Clinical trial NCT03644810: 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
Overall status: COMPLETED
Phase: NA
Conditions: Catastrophizing Pain
Pain, Somatic
Chronic Low Back Pain
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Spine Centre of Southern Denmark
First posted: 2018-08-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Association between levels of pain catastrophizing thoughts and endogenous pain inhibition
timeFrame: One session (45 min)
Secondary outcomes:
measure: Changes in pressure pain thresholds (determined with pressure algometry) before and after the cold pressor test
timeFrame: 30 minutes
measure: Catastrophizing thoughts measured with the Pain Catastrophizing Scale
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Middelfart
country: Denmark
facility: Spine Centre of Southern Denmark
state: Southern Denmark
Study officials:
affiliation: Aalborg University
name: Thorvaldur S Palsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.