Asymptomatic ConditionNCT04360668
Muscle Energy Techniques and Trigger Point Therapy in Asymptomatic Persons With Latent Trigger Point
A study testing Muscle Energy Technique (MET), Trigger Point Therapy (TPT) and Muscle Energy Technique (MET) combined with Trigger Point Therapy (TPT) in people with Asymptomatic Condition, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Condition
- What is being tested?
- Muscle Energy Technique (MET), Trigger Point Therapy (TPT) and Muscle Energy Technique (MET) combined with Trigger Point Therapy (TPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 29 Apr 2020to 12 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Physical Education, Department of Biology and Anatomy, Department of Motor Organ Rehabilitation
Poznan, Wielkopolska, 61-871
About this study
Official title: Determining the Effect of a Combination of Muscle Energy Techniques and Trigger Point Therapy on Subjective and Objective Indicators Assessing the Condition of the Musculoskeletal System in Asymptomatic Persons With Latent Trigger Point
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:
Read more
- 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
Read the detailed description
The randomized study will focus on assessing the effectiveness of 3 different physiotherapeutic interventions. The physiotherapist with 10 years of professional experience will be responsible for performing all diagnostic procedures and therapeutic interventions.
Diagnosis of latent trigger point will be performed on subjects in the supine position. The therapist using a pincer grip will perform palpation in the area of the entire upper trapezius muscle. Testing for the presence of trigger point can be considered positive when it is noted: 1) the presence of a detectable strained band in the muscle, 2) the presence of an excessively sensitive area in the strained muscle band, 3) the response of local vibration caused by compression of the strained band, 4) occurrence of characteristic transferred symptoms (pain radiating to the posterior-lateral side of the neck, and/or mastoid process of the temporal bone, and/or the temporal bone area, and/or the angle of the jaw) as a result of compression of the hypersensitive muscle band. The test will be performed on both sides of this muscle.
The following measurement methods are planned to be used:
- Electrogoniometry of the cervical spine. A Penny \& Giles strain tensometric electrogoniometer will be used. Using this device, the angular values of cervical spine movements will be examined. The SG150 two-plane sensor and the Q110 single-plane sensor will be used. The lower edge of the upper sensor will be attached around the occipital tuberosity, while the upper edge of the lower sensor on the C7 spinous process. The examined person will be in a sitting position. Double-sided tape from Biometrics will be used to stick the electrogoniometer sensors. For the measurements of each movement, the subject will perform 3 repetitions. Then the mean value will be calculated, which will be the result.
- Myotonometry. In order to examine the biophysical parameters of soft tissues a MyotonPRO will be used. Measurements will be made on the upper part of the trapezius muscle at the point located in the middle of the segment between the C7 spinous process and the shoulder angle of the acromion. During measurements, the subject will be lying down.
- Pressure pain threshold (PPT). The Wagner Instruments Algometer will be used to assess the subjective parameter - pressure pain threshold of first discomfort. The place of measurement will be the point located on the upper trapezius muscle in the middle of the segment between the C7 spinous process and the shoulder angle of the acromion. The subject will be lying down on his back. Pressure from the algometer sensor will be applied from above and perpendicular to the examined muscle. Three measurements will be taken alternately for both sides of the upper trapezius. The mean value will be calculated, which will be the results for the right and left sides of the examined muscle.
The order of measurements will be: 1) myotometry, 2) pressure pain threshold test, 3) cervical spine electrogoniometry.
Participation in the study will be voluntary, free and fully anonymous. The participant will be able to opt out of the study at any stage. All planned therapeutic and measurement methods are non-invasive and safe. They do not threaten the health and life of the respondents.
- Conditions
- Asymptomatic Condition
- Being tested
- Muscle Energy Technique (MET), Trigger Point Therapy (TPT), Muscle Energy Technique (MET) combined with Trigger Point Therapy (TPT)
- Keywords
- muscle energy techniques, trigger point therapy, range of motion, soft tissue properties, pressure pain threshold, combination of therapeutic methods
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy Technique (MET)Other
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.
Trigger Point Therapy (TPT)Other
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.
Muscle Energy Technique (MET) combined with Trigger Point Therapy (TPT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Muscle Energy Technique (MET) |
| Trigger Point Therapy | Active comparator | For this group of participants, a single method (Trigger Point Therapy) will be used Receives: Other: Trigger Point Therapy (TPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Anterior Flexion before the intervention
Electrogoniometric measurement of the angular range of motion immediately before the intervention.
