Pain Sensitivity Evaluation in Respiratory Patients

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 Overview

• Status: Unknown
• Conditions: Asthma; Allergy; Pain, Chronic

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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).

Description

Inclusion Criteria:

• Between 18 and 65 years of age.
• Accepted to sign the informed consent.
• Diagnosis of asthma or allergy.

Exclusion Criteria:

• Cognitive impairment.
• Orthopedic pathologies limiting test performance.
• Active smokers.
• Neurologic pathologies limiting voluntary mobility.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Control group
Asthmatic patients
Allergic patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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.	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.	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.	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.	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.	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.	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.	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.	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	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	Up to 24 weeks
Kinesiophobia	Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.	Baseline
Kinesiophobia	Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Anticipated): February 24, 2020
• Primary Completion (Anticipated): May 12, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: DF0090UG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No