Pain and Muscle Biopsy

NCT ID: NCT06379932

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-06
• Study Completion Date: 2025-06-12

Brief 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.

Detailed Description

The patients will be followed for 30 days +/-2 days from the date of inclusion (day de la biopsy). The duration of the inclusion period will be 5 months. The total duration of the study until the phone call to the last patient included will be 6 months +/- 2 days.Sample size estimated: 100 patients, both male and female. Patients will present to the study site for a scheduled diagnostic muscle biopsy, with no additional visits required for study data collection. Prior to performing the procedure as part of the care, the investigator will verify that the inclusion and non-inclusion criteria are met and the patient will be informed of the opportunity to participate in this study. The study investigator will explain the details of the study (including the objective and how it will be carried out) and will obtain the patient's non-opposition to the study. Assessment of the participant's frailty using the frailty scale will be carried out prior to the procedure as part of the care.

The overall assessment of the patient on the day of the procedure will be carried out in accordance with the standard of care and will include the collection of vital signs parameters, height and weight.

The biopsy will be carried out in accordance with the department's care protocol. The self-reported questionnaire assessing pain during and after muscle biopsy (investigator-generated) and including NRS (Numerical Rating Scale) will be provided on the day of the procedure, immediately after the biopsy, in the treatment room and without staff intervention (responses will be analysed by two study physicians 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. Other data will be collected by telephone by a study investigator 15 days +/- 2 days after the biopsy and 30 days +/- 2 days after the biopsy. Responses will be analysed pseudonymously and will not prejudge the patient's continued treatment.Once collected, the paper data is organised, cleaned and stored appropriately in the paper CRF and transferred to Excel. Data obtained during telephone interviews will be entered directly into the Excel CRF. Medical data from the medical records will be transferred to Excel.

Two study investigators will enter and validate the data, including data quality control measures to ensure accuracy and reliability.

The data collected will be analysed by the investigators using the following statistical methods: descriptive statistics to summarise the characteristics of the study population and inferential statistics to test hypotheses or associations between variables. After analysing the data, the researchers interpret the results in the context of the research question and the existing literature. "

Conditions

Neuromuscular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥18 years
• Patients with clinical suspicion of myopathy.
• Patients requiring open muscle biopsy in the neuropathology unit at GH Pitié Salpêtrière.
• Patients who do not object to their participation in the study."

Exclusion Criteria

• Patients who do not understand French.
• Pregnant women
• No social security and patient under AME.
• Patient deprived of liberty by court or administrative order, or under legal protection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teresinha Maria DIAS EVANGELISTA

Role: PRINCIPAL_INVESTIGATOR

Sorbonne University, Pitié salpêtrière hospital

Locations

Pitié-Salpêtrière

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

APHP240433

Identifier Type: -

Identifier Source: org_study_id