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

Sponsor

Medical University Innsbruck (Other)

Overall Status

Completed

CT.gov ID

NCT03704311

Collaborator

(none)

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Neck Pain, Back Myofascial Trigger Point Pain Myofascial Pain Mitochondrial Pathology	Procedure: Muscle biopsy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

Assessor doing high Resolution respirometry was blinded with respect to diagnosis, location of biopsy and all Patient related data

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Mitochondrial function in myofascial trigger points [Baseline measurement]
Mitochondrial respiration was assessed from muscle biopsy samples obtained from trigger points of the musculus trapezius and the musculus gluteus medius

Secondary Outcome Measures

Number of participants with biopsy-related impaired wound healing [Baseline and follow-up assessment (1 week after the baseline biopsy)]
Clinical wound assessment (number of patients with signs for local infection and inflammation)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University Innsbruck

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University Innsbruck

ClinicalTrials.gov Identifier:

NCT03704311

Other Study ID Numbers:

MUInnsbruck

First Posted:

Oct 12, 2018

Last Update Posted:

Oct 12, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myofascial Pain Syndromes

Back Pain

Neck Pain

Study Results

No Results Posted as of Oct 12, 2018