NCT03704311

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

October 9, 2018

Last Update Submit

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

EXPERIMENTAL

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

Procedure: Muscle biopsy

Interventions

Muscle biopsyPROCEDURE

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).

Single

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

MeSH Terms

Conditions

Neck PainBack PainMyofascial Pain Syndromes

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Michael J Fischer, MD, PhD

    Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

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