Catastrophizing PainNCT03644810

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

A study testing PPT measurement, Pain catastrophizing scale and Cold Pressor Test in people with Catastrophizing Pain and Pain, Somatic, run by Aalborg University at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Catastrophizing Pain, Pain, Somatic, Chronic Low Back Pain
What is being tested?: PPT measurement, Pain catastrophizing scale and Cold Pressor Test
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteDenmark
Study dates: 1 May 2017to 8 Nov 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Spine Centre of Southern Denmark
Middelfart, Southern Denmark, 5500

Other trials in Denmark

About this study

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

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.

Conditions: Catastrophizing Pain, Pain, Somatic, Chronic Low Back Pain
Being tested: PPT measurement, Pain catastrophizing scale, Cold Pressor Test
Medical subject headings: Nociceptive Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PPT measurementDiagnostic test
Also called Assessment of pain sensitivity
The sensitivity to pressure which is gradually increased is assessed. The procedure is performed at the back and the lower leg
Pain catastrophizing scaleDiagnostic test
A validated questionnaire that measures three domains of pain-related catastrophizing thoughts: helplessness, rumination and excessive magnification
Cold Pressor TestProcedure or surgery
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

Study groups in NCT03644810
Study group	Role	What they receive
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 Receives: 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 Receives: Diagnostic Test: PPT measurement; Diagnostic Test: Pain catastrophizing scale; Procedure: Cold Pressor Test

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: One session (45 min)

Secondary outcomes (2)

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
Measured: 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.
Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20178 Nov 2018

First posted23 Aug 2018
Study start1 May 2017
Primary completion1 Sep 2017
Study completion8 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Catastrophizing PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
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: Single blind
Who is masked: Participant
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03644810
Sponsor's protocol ID: S-20170021
Status last verified: Dec 2018
First submitted: 14 Aug 2018
Last updated: 24 Dec 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There are currently no plans on sharing data from this study with other researchers

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficiency of Conditioned Pain Modulation is Associated With Levels of Pain Catastrophizing in Patients With Chronic Low Back Pain
ClinicalTrials.gov ID: NCT03644810
Acronym / sponsor ID: S-20170021
Conditions: Catastrophizing Pain, Pain, Somatic, Chronic Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Aalborg UniversityUniversity, hospital or other
Collaborators: Spine Centre of Southern Denmark
Study start: 1 May 2017 (actual)
Primary completion: 1 Sep 2017 (actual)
Study completion: 8 Nov 2018 (actual)
First posted: 23 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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

Arm	Type	Receives
Chronic low back pain	Active comparator	Diagnostic Test: PPT measurement, Diagnostic Test: Pain catastrophizing scale, Procedure: Cold Pressor TestIndividuals 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 controls	Active comparator	Diagnostic Test: PPT measurement, Diagnostic Test: Pain catastrophizing scale, Procedure: Cold Pressor TestHealthy, 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

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.
No current or previous history of musculoskeletal pain of ongoing nature

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PPT measurementAlso: Assessment of pain sensitivityThe sensitivity to pressure which is gradually increased is assessed. The procedure is performed at the back and the lower leg	Diagnostic test	Chronic low back pain, Healthy controls
Pain catastrophizing scaleA validated questionnaire that measures three domains of pain-related catastrophizing thoughts: helplessness, rumination and excessive magnification	Diagnostic test	Chronic low back pain, Healthy controls
Cold Pressor TestThe 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	Procedure or surgery	Chronic low back pain, Healthy controls

Primary outcome

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)

2 secondary outcomes

Changes in pressure pain thresholds (determined with pressure algometry) before and after the cold pressor test
Time frame: 30 minutes
Catastrophizing thoughts measured with the Pain Catastrophizing Scale
Time frame: 15 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
Background: PubMed 16988570Edwards 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 publication: PubMed 28344100Vaegter 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 publication: PubMed 30025944Meints 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.
Results publication: PubMed 26741741Mlekusch 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 publication: PubMed 25963754Correa 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.
Individual participant dataSharing planned: No. There are currently no plans on sharing data from this study with other researchers

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thorvaldur S Palsson, PhD principal investigator

Aalborg University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PPT measurement, Pain catastrophizing scale and Cold Pressor Test in people with Catastrophizing Pain and Pain, Somatic, run by Aalborg University at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association between levels of pain catastrophizing thoughts and endogenous pain inhibition (time frame: One session (45 min)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03644810, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.