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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Assistance Publique Hopitaux De Marseille

Tracking Information

First Submitted Date

August 16, 2018

First Posted Date

August 17, 2018

Last Update Posted Date

August 17, 2018

Actual Study Start Date

May 31, 2018

Estimated Primary Completion Date

June 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

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

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

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.

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.

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).

Study Type

Observational [Patient Registry]

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

1 Year

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

patient registered on the lung transplant waiting list of the CHU de Marseille

Condition

Respiratory Insufficiency

Intervention

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).

Study Groups/Cohorts

EXPERIMENTAL GROUP

Patient with respiratory failure and on a lung transplant waiting list

Intervention: Other: Questionnaire BPI

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Unknown status

Estimated Enrollment

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

December 2020

Estimated Primary Completion Date

June 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

France

Removed Location Countries

Administrative Information

NCT Number

NCT03636802

Other Study ID Numbers

2017-48

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Not Provided

Current Responsible Party

Assistance Publique Hopitaux De Marseille

Original Responsible Party

Same as current

Current Study Sponsor

Assistance Publique Hopitaux De Marseille

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Study Director:

EMILIE GARRIDO PRADALIE

APHM

PRS Account

Assistance Publique Hopitaux De Marseille

Verification Date

August 2018

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