AsthmaNCT04297098
Pain Sensitivity Evaluation in Respiratory Patients
An observational study of Asthma and Pain, Chronic, run by Universidad de Granada.
Trial summary
Previous studies have reported that asthmatic or chronic pulmonary obstructive disease patients have an increased response to pain stimulus. However, this aspect has not been evaluated in allergic patients. Additionally, the difference in pain sensitivity between asymptomatic period crisis have not been evaluated yet. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Pain, Chronic, Allergy
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2020to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were between 18 and 65 years of age, accepted to sign the informed consent and presented a diagnosis of persistent asthma, in a well-controlled phase, were recruited from the Pneumology Service of the "Complejo Hospitalario Universitario" (Granada).
Who may be able to join
- Between 18 and 65 years of age.
- Accepted to sign the informed consent.
- Diagnosis of asthma or allergy.
Who cannot join
- Cognitive impairment.
- Orthopedic pathologies limiting test performance.
- Active smokers.
- Neurologic pathologies limiting voluntary mobility.
Trial locations and contacts
No sites are listed yet.
About this study
Previous studies have reported that asthmatic or chronic pulmonary obstructive disease patients have an increased response to pain stimulus. However, this aspect has not been evaluated in allergic patients. Additionally, the difference in pain sensitivity between asymptomatic period crisis have not been evaluated yet.
- Conditions
- Asthma, Pain, Chronic, Allergy
- Medical subject headings
- Asthma, Chronic Pain, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic patients | Not described | |
| Allergic patients | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threslhold
The pain pressure thresholds (PPTs) were evaluated by an analogic manual mechanical algometer. This tool consisted of a circular platform with an area of 1 cm2 area, which was perpendicularly applied to generate progressive pressure on the skin at a 1 kg/sec rate. The points selected were chose based on a previous study in asthma patients. Patient was assessed in a seated position and pressure was applied two times at five bilateral points of the body: At two distal points, the distal thumb phalangeal and the gracilis muscle tendon at the inside of the knee. Further at three points at the chest, the costae II, distal of the midst part of the clavicle, the supraspinous muscle and the trapezius muscle's second portion, between the angulus superior at scapulae and the vertebral column.
Measured: Baseline
Pressure pain threslhold
The pain pressure thresholds (PPTs) were evaluated by an analogic manual mechanical algometer. This tool consisted of a circular platform with an area of 1 cm2 area, which was perpendicularly applied to generate progressive pressure on the skin at a 1 kg/sec rate. The points selected were chose based on a previous study in asthma patients. Patient was assessed in a seated position and pressure was applied two times at five bilateral points of the body: At two distal points, the distal thumb phalangeal and the gracilis muscle tendon at the inside of the knee. Further at three points at the chest, the costae II, distal of the midst part of the clavicle, the supraspinous muscle and the trapezius muscle's second portion, between the angulus superior at scapulae and the vertebral column.
Measured: Up to 24 weeks
Secondary outcomes (16)
Leicester Cough Questionnaire
The Leicester Cough Questionnaire (LCQ) was used to evaluate cough. This questionnaire brief, easy to administer and well-validated. It consists of 19 items with scores ranging from 1 to 7 and it is divided in three subscales: physical, psychological, and social. The minimum and maximum achievable LCQ total scores are 3 and 21, respectively. A lower LCQ score signifies more cough
Measured: Baseline
Leicester Cough Questionnaire
The Leicester Cough Questionnaire (LCQ) was used to evaluate cough. This questionnaire brief, easy to administer and well-validated. It consists of 19 items with scores ranging from 1 to 7 and it is divided in three subscales: physical, psychological, and social. The minimum and maximum achievable LCQ total scores are 3 and 21, respectively. A lower LCQ score signifies more cough
Measured: Up to 24 weeks
Borg scale
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
Measured: Baseline
Borg scale
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
Measured: Up to 24 weeks
Catastrophizing about Asthma Scale
In the Catastrophizing about Asthma Scale (CAS) patients rate the extent to which 24 items expressing catastrophic thoughts and feelings about asthma are applicable to themselves (e.g., "There is nothing I can do to reduce the intensity of the asthma attack", "I worry all the time about whether the asthma attack will end", "I feel I can't go on"). The scale has two subscales, one referring to the situation of an asthma exacerbation (the exacerbation scale; 13 items), the other scale referring to daily life, whenever no exacerbation is present (general scale; 11 items). The CAS has high internal consistency (Cronbach's alpha = .93), excellent test-retest reliability (r = .94), and good construct validity.
Measured: Baseline
Catastrophizing about Asthma Scale
In the Catastrophizing about Asthma Scale (CAS) patients rate the extent to which 24 items expressing catastrophic thoughts and feelings about asthma are applicable to themselves (e.g., "There is nothing I can do to reduce the intensity of the asthma attack", "I worry all the time about whether the asthma attack will end", "I feel I can't go on"). The scale has two subscales, one referring to the situation of an asthma exacerbation (the exacerbation scale; 13 items), the other scale referring to daily life, whenever no exacerbation is present (general scale; 11 items). The CAS has high internal consistency (Cronbach's alpha = .93), excellent test-retest reliability (r = .94), and good construct validity.
Measured: Up to 24 weeks
Latency and summation
In each testing session two series of contacts of the mechanical probe with the flexor digitorum muscle (one at ISI 3 s and one at ISI 5 s) were presented to each forearm. The forearms were always alternated between each series of contacts. Ratings of both forearms were used to control for differences in hand dominance and sites of pain.
Measured: Baseline
Latency and summation
In each testing session two series of contacts of the mechanical probe with the flexor digitorum muscle (one at ISI 3 s and one at ISI 5 s) were presented to each forearm. The forearms were always alternated between each series of contacts. Ratings of both forearms were used to control for differences in hand dominance and sites of pain.
Measured: Up to 24 weeks
Fatigue
Fatigue was measured by the Fatigue Severity Scale. The Fatigue Severity Scale (FSS) was used to assess fatigue and is a 9-item scale, scored from 1 to 7, with the greater the number suggesting more severe fatigue.
Measured: Baseline
Fatigue
Fatigue was measured by the Fatigue Severity Scale. The Fatigue Severity Scale (FSS) was used to assess fatigue and is a 9-item scale, scored from 1 to 7, with the greater the number suggesting more severe fatigue.
Measured: Up to 24 weeks
Health status
The EQ-5D was used to evaluate self-perceived health status and is divided into two sections. The first section contains five questions about mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each question, problems within the domain are evaluated on a three-level basis. Responders can choose between Bno problems^, Bsome problems^, or Bextreme problems^. The second part is a VAS score, which records the responder's self-evaluated health, where 0 is the worst imaginable health and 100 is the best imaginable health.
Measured: Baseline
Health status
The EQ-5D was used to evaluate self-perceived health status and is divided into two sections. The first section contains five questions about mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each question, problems within the domain are evaluated on a three-level basis. Responders can choose between Bno problems^, Bsome problems^, or Bextreme problems^. The second part is a VAS score, which records the responder's self-evaluated health, where 0 is the worst imaginable health and 100 is the best imaginable health.
Measured: Up to 24 weeks
Exercise capacity
The 6MWT is a useful measure of functional capacity, targeted at people with at least moderately severe impairment. It has been widely used for measuring the response to therapeutic interventions for pulmonary and cardiac disease
Measured: Baseline
Exercise capacity
The 6MWT is a useful measure of functional capacity, targeted at people with at least moderately severe impairment. It has been widely used for measuring the response to therapeutic interventions for pulmonary and cardiac disease
Measured: Up to 24 weeks
Kinesiophobia
Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.
Measured: Baseline
Kinesiophobia
Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start24 Feb 2020 (estimated)
- Primary completion12 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297098
- Sponsor's protocol ID
- DF0090UG
- Status last verified
- Mar 2020
- First submitted
- 21 Feb 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Sensitivity Evaluation in Respiratory Patients
- ClinicalTrials.gov ID
- NCT04297098
- Acronym / sponsor ID
- DF0090UG
- Conditions
- Asthma, Pain, Chronic, Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 24 Feb 2020 (estimated)
- Primary completion
- 12 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have reported that asthmatic or chronic pulmonary obstructive disease patients have an increased response to pain stimulus. However, this aspect has not been evaluated in allergic patients. Additionally, the difference in pain sensitivity between asymptomatic period crisis have not been evaluated yet.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthmatic patients | – | – |
| Allergic patients | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were between 18 and 65 years of age, accepted to sign the informed consent and presented a diagnosis of persistent asthma, in a well-controlled phase, were recruited from the Pneumology Service of the "Complejo Hospitalario Universitario" (Granada).
Key inclusion criteria (3 listed)
- Between 18 and 65 years of age.
- Accepted to sign the informed consent.
- Diagnosis of asthma or allergy.
Key exclusion criteria (4 listed)
- Cognitive impairment.
- Orthopedic pathologies limiting test performance.
- Active smokers.
- Neurologic pathologies limiting voluntary mobility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pressure pain threslhold
Time frame: Baseline
The pain pressure thresholds (PPTs) were evaluated by an analogic manual mechanical algometer. This tool consisted of a circular platform with an area of 1 cm2 area, which was perpendicularly applied to generate progressive pressure on the skin at a 1 kg/sec rate. The points selected were chose based on a previous study in asthma patients. Patient was assessed in a seated position and pressure was applied two times at five bilateral points of the body: At two distal points, the distal thumb phalangeal and the gracilis muscle tendon at the inside of the knee. Further at three points at the chest, the costae II, distal of the midst part of the clavicle, the supraspinous muscle and the trapezius muscle's second portion, between the angulus superior at scapulae and the vertebral column.
Pressure pain threslhold
Time frame: Up to 24 weeks
The pain pressure thresholds (PPTs) were evaluated by an analogic manual mechanical algometer. This tool consisted of a circular platform with an area of 1 cm2 area, which was perpendicularly applied to generate progressive pressure on the skin at a 1 kg/sec rate. The points selected were chose based on a previous study in asthma patients. Patient was assessed in a seated position and pressure was applied two times at five bilateral points of the body: At two distal points, the distal thumb phalangeal and the gracilis muscle tendon at the inside of the knee. Further at three points at the chest, the costae II, distal of the midst part of the clavicle, the supraspinous muscle and the trapezius muscle's second portion, between the angulus superior at scapulae and the vertebral column.
16 secondary outcomes
Leicester Cough Questionnaire
Time frame: Baseline
Leicester Cough Questionnaire
Time frame: Up to 24 weeks
Borg scale
Time frame: Baseline
Borg scale
Time frame: Up to 24 weeks
Catastrophizing about Asthma Scale
Time frame: Baseline
Catastrophizing about Asthma Scale
Time frame: Up to 24 weeks
Latency and summation
Time frame: Baseline
Latency and summation
Time frame: Up to 24 weeks
Fatigue
Time frame: Baseline
Fatigue
Time frame: Up to 24 weeks
Health status
Time frame: Baseline
Health status
Time frame: Up to 24 weeks
Exercise capacity
Time frame: Baseline
Exercise capacity
Time frame: Up to 24 weeks
Kinesiophobia
Time frame: Baseline
Kinesiophobia
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Pain, Chronic, run by Universidad de Granada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Carmen Valenza (958248035, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threslhold (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.