- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04319523
Abnormal Pain Processing in COPD Patients
March 20, 2020 updated by: Marie Carmen Valenza, Universidad de Granada
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
65
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Andalucia
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Granada, Andalucia, Spain, 18071
- Faculty of Health Sciences. University of Granada.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy subjects
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COPD patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure pain thresholds
Time Frame: Baseline
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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.
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Baseline
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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).
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Sensitivity Questionnaire
Time Frame: Baseline
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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.
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Baseline
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Borg scale
Time Frame: Baseline
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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
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Baseline
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International Physical Activity Questionnaire
Time Frame: Baseline
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The International Physical Activity Questionnaire (IPAQ) measures total physical activity (MET·minutes·days per week).
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Baseline
|
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.
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Baseline
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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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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Anticipated)
June 15, 2020
Study Completion (Anticipated)
December 3, 2021
Study Registration Dates
First Submitted
March 20, 2020
First Submitted That Met QC Criteria
March 20, 2020
First Posted (Actual)
March 24, 2020
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 20, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0087UG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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