Chronic Low Back Pain Clinical Trial
Official title:
The Efficiency of Conditioned Pain Modulation is Associated With Levels of Pain Catastrophizing in Patients With Chronic Low Back Pain
NCT number | NCT03644810 |
Other study ID # | S-20170021 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | November 8, 2018 |
Verified date | December 2018 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 44 |
Est. completion date | November 8, 2018 |
Est. primary completion date | September 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Spine Centre of Southern Denmark | Middelfart | Southern Denmark |
Lead Sponsor | Collaborator |
---|---|
Aalborg University | Spine Centre of Southern Denmark |
Denmark,
Corrêa 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- — View 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. — View 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)
Mlekusch S, Neziri AY, Limacher A, Jüni 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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