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Pain and Muscle Biopsy

NCT06379932 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-06-29

No results posted yet for this study

Summary

Few studies have been conducted on pain assessment during and after open muscle biopsy. Furthermore, no clinical factors likely to influence pain perception during and after open muscle biopsy have been evaluated in previous studies.The proposed observational study aims to study pain perception in subjects over the aged of 18 years old who underwent an open muscle biopsy for a suspected myopathic disorder. Describing the main characteristics of pain during and after open muscle biopsy using a questionnaire will not only clarify this aspect, which is little studied in the literature, but will also provide information for improving analgesic management of the procedure.Studying the prognostic aspects of pain perception will give healthcare professionals an idea of which patients are at risk of suffering greater adverse effects from the procedure, so that they can be offered a personalised service in the future.

Conditions

Interventions

OTHER

Surveys completion

A questionnaire (including the NRS) will be given to the patient on the day of the procedure, immediately after the biopsy, in the treatment room and without staff intervention (responses will be analyzed by two study investigators at a later date). The patient health questionnaire (PHQ-9) will also be provided at the same time as the self-report questionnaire, for the assessment of depressive symptoms. Assessment of the participant's frailty using the Clinical Frailty Scale (CFS) will be carried out prior to the procedure. Further data will be collected by telephone by a study investigator 15 +/- 2 days after the biopsy and 30 +/- 2 days after the biopsy.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Teresinha Maria DIAS EVANGELISTA · Sorbonne University, Pitié salpêtrière hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2025-06-12
Completion
2025-06-12

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06379932 on ClinicalTrials.gov