NCT03463759

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

April 10, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2019

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

March 7, 2018

Last Update Submit

December 10, 2020

Conditions

Recurrent Low Back PainHealthy

Outcome Measures

Primary Outcomes (2)

  • Conditioned Pain Modulation

    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

    Pain rating (VAS) change over a series of 10 repeated mechanical stimuli

    Day 0 vs. Day 28

Secondary Outcomes (5)

  • Pressure Pain Thresholds

    Day 0 vs. Day 28

  • Thermal Pain Thresholds

    Day 0 vs. Day 28

  • Two Point Discrimination

    Day 0 vs. Day 28

  • Proprioceptive Weighting

    Day 0 vs. Day 28

  • Sensory Evoked Potentials

    Day 0 vs. Day 28

Other Outcomes (2)

  • Affective Regulation

    Day 0 vs. Day 28

  • Attentional Regulation

    Day 0 vs. Day 28

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Population recruited from university, college, and wider Aalborg community

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNAP, SMI, Aalborg University

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34382603DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Megan E McPhee, BPhty MSc

    Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Fellow

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 13, 2018

Study Start

April 10, 2018

Primary Completion

December 14, 2018

Study Completion

December 14, 2019

Last Updated

December 11, 2020

Record last verified: 2020-12

Locations

DK(1)