Myofascial Pain SyndromeNCT05187468
The Effectiveness of Radial ESWT on Upper Trapezius Mtrps
A study testing Extracorporeal Shockwave Therapy and Ultrasound therapy, Massage, Heat pack in people with Myofascial Pain Syndrome and Myofascial Trigger Point Pain, run by European University Cyprus at 1 site in Cyprus.
Trial summary
This study looked after the effectiveness of radial ESWT on upper trapezius mtrps. There were three intervention groups which recieved either ESWT or standard care. VAS, PPT, Neck ROM and Cervical functionality were the main outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome, Myofascial Trigger Point Pain, Upper Trapezius Trigger Points
- What is being tested?
- Extracorporeal Shockwave Therapy and Ultrasound therapy, Massage, Heat pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Aug 2019to 28 Feb 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain between shoulder and neck on upper trapezius muscle
- Three out of five of Travel and Simons criteria for myofascial trigger points
Who cannot join
- Fibromyalgia diagnosis
- Systemic diseases diagnosis,
- Pacemaker, under 18,
- Any kind of cervical disorder or surgery,
- Mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Radial Extracorporeal Shockwave on Upper Trapezius Myofascial Trigger Points
This study looked after the effectiveness of radial ESWT on upper trapezius mtrps. There were three intervention groups which recieved either ESWT or standard care. VAS, PPT, Neck ROM and Cervical functionality were the main outcomes.
Read the detailed description
This study was a randomized controlled trial consisted of three intervention groups. Two of them recieved ESWT with different parameters in each group, while the third one was standard care recieving Ultrasound therapy, Therapeutic massage and Heat packs Participants were divided randomly into the three groups. Participants were blind to the group allocated and also the therapist and outcome investigator were blind.
The participants recieved three weekly sessions. The evaluation took place before therapy, after each session and one month after last session.
The outcome measures was the pain intensity with VAS, the pain tolerance to pressure by an algometer device, the range of motion of neck measured by electronic goniometer and and functionality of neck measured by the Northwick Park Neck Pain
- Being tested
- Extracorporeal Shockwave Therapy, Ultrasound therapy, Massage, Heat pack
- Keywords
- Myofascial Trigger points, upper trapezius, Myofascial pain syndrome, Mtrps
- 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 Shockwave TherapyDevice
Also called ESWT, rSWT
1000 pulses at 60 mj, 10 Hz
Extracorporeal Shockwave TherapyDevice
2000 pulses at 60 mj, 10 Hz
Ultrasound therapy, Massage, Heat packDevice
Ultrasound therapy 5 min, 1,2W/cm2, 10 min Massage, 10 min heat pack
| Study group | Role | What they receive |
|---|---|---|
| ESWT 1 | Experimental | Extracorporeal Shockwave Therapy 1000 pulses, 60 mJ, 10 Hz Receives: Device: Extracorporeal Shockwave Therapy |
| ESWT 2 | Experimental | Extracorporeal Shockwave Therapy 2000 pulses, 60 mJ, 10 Hz Receives: Device: Extracorporeal Shockwave Therapy |
| Ultrasound therapy, Massage, Heat Pack | Active comparator | 10 Min massage 5 min US therapy 10 min Heat pack Receives: Device: Ultrasound therapy, Massage, Heat pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity on myofascial trigger points
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Measured: baseline
Pain intensity on myofascial trigger points
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Measured: one week
Pain intensity on myofascial trigger points
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Measured: two weeks
Pain intensity on myofascial trigger points
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Measured: three weeks
Pain intensity on myofascial trigger points
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Measured: 1 month after
Pressure Pain Threshold
Pain tolerance to compression. Measured in kilos
Measured: baseline
Pressure Pain Threshold
Pain tolerance to compression. Measured in kilos
Measured: one week
Pressure Pain Threshold
Pain tolerance to compression. Measured in kilos
Measured: two weeks
Pressure Pain Threshold
Pain tolerance to compression. Measured in kilos
Measured: three weeks
Pressure Pain Threshold
Pain tolerance to compression. Measured in kilos
Measured: one month after
cervical range of motion
Goniometer (measured in degrees)
Measured: baseline
cervical range of motion
Goniometer (measured in degrees)
Measured: one week
cervical range of motion
Goniometer (measured in degrees)
Measured: two weeks
cervical range of motion
Goniometer (measured in degrees)
Measured: three weeks
cervical range of motion
Goniometer (measured in degrees)
Measured: one month after
Northwick Park Neck Pain questionnaire
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Measured: baseline
Northwick Park Neck Pain questionnaire
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Measured: one week
Northwick Park Neck Pain questionnaire
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Measured: two weeks
Northwick Park Neck Pain questionnaire
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Measured: three weeks
Northwick Park Neck Pain questionnaire
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Measured: one month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Aug 2019
- Primary completion30 Oct 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rentzias Panagiotis, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187468
- Sponsor's protocol ID
- EuropeanUC
- Status last verified
- Sep 2021
- First submitted
- 19 Sep 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Radial Extracorporeal Shockwave on Upper Trapezius Myofascial Trigger Points
- ClinicalTrials.gov ID
- NCT05187468
- Acronym / sponsor ID
- EuropeanUC
- Keywords
- Myofascial Trigger points, upper trapezius, Myofascial pain syndrome, Mtrps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- European University CyprusUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 11 Jan 2022 (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.
