Neck Pain, PosteriorNCT03495076
Perceptual Distortions in Acute Neck Pain
A study testing Saline injection in people with Neck Pain, Posterior and Pain, Acute, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Posterior, Pain, Acute
- What is being tested?
- Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 20 Apr 2018to 20 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only participants without tactile dysfunction will be included.
- Participants reporting availability during the days in which the research will be performed.
Who cannot join
- 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
Show all 9Show fewer
- psychiatric illnesses
- any disease requiring systematic drug consumption
- diagnosed scoliosis.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Neck Pain, Posterior, Pain, Acute
- Being tested
- Saline injection, Sham injection
- Keywords
- Tactile acuity, Tactile dysfunction, Sensory dissociation, Two-point discrimination, Perception
- Medical subject headings
- Neck Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline injectionOther
Also called Pain induced by 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 injectionOther
Also called Pain induced by 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.
| Study group | Role | What they receive |
|---|---|---|
| Saline injection | Experimental | In the saline condition, acute neck pain will be induced via 0.5 ml hypertonic (5% NaCl) saline solution. Receives: 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. Receives: Other: Sham injection |
| Control | No intervention | Participants in the control condition will not receive any kind of pain or pinprick sensation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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: Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).
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: Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start20 Apr 2018
- Primary completion15 Jun 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neck Pain, PosteriorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luebeck
- Responsible party
- Principal investigator, Wacław Adamczyk, The Jerzy Kukuczka Academy of Physical Education in Katowice
- Investigators
- Wacław M Adamczyk, MSc, Study director, The Jerzy Kukuczka Academy of Physical Education, Department of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495076
- Sponsor's protocol ID
- 1/2018
- Status last verified
- Aug 2018
- First submitted
- 28 Mar 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29140929Adamczyk 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.
PubMed 29324082Adamczyk 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.
PubMed 28328700Harvie 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.
PubMed 29180111Elsig 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.
PubMed 24957711
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptual Distortions in Acute Neck Pain
- ClinicalTrials.gov ID
- NCT03495076
- Acronym / sponsor ID
- 1/2018
- Conditions
- Neck Pain, Posterior, Pain, Acute
- Keywords
- Tactile acuity, Tactile dysfunction, Sensory dissociation, Two-point discrimination, Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Collaborators
- University of Luebeck
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Saline injection | Experimental | Other: Saline injectionIn the saline condition, acute neck pain will be induced via 0.5 ml hypertonic (5% NaCl) saline solution. |
| Sham injection | Sham comparator | Other: Sham injectionIn the sham injection condition, a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience. |
| Control | No intervention | –Participants in the control condition will not receive any kind of pain or pinprick sensation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Only participants without tactile dysfunction will be included.
- Participants reporting availability during the days in which the research will be performed.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline injectionAlso: Pain induced by saline injectionIn 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 | Saline injection |
| Sham injectionAlso: Pain induced by sham injectionIn 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 | Sham injection |
Primary outcome
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.
2 secondary outcomes
Laterality judgements measured by left/right recognition application.
Time frame: Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).
Sensory dissociation measured by two-point estimation task (TPE).
Time frame: Measured at baseline and ~30 seconds after manipulation (e.g. saline injection).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Background: PubMed 29140929Adamczyk 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.
- Background: PubMed 29324082Adamczyk 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.
- Background: PubMed 28328700Adamczyk 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.
- Background: PubMed 29180111Harvie 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.
- Background: PubMed 24957711Elsig 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wacław M Adamczyk, MSc study director
The Jerzy Kukuczka Academy of Physical Education, Department of Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline injection in people with Neck Pain, Posterior and Pain, Acute, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03495076, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.