Pain Sensitivity Evaluation in Respiratory Patients

Asthma Clinical Trial

Official title:

Pain Sensitivity Evaluation in Respiratory Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04297098
• Other study ID #: DF0090UG
• Status: Not yet recruiting
• Start date: February 24, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2020
• Source: Universidad de Granada
• Contact: Marie Carmen Valenza
• Phone: 958248035
• Email: cvalenza[@]ugr.es
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 1, 2020
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergy
• Asthma
• Chronic Pain
• Pain, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Kinesiophobia	Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.	Baseline
Secondary	Kinesiophobia	Kinesiophobia was assessed by the Tampa Scale for Kinesiophobia which evaluate the fear of movement due to dyspnea.	Up to 24 weeks