Evaluation of Mitochondrial Function in Myofascial Trigger Points Cohort Pilot Study Using High-resolution Respirometry (MitoTrigger)

Evaluation of Mitochondrial Function in Chronic Myofascial Trigger Points - A Prospective Cohort Pilot Study Using High-resolution Respirometry

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

Study Overview

• Status: Completed
• Conditions: Myofascial Pain; Myofascial Trigger Point Pain; Pain, Back; Pain, Neck; Mitochondrial Pathology
• Intervention / Treatment: Procedure: Muscle biopsy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Single; Evaluation of mitochondrial function after muscle biopsy and follow-up for surgical complications.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Michael J Fischer, MD, PhD, Medical University Innsbruck

Publications and helpful links

General Publications

• Fischer MJ, Horvath G, Krismer M, Gnaiger E, Goebel G, Pesta DH. Evaluation of mitochondrial function in chronic myofascial trigger points - a prospective cohort pilot study using high-resolution respirometry. BMC Musculoskelet Disord. 2018 Oct 30;19(1):388. doi: 10.1186/s12891-018-2307-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (ACTUAL): October 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Back Pain; Neck Pain; Myofascial Pain Syndromes
• Other Study ID Numbers: MUInnsbruck

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No