Pain and Muscle Biopsy

NCT06379932 | Completed

• 1 other identifier: APHP240433
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Diseases

Keywords

pain; neuromuscular disease; open muscle biopsy

Outcome Measures

Primary Outcomes (1)

• To describe the characteristics and intensity of pain during and after open muscle biopsy on the basis of a questionnaire including NRS scale.

  Completion of a questionnaire after the biopsy. The questionnaire is made up of several sections of questions, which will assess preoperative aspects (anxiety, quality of information received from healthcare staff) and intraoperative aspects, such as the assessment of perceived pain using the NRS scale. The questionnaire, which lasts around 5-10 minutes, is completed by the patient independently. Information on post-operative progress will be gathered during two follow-up telephone interviews at 15 and 30 days. These interviews will consist of answering the questions in the second part of the questionnaire and will last approximately 10 minutes.

  Day of musclebiopsy until 30 days +/- 2 days after the biopsy

Secondary Outcomes (2)

• To identify prognostic factors that may influence pain perception and to gather opinions to improve quality service

  Day of musclebiopsy until 30 days +/- 2 days after the biopsy

• Gather patient feedback on procedures, facilities and reception to improve our service to patients.

  Day of musclebiopsy

Interventions

Surveys completion OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults undergoing open muscle biopsy for suspicion of neuromuscular disorder

You may qualify if:

• 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."

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié-Salpêtrière

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Pain

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Teresinha Maria DIAS EVANGELISTA

  Sorbonne University, Pitié salpêtrière hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: August 6, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (1)