Low Back PainNCT03362827
Assessment of LTP-like Pain Amplification in Chronic Low Back Pain Patients
An observational study of Low Back Pain, run by Peking University People's Hospital.
Trial summary
The present study is aimed to assess the LTP-like pain amplification in chronic low back pain patients to explore the central and peripheral effect for pain LTP. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Chronic low back pain patients and Subjects without chronic low back pain
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 31 Dec 2018
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 1. Chronic low back pain patients Age 21-80 years old.People must have experienced low back pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.Patients were excluded if they had taken pain medications on the day of the assessment or if they had serious spinal pathologies, such as fractures, tumors or inflammatory diseases. Those who were pregnant, patients with cancer and those with a cardiac pacemaker were also excluded. 2. Healthy volunteers. Age 21-80 years old.These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
Who may be able to join
- Age 21-80 years old.
- People must have experienced low back pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.
- Age 21-80 years old.
- These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
Who cannot join
- Age below 21 or over 80 years old.
- Patients were excluded if they had taken pain medications on the day of the assessment or if they had serious spinal pathologies, such as fractures, tumors or inflammatory diseases, such as ankylosing spondylitis, nerve root compromise confirmed by clinical neurological tests or severe cardiorespiratory diseases. Those who were pregnant, patients with cancer and those with a cardiac pacemaker were also excluded.
- Healthy volunteers.
- Age below 21 or over 80 years old.
- These participants have presented episodes of low back pain for more than 7 days in the last 12 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Long-term Potentiation (LTP)-Like Pain Amplification in Chronic Low Back Pain Patients
The present study is aimed to assess the LTP-like pain amplification in chronic low back pain patients to explore the central and peripheral effect for pain LTP.
Read the detailed description
This study is a cross-sectional study. Two groups, including low back pain group and healthy subjects group will be arranged in this study. 50 subjects will be recruited in each group, The healthy subjects were matched for sex and age in relation to the low back pain group. Conditioning electrical stimulation (100 Hz, repeated 5 times with 10 s intervals, 500 impulses) using circular pin electrodes will be used in both groups to induce LTP-like pain amplification. The pain intensity changes to pinprick and light touch stimuli will be compared between two groups.
- Conditions
- Low Back Pain
- Being tested
- Chronic low back pain patients, Subjects without chronic low back pain
- Keywords
- Low back pain, Long-term potentiation, Hyperalgesia, Allodynia
- Medical subject headings
- Low Back Pain, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic low back pain patientsOther
People must have experienced low back pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.
Subjects without chronic low back painOther
These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Chronic low back pain patients | People must have experienced low back pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days. Receives: Other: Chronic low back pain patients | |
| Subjects without chronic low back pain | Participants must not have presented episodes of low back pain for more than 7 days in the last 12 months. Receives: Other: Subjects without chronic low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain intensity to pinprick stimuli
Mechanical pinprick-evoked perception was assessed by three weighted pinprick stimulators which were randomly applied in the area adjacent to the conditioned site. The subjects indicated the perceived intensity on the same visual analogue scale(VAS).
Measured: The pinprick sensation will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes).
Secondary outcomes (3)
Perception Features of conditioning electrical stimulation (CES)
The subjects were asked to rate continuously the magnitude of pain induced by the 100 Hz CES using a hand-held visual analogue scale (VAS) device. These VAS ratings were sampled by a computer. The VAS ranges from "0"(no sensation") to "100" (most imaginable pain) where "30" means pain threshold.
Measured: All subjects will rate the pain ratings during the 50 seconds stimulation.
Change of pain intensity to light-stroking stimuli
A cotton swab was used for light stroking stimuli (~100mN) for assessing the tactile perception around the conditioned site.
Measured: The light-touch sensation will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes).
Change of pain intensity to single electrical stimulation (SES)
A single rectangular 1 ms constant-current electrical stimulation was applied as a homotopic electrical test stimulus using the same conditioning electrode placed at the conditioned site.
Measured: The pain ratings to SES will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Mar 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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 Low Back PainStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Chenjun, Peking University People's Hospital
- Investigators
- Chenjun Liu, Ph.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362827
- Sponsor's protocol ID
- BackpainLTP
- Status last verified
- Nov 2017
- First submitted
- 25 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biurrun Manresa JA, Morch CD, Andersen OK. Long-term facilitation of nociceptive withdrawal reflexes following low-frequency conditioning electrical stimulation: a new model for central sensitization in humans. Eur J Pain. 2010 Sep;14(8):822-31. doi: 10.1016/j.ejpain.2009.12.008. Epub 2010 Jan 27.
PubMed 20110183Mouraux A, Iannetti GD, Plaghki L. Low intensity intra-epidermal electrical stimulation can activate Adelta-nociceptors selectively. Pain. 2010 Jul;150(1):199-207. doi: 10.1016/j.pain.2010.04.026. Epub 2010 May 26.
