Acute PainNCT03021278
Tactile Acuity in Experimentally Induced Acute Low Back Pain
A study testing Saline injection in people with Acute Pain and Low Back Pain, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
Trial summary
The purpose of this study is to determine whether experimentally induced acute low back pain might lead to alteration in lumbar tactile acuity measured in region affected by pain compared to pain-free side and pain-free controls. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Low Back Pain
- 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
- 57 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2017to Jul 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only participants with similar mechanical detection threshold (MDT) on both sides of the spine will be included.
Who cannot join
- sex: female
- age < 18 or > 35 years
- laterality: left-handed
- current pain experience
- episodes of back pain lasting more than 24 hours within the previous one-month period
- history of chronic pain, i.e. pain lasting more than one-month
Show all 11Show fewer
- comorbidities affecting the nervous system
- cardio-vascular diseases
- psychiatric illnesses
- any disease requiring systematic drug consumption.
- diagnosed hypersensitive reaction to saline solution
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lumbar Tactile Acuity in Experimentally Induced Acute Low Back Pain
The purpose of this study is to determine whether experimentally induced acute low back pain might lead to alteration in lumbar tactile acuity measured in region affected by pain compared to pain-free side and pain-free controls.
Read the detailed description
Healthy male participants will be recruited at the Academy of Physical Education in Katowice. Each participant will be assessed only once. All participants will be asked to provide written informed consent for participation prior to the experimental procedure and will be naïve to the experimental hypothesis. The plan for this research project has been previously approved by the local bioethical committee.
Between-subject (real-injection, sham-injection and control group) and within-subject (assessment 1 versus assessment 2 and 3) design will be used for the purpose of this experiment. After the screening procedure and preparation phase, participants will be randomly assigned to one of three groups: control, saline injection or sham-injection. Groups will differ only in terms of the specific manipulation: the experimental group will receive intra-muscular saline injection, the sham-injection group will be stimulated by pinprick sensation produced by a PinPrick device. No manipulation will take place in the control group allowing to control for the learning effect. In fact, participants will be informed that the study includes only two branches so they can be assigned either to the group with pain evoked as a result of an injection or to the control group without any noxious stimuli. Not revealing the sham-injection condition will allow for comparison between nociceptive (injection) and non-nociceptive (sham-injection) condition.
Because no previous studies have investigated tactile acuity changes in acute low back pain, the sample size calculation was based on the data from our own systematic review and meta-analysis (Adamczyk et al., under review) and previous cross-sectional data among healthy controls (Adamczyk et al., 2016). Based on reported mean difference of 9.49mm between chronic low back pain patients and healthy controls and standard deviation of 9.90mm, a total sample size of 57 participants (19 per group) is required to detect a significant effect. Power calculation was performed for specific planned-comparison tests that were described in detailed under 'statistical analysis' section below. Calculation was performed in G*Power (G*Power 3.1.9.2 statistical software) with the alpha level set at =0.05 and 80% power.
Baseline differences in descriptive statistics will be analysed by one-way analysis of variance (ANOVA) with 'group' as the between-subject factor. Further statistical comparisons will be performed using a repeated-measures ANOVA design, with 'group' (real-injection, sham-injection, and control group) as between-subject factor and repeated measures (assessment 1, 2 and 3) as a within-subject factor. In order to test hypothesis on tactile acuity alteration during pain induction, F-tests will be followed by planned comparisons on data from assessment 1 versus assessment 2 in experimental group. To determine whether the magnitude of tactile acuity alteration has differed between the groups, planned comparisons will be performed on the difference in tactile acuity (assessment 1 vs. assessment 2) between real-injection and sham-injection group and between real-injection and control group. Bonferroni correction will be used for multiple planned comparisons. Forward, stepwise multiple regression will be performed to determine the degree to which tactile acuity change is predicted by either pain intensity or the size of its distribution. All the analyses will be conducted using the STATISTICA data analysis software, version 12 (StatSoft Inc., Tulsa, OK, USA). The level of significance will be set at p < 0.05.
