Pro-Nociceptive and Anti-Nociceptive Mechanisms Across an Episode of Recurrent Low Back Pain

Pain Inhibition and Facilitation in Recurrent Low Back Pain

Sponsors

Lead sponsor: Aalborg University

Source Aalborg University
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.

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.

Overall Status Active, not recruiting
Start Date April 10, 2018
Completion Date September 2019
Primary Completion Date December 14, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Conditioned Pain Modulation Day 0 vs. Day 28
Temporal Summation of Pain Day 0 vs. Day 28
Secondary Outcome
Measure Time Frame
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
Enrollment 60
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Megan E McPhee, BPhty MSc Principal Investigator Aalborg University
Location
facility CNAP, SMI, Aalborg University
Location Countries

Denmark

Verification Date

July 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Aalborg University

Investigator full name: Megan McPhee

Investigator title: PhD Fellow

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Recurrent Low Back Pain Patients

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

Arm group label: Healthy Volunteers

Description: 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.

Patient Data Undecided
Study Design Info

Observational model: Case-Control

Time perspective: Prospective

Source: ClinicalTrials.gov