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NCT Number: NCT03644810

The Association Between Conditioned Pain Modulation and Pain Catastrophizing in Chronic Low Back Pain

This study evaluates the potential association between pain catastrophizing thoughts and the ability to dampen pain via endogenous descending inhibition. Half of the participants are persons with chronic low back pain and the other half are age and gender-matched controls

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Key information

Conditions

Catastrophizing Pain Chronic Low Back Pain Neurologic Manifestations Nociceptive Pain Pain Pain, Somatic Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spine Centre of Southern Denmark

Middelfart, Southern Denmark, 5500, Denmark

About this study

Pain catastrophizing is a cognitive feature commonly seen in various musculoskeletal pain population and is considered an important factor to account for in rehabilitation. The ability to dampen pain via endogenous pain modulatory mechanisms is likewise known to be reduced in musculoskeletal pain conditions.

Studies utilizing functional magnetic resonance imaging (fMRI) have demonstrated that the supraspinal areas involved in pain-related cognitive processing to a great extent overlap with those involved in endogenous pain modulation. Therefore, it is plausible that factors such as pain catastrophizing thoughts may affect the nervous systems ability to dampen pain.

Chronic low back pain is the single clinical problem with the biggest impact in the modern society. Previous studies have demonstrated that pain catastrophizing and reduced endogenous pain inhibition are part of the clinical picture. However, previous studies have never investigated a potential relationship between these two factors.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Low back pain group:

  • chronic low back pain ( lasting more than 3 months)
  • intensity of ≥ 3/10 on a numeric rating scale
  • pain is located in the area between the gluteal folds below to the thoracolumbal junction above.

Controls:

No current or previous history of musculoskeletal pain of ongoing nature

Exclusion criteria

Applies for both groups:

  • Signs of radicular pain or other specific medical conditions e.g. rheumatologic disease or diabetes
  • Pregnancy

Treatment and study plan

PPT measurement

Diagnostic Test

The sensitivity to pressure which is gradually increased is assessed. The procedure is performed at the back and the lower leg

Other names: Assessment of pain sensitivity

Pain Catastrophizing Scale

Diagnostic Test

A validated questionnaire that measures three domains of pain-related catastrophizing thoughts: helplessness, rumination and excessive magnification

Cold Pressor test

Procedure

The participant submerges one hand into a tank of cold (5 deg C), circulating water. The procedure is commonly know to decrease the sensitivity to pressure (PPT procedure) so that a difference appears in pain sensitivity when comparing PPT values before and after the procedure

Primary outcomes

  1. Association between levels of pain catastrophizing thoughts and endogenous pain inhibition

    Time frame: One session (45 min)

    The pain catastrophizing scale score is correlated with the changes in Pressure Pain Thresholds before and after the cold pressor test

    See descriptions of each assessment method below (outcome 2 and outcome 3, respectively)

Secondary outcomes

  1. Changes in pressure pain thresholds (determined with pressure algometry) before and after the cold pressor test

    Time frame: 30 minutes

    Pressure Pain Thresholds (PPT) are assessed before and after the cold pressor test

    PPT measure the pressure needed to experience the first instance of pain. For this purpose, a pressure algometer (a pistol-like device with a 1cm2 contact surface) is used. Higher levels of pressure reflect lower pain sensitivity.

    In the cold pressor test, the subject is asked to submerge one hand into circulating water (constant temperature: 4 degrees C) for 2 minutes. When removing it from the water, the subject is asked to indicate the perceived pain using a numeric rating scale (see below). Before and after the cold pressor test, the PPT measurements are performed. The difference in PPT values before and after the cold pressor test is used in the correlation analysis described in outcome 1.

    The numeric rating scale is used to determine the perceived pain intensity from the cold water. The scale is runs from 0 - 10 where 0 is anchored with no pain and 10 reflects the worst pain imaginable

  2. Catastrophizing thoughts measured with the Pain Catastrophizing Scale

    Time frame: 15 minutes

    The pain catastrophizing score by filling out the pain catastrophizing scale.The pain catastrophizing scale consists of 13 sentences describing pain-related thoughts or feelings. These are divided into 3 domains: rumination, magnification and helplessness. The subject is asked to indicate how how well each sentence applies for them: 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree and 4 = all the time.

    The total score on the questionnaire can lie between 0 - 52 where a higher score indicates higher levels of pain catastrophizing thoughts.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Spine Centre of Southern Denmark

Registry information

Official study title

The Efficiency of Conditioned Pain Modulation is Associated With Levels of Pain Catastrophizing in Patients With Chronic Low Back Pain

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 23, 2018
Registry last updated
Dec 24, 2018

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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