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

NCT03644810 | Completed DMC

• 1 other identifier: S-20170021
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Catastrophizing Pain; Pain, Somatic; Chronic Low Back Pain

Outcome Measures

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)

  One session (45 min)

Secondary Outcomes (2)

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

  30 minutes

• Catastrophizing thoughts measured with the Pain Catastrophizing Scale

  15 minutes

Study Arms (2)

Chronic low back pain

ACTIVE COMPARATOR

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

Healthy controls

ACTIVE COMPARATOR

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

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

Also known as: Assessment of pain sensitivity

Chronic low back pain; Healthy controls

Pain catastrophizing scale DIAGNOSTIC_TEST

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

Chronic low back pain; Healthy controls

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

Chronic low back pain; Healthy controls

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Applies for both groups:
• Signs of radicular pain or other specific medical conditions e.g. rheumatologic disease or diabetes
• Pregnancy

Sponsors & Collaborators

• Aalborg University: lead
• Spine Centre of Southern Denmark: collaborator

Study Sites (1)

Spine Centre of Southern Denmark

Middelfart, Southern Denmark, 5500, Denmark

Location

Related Publications (5)

• 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.

  PMID: 16988570 BACKGROUND

• 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.

  PMID: 28344100 RESULT

• 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.

  PMID: 30025944 RESULT

• 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.

  PMID: 26741741 RESULT

• 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.

  PMID: 25963754 RESULT

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thorvaldur S Palsson, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants are blind to the study hypothesis and therefore the expected outcome of the tests performed
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study has a cross-sectional design and includes individuals (males and females) with and without chronic low back pain into two, equally large groups

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 23, 2018
• Study Start: May 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: November 8, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)