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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03704311
Recruitment Status : Completed
First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : October 1, 2013
Actual Primary Completion Date : February 1, 2014
Actual Study Completion Date : December 1, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Mitochondrial function in myofascial trigger points [ Time Frame: 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 :
  1. Number of participants with biopsy-related impaired wound healing [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704311


Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Michael J Fischer, MD, PhD Medical University Innsbruck
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03704311    
Other Study ID Numbers: MUInnsbruck
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Back Pain
Neck Pain
Muscular Diseases
 Musculoskeletal Diseases
Pain
Neurologic Manifestations