Measured: PRE (immediately before the intervention)
Cervical Anterior Flexion after the intervention
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Measured: 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.
Measured: 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.
Measured: PRE (immediately before the intervention)
Cervical Posterior Flexion after the intervention
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Measured: 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.
Measured: 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.
Measured: PRE (immediately before the intervention)
Cervical Right Flexion after the intervention
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Measured: 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.
Measured: 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.
Measured: PRE (immediately before the intervention)
Cervical Left Flexion after the intervention
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Measured: 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.
Measured: 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.
Measured: PRE (immediately before the intervention)
Cervical Right Rotation after the intervention
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Measured: 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.
Measured: 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.
Measured: PRE (immediately before the intervention)
Cervical Left Rotation after the intervention
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: FOLLOW-UP (the next day after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start29 Apr 2020
- Primary completion12 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Wendt, Poznan University of Physical Education
- Investigators
- Michał Wendt, PhD, Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360668
- Sponsor's protocol ID
- PoznanUPhyEd
- Status last verified
- May 2020
- First submitted
- 18 Apr 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29599041Dellalana 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.
PubMed 30414198Dissanayaka 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.
PubMed 30299201Chen 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.
PubMed 26461163Vernon 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.
PubMed 19121461Clark BC, Thomas JS, Walkowski SA, Howell JN. The biology of manual therapies. J Am Osteopath Assoc. 2012 Sep;112(9):617-29.
PubMed 22984235Ribeiro 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.
PubMed 30045708Fernandez-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.
PubMed 24264721Giamberardino 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.
PubMed 22094195Ge 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.
PubMed 21439050Munoz-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.
PubMed 23158466Cagnie 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.
PubMed 23993756Yoo 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.
PubMed 24926152Yeganeh 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.
PubMed 26304789Sadria 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.
PubMed 29037649
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of a Combination of Muscle Energy Techniques and Trigger Point Therapy on Subjective and Objective Indicators Assessing the Condition of the Musculoskeletal System in Asymptomatic Persons With Latent Trigger Point
- ClinicalTrials.gov ID
- NCT04360668
- Acronym / sponsor ID
- PoznanUPhyEd
- Conditions
- Asymptomatic Condition
- Keywords
- muscle energy techniques, trigger point therapy, range of motion, soft tissue properties, pressure pain threshold, combination of therapeutic methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The randomized study will focus on assessing the effectiveness of 3 different physiotherapeutic interventions. The physiotherapist with 10 years of professional experience will be responsible for performing all diagnostic procedures and therapeutic interventions.
Diagnosis of latent trigger point will be performed on subjects in the supine position. The therapist using a pincer grip will perform palpation in the area of the entire upper trapezius muscle. Testing for the presence of trigger point can be considered positive when it is noted: 1) the presence of a detectable strained band in the muscle, 2) the presence of an excessively sensitive area in the strained muscle band, 3) the response of local vibration caused by compression of the strained band, 4) occurrence of characteristic transferred symptoms (pain radiating to the posterior-lateral side of the neck, and/or mastoid process of the temporal bone, and/or the temporal bone area, and/or the angle of the jaw) as a result of compression of the hypersensitive muscle band. The test will be performed on both sides of this muscle.
The following measurement methods are planned to be used:
- Electrogoniometry of the cervical spine. A Penny \& Giles strain tensometric electrogoniometer will be used. Using this device, the angular values of cervical spine movements will be examined. The SG150 two-plane sensor and the Q110 single-plane sensor will be used. The lower edge of the upper sensor will be attached around the occipital tuberosity, while the upper edge of the lower sensor on the C7 spinous process. The examined person will be in a sitting position. Double-sided tape from Biometrics will be used to stick the electrogoniometer sensors. For the measurements of each movement, the subject will perform 3 repetitions. Then the mean value will be calculated, which will be the result.
- Myotonometry. In order to examine the biophysical parameters of soft tissues a MyotonPRO will be used. Measurements will be made on the upper part of the trapezius muscle at the point located in the middle of the segment between the C7 spinous process and the shoulder angle of the acromion. During measurements, the subject will be lying down.
- Pressure pain threshold (PPT). The Wagner Instruments Algometer will be used to assess the subjective parameter - pressure pain threshold of first discomfort. The place of measurement will be the point located on the upper trapezius muscle in the middle of the segment between the C7 spinous process and the shoulder angle of the acromion. The subject will be lying down on his back. Pressure from the algometer sensor will be applied from above and perpendicular to the examined muscle. Three measurements will be taken alternately for both sides of the upper trapezius. The mean value will be calculated, which will be the results for the right and left sides of the examined muscle.
The order of measurements will be: 1) myotometry, 2) pressure pain threshold test, 3) cervical spine electrogoniometry.
Participation in the study will be voluntary, free and fully anonymous. The participant will be able to opt out of the study at any stage. All planned therapeutic and measurement methods are non-invasive and safe. They do not threaten the health and life of the respondents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Muscle Energy Technique combined with Trigger Point Therapy | Experimental | Other: Muscle Energy Technique (MET) combined with Trigger Point Therapy (TPT)For this group of participants, combined therapy (Muscle Energy Technique with Trigger Point Therapy) will be used |
| Muscle Energy Technique | Active comparator | Other: Muscle Energy Technique (MET)For this group of participants, a single method (Muscle Energy Technique) will be used |
| Trigger Point Therapy | Active comparator | Other: Trigger Point Therapy (TPT)For this group of participants, a single method (Trigger Point Therapy) will be used |
Who may qualify
- Ages
- 19 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Energy Technique (MET)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. | Other | Muscle Energy Technique |
| Trigger Point Therapy (TPT)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. | Other | Trigger Point Therapy |
| Muscle Energy Technique (MET) combined with Trigger Point Therapy (TPT)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. | Other | Muscle Energy Technique combined with Trigger Point Therapy |
Primary outcome
Cervical Anterior Flexion before the intervention
Time frame: PRE (immediately before the intervention)
Electrogoniometric measurement of the angular range of motion immediately before the intervention.
Cervical Anterior Flexion after the intervention
Time frame: POST (immediately after the intervention)
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Cervical Anterior Flexion on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Electrogoniometric measurement of the angular range of motion on the next day after the intervention.
Cervical Posterior Flexion before the intervention
Time frame: PRE (immediately before the intervention)
Electrogoniometric measurement of the angular range of motion immediately before the intervention.
Cervical Posterior Flexion after the intervention
Time frame: POST (immediately after the intervention)
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Cervical Posterior Flexion on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Electrogoniometric measurement of the angular range of motion on the next day after the intervention.
Cervical Right Flexion before the intervention
Time frame: PRE (immediately before the intervention)
Electrogoniometric measurement of the angular range of motion immediately before the intervention.
Cervical Right Flexion after the intervention
Time frame: POST (immediately after the intervention)
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Cervical Right Flexion on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Electrogoniometric measurement of the angular range of motion on the next day after the intervention.
Cervical Left Flexion before the intervention
Time frame: PRE (immediately before the intervention)
Electrogoniometric measurement of the angular range of motion immediately before the intervention.
Cervical Left Flexion after the intervention
Time frame: POST (immediately after the intervention)
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Cervical Left Flexion on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Electrogoniometric measurement of the angular range of motion on the next day after the intervention.
Cervical Right Rotation before the intervention
Time frame: PRE (immediately before the intervention)
Electrogoniometric measurement of the angular range of motion immediately before the intervention.
Cervical Right Rotation after the intervention
Time frame: POST (immediately after the intervention)
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Cervical Right Rotation on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Electrogoniometric measurement of the angular range of motion on the next day after the intervention.
Cervical Left Rotation before the intervention
Time frame: PRE (immediately before the intervention)
Electrogoniometric measurement of the angular range of motion immediately before the intervention.
Cervical Left Rotation after the intervention
Time frame: POST (immediately after the intervention)
Electrogoniometric measurement of the angular range of motion immediately after the intervention.
Cervical Left Rotation on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Electrogoniometric measurement of the angular range of motion on the next day after the intervention.
Stiffness (S) of the upper right trapezius muscle before the intervention
Time frame: PRE (immediately before the intervention)
Myotonometric examination of soft tissue properties immediately before the intervention.
Stiffness (S) of the upper right trapezius muscle after the intervention
Time frame: POST (immediately after the intervention)
Myotonometric examination of soft tissue properties immediately after the intervention.
Stiffness (S) of the upper right trapezius muscle on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Myotonometric examination of soft tissue properties on the next day after the intervention.
Stiffness (S) of the upper left trapezius muscle before the intervention
Time frame: PRE (immediately before the intervention)
Myotonometric examination of soft tissue properties immediately before the intervention.