- Conditions
- Acute Pain, Low Back Pain
- Being tested
- Saline injection, Sham injection
- Keywords
- Tactile acuity, Chronic pain, Two-point discrimination, Point-to-point test, Two-point estimation, Body image
- Medical subject headings
- Acute Pain, Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline injectionOther
Also called Experimental pain
In the saline injection group, low back pain will be induced via 1.0 ml hypertonic (5% NaCl) saline bolus injection which is a commonly used model of acute low back pain. Saline will be injected into the right (or left) lumbar longissimus muscle 50 mm lateral to the spinous process just above (5 mm) previously marked point. Injections will be performed by a physician under ultrasound imaging guidance to ensure that each single injection will be equally placed at a depth of 30 mm. 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.
Sham injectionOther
Also called Sham pain
In the sham-injection group (placebo 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 just above without piercing the skin. A stimulus of 512 mN will be used to produce a pinprick sensation and activation of cutaneous nociceptors. Adhesive tapes covering stimulation points will also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Saline Injection | Experimental | In the saline injection group, low back pain will be induced via 1.0 ml hypertonic (5% NaCl). Receives: Other: Saline injection |
| Sham Injection | Experimental | In the sham injection group, a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience. Receives: Other: Sham injection |
| Control Group | No intervention | The control group 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.
Lumbar tactile acuity measured by two-point discrimination test (TPD).
Mechanical callipers will be delicately applied to the pre-marked axis 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: Measured an average 3 minutes after manipulation (e.g. saline injection).
Secondary outcomes (5)
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"
Measured: Pain intensity will be measured just after saline/sham injection and every 30 seconds after this time point up until 12 minutes.
Distribution of pain measured by estimating the diameter of the circle representing area affected by pain. Greater circle (diameter) will refer to the greater distribution of pain (larger body surface affected).
Greater circle (diameter in cm) will refer to the greater distribution of pain (larger body surface affected).
Measured: Pain distribution will be measured just after saline/sham injection and every 30 seconds after this time point up until 12 minutes.
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".
Measured: Fear of pain measured only at baseline
Lumbar tactile acuity measured by point-to-point test (PTP).
To perform PTP, participants will be asked to maintain a pen perpendicularly to the surface around the sacrum. Then, the examiner will lightly touch one of the pre-marked point at the participants' back. The participants will be instructed to touch the point that was stimulated by assessor. To analyse PTP, the distance between pre-marked point and points indicated by the participants will be measured with callipers.
Measured: PTP measured at baseline (1), an average 3 minutes after manipulation (2) (e.g. saline injection) and 12 minutes after manipulation (3)
Lumbar tactile acuity measured by two-point estimation test (TPE)
For the two-point estimation test, assessor will apply one tactile stimulus until the very first blanching of the skin, with a 120 mm horizontal separation between the callipers' tips. Subsequently to the tactile stimulation, patients will be asked to manually indicate with their callipers the distance they have perceived (TPE score).
Measured: PTP measured at baseline (1), an average 3 minutes after manipulation (2) (e.g. saline injection) and 12 minutes after manipulation (3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017
- Study completionJul 2017
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 Acute PainStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Wacław Adamczyk, The Jerzy Kukuczka Academy of Physical Education in Katowice
- Investigators
- Wacław M Adamczyk, Msc, Principal investigator, The Jerzy Kukuczka Academy of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021278
- Sponsor's protocol ID
- 8/2016
- Status last verified
- Jul 2017
- First submitted
- 9 Jan 2017
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Adamczyk W, Slugocka A, Saulicz O, Saulicz E. The point-to-point test: A new diagnostic tool for measuring lumbar tactile acuity? Inter and intra-examiner reliability study of pain-free subjects. Man Ther. 2016 Apr;22:220-6. doi: 10.1016/j.math.2015.12.012. Epub 2016 Jan 2.
PubMed 26797175Catley MJ, O'Connell NE, Berryman C, Ayhan FF, Moseley GL. Is tactile acuity altered in people with chronic pain? a systematic review and meta-analysis. J Pain. 2014 Oct;15(10):985-1000. doi: 10.1016/j.jpain.2014.06.009. Epub 2014 Jun 28.