PubMed 20510515Morch CD, Hennings K, Andersen OK. Estimating nerve excitation thresholds to cutaneous electrical stimulation by finite element modeling combined with a stochastic branching nerve fiber model. Med Biol Eng Comput. 2011 Apr;49(4):385-95. doi: 10.1007/s11517-010-0725-8. Epub 2011 Jan 5.
PubMed 21207174Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
PubMed 3670870Xia W, Morch CD, Andersen OK. Test-Retest Reliability of 10 Hz Conditioning Electrical Stimulation Inducing Long-Term Potentiation (LTP)-Like Pain Amplification in Humans. PLoS One. 2016 Aug 16;11(8):e0161117. doi: 10.1371/journal.pone.0161117. eCollection 2016.
PubMed 27529175
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Long-term Potentiation (LTP)-Like Pain Amplification in Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT03362827
- Acronym / sponsor ID
- BackpainLTP
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Long-term potentiation, Hyperalgesia, Allodynia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 5 Dec 2017 (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.
The present study is aimed to assess the LTP-like pain amplification in chronic low back pain patients to explore the central and peripheral effect for pain LTP.
Detailed description
This study is a cross-sectional study. Two groups, including low back pain group and healthy subjects group will be arranged in this study. 50 subjects will be recruited in each group, The healthy subjects were matched for sex and age in relation to the low back pain group. Conditioning electrical stimulation (100 Hz, repeated 5 times with 10 s intervals, 500 impulses) using circular pin electrodes will be used in both groups to induce LTP-like pain amplification. The pain intensity changes to pinprick and light touch stimuli will be compared between two groups.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic low back pain patients | – | Other: Chronic low back pain patientsPeople must have experienced low back pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days. |
| Subjects without chronic low back pain | – | Other: Subjects without chronic low back painParticipants must not have presented episodes of low back pain for more than 7 days in the last 12 months. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Chronic low back pain patients Age 21-80 years old.People must have experienced low back pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.Patients were excluded if they had taken pain medications on the day of the assessment or if they had serious spinal pathologies, such as fractures, tumors or inflammatory diseases. Those who were pregnant, patients with cancer and those with a cardiac pacemaker were also excluded. 2. Healthy volunteers. Age 21-80 years old.These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
Key inclusion criteria (4 listed)
- Age 21-80 years old.
- These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
Key exclusion criteria (5 listed)
- Healthy volunteers.
- Age below 21 or over 80 years old.
- These participants have presented episodes of low back pain for more than 7 days in the last 12 months.
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 |
|---|---|---|
| Chronic low back pain patientsPeople must have experienced low back pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days. | Other | Chronic low back pain patients |
| Subjects without chronic low back painThese participants must not have presented episodes of low back pain for more than 7 days in the last 12 months. | Other | Subjects without chronic low back pain |
Primary outcome
Change of pain intensity to pinprick stimuli
Time frame: The pinprick sensation will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes).
Mechanical pinprick-evoked perception was assessed by three weighted pinprick stimulators which were randomly applied in the area adjacent to the conditioned site. The subjects indicated the perceived intensity on the same visual analogue scale(VAS).
3 secondary outcomes
Perception Features of conditioning electrical stimulation (CES)
Time frame: All subjects will rate the pain ratings during the 50 seconds stimulation.
Change of pain intensity to light-stroking stimuli
Time frame: The light-touch sensation will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes).
Change of pain intensity to single electrical stimulation (SES)
Time frame: The pain ratings to SES will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Background: PubMed 20110183Biurrun Manresa JA, Morch CD, Andersen OK. Long-term facilitation of nociceptive withdrawal reflexes following low-frequency conditioning electrical stimulation: a new model for central sensitization in humans. Eur J Pain. 2010 Sep;14(8):822-31. doi: 10.1016/j.ejpain.2009.12.008. Epub 2010 Jan 27.
- Background: PubMed 20510515Mouraux A, Iannetti GD, Plaghki L. Low intensity intra-epidermal electrical stimulation can activate Adelta-nociceptors selectively. Pain. 2010 Jul;150(1):199-207. doi: 10.1016/j.pain.2010.04.026. Epub 2010 May 26.
- Background: PubMed 21207174Morch CD, Hennings K, Andersen OK. Estimating nerve excitation thresholds to cutaneous electrical stimulation by finite element modeling combined with a stochastic branching nerve fiber model. Med Biol Eng Comput. 2011 Apr;49(4):385-95. doi: 10.1007/s11517-010-0725-8. Epub 2011 Jan 5.
- Background: PubMed 3670870Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- Background: PubMed 27529175Xia W, Morch CD, Andersen OK. Test-Retest Reliability of 10 Hz Conditioning Electrical Stimulation Inducing Long-Term Potentiation (LTP)-Like Pain Amplification in Humans. PLoS One. 2016 Aug 16;11(8):e0161117. doi: 10.1371/journal.pone.0161117. eCollection 2016.
- 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.
Chenjun Liu, Ph.D. principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Peking University People's Hospital.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiwei Xia, Ph.D. (008613260001978, 523526767@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain intensity to pinprick stimuli (time frame: The pinprick sensation will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes).). 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 NCT03362827, 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 5 Dec 2017.