Stiffness (S) of the upper left trapezius muscle after the intervention
Time frame: POST (immediately after the intervention)
Myotonometric examination of soft tissue properties immediately after the intervention.
Stiffness (S) of the upper left trapezius muscle on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Myotonometric examination of soft tissue properties on the next day after the intervention.
Elasticity (D) of the upper right trapezius muscle muscle before the intervention
Time frame: PRE (immediately before the intervention)
Myotonometric examination of soft tissue properties immediately before the intervention.
Elasticity (D) of the upper right trapezius muscle after the intervention
Time frame: POST (immediately after the intervention)
Myotonometric examination of soft tissue properties immediately after the intervention.
Elasticity (D) of the upper right trapezius muscle on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Myotonometric examination of soft tissue properties on the next day after the intervention.
Elasticity (D) of the upper left trapezius muscle before the intervention
Time frame: PRE (immediately before the intervention)
Myotonometric examination of soft tissue properties immediately before the intervention.
Elasticity (D) of the upper left trapezius muscle after the intervention
Time frame: POST (immediately after the intervention)
Myotonometric examination of soft tissue properties immediately after the intervention.
Elasticity (D) of the upper left trapezius muscle on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Myotonometric examination of soft tissue properties on the next day after the intervention.
Muscle tone (F) of the upper right trapezius muscle before the intervention
Time frame: PRE (immediately before the intervention)
Myotonometric examination of soft tissue properties immediately before the intervention.
Muscle tone (F) of the upper right trapezius muscle after the intervention
Time frame: POST (immediately after the intervention)
Myotonometric examination of soft tissue properties immediately after the intervention.
Muscle tone (F) of the upper right trapezius muscle on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Myotonometric examination of soft tissue properties on the next day after the intervention.
Muscle tone (F) of the upper left trapezius muscle before the intervention
Time frame: PRE (immediately before the intervention)
Myotonometric examination of soft tissue properties immediately before the intervention.
Muscle tone (F) of the upper left trapezius muscle after the intervention
Time frame: POST (immediately after the intervention)
Myotonometric examination of soft tissue properties immediately after the intervention.
Muscle tone (F) of the upper left trapezius muscle on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Myotonometric examination of soft tissue properties on the next day after the intervention.
Pressure pain threshold (PPT) of the upper right trapezius muscle before the intervention
Time frame: PRE (immediately before the intervention)
Examination of the first discomfort threshold using an algometer immediately before the intervention.
Pressure pain threshold (PPT) of the upper right trapezius muscle after the intervention
Time frame: POST (immediately after the intervention)
Examination of the first discomfort threshold using an algometer immediately after the intervention.
Pressure pain threshold (PPT) of the upper right trapezius muscle on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Examination of the first discomfort threshold using an algometer on the next day after the intervention.
Pressure pain threshold (PPT) of the upper left trapezius muscle before the intervention
Time frame: PRE (immediately before the intervention)
Examination of the first discomfort threshold using an algometer immediately before the intervention.
Pressure pain threshold (PPT) of the upper left trapezius muscle after the intervention
Time frame: POST (immediately after the intervention)
Examination of the first discomfort threshold using an algometer immediately after the intervention.
Pressure pain threshold (PPT) of the upper left trapezius muscle on the next day after the intervention
Time frame: FOLLOW-UP (the next day after the intervention)
Examination of the first discomfort threshold using an algometer on the next day after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Background: PubMed 29599041Ko 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.
- Background: PubMed 30414198Dellalana 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.
- Background: PubMed 30299201Dissanayaka 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.
- Background: PubMed 26461163Chen 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.
- Background: PubMed 19121461Vernon 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.
- Background: PubMed 22984235Clark BC, Thomas JS, Walkowski SA, Howell JN. The biology of manual therapies. J Am Osteopath Assoc. 2012 Sep;112(9):617-29.
- Background: PubMed 30045708Ribeiro 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.
- Background: PubMed 24264721Fernandez-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.
- Background: PubMed 22094195Giamberardino 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.
- Background: PubMed 21439050Ge 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.
- Results publication: PubMed 23158466Munoz-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.
- Results publication: PubMed 23993756Cagnie 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michał Wendt, PhD principal investigator
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Energy Technique (MET), Trigger Point Therapy (TPT) and Muscle Energy Technique (MET) combined with Trigger Point Therapy (TPT) in people with Asymptomatic Condition, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Anterior Flexion before the intervention (time frame: PRE (immediately before the intervention)). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360668, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.