Pain Inhibition and Facilitation in Recurrent Low Back Pain

December 10, 2020 updated by: Megan McPhee, Aalborg University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • CNAP, SMI, Aalborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population recruited from university, college, and wider Aalborg community

Description

Inclusion:

  • 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

Exclusion:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 0 vs. Day 28
Temporal Summation of Pain
Time Frame: Day 0 vs. Day 28
Pain rating (VAS) change over a series of 10 repeated mechanical stimuli
Day 0 vs. Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pressure Pain Thresholds
Time Frame: Day 0 vs. Day 28
Threshold of pain detection (kPa) with handheld algometry over the low back and distant sites
Day 0 vs. Day 28
Thermal Pain Thresholds
Time Frame: Day 0 vs. Day 28
Hot and cold pain detection thresholds (degrees)
Day 0 vs. Day 28
Two Point Discrimination
Time Frame: Day 0 vs. Day 28
The smallest distance (mm) for which two separate points can be distinguished over the low back
Day 0 vs. Day 28
Proprioceptive Weighting
Time Frame: Day 0 vs. Day 28
Center of pressure displacement during 1-minute of quiet standing
Day 0 vs. Day 28
Sensory Evoked Potentials
Time Frame: Day 0 vs. Day 28
EEG signals recorded in response to laser and electrical stimuli applied to the back
Day 0 vs. Day 28

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Affective Regulation
Time Frame: Day 0 vs. Day 28
Pressure pain ratings pre, during and post affective image set
Day 0 vs. Day 28
Attentional Regulation
Time Frame: Day 0 vs. Day 28
Pressure pain ratings pre, during and post computerised attention-demanding task
Day 0 vs. Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Megan E McPhee, BPhty MSc, Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N-20170034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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