This study looked after the effectiveness of radial ESWT on upper trapezius mtrps. There were three intervention groups which recieved either ESWT or standard care. VAS, PPT, Neck ROM and Cervical functionality were the main outcomes.
Detailed description
This study was a randomized controlled trial consisted of three intervention groups. Two of them recieved ESWT with different parameters in each group, while the third one was standard care recieving Ultrasound therapy, Therapeutic massage and Heat packs Participants were divided randomly into the three groups. Participants were blind to the group allocated and also the therapist and outcome investigator were blind.
The participants recieved three weekly sessions. The evaluation took place before therapy, after each session and one month after last session.
The outcome measures was the pain intensity with VAS, the pain tolerance to pressure by an algometer device, the range of motion of neck measured by electronic goniometer and and functionality of neck measured by the Northwick Park Neck Pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESWT 1 | Experimental | Device: Extracorporeal Shockwave TherapyExtracorporeal Shockwave Therapy 1000 pulses, 60 mJ, 10 Hz |
| ESWT 2 | Experimental | Device: Extracorporeal Shockwave TherapyExtracorporeal Shockwave Therapy 2000 pulses, 60 mJ, 10 Hz |
| Ultrasound therapy, Massage, Heat Pack | Active comparator | Device: Ultrasound therapy, Massage, Heat pack10 Min massage 5 min US therapy 10 min Heat pack |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pain between shoulder and neck on upper trapezius muscle
- Three out of five of Travel and Simons criteria for myofascial trigger points
Key exclusion criteria (5 listed)
- Fibromyalgia diagnosis
- Systemic diseases diagnosis,
- Pacemaker, under 18,
- Any kind of cervical disorder or surgery,
- Mental disorders
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 |
|---|---|---|
| Extracorporeal Shockwave TherapyAlso: ESWT, rSWT1000 pulses at 60 mj, 10 Hz | Device | ESWT 1 |
| Extracorporeal Shockwave Therapy2000 pulses at 60 mj, 10 Hz | Device | ESWT 2 |
| Ultrasound therapy, Massage, Heat packUltrasound therapy 5 min, 1,2W/cm2, 10 min Massage, 10 min heat pack | Device | Ultrasound therapy, Massage, Heat Pack |
Primary outcome
Pain intensity on myofascial trigger points
Time frame: baseline
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Pain intensity on myofascial trigger points
Time frame: one week
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Pain intensity on myofascial trigger points
Time frame: two weeks
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Pain intensity on myofascial trigger points
Time frame: three weeks
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Pain intensity on myofascial trigger points
Time frame: 1 month after
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Pressure Pain Threshold
Time frame: baseline
Pain tolerance to compression. Measured in kilos
Pressure Pain Threshold
Time frame: one week
Pain tolerance to compression. Measured in kilos
Pressure Pain Threshold
Time frame: two weeks
Pain tolerance to compression. Measured in kilos
Pressure Pain Threshold
Time frame: three weeks
Pain tolerance to compression. Measured in kilos
Pressure Pain Threshold
Time frame: one month after
Pain tolerance to compression. Measured in kilos
cervical range of motion
Time frame: baseline
Goniometer (measured in degrees)
cervical range of motion
Time frame: one week
Goniometer (measured in degrees)
cervical range of motion
Time frame: two weeks
Goniometer (measured in degrees)
cervical range of motion
Time frame: three weeks
Goniometer (measured in degrees)
cervical range of motion
Time frame: one month after
Goniometer (measured in degrees)
Northwick Park Neck Pain questionnaire
Time frame: baseline
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Northwick Park Neck Pain questionnaire
Time frame: one week
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Northwick Park Neck Pain questionnaire
Time frame: two weeks
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Northwick Park Neck Pain questionnaire
Time frame: three weeks
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Northwick Park Neck Pain questionnaire
Time frame: one month after
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
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 11 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy and Ultrasound therapy, Massage, Heat pack in people with Myofascial Pain Syndrome and Myofascial Trigger Point Pain, run by European University Cyprus at 1 site in Cyprus.
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 2 inclusion and 5 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 11 Jan 2022. 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 Cyprus. 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?
Pain intensity on myofascial trigger points (time frame: baseline). The study lists 20 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 11 Jan 2022.