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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03171792
Other study ID # NI16015
Secondary ID 2017-A00842-51
Status Completed
Phase
First received May 26, 2017
Last updated March 16, 2018
Start date September 21, 2017
Est. completion date January 30, 2018

Study information

Verified date January 2018
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date January 30, 2018
Est. primary completion date January 30, 2018
Accepts healthy volunteers No
Gender All
Age group 25 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
France Cochin hospital Paris
France Necker Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (14)

- Lachal J, Speranza M, Schmitt A, Spodenkiewicz M, Falissard B, Moro MR, Revah-Levy A. Depression in adolescent from qualitative research to measurement. Adolescent Psychiatry 2012,2(4):296-308.

- Smith J. Interpretative phenomenological analysis. In: Qualitative Psychology: A Practical Guide to Research Methods. 2e éd. Sage Publications Ltd; 2008.

Anthony KK, Schanberg LE. Pediatric pain syndromes and management of pain in children and adolescents with rheumatic disease. Pediatr Clin North Am. 2005 Apr;52(2):611-39, vii. Review. — View Citation

Bell DS, Bell KM, Cheney PR. Primary juvenile fibromyalgia syndrome and chronic fatigue syndrome in adolescents. Clin Infect Dis. 1994 Jan;18 Suppl 1:S21-3. — View Citation

Chapman E, Smith JA. Interpretative phenomenological analysis and the new genetics. J Health Psychol. 2002 Mar;7(2):125-30. doi: 10.1177/1359105302007002397. — View Citation

De Inocencio J. Epidemiology of musculoskeletal pain in primary care. Arch Dis Child. 2004 May;89(5):431-4. — View Citation

Goodman JE, McGrath PJ. The epidemiology of pain in children and adolescents: a review. Pain. 1991 Sep;46(3):247-64. Review. — View Citation

Jaremko JL, Liu L, Winn NJ, Ellsworth JE, Lambert RG. Diagnostic utility of magnetic resonance imaging and radiography in juvenile spondyloarthritis: evaluation of the sacroiliac joints in controls and affected subjects. J Rheumatol. 2014 May;41(5):963-70. doi: 10.3899/jrheum.131064. Epub 2014 Mar 15. — View Citation

Kashikar-Zuck S, Goldschneider KR, Powers SW, Vaught MH, Hershey AD. Depression and functional disability in chronic pediatric pain. Clin J Pain. 2001 Dec;17(4):341-9. — View Citation

McGhee JL, Burks FN, Sheckels JL, Jarvis JN. Identifying children with chronic arthritis based on chief complaints: absence of predictive value for musculoskeletal pain as an indicator of rheumatic disease in children. Pediatrics. 2002 Aug;110(2 Pt 1):354-9. — View Citation

Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, He X, Maldonado-Cocco J, Orozco-Alcala J, Prieur AM, Suarez-Almazor ME, Woo P; International League of Associations for Rheumatology. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004 Feb;31(2):390-2. — View Citation

Sherry DD, McGuire T, Mellins E, Salmonson K, Wallace CA, Nepom B. Psychosomatic musculoskeletal pain in childhood: clinical and psychological analyses of 100 children. Pediatrics. 1991 Dec;88(6):1093-9. — View Citation

Smith JA, Michie S, Stephenson M, Quarrell O. Risk Perception and Decision-making Processes in Candidates for Genetic Testing for Huntington's Disease: An Interpretative Phenomenological Analysis. J Health Psychol. 2002 Mar;7(2):131-44. doi: 10.1177/1359105302007002398. — View Citation

Taïeb O, Bricou O, Baubet T, Gaboulaud V, Gal B, Mouthon L, Dhote R, Guillevin L, Rose Moro M. Patients' beliefs about the causes of systemic lupus erythematosus. Rheumatology (Oxford). 2010 Mar;49(3):592-9. doi: 10.1093/rheumatology/kep430. Epub 2009 Dec 29. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative description of the experience of health professionals faced to adolescents consulting for chronic (non-malignant) musculoskeletal pain 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. 1 day