain and Healthy Controls: Systematic Review and Meta-Analysis. Clin J Pain. 2018 Jan;34(1):82-94. doi: 10.1097/AJP.0000000000000499.

  PMID: 28328700 BACKGROUND

• Harvie DS, Edmond-Hank G, Smith AD. Tactile acuity is reduced in people with chronic neck pain. Musculoskelet Sci Pract. 2018 Feb;33:61-66. doi: 10.1016/j.msksp.2017.11.009. Epub 2017 Nov 21.

  PMID: 29180111 BACKGROUND

• Elsig S, Luomajoki H, Sattelmayer M, Taeymans J, Tal-Akabi A, Hilfiker R. Sensorimotor tests, such as movement control and laterality judgment accuracy, in persons with recurrent neck pain and controls. A case-control study. Man Ther. 2014 Dec;19(6):555-61. doi: 10.1016/j.math.2014.05.014. Epub 2014 Jun 10.

  PMID: 24957711 BACKGROUND

MeSH Terms

Conditions

Neck Pain; Acute Pain

Interventions

Sodium Chloride; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Wacław M Adamczyk, MSc

  The Jerzy Kukuczka Academy of Physical Education, Department of Physiotherapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, main director of the project

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 11, 2018
• Study Start: April 20, 2018
• Primary Completion: June 15, 2018
• Study Completion: July 20, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)