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CompletedNCT03644810Updated Dec 24, 2018

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

An interventional study of PPT measurement and Pain catastrophizing scale in Catastrophizing Pain, Pain, Somatic and Chronic Low Back Pain, sponsored by Aalborg University. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-24.

Sponsored by Aalborg University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled May 2017, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Catastrophizing Pain
  • Pain, Somatic
  • Chronic Low Back Pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 44 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

Applies for both groups:

  • Signs of radicular pain or other specific medical conditions e.g. rheumatologic disease or diabetes
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    Chronic low back pain

    Individuals with chronic low back pain. Baseline assessment of pain intensity, function, pain duration and pain catastrophizing thoughts is performed Pain sensitivity at the back and lower leg is measured at baseline and immediately after performing the cold pressor test

    Diagnostic Test: PPT measurement · Diagnostic Test: Pain catastrophizing scale · Procedure: Cold Pressor Test

  • Active comparator
    Healthy controls

    Healthy, pain-free individuals who are age and gender matched to the low back pain group fill out the pain catastrophizing scale Pain sensitivity at the back and lower leg is measured at baseline and immediately after performing the cold pressor test

    Diagnostic Test: PPT measurement · Diagnostic Test: Pain catastrophizing scale · Procedure: Cold Pressor Test

Interventions

  • Diagnostic testPPT measurement

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

    Also known as: Assessment of pain sensitivity

  • Diagnostic testPain catastrophizing scale

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

  • ProcedureCold Pressor Test

    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

06

What researchers measure

Primary outcomes

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

    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)

    Time frame: One session (45 min)

Secondary outcomes

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

    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

    Time frame: 30 minutes

  2. Catastrophizing thoughts measured with the Pain Catastrophizing Scale

    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.

    Time frame: 15 minutes

07

Study locations

1 site
  • Spine Centre of Southern Denmark
    Middelfart, Southern Denmark 5500, Denmark
08

References and documents

Publications

  • Edwards RR, Smith MT, Stonerock G, Haythornthwaite JA. Pain-related catastrophizing in healthy women is associated with greater temporal summation of and reduced habituation to thermal pain. Clin J Pain. 2006 Oct;22(8):730-7. doi: 10.1097/01.ajp.0000210914.72794.bc. PubMed 16988570 ↗
  • Vaegter HB, Palsson TS, Graven-Nielsen T. Facilitated Pronociceptive Pain Mechanisms in Radiating Back Pain Compared With Localized Back Pain. J Pain. 2017 Aug;18(8):973-983. doi: 10.1016/j.jpain.2017.03.002. Epub 2017 Mar 24. PubMed 28344100 ↗
  • Meints SM, Wang V, Edwards RR. Sex and Race Differences in Pain Sensitization among Patients with Chronic Low Back Pain. J Pain. 2018 Dec;19(12):1461-1470. doi: 10.1016/j.jpain.2018.07.001. Epub 2018 Jul 17. PubMed 30025944 ↗
  • Mlekusch S, Neziri AY, Limacher A, Juni P, Arendt-Nielsen L, Curatolo M. Conditioned Pain Modulation in Patients With Acute and Chronic Low Back Pain. Clin J Pain. 2016 Feb;32(2):116-21. doi: 10.1097/AJP.0000000000000238. PubMed 26741741 ↗
  • Correa JB, Costa LO, de Oliveira NT, Sluka KA, Liebano RE. Central sensitization and changes in conditioned pain modulation in people with chronic nonspecific low back pain: a case-control study. Exp Brain Res. 2015 Aug;233(8):2391-9. doi: 10.1007/s00221-015-4309-6. Epub 2015 May 12. PubMed 25963754 ↗

Individual participant data

Plan to share: No — There are currently no plans on sharing data from this study with other researchers

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03644810
Lead sponsor
Aalborg University
Collaborators
Spine Centre of Southern Denmark
Responsible party
Thorvaldur Skuli Palsson (Principal Investigator, Aalborg University) — Principal investigator
First posted
Aug 23, 2018
Start date
May 1, 2017
Primary completion
Sep 1, 2017
Completion
Nov 8, 2018
Last update
Dec 24, 2018

Study contacts

Thorvaldur S Palsson, PhD
principal investigator · Aalborg University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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