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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03463759
Other study ID # N-20170034
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 10, 2018
Est. completion date December 14, 2019

Study information

Verified date December 2020
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 14, 2019
Est. primary completion date December 14, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark CNAP, SMI, Aalborg University Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Affective Regulation Pressure pain ratings pre, during and post affective image set Day 0 vs. Day 28
Other Attentional Regulation Pressure pain ratings pre, during and post computerised attention-demanding task Day 0 vs. Day 28
Primary 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
Primary Temporal Summation of Pain Pain rating (VAS) change over a series of 10 repeated mechanical stimuli Day 0 vs. Day 28
Secondary Pressure Pain Thresholds Threshold of pain detection (kPa) with handheld algometry over the low back and distant sites Day 0 vs. Day 28
Secondary Thermal Pain Thresholds Hot and cold pain detection thresholds (degrees) Day 0 vs. Day 28
Secondary Two Point Discrimination The smallest distance (mm) for which two separate points can be distinguished over the low back Day 0 vs. Day 28
Secondary Proprioceptive Weighting Center of pressure displacement during 1-minute of quiet standing Day 0 vs. Day 28
Secondary Sensory Evoked Potentials EEG signals recorded in response to laser and electrical stimuli applied to the back Day 0 vs. Day 28
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