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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03704311
Other study ID # MUInnsbruck
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2013
Est. completion date December 1, 2014

Study information

Verified date October 2018
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot study established a minimally invasive biopsy technique to obtain high-quality MTrP tissue samples to evaluate mitochondrial function via high-resolution respirometry.


Description:

Myofascial trigger points (MTrPs) are hyperirritable areas in the fascia of the affected muscle, possibly related to mitochondrial impairment. They can result in pain and hypoxic areas within the muscle. This pilot study established a minimally invasive biopsy technique to obtain high-quality MTrP tissue samples to evaluate mitochondrial function via high-resolution respirometry. Secondary objectives included the safety of the biopsy procedure assessed via clinical wound healing (number of patients with signs for local infection and inflammation). For this purpose, twenty healthy males participated in this study, 10 with a diagnosis of myofascial pain in the musculus (m.) trapezius MTrP (TTP group) and 10 with a diagnosis of myofascial pain in the m. gluteus medius (GTP group). The affected muscle was biopsied followed by a biopsy from the vastus lateralis to be used as a control. Measurements of oxygen consumption were carried out using high-resolution respirometry.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 1, 2014
Est. primary completion date February 1, 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Male patients aged 18-45 years

- Clinical diagnosis of myofascial pain syndrome within the region of the shoulder-neck muscles or the lumbogluteal region and the presence of an MTrP, defined as a firm palpation of a hard, tender nodule resulting in a spontaneous pain complaint

- with symptoms present for 1 to 12 months

Exclusion Criteria:

- Signs that the participant's prescriptive compliance was not expected (e.g., lack of cooperation)

- Disorders of the respiratory tract

- Neurological disorders, in particular neurodegenerative and neuromuscular diseases

- Disorders of the cardiovascular system or the musculoskeletal system

- Civil servants and military service personnel.

Study Design


Intervention

Procedure:
Muscle biopsy
Local anesthesia was applied to the superficial skin covering the MTrP of each participant. Percutaneous biopsy sampling optimized with a suction-enhancement technique was used to obtain muscle biopsies of the m. trapezius MTrP or the m. gluteus medius MTrP from each participant using small Bergstrom muscle biopsy needle, 8 swg (4.0mm) x 100 mm (Dixons Surgical Instruments, Essex, United Kingdom).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Outcome

Type Measure Description Time frame Safety issue
Primary Mitochondrial function in myofascial trigger points Mitochondrial respiration was assessed from muscle biopsy samples obtained from trigger points of the musculus trapezius and the musculus gluteus medius Baseline measurement
Secondary Number of participants with biopsy-related impaired wound healing Clinical wound assessment (number of patients with signs for local infection and inflammation) Baseline and follow-up assessment (1 week after the baseline biopsy)
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