Pain Inhibition and Facilitation in Recurrent Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-10

Study Completion Date

2019-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Low Back Pain Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Recurrent Low Back Pain Patients

Participants experiencing a current episode of their recurrent non-specific low back pain at the time of recruitment.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Megan McPhee

PhD Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Megan E McPhee, BPhty MSc

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CNAP, SMI, Aalborg University

Aalborg, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 34382603 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N-20170034

Identifier Type: -

Identifier Source: org_study_id