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
About this trial
This is an interventional basic science trial for Pain, Neck
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.
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
NCT ID
NCT03704311
First Posted
October 9, 2018
Last Updated
October 11, 2018
Sponsor
Medical University Innsbruck
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
Learn more about this trial
Evaluation of Mitochondrial Function in Myofascial Trigger Points Cohort Pilot Study Using High-resolution Respirometry
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