PubMed 24983492Tsao H, Tucker KJ, Coppieters MW, Hodges PW. Experimentally induced low back pain from hypertonic saline injections into lumbar interspinous ligament and erector spinae muscle. Pain. 2010 Jul;150(1):167-172. doi: 10.1016/j.pain.2010.04.023. Epub 2010 May 26.
PubMed 20510516Wand BM, Di Pietro F, George P, O'Connell NE. Tactile thresholds are preserved yet complex sensory function is impaired over the lumbar spine of chronic non-specific low back pain patients: a preliminary investigation. Physiotherapy. 2010 Dec;96(4):317-23. doi: 10.1016/j.physio.2010.02.005.
PubMed 21056167Adamczyk 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 29140929
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Tactile Acuity in Experimentally Induced Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT03021278
- Acronym / sponsor ID
- 8/2016
- Conditions
- Acute Pain, Low Back Pain
- Keywords
- Tactile acuity, Chronic pain, Two-point discrimination, Point-to-point test, Two-point estimation, Body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- 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.
The purpose of this study is to determine whether experimentally induced acute low back pain might lead to alteration in lumbar tactile acuity measured in region affected by pain compared to pain-free side and pain-free controls.
Detailed description
Healthy male participants will be recruited at the Academy of Physical Education in Katowice. Each participant will be assessed only once. All participants will be asked to provide written informed consent for participation prior to the experimental procedure and will be naïve to the experimental hypothesis. The plan for this research project has been previously approved by the local bioethical committee.
Between-subject (real-injection, sham-injection and control group) and within-subject (assessment 1 versus assessment 2 and 3) design will be used for the purpose of this experiment. After the screening procedure and preparation phase, participants will be randomly assigned to one of three groups: control, saline injection or sham-injection. Groups will differ only in terms of the specific manipulation: the experimental group will receive intra-muscular saline injection, the sham-injection group will be stimulated by pinprick sensation produced by a PinPrick device. No manipulation will take place in the control group allowing to control for the learning effect. In fact, participants will be informed that the study includes only two branches so they can be assigned either to the group with pain evoked as a result of an injection or to the control group without any noxious stimuli. Not revealing the sham-injection condition will allow for comparison between nociceptive (injection) and non-nociceptive (sham-injection) condition.
Because no previous studies have investigated tactile acuity changes in acute low back pain, the sample size calculation was based on the data from our own systematic review and meta-analysis (Adamczyk et al., under review) and previous cross-sectional data among healthy controls (Adamczyk et al., 2016). Based on reported mean difference of 9.49mm between chronic low back pain patients and healthy controls and standard deviation of 9.90mm, a total sample size of 57 participants (19 per group) is required to detect a significant effect. Power calculation was performed for specific planned-comparison tests that were described in detailed under 'statistical analysis' section below. Calculation was performed in G*Power (G*Power 3.1.9.2 statistical software) with the alpha level set at =0.05 and 80% power.
Baseline differences in descriptive statistics will be analysed by one-way analysis of variance (ANOVA) with 'group' as the between-subject factor. Further statistical comparisons will be performed using a repeated-measures ANOVA design, with 'group' (real-injection, sham-injection, and control group) as between-subject factor and repeated measures (assessment 1, 2 and 3) as a within-subject factor. In order to test hypothesis on tactile acuity alteration during pain induction, F-tests will be followed by planned comparisons on data from assessment 1 versus assessment 2 in experimental group. To determine whether the magnitude of tactile acuity alteration has differed between the groups, planned comparisons will be performed on the difference in tactile acuity (assessment 1 vs. assessment 2) between real-injection and sham-injection group and between real-injection and control group. Bonferroni correction will be used for multiple planned comparisons. Forward, stepwise multiple regression will be performed to determine the degree to which tactile acuity change is predicted by either pain intensity or the size of its distribution. All the analyses will be conducted using the STATISTICA data analysis software, version 12 (StatSoft Inc., Tulsa, OK, USA). The level of significance will be set at p < 0.05.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline Injection | Experimental | Other: Saline injectionIn the saline injection group, low back pain will be induced via 1.0 ml hypertonic (5% NaCl). |
| Sham Injection | Experimental | Other: Sham injectionIn the sham injection group, a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience. |
| Control Group | No intervention | –The control group will not receive any kind of pain or pinprick sensation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Only participants with similar mechanical detection threshold (MDT) on both sides of the spine will be included.
