Evaluation of Mitochondrial Function in Myofascial Trigger Points Cohort Pilot Study Using High-resolution Respirometry
MitoTrigger
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedOctober 12, 2018
October 1, 2018
4 months
October 9, 2018
October 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of participants with biopsy-related impaired wound healing
Baseline and follow-up assessment (1 week after the baseline biopsy)
Study Arms (1)
Single
EXPERIMENTALEvaluation of mitochondrial function after muscle biopsy and follow-up for surgical complications.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 30376863DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Fischer, MD, PhD
Medical University Innsbruck
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Assessor doing high Resolution respirometry was blinded with respect to diagnosis, location of biopsy and all Patient related data
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2018
First Posted
October 12, 2018
Study Start
October 1, 2013
Primary Completion
February 1, 2014
Study Completion
December 1, 2014
Last Updated
October 12, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share