Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2018
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

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

Study Design


Intervention

Diagnostic Test:
PPT measurement
The sensitivity to pressure which is gradually increased is assessed. The procedure is performed at the back and the lower leg
Pain catastrophizing scale
A validated questionnaire that measures three domains of pain-related catastrophizing thoughts: helplessness, rumination and excessive magnification
Procedure:
Cold Pressor Test
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

Locations

Country Name City State
Denmark Spine Centre of Southern Denmark Middelfart Southern Denmark

Sponsors (2)

Lead Sponsor Collaborator
Aalborg University Spine Centre of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

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

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT03243084 - Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy N/A
Suspended NCT04735185 - Stem Cells vs. Steroids for Discogenic Back Pain N/A
Completed NCT03162952 - RAND Center of Excellence for the Study of Appropriateness of Care in CAM
Completed NCT03240146 - Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain N/A
Completed NCT05282589 - Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients N/A
Completed NCT03637998 - Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain N/A
Recruiting NCT02289170 - Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100) N/A
Active, not recruiting NCT01944163 - The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain N/A
Completed NCT02231554 - Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial N/A
Recruiting NCT02063503 - Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients N/A
Completed NCT01704677 - Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT01490905 - A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain Phase 4
Completed NCT01177254 - Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions N/A
Completed NCT01177280 - Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes N/A
Completed NCT01177241 - Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids N/A
Completed NCT00984815 - Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment Phase 3
Completed NCT00763321 - Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) Phase 3
Completed NCT00767806 - A Study for Patient With Chronic Low Back Pain Phase 3
Completed NCT00761150 - Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP) Phase 3