Recurrent Low Back PainNCT03463759
Pain Inhibition and Facilitation in Recurrent Low Back Pain
An observational study of Recurrent Low Back Pain and Healthy, run by Aalborg University at 1 site in Denmark.
Trial summary
This study evaluates psychophysical measures of pain inhibition and facilitation, along with cortical responses to different sensory stimuli, in patients with recurrent low back pain and matched healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Low Back Pain, Healthy
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Apr 2018to 14 Dec 2019
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Population recruited from university, college, and wider Aalborg community
Who may be able to join
- Healthy men and women
- Aged 18-60 years
- No previous back pain OR >1 previous episode of low back pain in past 12 months
- No current back pain OR Pain in the region posteriorly between the inferior border of the 12th rib and the lower gluteal fold (low back pain) at time of recruitment lasting >24 hours
- Able to speak, read and understand English
Who cannot join
- Pregnancy
- First episode of low back pain
- Low back pain associated with menstruation
- Chronic low back pain (continuous pain episode for >3 months)
- Currently seeking active treatment for low back pain
- Red flags symptoms
Show all 13Show fewer
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Current or previous neurologic, musculoskeletal, mental, or other illnesses which may affect the trial
- Current or previous chronic or recurrent pain condition other than low back pain
- Current regular use of analgesic or other medication which may affect the trial
- Lack of ability to cooperate
- Recent history of acute pain particularly in the lower limbs (unless related to LBP)
- Abnormally disrupted sleep in 24 hours preceding experiment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pro-Nociceptive and Anti-Nociceptive Mechanisms Across an Episode of Recurrent Low Back Pain
This study evaluates psychophysical measures of pain inhibition and facilitation, along with cortical responses to different sensory stimuli, in patients with recurrent low back pain and matched healthy individuals.
Read the detailed description
Pain inhibitory and facilitatory mechanisms have been suggested to play a role in the development of persistent low back pain; however, there is still debate on when changes in these mechanisms occur. Similarly, evoked cortical responses can reflect neuroplastic changes in pain processing regions, which are also thought to play a role in the transition to persistent pain, but there is also debate on when these neuroplastic changes develop relative to low back pain. Therefore, this study will use patients with an intermediary clinical pain state, recurrent low back pain, and matched healthy control participants, to investigate within and between subject differences in pain inhibitory, facilitatory and neuroplastic mechanisms.
- Conditions
- Recurrent Low Back Pain, Healthy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent Low Back Pain Patients | Participants experiencing a current episode of their recurrent non-specific low back pain at the time of recruitment. | |
| Healthy Volunteers | Participants matched in age and gender to one of the recurrent low back pain patients, with no significant past low back pain, chronic pain or other relevant medical disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned Pain Modulation
Pressure pain threshold (kPa) as test stimulus before compared to during a pressure conditioning stimulus on the lower leg
Measured: Day 0 vs. Day 28
Temporal Summation of Pain
Pain rating (VAS) change over a series of 10 repeated mechanical stimuli
Measured: Day 0 vs. Day 28
Secondary outcomes (5)
Pressure Pain Thresholds
Threshold of pain detection (kPa) with handheld algometry over the low back and distant sites
Measured: Day 0 vs. Day 28
Thermal Pain Thresholds
Hot and cold pain detection thresholds (degrees)
Measured: Day 0 vs. Day 28
Two Point Discrimination
The smallest distance (mm) for which two separate points can be distinguished over the low back
Measured: Day 0 vs. Day 28
Proprioceptive Weighting
Center of pressure displacement during 1-minute of quiet standing
Measured: Day 0 vs. Day 28
Sensory Evoked Potentials
EEG signals recorded in response to laser and electrical stimuli applied to the back
Measured: Day 0 vs. Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start10 Apr 2018
- Primary completion14 Dec 2018
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Low Back 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan McPhee, Aalborg University
- Investigators
- Megan E McPhee, BPhty MSc, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463759
- Sponsor's protocol ID
- N-20170034
- Status last verified
- Dec 2020
- First submitted
- 7 Mar 2018
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McPhee ME, Graven-Nielsen T. Positive affect and distraction enhance whereas negative affect impairs pain modulation in patients with recurrent low back pain and matched controls. Pain. 2022 May 1;163(5):887-896. doi: 10.1097/j.pain.0000000000002442.
