Pain Inhibition and Facilitation in Recurrent Low Back Pain

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463759
• Other study ID #: N-20170034
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Back Pain
• Healthy
• Low Back Pain
• Recurrent Low Back Pain

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