Back to resultsPerceptual Distortions in Acute Neck Pain
Primary Purpose
Neck Pain, Posterior, Pain, Acute
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Saline injection
Sham injection
Sponsored by
About this trial
This is an interventional basic science trial for Neck Pain, Posterior focused on measuring Tactile acuity, Tactile dysfunction, Sensory dissociation, Two-point discrimination, Perception
Eligibility 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.
Sites / Locations
- The Jerzy Kukuczka Academy of Physical Education
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Saline injection
Sham injection
Control
Arm Description
In the saline condition, acute neck pain will be induced via 0.5 ml hypertonic (5% NaCl) saline solution.
In the sham injection condition, a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience.
Participants in the control condition will not receive any kind of pain or pinprick sensation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Laterality judgements measured by left/right recognition application.
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.
Sensory dissociation measured by two-point estimation task (TPE).
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.
Full Information
NCT ID
NCT03495076
First Posted
March 28, 2018
Last Updated
August 7, 2018
Sponsor
The Jerzy Kukuczka Academy of Physical Education in Katowice
Collaborators
University of Luebeck
1. Study Identification
Unique Protocol Identification Number
NCT03495076
Brief Title
Perceptual Distortions in Acute Neck Pain
Official Title
Perceptual Distortions in Acute Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
July 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Jerzy Kukuczka Academy of Physical Education in Katowice
Collaborators
University of Luebeck
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Posterior, Pain, Acute
Keywords
Tactile acuity, Tactile dysfunction, Sensory dissociation, Two-point discrimination, Perception
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
ParticipantOutcomes 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).
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline injection
Arm Type
Experimental
Arm Description
In the saline condition, acute neck pain will be induced via 0.5 ml hypertonic (5% NaCl) saline solution.
Arm Title
Sham injection
Arm Type
Sham Comparator
Arm Description
In the sham injection condition, a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the control condition will not receive any kind of pain or pinprick sensation.
Intervention Type
Other
Intervention Name(s)
Saline injection
Other Intervention Name(s)
Pain induced by saline injection
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham injection
Other Intervention Name(s)
Pain induced by sham injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tactile acuity measured by two-point discrimination test (TPD).
Description
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.
Time Frame
TPD change from baseline at 30 seconds post-manipulation period (e.g. saline injection).
Secondary Outcome Measure Information:
Title
Laterality judgements measured by left/right recognition application.
Description
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.
Time Frame
Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).
Title
Sensory dissociation measured by two-point estimation task (TPE).
Description
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.
Time Frame
Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).
Other Pre-specified Outcome Measures:
Title
Pain intensity measured behaviourally on a Numerical Rating Scale (NRS).
Description
The scale for pain intensity ratings will range from 0 = "no pain" to 10 = "the worst pain imaginable"
Time Frame
Pain intensity will be measured just after saline/sham injection and every 10 seconds after this time point up until 30 seconds.
Title
Distribution of pain measured by estimating the diameter of the circle representing area affected by pain.
Description
Greater circle (diameter in cm) will refer to the greater distribution of pain (larger body surface affected).
Time Frame
Pain distribution will be measured just after saline/sham injection and every 10 seconds after this time point up until 30 seconds.
Title
Fear of pain measured on a Numerical Rating Scale (NRS)
Description
Fear of pain will be rated on a scale ranging from 0 = "not at all" to 10 = "very much".
Time Frame
Fear of pain (state) measured only at baseline
Title
Fear of Pain Questionnaire (FPQ-III).
Description
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.
Time Frame
Measured only at baseline.
Title
Pain duration
Description
Pain duration measured by physician in seconds.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wacław M Adamczyk, MSc
Organizational Affiliation
The Jerzy Kukuczka Academy of Physical Education, Department of Physiotherapy
Official's Role
Study Director
Facility Information:
Facility Name
The Jerzy Kukuczka Academy of Physical Education
City
Katowice
ZIP/Postal Code
40-065
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29140929
Citation
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.
Results Reference
background
PubMed Identifier
29324082
Citation
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.
Results Reference
background
PubMed Identifier
28328700
Citation
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.
Results Reference
background
PubMed Identifier
29180111
Citation
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.
Results Reference
background
PubMed Identifier
24957711
Citation
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.
Results Reference
background
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Perceptual Distortions in Acute Neck Pain
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