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Study of the Prevalence of Painful Symptoms of the Musculoskeletal System After Lung Transplantation

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ClinicalTrials.gov Identifier: NCT03636802
Recruitment Status : Unknown
Verified August 2018 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Pulmonary transplantation (PT) is a therapeutic option now accepted in the management of selected patients who have reached the irreversible and terminal stage of their chronic respiratory insufficiency. Its main indications are: cystic fibrosis and other bronchial diseases, emphysema , interstitial lung diseases with idiopathic pulmonary fibrosis in the foreground, and severe pulmonary hypertension.

The evocation of osteo-articular and musculotendinous pain symptoms in the aftermath of PT is frequent and very diversified. These complications are poorly codified and hinder the rehabilitation and early resumption of physical activity and sports. Few data are available on this subject in the literature.

Following transplantation, improvements in respiratory function, quality of life, and exercise capacity are observed, with large inter-individual variations;

Patients are encouraged to resume physical activity, initially as part of a rehabilitation exercise.

Among the factors limiting exercise, some have been more widely studied, such as muscular deconditioning related to pre-existing chronic respiratory insufficiency , prolonged stay in intensive care, side effects of transplant-related treatments (corticosteroids and immunosuppressants).

Pain is also a factor limiting the recovery of physical activity and quality of life. Pain related directly to thoracotomy surgery has been explored but there is little data available on musculoskeletal pain.

The purpose of this study is to better understand the musculoskeletal pain occurring in the aftermath of a lung transplantation. Conducting this study for a period of 1 year will allow you to move away from the immediate post-transplant time, and the pain associated with the transplant will no longer have any interference.

The main objective of our study is to better know the prevalence of algic manifestations of the musculoskeletal system (osteo-articular, musculotendinous ...) occurring in the year following a TP, and may constitute a brake on the rehabilitation of the musculoskeletal system. effort and recovery of physical activity or sport.


Condition or disease Intervention/treatment
Respiratory Insufficiency Other: Questionnaire BPI

Detailed Description:

Pulmonary transplantation (PT) is a therapeutic option now accepted in the management of selected patients who have reached the irreversible and terminal stage of their chronic respiratory insufficiency. Its main indications are: cystic fibrosis and other bronchial diseases, emphysema (primary deficit or in the context of COPD), interstitial lung diseases with idiopathic pulmonary fibrosis in the foreground, and severe pulmonary hypertension.

The evocation of osteo-articular and musculotendinous pain symptoms in the aftermath of PT is frequent and very diversified. These complications are poorly codified and hinder the rehabilitation and early resumption of physical activity and sports. Few data are available on this subject in the literature.

Following transplantation, improvements in respiratory function, quality of life, and exercise capacity are observed, with large inter-individual variations.

Patients are encouraged to resume physical activity, initially as part of a rehabilitation exercise.

Among the factors limiting exercise, some have been more widely studied, such as muscular deconditioning related to pre-existing chronic respiratory insufficiency, prolonged stay in intensive care, side effects of transplant-related treatments (corticosteroids and immunosuppressants).

Pain is also a factor limiting the recovery of physical activity and quality of life. Pain related directly to thoracotomy surgery has been explored but there is little data available on musculoskeletal pain.

The purpose of this study is to better understand the musculoskeletal pain occurring in the aftermath of a lung transplantation. Conducting this study for a period of 1 year will allow you to move away from the immediate post-transplant time, and the pain associated with the transplant will no longer have any interference.

The main objective of our study is to better know the prevalence of algic manifestations of the musculoskeletal system (osteo-articular, musculotendinous ...) occurring in the year following a TP, and may constitute a brake on the rehabilitation of the musculoskeletal system. effort and recovery of physical activity or sport.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Study of the Prevalence, Nature and Contributing Factors of Painful Symptoms of the Musculoskeletal System After Lung Transplantation; Impact on Physical Activity and Quality of Life
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
EXPERIMENTAL GROUP
Patient with respiratory failure and on a lung transplant waiting list
 Other: Questionnaire BPI
Brief Pain Inventory (BPI) This is a scale of self-assessment, the Concise Pain Questionnaire in French. For all adult patients For any type of pain This is to ask the patient to answer questions in order to learn about us characteristics of his pain (its intensity and its repercussions on the plane biopsychosocial).


Outcome Measures
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Primary Outcome Measures :
  1. numbers of patients with symptoms of the musculoskeletal system [ Time Frame: 1 years ]
    numbers of patients presenting symptoms of the musculoskeletal system during the study


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient registered on the lung transplant waiting list of the CHU de Marseille
Criteria

Inclusion Criteria:

Patient over 18

  • Having agreed to no opposition
  • Registered on the lung transplant waiting list of the CHU de Marseille
  • Able to read, understand and complete the self-questionnaires of the study

Exclusion Criteria:

Patient under 18 years

  • Patient refusing follow up until 12 months post transplant
  • Pregnant women, persons deprived of their liberty, persons under guardianship or trusteeship, persons in an emergency situation
  • Person not affiliated to a social security scheme or not entitled to
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636802


Contacts
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Contact: PHILIPPE GIOVANnETTI +33 491366141 Philippe.GIOVANNETTI@ap-hm.fr

Locations
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France
Assistance Publique Des Hopitaux de Marseille Recruiting
Marseille, Paca, France, 13354
Contact: PHILIPPE GIOVANNETTI    +33 491366141    Philippe.GIOVANNETTI@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: EMILIE GARRIDO PRADALIE APHM
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03636802    
Other Study ID Numbers: 2017-48
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases