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

Primary Purpose

Pain, Neck, Pain, Back, Myofascial Trigger Point Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Muscle biopsy
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain, Neck

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single

    Arm Description

    Evaluation of mitochondrial function after muscle biopsy and follow-up for surgical complications.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Number of participants with biopsy-related impaired wound healing
    Clinical wound assessment (number of patients with signs for local infection and inflammation)

    Full Information

    First Posted
    October 9, 2018
    Last Updated
    October 11, 2018
    Sponsor
    Medical University Innsbruck
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03704311
    Brief Title
    Evaluation of Mitochondrial Function in Myofascial Trigger Points Cohort Pilot Study Using High-resolution Respirometry
    Acronym
    MitoTrigger
    Official Title
    Evaluation of Mitochondrial Function in Chronic Myofascial Trigger Points - A Prospective Cohort Pilot Study Using High-resolution Respirometry
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2013 (Actual)
    Primary Completion Date
    February 1, 2014 (Actual)
    Study Completion Date
    December 1, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University Innsbruck

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Neck, Pain, Back, Myofascial Trigger Point Pain, Myofascial Pain, Mitochondrial Pathology

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study 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
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single
    Arm Type
    Experimental
    Arm Description
    Evaluation of mitochondrial function after muscle biopsy and follow-up for surgical complications.
    Intervention Type
    Procedure
    Intervention Name(s)
    Muscle biopsy
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Mitochondrial function in myofascial trigger points
    Description
    Mitochondrial respiration was assessed from muscle biopsy samples obtained from trigger points of the musculus trapezius and the musculus gluteus medius
    Time Frame
    Baseline measurement
    Secondary Outcome Measure Information:
    Title
    Number of participants with biopsy-related impaired wound healing
    Description
    Clinical wound assessment (number of patients with signs for local infection and inflammation)
    Time Frame
    Baseline and follow-up assessment (1 week after the baseline biopsy)

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael J Fischer, MD, PhD
    Organizational Affiliation
    Medical University Innsbruck
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30376863
    Citation
    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.
    Results Reference
    derived

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

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