Myofascial Pain SyndromeNCT03006822
Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points
A study testing Pressure release 90, Pressure release 60 and Pressure release 30 in people with Myofascial Pain Syndrome, run by University of Alcala at 1 site in Spain.
Trial summary
Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high prevalent and may influence the neck and shoulder conditions. The pressure release is one of the most recommended manual therapy techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Pressure release 90, Pressure release 60 and Pressure release 30
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2017to 10 Jul 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with aged between 18 and 60 years.
- Subjects with presence of latent PGM levator scapulae muscle.
Who cannot join
- Pregnant.
- Subjects with spontaneous pain.
- Subjects with neck or shoulder pain.
- Subjects with musculoskeletal injuries.
- Subjects with neurological problems.
- Fibromyalgia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points of the Levator Scapulae
Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high prevalent and may influence the neck and shoulder conditions. The pressure release is one of the most recommended manual therapy techniques.
Objective: To determine the time effect of the pressure release technique application in the latent MTrPs of the levator scapulae muscle.
Read more
Design: A three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial.
The manual technique than us apply, be sustained digital pressure with thumbs or with the 2nd-3rd fingers on the PGM below the pain threshold and gradually increases up to a ceiling of tissue resistance (barrier), as decreases, adds more pressure. different times of sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a control), 60 (group 2) and 90 seconds (group 3) shall apply.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Pressure release 90, Pressure release 60, Pressure release 30
- Keywords
- Myofascial Trigger Points, Liberation for Pression, Therapy Soft Tissue
- 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.
Pressure release 90Other
Also called soft tissue massage, Compression ischemic massage technique
This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
Pressure release 60Other
Also called Compression ischemic massage technique, soft tissue massage
This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
Pressure release 30Other
Also called Compression ischemic massage technique, soft tissue massage
This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
| Study group | Role | What they receive |
|---|---|---|
| Application 90 minutes pressure release | Experimental | Subjects will receive a pressure release technique for 90 seconds in the levator scapula muscle Receives: Other: Pressure release 90 |
| Application 60 minutes pressure release | Experimental | Subjects will receive a pressure release technique for 60 seconds in the levator scapula muscle Receives: Other: Pressure release 60 |
| Application 30 minutes pressure release | Experimental | Subjects will receive a pressure release technique for 30 seconds in the levator scapula muscle Receives: Other: Pressure release 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold (PPT)
PPT is defined as the minimal amount of pressure that produce pain. The investigators will measure the muscle levator scapular tenderness.
Measured: Change from Baseline PPT at one week
Secondary outcomes (1)
Strength muscle
The investigators will measure strength muscle with a handheld dynamometer. the subject will have to perform a movement of cervical extension resistance against.
Measured: Change from Baseline strength muscle at one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start15 Mar 2017
- Primary completion20 Mar 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, Doctor, Study director, Alcalá University (Physical Therapy and pain group)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006822
- Sponsor's protocol ID
- Universidad de Alcalá
- Status last verified
- Oct 2017
- First submitted
- 27 Oct 2016
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pecos-Martin D, Ponce-Castro MJ, Jimenez-Rejano JJ, Nunez-Nagy S, Calvo-Lobo C, Gallego-Izquierdo T. Immediate effects of variable durations of pressure release technique on latent myofascial trigger points of the levator scapulae: a double-blinded randomised clinical trial. Acupunct Med. 2019 Jun;37(3):141-150. doi: 10.1136/acupmed-2018-011738. Epub 2019 May 7.
PubMed 31060367
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points of the Levator Scapulae
- ClinicalTrials.gov ID
- NCT03006822
- Acronym / sponsor ID
- Universidad de Alcalá
- Conditions
- Myofascial Pain Syndrome
- Keywords
- Myofascial Trigger Points, Liberation for Pression, Therapy Soft Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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.
Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high prevalent and may influence the neck and shoulder conditions. The pressure release is one of the most recommended manual therapy techniques.
Objective: To determine the time effect of the pressure release technique application in the latent MTrPs of the levator scapulae muscle.
Design: A three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial.
The manual technique than us apply, be sustained digital pressure with thumbs or with the 2nd-3rd fingers on the PGM below the pain threshold and gradually increases up to a ceiling of tissue resistance (barrier), as decreases, adds more pressure. different times of sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a control), 60 (group 2) and 90 seconds (group 3) shall apply.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Application 90 minutes pressure release | Experimental | Other: Pressure release 90Subjects will receive a pressure release technique for 90 seconds in the levator scapula muscle |
| Application 60 minutes pressure release | Experimental | Other: Pressure release 60Subjects will receive a pressure release technique for 60 seconds in the levator scapula muscle |
| Application 30 minutes pressure release | Experimental | Other: Pressure release 30Subjects will receive a pressure release technique for 30 seconds in the levator scapula muscle |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects with aged between 18 and 60 years.
- Subjects with presence of latent PGM levator scapulae muscle.
Key exclusion criteria (6 listed)
- Pregnant.
- Subjects with spontaneous pain.
- Subjects with neck or shoulder pain.
- Subjects with musculoskeletal injuries.
- Subjects with neurological problems.
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 |
|---|---|---|
| Pressure release 90Also: soft tissue massage, Compression ischemic massage techniqueThis is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain. | Other | Application 90 minutes pressure release |
| Pressure release 60Also: Compression ischemic massage technique, soft tissue massageThis is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain. | Other | Application 60 minutes pressure release |
| Pressure release 30Also: Compression ischemic massage technique, soft tissue massageThis is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain. | Other | Application 30 minutes pressure release |
Primary outcome
Pain pressure threshold (PPT)
Time frame: Change from Baseline PPT at one week
PPT is defined as the minimal amount of pressure that produce pain. The investigators will measure the muscle levator scapular tenderness.
1 secondary outcome
Strength muscle
Time frame: Change from Baseline strength muscle at one week
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 4 Oct 2017.
- Derived from this study: PubMed 31060367Pecos-Martin D, Ponce-Castro MJ, Jimenez-Rejano JJ, Nunez-Nagy S, Calvo-Lobo C, Gallego-Izquierdo T. Immediate effects of variable durations of pressure release technique on latent myofascial trigger points of the levator scapulae: a double-blinded randomised clinical trial. Acupunct Med. 2019 Jun;37(3):141-150. doi: 10.1136/acupmed-2018-011738. Epub 2019 May 7.
- Individual participant dataSharing planned: No
Related trials for Myofascial Pain Syndrome
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
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.
Daniel Pecos-Martin, Doctor study director
Alcalá University (Physical Therapy and pain group)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure release 90, Pressure release 60 and Pressure release 30 in people with Myofascial Pain Syndrome, run by University of Alcala at 1 site in Spain.
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 6 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 4 Oct 2017. 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 Spain. 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 pressure threshold (PPT) (time frame: Change from Baseline PPT at one week). 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 NCT03006822, which also lists 1 linked publication.
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 4 Oct 2017.