NCT03376204

Brief Summary

Pain mechanisms and their clinical impact in patients with bronchiectasis have not been investigated yet. The aim of the research is to assess the presence of central pain mechanisms in patients with bronchiectasis using the Quantitative Sensory Testing (QST) assumptions.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

October 19, 2017

Last Update Submit

January 29, 2019

Conditions

BronchiectasisRespiratory Disease

Keywords

BronchiectasisPain mechanismsPressure pain thresholdReferred pain

Outcome Measures

Primary Outcomes (1)

  • Referred pain area

    Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.

    Baseline

Secondary Outcomes (19)

  • Number of body areas affected by referred pain

    Baseline

  • Pain intensity after supra threshold pain stimulus (STPS)

    Baseline

  • Pressure pain thresholds (PPTs)

    Baseline

  • PPTs with a Conditioned Pain Modulation (CPM) pressure stimulus

    Baseline

  • Total physical activity time

    7 days period

  • +14 more secondary outcomes

Study Arms (1)

Adult subjets

Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase, matched by by sex and age with healthy subjects.

Other: No intervention

Interventions

No interventionOTHER

No intervention

Adult subjets

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.

You may qualify if:

  • Diagnosis of bronchiectasis by high-resolution computed tomography.
  • Ability to understand and perform all the clinical procedure.
  • Acquisition of informed consent.

You may not qualify if:

  • Diagnosis or clinical suspicion of cystic fibrosis by genetic test or sweat electrolytes test.
  • Diagnosis of rheumatic disease.
  • Being on a waiting list for lung transplantation.
  • Thoraco-abdominal surgery in the last 6 months.
  • Chronic use of pain medication.
  • Control Group
  • Healthy subjects matched by age and sex with Bronchiectasis Group's subjects
  • Be taking pain medication.
  • Presence of pain condition or pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Jorge

Villanueva de Gállego, Zaragoza, 50830, Spain

Location

MeSH Terms

Conditions

BronchiectasisRespiration DisordersPain, Referred

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy Lecturer at San Jorge University and Researcher at iPhysio Research Group from San Jorge University.

Study Record Dates

First Submitted

October 19, 2017

First Posted

December 18, 2017

Study Start

September 29, 2017

Primary Completion

October 31, 2019

Study Completion

November 30, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

ES(1)