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Abnormal Pain Processing in COPD Patients

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ClinicalTrials.gov Identifier: NCT04319523
Recruitment Status : Enrolling by invitation
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Brief Summary:
Dyspnea, cough, and fatigue are the symptoms characteristic of moderate-severe COPD. Within the progression of disease was also reported a prevalence of 34-77% of pain symptoms in these patients. A review observed a higher score in pain intensity/interference associated with multiples pain locations of COPD patients. Pain in chronic diseases may appear to result from abnormalities in pain processing because of the damage and/or inflammation of peripheral structures.

Condition or disease
Pulmonary Disease, Chronic Obstructive Pain

Detailed Description:
Dyspnea, cough, and fatigue are the symptoms characteristic of moderate-severe COPD. Within the progression of disease was also reported a prevalence of 34-77% of pain symptoms in these patients. A review observed a higher score in pain intensity/interference associated with multiples pain locations of COPD patients. Several studies reported that comorbidities, GOLD grade, and breathlessness may contribute to a higher pain prevalence in COPD patients because of the systemic inflammatory process and lung hyperinflation. Pain in chronic diseases may appear to result from abnormalities in pain processing and alteration of sensitization due to the damage and/or inflammation of peripheral structures.

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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Abnormal Pain Processing in COPD Patients
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : December 3, 2021

Group/Cohort
COPD patients
Healthy subjects



Primary Outcome Measures :
  1. Pressure pain thresholds [ Time Frame: Baseline ]
    Pressure pain thresholds (PPT) was used to measure pressure pain sensitivity in muscles with an algometer. With the patient in a seated position, pressure was applied three times at five bilateral points of the body: the distal thumb phalangeal, the gracilis muscle tendon at the inside of the knee, the distal of the middle part of the clavicle, the supraspinous muscle and the trapezius muscle's second portion. When the participant reported that pressure changed to pain, the pressure was stopped, and the mean value was registered.

  2. Temporal summation [ Time Frame: Baseline ]
    Temporal summation (TS) was used to evaluated peripheral sensitization. First, the pressure was applied with gradually increasing pressure until the subject reported pain in the flexor digitorum muscle of each arm. Second, 15 stimuli were applicated to one arm at an interstimulus interval (ISI) of 3 s and then to the other arm at an ISI of 5 s. After a 5 min, the series of stimuli were repeated in reverse order. The evaluation of TS was measured with a standardized numerical scale for rating the magnitude of late sensations experienced during the first, fifth, tenth, and fifteenth stimuli, and 15 and 60 s after the last stimulus in each series to evaluated the temporal summation. The scale ranged from 0 (no pain) to 100 (intolerable pain).


Secondary Outcome Measures :
  1. Pain Sensitivity Questionnaire [ Time Frame: Baseline ]
    The Pain Sensitivity Questionnaire (PSQ) measured general pain sensitivity. It consists of 17 items, each describing a daily life situation and asking the patients to rate how painful this situation would be for them on a numeric rating scale ranging from 0 (not painful) to 10 (worst pain imaginable). A major score in the questionnaire a higher pain sensitivity.

  2. Borg scale [ Time Frame: Baseline ]
    The Borg scale was used to assess the dyspnea, which is a comprehensive instrument designed to measure breathlessness in patients with respiratory pathology. Patients rated their dyspnoea from 0 to 10, where 0 represents "no dyspnoea" and 10 represents "maximum dyspnoea." A difference of 0.9 units was considered as the minimal clinically important difference (MCID), according to previous studies in patients with respiratory disease

  3. International Physical Activity Questionnaire [ Time Frame: Baseline ]
    The International Physical Activity Questionnaire (IPAQ) measures total physical activity (MET·minutes·days per week).

  4. Hospital Anxiety and Depression Scale [ Time Frame: Baseline ]
    The HADS is a self-rated questionnaire originally developed for minor depressive symptoms in general medical outpatients. It consists of 14 items, depression (seven items) and anxiety (seven times), each with four choices numbered alphabetically. Each of the subscales' scores ranges from 0 to 21, corresponding to total scores of 0 to 42, with higher scores indicating greater distress.

  5. London Chest Activity of Daily Living [ Time Frame: Baseline ]
    The London Chest Activity of Daily Living (LCADL) was used to assess the impact and severity of breathlessness on ADLs. The LCADL has been used as an outcome measure in COPD. Higher scores reflect greater breathlessness during daily activity and the tool includes an anchor question identifying an individual's overall perception of the impact of breathlessness on their daily life.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Stable COPD patients with a grade III and IV of Global Initiative for Chronic Obstructive Lung Disease (GOLD). Patients were recruited in the pneumology services of San Cecilio and Virgen de las Nieves University Hospitals (Granada, Spain).
Criteria

Inclusion Criteria:

  • Between 50 and older age
  • Accepted to sign the informed consent

Exclusion Criteria:

  • comorbidities with a course of chronic pain that interfered with evaluation
  • the presence of cognitive impairment to understand the questionnaire

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): NCT04319523


Locations
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Spain
Faculty of Health Sciences. University of Granada.
Granada, Andalucia, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
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Responsible Party: Marie Carmen Valenza, University of Granada, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04319523    
Other Study ID Numbers: DF0087UG
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive