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Trial record 1 of 2 for:    LACHAL | paris, France
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Experience of Chronic (Non-malignant) Musculoskeletal Pain of French Adolescent and Young Adult: a Qualitative Research With Their Physicians and Non-medical Practitioners (DMS-AJA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03171792
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date May 26, 2017
First Posted Date May 31, 2017
Last Update Posted Date March 19, 2018
Actual Study Start Date September 21, 2017
Actual Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2017)
Qualitative description of the experience of health professionals faced to adolescents consulting for chronic (non-malignant) musculoskeletal pain [ Time Frame: 1 day ]
The data collection will consist in health professionals' interviews. All the content of the interviews will be included in the data analysis. The interviews will contain the deepest experience of these professionals in their confrontation of adolescents who present chronic musculoskeletal pain.
Original Primary Outcome Measures Same as current
Change History
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 Experience of Chronic (Non-malignant) Musculoskeletal Pain of French Adolescent and Young Adult: a Qualitative Research With Their Physicians and Non-medical Practitioners
Official Title Experience of Chronic (Non-malignant) Musculoskeletal Pain of French Adolescent and Young Adult: a Qualitative Research With Their Physicians and Non-medical Practitioners
Brief Summary

The purpose of this study is to explore the perspectives of health professionals on chronic (non-malignant) musculoskeletal pain in adolescence and young adulthood. The prevalence of this pain symptom is rising for ten years, and most of the time the diagnosis is complex. Health professionals have to differentiate between the continuing activity of a somatic problem, some painful sequelae, a low threshold for the perception of pain, and psychological symptoms with somatic expression. Diagnosis in this case takes time, and is a matter of trained specialists. No protocol exists to assess the sub-clinical symptoms which will be used to help doing this complex task.

This qualitative study will elicit the perspectives of trained specialists on this diagnosis: how do they deal with these patients? What signs and symptoms helps them? The results will present their clinical experiences. The overall goal is to construct the first chronic musculoskeletal pain multidimensional scale that will help the practitioners with this complex diagnosis.

Detailed Description

Recent research suggests that musculoskeletal pain may be the most common complaint for which children are referred to a pediatric rheumatologist and is present in approximately 50% of all new patients. A small percentage of these patients will be diagnosed with a form of juvenile idiopathic arthritis (JIA), which is marked by clinically significant pain. A larger percentage will be diagnosed with a musculoskeletal pain syndrome, that approximately 25% of them are chronic and defined as > = 3 months. The chronic pain symptom is a subjective one that professionals have to precise its outlines in term of semiology, nature and efficacity of past treatments, medical and family backgrounds. The professional then will have to pinpoint a diagnosis, while assessing the consequences of the pain and treating it.

Most of the time this task is a complex one and professionals have to build their diagnostic on a body of clinical, paraclinical and more social, familial and psychological evidences. No clear protocol exists to help the professionals with differentiating the continuing activity of a somatic problem, some painful sequelae, a low threshold for the perception of pain, and psychological symptoms with somatic expression. This diagnostic process is lying on sub-clinical symptoms that investigators have to elicit in order to help professionals to better support their patients.

This qualitative study will explore the daily clinical experience of the health professionals involved in the care of adolescents suffering from chronic musculoskeletal pain. Semi-structured interviews will be analyzed with a phenomenological approach (interpretative phenomenological analysis). The rich phenomenological description will be the first step of a more ambitious project of constructing a multidimensional scale that will help the practitioners with this complex diagnosis.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study will concern the health professionals who takes care of adolescents suffering from chronic (non-malignant) musculoskeletal pain. In France, the medical specialities concerned are paediatric medicine, rheumatology, pain medicine, adolescent medicine and psychiatry. The investigators also want to include participants from paramedical fields: physiotherapists, ergotherapists and psychologists. The participants will be selected in the large repository of the professionals working with the French National Reference Center in Paediatric Rheumatology and Inflammatory Diseases
Condition Chronic (Non-malignant) Musculoskeletal Pain
Intervention Other: semi-structured interviews
Semi-structured face to face or telephone interviews with an open-ended approach. Duration: about 45 minutes. Audio-recorded. Exploration of the experience of taking care of the suffering adolescents.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 26, 2017)
25
Original Estimated Enrollment Same as current
Actual Study Completion Date January 30, 2018
Actual Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Health care professionals working with the French National Reference in Center Pediatric Rheumatology and Inflammatory Diseases
  • Professional experiences on the care of chronic musculoskeletal pain

Exclusion Criteria:

- Refusal to participate in the study

Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03171792
Other Study ID Numbers NI16015
2017-A00842-51 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Study Chair: Pierre QUARTIER, MD, PhD Assistance Publique - Hôpitaux de Paris
Study Chair: Jonathan LACHAL, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2018