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Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01811888
Recruitment Status : Completed
First Posted : March 15, 2013
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
CDursteler, Parc de Salut Mar

Brief Summary:
This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.

Condition or disease Intervention/treatment
Knee Osteoarthritis Behavioral: Quantitative sensory testing (QST)

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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.
Study Start Date : January 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with knee osteoarthritis Behavioral: Quantitative sensory testing (QST)



Primary Outcome Measures :
  1. Presence of pain in the operated knee, 6 months after surgery. [ Time Frame: Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery. ]

Secondary Outcome Measures :
  1. Endogenous Analgesia efficiency measured with QST (Quantitative sensory testing) techniques. [ Time Frame: From start of recruitment untill day 180. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with knee osteoarthritis scheduled for total knee artheroplasty.
Criteria

Inclusion Criteria:

  • Older than 18 patients
  • Scheduled for primary total knee arthroplasty
  • Disposition to visits and scheduled tests

Exclusion Criteria:

  • Previous surgery on knee to be operated
  • Documented peripheral neuropathy
  • Severe disease or condition that could potentially interfere with interpretation of tests.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811888


Locations
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Spain
Servicio d'Anestesia i Reanimació, Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar

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Responsible Party: CDursteler, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01811888    
Other Study ID Numbers: TKAPAIN
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases