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

Primary Purpose

Catastrophizing Pain, Pain, Somatic, Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PPT measurement
Pain catastrophizing scale
Cold Pressor Test
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Catastrophizing Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Spine Centre of Southern Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Chronic low back pain

Healthy controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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.

Full Information

First Posted
August 14, 2018
Last Updated
December 21, 2018
Sponsor
Aalborg University
Collaborators
Spine Centre of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03644810
Brief Title
The Association Between Conditioned Pain Modulation and Pain Catastrophizing in Chronic Low Back Pain
Official Title
The Efficiency of Conditioned Pain Modulation is Associated With Levels of Pain Catastrophizing in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
November 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Spine Centre of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catastrophizing Pain, Pain, Somatic, Chronic Low Back Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Participant
Masking Description
The participants are blind to the study hypothesis and therefore the expected outcome of the tests performed
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic low back pain
Arm Type
Active Comparator
Arm Description
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
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
PPT measurement
Other Intervention Name(s)
Assessment of pain sensitivity
Intervention Description
The sensitivity to pressure which is gradually increased is assessed. The procedure is performed at the back and the lower leg
Intervention Type
Diagnostic Test
Intervention Name(s)
Pain catastrophizing scale
Intervention Description
A validated questionnaire that measures three domains of pain-related catastrophizing thoughts: helplessness, rumination and excessive magnification
Intervention Type
Procedure
Intervention Name(s)
Cold Pressor Test
Intervention Description
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 Outcome Measure Information:
Title
Association between levels of pain catastrophizing thoughts and endogenous pain inhibition
Description
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 Outcome Measure Information:
Title
Changes in pressure pain thresholds (determined with pressure algometry) before and after the cold pressor test
Description
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
Title
Catastrophizing thoughts measured with the Pain Catastrophizing Scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorvaldur S Palsson, PhD
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spine Centre of Southern Denmark
City
Middelfart
State/Province
Southern Denmark
ZIP/Postal Code
5500
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are currently no plans on sharing data from this study with other researchers
Citations:
PubMed Identifier
16988570
Citation
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.
Results Reference
background
PubMed Identifier
28344100
Citation
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.
Results Reference
result
Citation
Meints S and Edwards R. Altered pain sensitivity in patients with chronic low back pain. The Journal of Pain 2018;19:S57 (In Press)
Results Reference
result
PubMed Identifier
26741741
Citation
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.
Results Reference
result
PubMed Identifier
25963754
Citation
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.
Results Reference
result

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

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