Key exclusion criteria (11 listed)
- sex: female
- age < 18 or > 35 years
- laterality: left-handed
- current pain experience
- episodes of back pain lasting more than 24 hours within the previous one-month period
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: Experimental painIn the saline injection group, low back pain will be induced via 1.0 ml hypertonic (5% NaCl) saline bolus injection which is a commonly used model of acute low back pain. Saline will be injected into the right (or left) lumbar longissimus muscle 50 mm lateral to the spinous process just above (5 mm) previously marked point. Injections will be performed by a physician under ultrasound imaging guidance to ensure that each single injection will be equally placed at a depth of 30 mm. 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. | Other | Saline Injection |
| Sham injectionAlso: Sham painIn the sham-injection group (placebo 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 just above without piercing the skin. A stimulus of 512 mN will be used to produce a pinprick sensation and activation of cutaneous nociceptors. Adhesive tapes covering stimulation points will also be provided. | Other | Sham Injection |
Primary outcome
Lumbar tactile acuity measured by two-point discrimination test (TPD).
Time frame: Measured an average 3 minutes after manipulation (e.g. saline injection).
Mechanical callipers will be delicately applied to the pre-marked axis 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.
5 secondary outcomes
Pain intensity measured behaviourally on a Numerical Rating Scale (NRS).
Time frame: Pain intensity will be measured just after saline/sham injection and every 30 seconds after this time point up until 12 minutes.
Distribution of pain measured by estimating the diameter of the circle representing area affected by pain. Greater circle (diameter) 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 30 seconds after this time point up until 12 minutes.
Fear of pain measured on a Numerical Rating Scale (NRS).
Time frame: Fear of pain measured only at baseline
Lumbar tactile acuity measured by point-to-point test (PTP).
Time frame: PTP measured at baseline (1), an average 3 minutes after manipulation (2) (e.g. saline injection) and 12 minutes after manipulation (3)
Lumbar tactile acuity measured by two-point estimation test (TPE)
Time frame: PTP measured at baseline (1), an average 3 minutes after manipulation (2) (e.g. saline injection) and 12 minutes after manipulation (3)
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 31 Jul 2017.
- Background: PubMed 26797175Adamczyk W, Slugocka A, Saulicz O, Saulicz E. The point-to-point test: A new diagnostic tool for measuring lumbar tactile acuity? Inter and intra-examiner reliability study of pain-free subjects. Man Ther. 2016 Apr;22:220-6. doi: 10.1016/j.math.2015.12.012. Epub 2016 Jan 2.
- Background: PubMed 24983492Catley MJ, O'Connell NE, Berryman C, Ayhan FF, Moseley GL. Is tactile acuity altered in people with chronic pain? a systematic review and meta-analysis. J Pain. 2014 Oct;15(10):985-1000. doi: 10.1016/j.jpain.2014.06.009. Epub 2014 Jun 28.
- Background: PubMed 20510516Tsao H, Tucker KJ, Coppieters MW, Hodges PW. Experimentally induced low back pain from hypertonic saline injections into lumbar interspinous ligament and erector spinae muscle. Pain. 2010 Jul;150(1):167-172. doi: 10.1016/j.pain.2010.04.023. Epub 2010 May 26.
- Background: PubMed 21056167Wand BM, Di Pietro F, George P, O'Connell NE. Tactile thresholds are preserved yet complex sensory function is impaired over the lumbar spine of chronic non-specific low back pain patients: a preliminary investigation. Physiotherapy. 2010 Dec;96(4):317-23. doi: 10.1016/j.physio.2010.02.005.
- Derived from this study: 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.
- Protocol of the meta-analysis on lumbar tactile acuity in patients with low back pain and healthy controlsLink provided by the sponsor.
- 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 principal investigator
The Jerzy Kukuczka Academy of Physical Education
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 Acute Pain and Low Back Pain, 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 1 inclusion and 11 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 31 Jul 2017. 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. 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?
Lumbar tactile acuity measured by two-point discrimination test (TPD). (time frame: Measured an average 3 minutes after manipulation (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 NCT03021278, 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 31 Jul 2017.