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Trigger Point Pain, MyofascialNCT04778462

Myoelectric Activity of Upper Trapezius Trigger Point

A study testing extracorporeal shock wave and conventional treament, high pain threshold ultrasound and conventional treatment for myofascial pain syndrome trigger points and conventional treatment for myofascial pain trigger point in people with Trigger Point Pain, Myofascial, run by MTI University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Myofascial trigger points are a muscular dysfunction at the level of the motor end-plate and the sarcoplasmic reticula that, in turn, cause a local contraction with ischemia -induced hypoxia. Along with the hypoxia, the resulting energy crisis leads to a sensation of the surrounding nociceptors . Read more about this study

Who is it for?
Ages 20 to 26 years
Conditions the study is for
Trigger Point Pain, Myofascial
What is being tested?
extracorporeal shock wave and conventional treament, high pain threshold ultrasound and conventional treatment for myofascial pain syndrome trigger points and conventional treatment for myofascial pain trigger point
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
15 Feb 2020to 14 Apr 2021
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 20 to 26 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Both genders will be included with their age between
  • . •Symptoms of active TrPs unilateral on at least one side of the upper fiber of trapezius muscle presence of at least one trigger point symptoms lasting from 0 to 2 weeks age
  • Subjects have pain at rest, local twitch response, jump sign, limited range of motion and referred pain lies over the lateral aspect of the upper trapezius fiber and superiorly to the ipsilateral occiput .

Who cannot join

  • patients who had medication or other therapies for myofascial pain syndrome (Ji Hm et al., 2012) (2)
  • patients who had neurological deficits involving the upper limbs, advance osteopathic or arthropathic disorders of the cervical spine or the shoulder of the investigated side
  • contraindication of ESWT such as hypertension, coagulopathy, ulcer, recent severe hemorrhage, neoplasm, renal insufficiency, severe hepatic disease, epilepsy, cutaneous pathology, central pain, pregnancy and mental retardation
  • The presence of previously diagnosed disease such as (diabetes mellitus, fibromyalgia, hormonal disorder hypothyroidism, hyperthyroidism and rheumatoid arthritis

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of physical therapy modern University for technology and science

    Cairo, 002

Other trials in Egypt

About this study

Official title: Effect of High- Power Pain Threshold Ultrasound Versus Extracorporeal Shock Wave on Myoelectric Activity of Upper Trapezius Myofascial Trigger Point

Myofascial trigger points are a muscular dysfunction at the level of the motor end-plate and the sarcoplasmic reticula that, in turn, cause a local contraction with ischemia -induced hypoxia. Along with the hypoxia, the resulting energy crisis leads to a sensation of the surrounding nociceptors . Extracorporeal shock wave therapy (ESWT) is recently considered an effective treatment for myofascial pain syndrome. It's been proved an effective in musculoskeletal disease fasciitis

. It is significant since it is a non-invasive and simple treatment, easy to apply at a large surface, and has fewer side effects with low intensity even if it requires relatively high cost, ESWT has been proved to be more effective than conventional ultrasound on MTrPs in the upper trapezius muscle and showed that ESWT is more effective

Read more

. It has been found that three sessions of ESWT significantly improved pain levels, neck disabilities, and the quality of life by reducing the number of MTrPs .

ESWT could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia.

Ultrasound with deep heat is used in treatment of myofascial trigger point due to the properties of achieving vasodilation, accelerating the metabolism, increasing viscoelasticity and reducing pain and muscle spasm

High power pain threshold ultrasound found to be effective in many literatures in treatment of myofascial trigger point

. Study was performed comparing effect of high power pain threshold ultrasound with conventional ultrasound proved that high power pain threshold is more effective in treating upper trapezius myofascial It was found in the treatment of MPS, HPPT US therapy could be considered as a reliable and more effective and has positive effect method than low-dose and conventional US therapies

This study will be presented as a part of ongoing study. The ongoing study investigates the effect of different intensities of ultrasound on upper trapezius trigger points. The current study will investigate the myoelectric activities of trigger points after application of high power pain threshold ultrasound

