Perceptual Distortions in Acute Neck Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03495076|
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain, Posterior Pain, Acute||Other: Saline injection Other: Sham injection||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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)|
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|
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.
- 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.
- 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.
- 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.
- 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"
- 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).
- 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 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.
- 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.
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
|The Jerzy Kukuczka Academy of Physical Education|
|Katowice, Poland, 40-065|
|Study Director:||Wacław M Adamczyk, MSc||The Jerzy Kukuczka Academy of Physical Education, Department of Physiotherapy|