PubMed 34382603
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pro-Nociceptive and Anti-Nociceptive Mechanisms Across an Episode of Recurrent Low Back Pain
- ClinicalTrials.gov ID
- NCT03463759
- Acronym / sponsor ID
- N-20170034
- Conditions
- Recurrent Low Back Pain, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 13 Mar 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.
This study evaluates psychophysical measures of pain inhibition and facilitation, along with cortical responses to different sensory stimuli, in patients with recurrent low back pain and matched healthy individuals.
Detailed description
Pain inhibitory and facilitatory mechanisms have been suggested to play a role in the development of persistent low back pain; however, there is still debate on when changes in these mechanisms occur. Similarly, evoked cortical responses can reflect neuroplastic changes in pain processing regions, which are also thought to play a role in the transition to persistent pain, but there is also debate on when these neuroplastic changes develop relative to low back pain. Therefore, this study will use patients with an intermediary clinical pain state, recurrent low back pain, and matched healthy control participants, to investigate within and between subject differences in pain inhibitory, facilitatory and neuroplastic mechanisms.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent Low Back Pain Patients | – | –Participants experiencing a current episode of their recurrent non-specific low back pain at the time of recruitment. |
| Healthy Volunteers | – | –Participants matched in age and gender to one of the recurrent low back pain patients, with no significant past low back pain, chronic pain or other relevant medical disorders. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Population recruited from university, college, and wider Aalborg community
Key inclusion criteria (5 listed)
- Healthy men and women
- Aged 18-60 years
- No previous back pain OR >1 previous episode of low back pain in past 12 months
- No current back pain OR Pain in the region posteriorly between the inferior border of the 12th rib and the lower gluteal fold (low back pain) at time of recruitment lasting >24 hours
- Able to speak, read and understand English
Key exclusion criteria (13 listed)
- Pregnancy
- First episode of low back pain
- Low back pain associated with menstruation
- Chronic low back pain (continuous pain episode for >3 months)
- Currently seeking active treatment for low back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Conditioned Pain Modulation
Time frame: Day 0 vs. Day 28
Pressure pain threshold (kPa) as test stimulus before compared to during a pressure conditioning stimulus on the lower leg
Temporal Summation of Pain
Time frame: Day 0 vs. Day 28
Pain rating (VAS) change over a series of 10 repeated mechanical stimuli
5 secondary outcomes
Pressure Pain Thresholds
Time frame: Day 0 vs. Day 28
Thermal Pain Thresholds
Time frame: Day 0 vs. Day 28
Two Point Discrimination
Time frame: Day 0 vs. Day 28
Proprioceptive Weighting
Time frame: Day 0 vs. Day 28
Sensory Evoked Potentials
Time frame: Day 0 vs. Day 28
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 11 Dec 2020.
- Derived from this study: PubMed 34382603McPhee ME, Graven-Nielsen T. Positive affect and distraction enhance whereas negative affect impairs pain modulation in patients with recurrent low back pain and matched controls. Pain. 2022 May 1;163(5):887-896. doi: 10.1097/j.pain.0000000000002442.
- Individual participant dataSharing planned: Undecided
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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.
Megan E McPhee, BPhty MSc principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Low Back Pain and Healthy, run by Aalborg University at 1 site in Denmark.
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 5 inclusion and 13 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 11 Dec 2020. 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 Denmark. 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?
Conditioned Pain Modulation (time frame: Day 0 vs. Day 28). The study lists 2 primary outcomes in all. 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 NCT03463759, which also lists 1 linked publication.
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 11 Dec 2020.