Perceptual Distortions in Acute Neck Pain

Pain, Acute Clinical Trial

Official title:

Perceptual Distortions in Acute Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03495076
• Other study ID #: 1/2018
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: July 20, 2018

Study information

• Verified date: August 2018
• Source: The Jerzy Kukuczka Academy of Physical Education in Katowice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 20, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Neck Pain
• Neck Pain, Posterior
• Pain, Acute

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	The Jerzy Kukuczka Academy of Physical Education	Katowice

Sponsors (2)

Lead Sponsor	Collaborator
The Jerzy Kukuczka Academy of Physical Education in Katowice	University of Luebeck

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain intensity measured behaviourally on a Numerical Rating Scale (NRS).	The scale for pain intensity ratings will range from 0 = "no pain" to 10 = "the worst pain imaginable"	Pain intensity will be measured just after saline/sham injection and every 10 seconds after this time point up until 30 seconds.
Other	Distribution of pain measured by estimating the diameter of the circle representing area affected by pain.	Greater circle (diameter in cm) will refer to the greater distribution of pain (larger body surface affected).	Pain distribution will be measured just after saline/sham injection and every 10 seconds after this time point up until 30 seconds.
Other	Fear of pain measured on a Numerical Rating Scale (NRS)	Fear of pain will be rated on a scale ranging from 0 = "not at all" to 10 = "very much".	Fear of pain (state) measured only at baseline
Other	Fear of Pain Questionnaire (FPQ-III).	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.	Measured only at baseline.
Other	Pain duration	Pain duration measured by physician in seconds.	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.
Primary	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	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.	Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).
Secondary	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.	Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).