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Completed

NCT Number: NCT03463759

Pain Inhibition and Facilitation in Recurrent Low Back Pain

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.

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Key information

Conditions

Recurrent Low Back Pain Back Pain Healthy Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CNAP, SMI, Aalborg University

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Conditioned Pain Modulation

    Time frame: Day 0 vs. Day 28

    Pressure pain threshold (kPa) as test stimulus before compared to during a pressure conditioning stimulus on the lower leg

  2. Temporal Summation of Pain

    Time frame: Day 0 vs. Day 28

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

Secondary outcomes

  1. Pressure Pain Thresholds

    Time frame: Day 0 vs. Day 28

    Threshold of pain detection (kPa) with handheld algometry over the low back and distant sites

  2. Thermal Pain Thresholds

    Time frame: Day 0 vs. Day 28

    Hot and cold pain detection thresholds (degrees)

  3. Two Point Discrimination

    Time frame: Day 0 vs. Day 28

    The smallest distance (mm) for which two separate points can be distinguished over the low back

  4. Proprioceptive Weighting

    Time frame: Day 0 vs. Day 28

    Center of pressure displacement during 1-minute of quiet standing

  5. Sensory Evoked Potentials

    Time frame: Day 0 vs. Day 28

    EEG signals recorded in response to laser and electrical stimuli applied to the back

Other outcomes

  1. Affective Regulation

    Time frame: Day 0 vs. Day 28

    Pressure pain ratings pre, during and post affective image set

  2. Attentional Regulation

    Time frame: Day 0 vs. Day 28

    Pressure pain ratings pre, during and post computerised attention-demanding task

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 13, 2018
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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