NCT04360668

Brief Summary

The main objective of this study is to evaluate the effectiveness of therapy which will be a combination of Muscle Energy Technique (MET) and Trigger Point Therapy (TPT), performed bilaterally on the upper trapezius muscle in the group of asymptomatic persons with latent trigger point. The study will show whether one-time therapy has an impact on: mobility of the cervical spine, biophysical parameters (muscle tone, stiffness and elasticity) of soft tissues and pressure pain threshold of upper trapezius muscle. An additional goal will be to compare the effectiveness of the three treatments used: combination of MET with TPT, single MET and single TPT. Research hypotheses:

  • The combination of MET with TPT will increase the angular ranges of basic cervical spine movements immediately after the therapy and these effects will persist the second day after the intervention.
  • The combination of MET with TPT will increase the elasticity and reduce muscle tone and stiffness in the area of the upper trapezius immediately after the therapy, and these effects will persist the second day after the intervention.
  • The combination of MET with TPT will increase the pressure pain threshold of upper trapezius muscle immediately after the therapy, and this effect will persist the second day after the intervention.
  • The combination of MET with TPT will be more effective than single MET and single TPT methods. Muscle Energy Techniques (MET) can be defined as a group of soft tissue manipulation methods. They are a multi-task techniques that can be performed to improve the function of the musculoskeletal system and reduce pain. METs are used by clinicians who treat various myofascial and joint dysfunctions as well as a form of prevention and protection of the musculoskeletal system. Trigger point therapy (TPT) uses manual techniques such as ischemic compression (IC), positional release (PR), dry needling and soft tissue manipulations \[TP1\]. Their main purpose is to reduce or eliminate the symptoms generated by myofascial trigger points (TrPs), which are defined as severely irritated areas within the hypertonic muscle fiber band or the fascia itself. Latent TrPs are described as those that do not generate symptoms on their own. However, they can cause refered pain at the time of provocation, i.e. pressure at the place of their occurrence. In the scientific literature there are no reports on the assessment of the combination of MET with TPT

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

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

First Submitted

Initial submission to the registry

April 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

April 29, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

13 days

First QC Date

April 18, 2020

Last Update Submit

May 13, 2020

Conditions

Keywords

muscle energy techniquestrigger point therapyrange of motionsoft tissue propertiespressure pain thresholdcombination of therapeutic methods

Outcome Measures

Primary Outcomes (42)

  • Cervical Anterior Flexion before the intervention

    Electrogoniometric measurement of the angular range of motion immediately before the intervention.

    PRE (immediately before the intervention)

  • Cervical Anterior Flexion after the intervention

    Electrogoniometric measurement of the angular range of motion immediately after the intervention.

    POST (immediately after the intervention)

  • Cervical Anterior Flexion on the next day after the intervention

    Electrogoniometric measurement of the angular range of motion on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Cervical Posterior Flexion before the intervention

    Electrogoniometric measurement of the angular range of motion immediately before the intervention.

    PRE (immediately before the intervention)

  • Cervical Posterior Flexion after the intervention

    Electrogoniometric measurement of the angular range of motion immediately after the intervention.

    POST (immediately after the intervention)

  • Cervical Posterior Flexion on the next day after the intervention

    Electrogoniometric measurement of the angular range of motion on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Cervical Right Flexion before the intervention

    Electrogoniometric measurement of the angular range of motion immediately before the intervention.

    PRE (immediately before the intervention)

  • Cervical Right Flexion after the intervention

    Electrogoniometric measurement of the angular range of motion immediately after the intervention.

    POST (immediately after the intervention)

  • Cervical Right Flexion on the next day after the intervention

    Electrogoniometric measurement of the angular range of motion on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Cervical Left Flexion before the intervention

    Electrogoniometric measurement of the angular range of motion immediately before the intervention.

    PRE (immediately before the intervention)

  • Cervical Left Flexion after the intervention

    Electrogoniometric measurement of the angular range of motion immediately after the intervention.