Read the detailed description

Myofascial pain is defined as pain that originates from myofascial trigger points in skeletal muscle. It is prevalent in regional musculoskeletal pain syndromes, either alone or in combination with other pain generators Myofascial pain syndrome is represented by many clinical symptoms such as pain, hyperirritable nodule of spot tenderness, referred pain, and muscle spasm by trigger points. The upper trapezius is probably the muscle most often beset by trigger points It was assumed that the muscle fibers are shortened and taut bands are made by calcium influx in damaged fibers or acetylcholine secretion in motor end plates. The trigger points are the hyperirritable nodules of spot tenderness in a palpable taut band of skeletal muscle that may cause pain to a distant point and also causes distant motor and autonomic effects Once myofascial trigger points are activated, changes in the structural characteristics and contraction function of the muscle will occur. The most distinctive changes are taut bands, tender nodules, referred pain, local twitch response, muscle weakness, and restricted range of motion Patients with unilateral pain of an upper trapezius muscle exposed to a fatiguing load analyzed with surface electromyography (sEMG) were found to have a difference in sEMG response between healthy and symptomatic muscle Surface electromyography (EMG) analyzes functional changes in muscle by measuring quantitative changes in motor unit action potential that is activated by muscle contraction

Surface EMG, which was used to evaluate the functionality of trigger points in this study, is nonintrusive and convenient; thus, it is widely used in studies on the functional characteristics of muscle, by analyzing the electrical activity of muscle Surface EMG recording fortrigger points shows changes in recruitment of fast-twitch muscle fibers and conduction velocity of motor unit action potential According to Gemmell and Bagust (2009) EMG recordings confirm increased spontaneous activity of motor units in patients with myofascial pain during the "resting state" of muscles.

The treatments of myofascial pain are divided into the invasive and the non-invasive therapy. The invasive therapy is about the injection of medications, dry needling and non-invasive therapy refers to massage, stretching and ultrasound Extracorporeal shock wave therapy (ESWT) is recently considered an effective treatment for myofascial pain

, It is a non-invasive and simple treatment, easy to apply at a large surface, and has fewer side effects with low intensity even if it requires relatively high cost.

ESWT could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia .

High power pain threshold ultrasound resolve acute active trigger points . High power-pain threshold ultrasound efficient method for relieving painand disability and increasing range of motion Although significant in decreasing tissue stiffness Previous study, which is the first to make a combined evaluation of the effectiveness of low-, moderate- and high dose (HPPT) US therapies in MPS, the results obtained considered significantly in that greater improvements in clinical parameters were generally determined going from low dose to high dose and that the effect was achieved in only four sessions of HPPT US therapy. the cycle of pain-spasm-ischemia-pain is more effectively resolved when the dosage of US, applied for the treatment of trigger points in MPS, is increased the cycle of pain-spasm-ischemia-pain is more effectively resolved when the dosage of US, applied for the treatment of trigger points in MPS, is increased. Therefore, HPPT US therapy can be considered as a more economical treatment than conventional US treatments due to less number of treatment sessions.

Being tested
extracorporeal shock wave and conventional treament, high pain threshold ultrasound and conventional treatment for myofascial pain syndrome trigger points, conventional treatment for myofascial pain trigger point
Medical subject headings
Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • extracorporeal shock wave and conventional treamentDevice

    Also called extracorporeal shock wave

    Extracorporeal shock wave for 700 impulses of 0.056 mJ/mm at a frequency of 10 Hz to the taut band and 300 impulses surrounding the taut band will be applied as low energy 2 sessions per week for 2 weeks The will be used as a radial type of shock wave therapy.

    Strengthening, stretching exercises and ischemic compression:

    1. Isometric neck extensor exercise:
    2. Isometric neck flexor exercise:
    3. Isometric neck side bending muscle exercise:

    Stretching exercise:

    Passive stretching for the neck extensor muscles:

    Passive stretching of the neck side-bending muscles:

    Ischemic compression

  • high pain threshold ultrasound and conventional treatment for myofascial pain syndrome trigger pointsDevice

    Also called HPPT

    will be applied in continuous mode, with the probe placed directly on the TrP and held motionless. To elicit threshold pain, the US probe will be kept static on the TrP. Intensity gradually will be increased to the level of maximum pain the patient could bear. It will be kept at that level for 3 to 4 seconds, then will be reduced to the half-intensity level for another 15 seconds. This procedure was repeated 3 times.the intensity of US will be dependent on the patient's level of pain. intensity will be applied in the range of 0.5 to 2.0 Watt per/cm2. Patients continually report their pain level and its localization and nature High-power pain threshold US will be applied 4 times, with a 3-day interval 2 sessions per week for 2 weeks .

    1)Isometric neck extensor exercise2)Isometric neck flexor exercise3)Isometric neck side bending muscle exercise,Stretching exercise:Passive stretching for the neck extensor muscles ,stretching of the neck side-bending muscles,Ischemic compression

  • conventional treatment for myofascial pain trigger pointOther

    Strengthening, stretching exercises and ischemic compression:

    1. Isometric neck extensor exercise:
    2. Isometric neck flexor exercise:
    3. Isometric neck side bending muscle exercise:

    Stretching exercise:

    Passive stretching for the neck extensor muscles:

    Passive stretching of the neck side-bending muscles:

    Ischemic compression

Study groups in NCT04778462
Study groupRoleWhat they receive
Extracorporeal shock waveExperimentalExtracorporeal shock wave group A consist of 15 subject will receive extracorporeal shock wave and conventional treatment for trigger points for two weeks four treatment sessions
Receives: Device: extracorporeal shock wave and conventional treament
High-power pain thershold ultrasoundExperimentalHigh -power pain thershold group b consist of 15 subject will receive high power pain threshold ultrasound and conventional treatment for upper trapezius trigger points for two weeks four treatment session
Receives: Device: high pain threshold ultrasound and conventional treatment for myofascial pain syndrome trigger points
Controlled groupOthercontrolled group consist of 15 subjects will receive conventional treatment for trigger point for two weeks
Receives: Other: conventional treatment for myofascial pain trigger point

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. surface electromyography

    change in electrical activity of Trigger points of upper trapezius using surface electromyography

    Measured: before treatment and after 2 weeks of treatment

  2. pressure algometer

    change in pressure pain threshold for upper trapezius trigger

    Measured: before treatment and 2 weeks after treatment

  3. Neck disability index

    change in the neck function scale contain 10 category each category contains six choices from zero to five ,score from zero to four no disability from five to fifteen this is mild,from fifteen to twenty-four this is moderate, from twenty-five to thirty-four this is severe

    Measured: before treatment and 2 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study start15 Feb 2020
  3. Primary completion1 Apr 2021
  4. Study completion14 Apr 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
1. sixty subjects from both genders with their age between 20 and 26 years old 2. Symptoms of active TrPs unilateral on at least one side of the upper fiber of trapezius muscle presence of at least one trigger point symptoms lasting from 0 to 2 weeks age 3. The patients will be randomly assigned into three different groups Group (A) will receive extracorporeal shock wave plus stretch, strength exercise and ischemic compression Group (B) will receive high-power pain threshold ultrasound plus stretch, strength exercise and ischemic compression Group (C) will receive conventional treatment (stretch, strength exercise and ischemic compression.
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04778462
Sponsor's protocol ID
Mti
Status last verified
May 2021
First submitted
18 Feb 2021
Last updated
26 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing extracorporeal shock wave and conventional treament, high pain threshold ultrasound and conventional treatment for myofascial pain syndrome trigger points and conventional treatment for myofascial pain trigger point in people with Trigger Point Pain, Myofascial, run by MTI University at 1 site in Egypt.

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 3 inclusion and 4 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 26 May 2021. 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 Egypt. 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?

surface electromyography (time frame: before treatment and after 2 weeks of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 May 2021.

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