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

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

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain; Catastrophizing Pain; Pain, Somatic
• Intervention / Treatment: Diagnostic test: PPT measurement; Diagnostic test: Pain catastrophizing scale; Procedure: Cold Pressor Test

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Southern Denmark
    • Middelfart, Southern Denmark, Denmark, 5500
      • Spine Centre of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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; Diagnostic test: Pain catastrophizing scale; A validated questionnaire that measures three domains of pain-related catastrophizing thoughts: helplessness, rumination and excessive magnification; Procedure: Cold 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
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; 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; Diagnostic test: Pain catastrophizing scale; A validated questionnaire that measures three domains of pain-related catastrophizing thoughts: helplessness, rumination and excessive magnification; Procedure: Cold 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	One session (45 min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 minutes
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.	15 minutes

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Spine Centre of Southern Denmark
• Investigators: Principal Investigator: Thorvaldur S Palsson, PhD, Aalborg University

Publications and helpful links

General 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.
• 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.
• Meints S and Edwards R. Altered pain sensitivity in patients with chronic low back pain. The Journal of Pain 2018;19:S57 (In Press)
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): November 8, 2018

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Nociceptive Pain
• Other Study ID Numbers: S-20170021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There are currently no plans on sharing data from this study with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No