    POST (immediately after the intervention)

  • Cervical Left Flexion on the next day after the intervention

    Electrogoniometric measurement of the angular range of motion on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Cervical Right Rotation before the intervention

    Electrogoniometric measurement of the angular range of motion immediately before the intervention.

    PRE (immediately before the intervention)

  • Cervical Right Rotation after the intervention

    Electrogoniometric measurement of the angular range of motion immediately after the intervention.

    POST (immediately after the intervention)

  • Cervical Right Rotation on the next day after the intervention

    Electrogoniometric measurement of the angular range of motion on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Cervical Left Rotation before the intervention

    Electrogoniometric measurement of the angular range of motion immediately before the intervention.

    PRE (immediately before the intervention)

  • Cervical Left Rotation after the intervention

    Electrogoniometric measurement of the angular range of motion immediately after the intervention.

    POST (immediately after the intervention)

  • Cervical Left Rotation on the next day after the intervention

    Electrogoniometric measurement of the angular range of motion on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Stiffness (S) of the upper right trapezius muscle before the intervention

    Myotonometric examination of soft tissue properties immediately before the intervention.

    PRE (immediately before the intervention)

  • Stiffness (S) of the upper right trapezius muscle after the intervention

    Myotonometric examination of soft tissue properties immediately after the intervention.

    POST (immediately after the intervention)

  • Stiffness (S) of the upper right trapezius muscle on the next day after the intervention

    Myotonometric examination of soft tissue properties on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Stiffness (S) of the upper left trapezius muscle before the intervention

    Myotonometric examination of soft tissue properties immediately before the intervention.

    PRE (immediately before the intervention)

  • Stiffness (S) of the upper left trapezius muscle after the intervention

    Myotonometric examination of soft tissue properties immediately after the intervention.

    POST (immediately after the intervention)

  • Stiffness (S) of the upper left trapezius muscle on the next day after the intervention

    Myotonometric examination of soft tissue properties on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Elasticity (D) of the upper right trapezius muscle muscle before the intervention

    Myotonometric examination of soft tissue properties immediately before the intervention.

    PRE (immediately before the intervention)

  • Elasticity (D) of the upper right trapezius muscle after the intervention

    Myotonometric examination of soft tissue properties immediately after the intervention.

    POST (immediately after the intervention)

  • Elasticity (D) of the upper right trapezius muscle on the next day after the intervention

    Myotonometric examination of soft tissue properties on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Elasticity (D) of the upper left trapezius muscle before the intervention

    Myotonometric examination of soft tissue properties immediately before the intervention.

    PRE (immediately before the intervention)

  • Elasticity (D) of the upper left trapezius muscle after the intervention

    Myotonometric examination of soft tissue properties immediately after the intervention.

    POST (immediately after the intervention)

  • Elasticity (D) of the upper left trapezius muscle on the next day after the intervention

    Myotonometric examination of soft tissue properties on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Muscle tone (F) of the upper right trapezius muscle before the intervention

    Myotonometric examination of soft tissue properties immediately before the intervention.

    PRE (immediately before the intervention)

  • Muscle tone (F) of the upper right trapezius muscle after the intervention

    Myotonometric examination of soft tissue properties immediately after the intervention.

    POST (immediately after the intervention)

  • Muscle tone (F) of the upper right trapezius muscle on the next day after the intervention

    Myotonometric examination of soft tissue properties on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Muscle tone (F) of the upper left trapezius muscle before the intervention

    Myotonometric examination of soft tissue properties immediately before the intervention.

    PRE (immediately before the intervention)

  • Muscle tone (F) of the upper left trapezius muscle after the intervention

    Myotonometric examination of soft tissue properties immediately after the intervention.

    POST (immediately after the intervention)

  • Muscle tone (F) of the upper left trapezius muscle on the next day after the intervention

    Myotonometric examination of soft tissue properties on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Pressure pain threshold (PPT) of the upper right trapezius muscle before the intervention

    Examination of the first discomfort threshold using an algometer immediately before the intervention.

    PRE (immediately before the intervention)

  • Pressure pain threshold (PPT) of the upper right trapezius muscle after the intervention

    Examination of the first discomfort threshold using an algometer immediately after the intervention.

    POST (immediately after the intervention)

  • Pressure pain threshold (PPT) of the upper right trapezius muscle on the next day after the intervention

    Examination of the first discomfort threshold using an algometer on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

  • Pressure pain threshold (PPT) of the upper left trapezius muscle before the intervention

    Examination of the first discomfort threshold using an algometer immediately before the intervention.

    PRE (immediately before the intervention)

  • Pressure pain threshold (PPT) of the upper left trapezius muscle after the intervention

    Examination of the first discomfort threshold using an algometer immediately after the intervention.

    POST (immediately after the intervention)

  • Pressure pain threshold (PPT) of the upper left trapezius muscle on the next day after the intervention

    Examination of the first discomfort threshold using an algometer on the next day after the intervention.

    FOLLOW-UP (the next day after the intervention)

Study Arms (3)

Muscle Energy Technique combined with Trigger Point Therapy

EXPERIMENTAL

For this group of participants, combined therapy (Muscle Energy Technique with Trigger Point Therapy) will be used

Other: Muscle Energy Technique (MET) combined with Trigger Point Therapy (TPT)

Muscle Energy Technique

ACTIVE COMPARATOR

For this group of participants, a single method (Muscle Energy Technique) will be used

Other: Muscle Energy Technique (MET)

Trigger Point Therapy

ACTIVE COMPARATOR

For this group of participants, a single method (Trigger Point Therapy) will be used

Other: Trigger Point Therapy (TPT)

Interventions

The Contract-Relax Agonist-Contract (CRAC) technique will be used, which belongs to the broad MET group. The participant will be in the supine position. The therapist will set the cervical segment in the lateral flexion until a slight soft tissue tension is felt. The technique will consist of two stages. In the first phase (contraction phase), the upper trapezius will be activated against the therapist's resistance (shoulder girdle elevation) - 10 seconds. Then the person undergoing the procedure breathes in and out deeply. Then 10 seconds of antagonist group contraction (shoulder girdle depression) will be performed. Next, the therapist will passively move the participant's shoulder girdle towards the depression. Then the second phase will follow (stretching phase), during which the participant will passively lie in the back position for 30 seconds. Both phases will make up the therapeutic cycle. Each participant will have 5 cycles on each side of the upper trapezius.

Muscle Energy Technique

The technique of Positional Release (PR) will be used, which is one of the broadly understood Trigger Point Therapy. It will consist in compressing the trigger point with a simultaneous shortening of muscle attachments (slight lateral flexion towards the relaxed muscle). The muscle on both sides will be treated. The pressure exerted by the therapist's pincer grip will be acceptable to the patient. The duration of the technique will be 2 minutes for each muscle. While performing this technique, the participant will passively lie on his back.

Trigger Point Therapy

For this type of intervention, TPT will first be performed on both sides of the upper trapezius muscle, followed by MET, which will also be performed bilaterally. The detailed method of performing the applied therapeutic techniques for the combined procedure will be identical as in the case of isolated (single) methods.

Muscle Energy Technique combined with Trigger Point Therapy

Eligibility Criteria

Age19 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • right-handed people
  • amateur practicing symmetrical sports (eg. swimming, running, cycling, gym, roller skates)
  • asymptomatic subjects (without pain symptoms of the cervical spine and shoulder girdle)
  • occurrence of latent trigger point of the upper trapezius muscle

You may not qualify if:

  • age above 21 years
  • no latent trigger point on the upper trapezius muscle
  • pain in the cervical spine or shoulder girdle
  • any neurological symptoms in the upper limb
  • previous operations in the cervical spine or shoulder girdle
  • practicing asymmetrical sports
  • professional sports

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Physical Education, Department of Biology and Anatomy, Department of Motor Organ Rehabilitation

Poznan, Wielkopolska, 61-871, Poland

Location

Related Publications (20)

  • Ko CY, Choi HJ, Ryu J, Kim G. Between-day reliability of MyotonPRO for the non-invasive measurement of muscle material properties in the lower extremities of patients with a chronic spinal cord injury. J Biomech. 2018 May 17;73:60-65. doi: 10.1016/j.jbiomech.2018.03.026. Epub 2018 Mar 17.

    PMID: 29599041BACKGROUND
  • Dellalana LE, Chen F, Vain A, Gandelman JS, Poldemaa M, Chen H, Tkaczyk ER. Reproducibility of the durometer and myoton devices for skin stiffness measurement in healthy subjects. Skin Res Technol. 2019 May;25(3):289-293. doi: 10.1111/srt.12646. Epub 2018 Nov 10.

    PMID: 30414198BACKGROUND
  • Dissanayaka TD, Farrell M, Zoghi M, Egan GF, Jaberzadeh S. Test-retest reliability of subjective supra-threshold scaling of multiple pressure-pain sensations among healthy individuals: a study using hydraulic pressure algometry. Somatosens Mot Res. 2018 Sep-Dec;35(3-4):153-161. doi: 10.1080/08990220.2018.1505608. Epub 2018 Oct 9.

    PMID: 30299201BACKGROUND
  • Chen Q, Wang HJ, Gay RE, Thompson JM, Manduca A, An KN, Ehman RE, Basford JR. Quantification of Myofascial Taut Bands. Arch Phys Med Rehabil. 2016 Jan;97(1):67-73. doi: 10.1016/j.apmr.2015.09.019. Epub 2015 Oct 14.

    PMID: 26461163BACKGROUND
  • Vernon H, Schneider M. Chiropractic management of myofascial trigger points and myofascial pain syndrome: a systematic review of the literature. J Manipulative Physiol Ther. 2009 Jan;32(1):14-24. doi: 10.1016/j.jmpt.2008.06.012.

    PMID: 19121461BACKGROUND
  • Clark BC, Thomas JS, Walkowski SA, Howell JN. The biology of manual therapies. J Am Osteopath Assoc. 2012 Sep;112(9):617-29.

    PMID: 22984235BACKGROUND
  • Ribeiro DC, Belgrave A, Naden A, Fang H, Matthews P, Parshottam S. The prevalence of myofascial trigger points in neck and shoulder-related disorders: a systematic review of the literature. BMC Musculoskelet Disord. 2018 Jul 25;19(1):252. doi: 10.1186/s12891-018-2157-9.

    PMID: 30045708BACKGROUND
  • Fernandez-de-las-Penas C, Dommerholt J. Myofascial trigger points: peripheral or central phenomenon? Curr Rheumatol Rep. 2014 Jan;16(1):395. doi: 10.1007/s11926-013-0395-2.

    PMID: 24264721BACKGROUND
  • Giamberardino MA, Affaitati G, Fabrizio A, Costantini R. Myofascial pain syndromes and their evaluation. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):185-98. doi: 10.1016/j.berh.2011.01.002.

    PMID: 22094195BACKGROUND
  • Ge HY, Fernandez-de-Las-Penas C, Yue SW. Myofascial trigger points: spontaneous electrical activity and its consequences for pain induction and propagation. Chin Med. 2011 Mar 25;6:13. doi: 10.1186/1749-8546-6-13.

    PMID: 21439050BACKGROUND
  • Munoz-Munoz S, Munoz-Garcia MT, Alburquerque-Sendin F, Arroyo-Morales M, Fernandez-de-las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in individuals with mechanical neck pain. J Manipulative Physiol Ther. 2012 Oct;35(8):608-13. doi: 10.1016/j.jmpt.2012.09.003.

  • Cagnie B, Dewitte V, Coppieters I, Van Oosterwijck J, Cools A, Danneels L. Effect of ischemic compression on trigger points in the neck and shoulder muscles in office workers: a cohort study. J Manipulative Physiol Ther. 2013 Oct;36(8):482-9. doi: 10.1016/j.jmpt.2013.07.001. Epub 2013 Aug 28.

  • Yoo WG. Comparison of the Symmetry of Right and Left Lateral Cervical Flexion and Rotation and the Cervical FRR in Young Computer Workers. J Phys Ther Sci. 2014 May;26(5):783-4. doi: 10.1589/jpts.26.783. Epub 2014 May 29.

  • Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.

  • Sadria G, Hosseini M, Rezasoltani A, Akbarzadeh Bagheban A, Davari A, Seifolahi A. A comparison of the effect of the active release and muscle energy techniques on the latent trigger points of the upper trapezius. J Bodyw Mov Ther. 2017 Oct;21(4):920-925. doi: 10.1016/j.jbmt.2016.10.005. Epub 2016 Oct 21.

  • Kisilewicz A, Janusiak M, Szafraniec R, Smoter M, Ciszek B, Madeleine P, Fernandez-de-Las-Penas C, Kawczynski A. Changes in Muscle Stiffness of the Trapezius Muscle After Application of Ischemic Compression into Myofascial Trigger Points in Professional Basketball Players. J Hum Kinet. 2018 Oct 15;64:35-45. doi: 10.2478/hukin-2018-0043. eCollection 2018 Sep.

  • Mohammadi Kojidi M, Okhovatian F, Rahimi A, Baghban AA, Azimi H. The influence of Positional Release Therapy on the myofascial trigger points of the upper trapezius muscle in computer users. J Bodyw Mov Ther. 2016 Oct;20(4):767-773. doi: 10.1016/j.jbmt.2016.04.006. Epub 2016 Apr 7.

  • Bron C, Wensing M, Franssen JL, Oostendorp RA. Treatment of myofascial trigger points in common shoulder disorders by physical therapy: a randomized controlled trial [ISRCTN75722066]. BMC Musculoskelet Disord. 2007 Nov 5;8:107. doi: 10.1186/1471-2474-8-107.

  • Gross A, Kay TM, Paquin JP, Blanchette S, Lalonde P, Christie T, Dupont G, Graham N, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Hoving JL, Bronfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2015 Jan 28;1(1):CD004250. doi: 10.1002/14651858.CD004250.pub5.

  • Burns DK, Wells MR. Gross range of motion in the cervical spine: the effects of osteopathic muscle energy technique in asymptomatic subjects. J Am Osteopath Assoc. 2006 Mar;106(3):137-42.

MeSH Terms

Conditions

Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • MichaÅ‚ Wendt, PhD

    Poznan University of Physical Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will not know which research group they will belong to. Each participant will draw a number that will be specific to the given research group. The investigator will also not know which group the participant belongs to (he will only use the participant's number). The outcomes assessor will not know which group is experimental and which are active comparators (they will be marked numerically instead of using a name). The correct course of the study will be supervised by a person who acts as a coordinator.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The first stage will involve recruitment. 60 people will be gathered based on the qualifying and disqualifying criteria. This group of participants will be randomized. Each participant will draw a number that will determine the assignment to a specific group (MET plus TPT group, single MET or single TPT group). Preliminary measurements will be collected before the intervention. Each participant will have a specific intervention depending on which research group they belong to. The therapist will be responsible for performing the given therapeutic technique. Immediately after the intervention and on the second day, data will be collected by the researcher. The person conducting the function of coordinator will supervise the proper conduct of the scientific research. The collected data will be analyzed by the outcomes assessor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 18, 2020

First Posted

April 24, 2020

Study Start

April 29, 2020

Primary Completion

May 12, 2020

Study Completion

May 12, 2020

Last Updated

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

University IPD sharing platform is under preparation. All data will also be available to researchers via the principal researcher's email (wendt@awf.poznan.pl) or Research Gate website.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available from June 2020.
Access Criteria
Available to all researchers
More information

Locations