NCT05666557

Brief Summary

The purpose of this experiment is to evaluate whether MyotonPRO can quantify the changes in the muscle characteristics of the erector spinae in different postures and after myofascial relaxation, and to test the validity of the muscle tone tester.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

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

May 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

November 9, 2022

Last Update Submit

December 18, 2022

Conditions

Keywords

Muscle tension testermuscle characteristicserector spinae musclesdifferent posturesmyofascial release

Outcome Measures

Primary Outcomes (6)

  • Muscle tone of manual erector spinae myofascial release

    Use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle tone (Hz)

    10 minutes

  • muscle stiffness of manual erector spinae myofascial realease

    use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle stiffness (N/m)

    10 minutes

  • muscle elasticity of manual erector spinae myofascial realease

    use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle elasticity (ln(first wave peak/second wave peak))

    10 minutes

  • muscle tone of self-myofascial release technique

    use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle tone (Hz)

    10 minutes

  • muscle stiffness of self-myofascial release technique

    use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle stiffness (N/m)

    10 minutes

  • muscle elasticity of self-myofascial release technique

    use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle elasticity (ln(first wave peak/second wave peak))

    10 minutes

Study Arms (2)

manual erector spinae myofascial realease

EXPERIMENTAL

Myofascial release is performed by a therapist. The patient prone and using two pillows, one on the head and the other under the abdomen, flexing the lumbar spine maximally under the abdomen with the erector spinae in extension. The therapist will then perform 3 sets of 15 reps with a 1-minute rest between sets with myofascial loosening using standard massage techniques.

Other: manual erector spinae myofascial realease

self-myofascial release technique

EXPERIMENTAL

Use a roller (roller) to release fascia. The subject stand beside the wall and roll back and forth 15 times as a group, rest for one minute in between, and do a total of 3 groups.

Other: self-myofascial release technique

Interventions

The subjects first positioned the third, fourth, and fifth lumbar vertebrae in a relaxed lying position, about 2-3 cm away from the left and right sides (depending on the size of the subjects' muscles). And then in six postures (prone, prone with leg raise, sit straight , slouch sitting, stand straight and slouch standing), MyotonPRO was used to test the above-mentioned 8 points in these position. Subjects will undergo a pre-mobilization assessment to see if MyotonPRO can detect changes in the erector spinae muscle properties, including changes in muscle tone, stiffness, and elasticity, under different test positions. After physical therapist manual mobilization, MyotonPRO's erector spinae muscle biomechanical data was collected again for data analysis to determine MyotonPRO could objectively quantify changes in erector spinae biomechanical characteristics.

manual erector spinae myofascial realease

The subjects first positioned the third, fourth, and fifth lumbar vertebrae in a relaxed lying position, about 2-3 cm away from the left and right sides (depending on the size of the subjects' muscles). And then in six postures (prone, prone with leg raise, sit straight , slouch sitting, stand straight and slouch standing), MyotonPRO was used to test the above-mentioned 8 points in these position. Subjects will undergo a pre-mobilization assessment to see if MyotonPRO can detect changes in the erector spinae muscle properties, including changes in muscle tone, stiffness, and elasticity, under different test positions. After self mobilization by roller, MyotonPRO's erector spinae muscle biomechanical data was collected again for data analysis to determine MyotonPRO could objectively quantify changes in erector spinae biomechanical characteristics.

self-myofascial release technique

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 20-65 healthy adult

You may not qualify if:

  • Radicular neurological signs
  • spinal deformity e.g.scoliosis, spondylolisthesis
  • infection or tumor
  • Rheumatologic conditions
  • Previous spinal surgery
  • History of hip or pelvic disorder that required treatment
  • male BMI\> 27 and female BMI\> 26

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, Taiwan

Location

Related Publications (6)

  • Aarrestad DD, Williams MD, Fehrer SC, Mikhailenok E, Leonard CT. Intra- and interrater reliabilities of the Myotonometer when assessing the spastic condition of children with cerebral palsy. J Child Neurol. 2004 Nov;19(11):894-901. doi: 10.1177/08830738040190110801.

    PMID: 15658795BACKGROUND
  • Jennings AG, Seedhom BB. The measurement of muscle stiffness in anterior cruciate injuries -- an experiment revisited. Clin Biomech (Bristol). 1998 Mar;13(2):138-140. doi: 10.1016/s0268-0033(97)00085-5.

    PMID: 11415781BACKGROUND
  • Bizzini M, Mannion AF. Reliability of a new, hand-held device for assessing skeletal muscle stiffness. Clin Biomech (Bristol). 2003 Jun;18(5):459-61. doi: 10.1016/s0268-0033(03)00042-1.

    PMID: 12763442BACKGROUND
  • Blackburn JT, Norcross MF, Cannon LN, Zinder SM. Hamstrings stiffness and landing biomechanics linked to anterior cruciate ligament loading. J Athl Train. 2013 Nov-Dec;48(6):764-72. doi: 10.4085/1062-6050-48.4.01. Epub 2013 Jun 14.

    PMID: 24303987BACKGROUND
  • Brashear A, Zafonte R, Corcoran M, Galvez-Jimenez N, Gracies JM, Gordon MF, McAfee A, Ruffing K, Thompson B, Williams M, Lee CH, Turkel C. Inter- and intrarater reliability of the Ashworth Scale and the Disability Assessment Scale in patients with upper-limb poststroke spasticity. Arch Phys Med Rehabil. 2002 Oct;83(10):1349-54. doi: 10.1053/apmr.2002.35474.

    PMID: 12370866BACKGROUND
  • Brocherie F, Millet GP, Girard O. Neuro-mechanical and metabolic adjustments to the repeated anaerobic sprint test in professional football players. Eur J Appl Physiol. 2015 May;115(5):891-903. doi: 10.1007/s00421-014-3070-z. Epub 2014 Dec 7.

    PMID: 25481506BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Heng-Yi Lin, Bachelor

    Yueh-Ling Hsieh's bachelor student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2022

First Posted

December 28, 2022

Study Start

May 11, 2021

Primary Completion

July 5, 2021

Study Completion

June 6, 2022

Last Updated

December 28, 2022

Record last verified: 2022-12

Locations