Myofascial Pain SyndromeTrP-TMDNCT03619889
The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder
A study testing Manual pressure release technique on trigger points. in people with Myofascial Pain Syndrome and Temporomandibular Disorder, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Participants with chronic orofacial pain caused by masticatory and neck muscles will be distributed in two groups, both followed with the same occlusal and self-care treatment. The experimental group will receive 5 sessions of physiotherapy applying a specific pressure on the trigger points while the control group… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain Syndrome, Temporomandibular Disorder
- What is being tested?
- Manual pressure release technique on trigger points.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years.
- Patients diagnosed of myofascial TMD with at least one TrP with referred pain.
- TMD patients with a current complaint of myofascial pain with more than 6 months of evolution.
- Patients with myofascial TMD initially treated with splint currently used, that has not been modified in the last 6 months, without improvement.
Who cannot join
- Patients treated with occlusal splint recently modified.
- Patients with acute TMJ diseases.
- Patients with systemic disease, neurological and muscular diseases.
- Patients with psychiatric or psychological disorders.
- Patients with cervical disc hernia and acute whiplash injury.
- Changes in the painkillers intake during the experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Pressure Release Technique on Masticatory and Neck Muscle Trigger Points in Patients With Chronic Myofascial Temporomandibular Disorder
Participants with chronic orofacial pain caused by masticatory and neck muscles will be distributed in two groups, both followed with the same occlusal and self-care treatment. The experimental group will receive 5 sessions of physiotherapy applying a specific pressure on the trigger points while the control group will receive placebo through a simulation of the same technique. Orofacial perceived pain, pain pressure thresholds, catastrophizing, kinesiophobia, cervical disability, depression and anxiety will be evaluated at baseline, immediately after treatment and 3 months later.
- Being tested
- Manual pressure release technique on trigger points., Sham
- Keywords
- Chronic Pain, Physical Therapy modalities
- Medical subject headings
- Myofascial Pain Syndromes, Temporomandibular Joint Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual pressure release technique on trigger points.Other
Also called Myofascial release
A specific pressure is applied on trigger points of masticatory and neck muscles between pain pressure threshold and pain tolerance (7-8 visual analog scale).
ShamOther
Also called Placebo
A simulated pressure release technique is applied around masticatory and neck muscles.
| Study group | Role | What they receive |
|---|---|---|
| Sham simulation group | Sham comparator | A simulation of the pressure release technique, applying a soft pressure or contact in the same muscles sites or trigger points than in the intervention group. Receives: Other: Sham |
| Pressure release technique group | Experimental | The release pressure technique is applied in the trigger points of masticatory and neck muscles (upper trapezius, sternal and clavicular sternocleidomastoid, deep and superficial masseter, posterior, medium and anterior temporalis. Receives: Other: Manual pressure release technique on trigger points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique)
The Visual Analogue Scale (0-10) was used, 0 representing no pain/better outcome, and 10 representing unbearable pain/worst outcome.
the clinical minimum relevance outcome is at least a change of 1.2 points in the scale.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Secondary outcomes (12)
Changes of Pain Pressure Thresholds Anterior Temporalis
An algometer Wagner Force One FDX 50 was used, measured in kgf/cm^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Range of the Opening of the Mouth
A calibrator Dentaurum München was used, measured in millimetres, with 0 representing no opening/worst outcome and as higher values/as a better outcome.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Neck Disability
The Neck Disability Index was used (0-50), with 0 representing no disability neck/best outcome and 50 maximum disability neck/worst outcome.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Kinesiophobia
The Tampa Scale for Kinesiophobia -11 was used (0-44), with 0 representing no kinesiophobia/best outcome and 44 representing the highest level of kinesiphobia/worst outcome.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Catastrophizing
The Pain Catastrophizing Scale was used (0-52), with 0 representing no catastrophizing/best outcome and 52 representing the highest level of catastrophizing/worst outcome.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the State Anxiety
The State-Trait Anxiety Index was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no state anxiety/best outcome and 80 representing the highest level of state anxiety/worst outcome.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the State Depression
The State-Trait Depression Inventory was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no state depression/best outcome and 80 representing the highest level of state depression/worst outcome
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Trait Anxiety
The State-Trait Anxiety Index was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no trait anxiety/best outcome and 80 representing the highest level of trait anxiety/worst outcome.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Trait Depression
The State-Trait Depression Inventory was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no Trait Depression/best outcome and 80 representing the highest level of Trait Depression/worst outcome
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes of Pain Pressure Thresholds Upper Trapezius
An algometer Wagner Force One FDX 50 was used, measured in kgf/cm^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid
An algometer Wagner Force One FDX 50 was used, measured in kgf/cm^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Changes of Pain Pressure Thresholds Superficial Masseter
An algometer Wagner Force One FDX 50 was used, measured in kgf/cm^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.
Measured: Change from baseline in the scale at post-treatment and at 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study startOct 2015
- Primary completion1 Apr 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Model description
- clinical trial, prospective, randomized and experimental with masking of the statistician and the participants
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gema Serrano-Hernanz, Universidad Complutense de Madrid
- Investigators
- Gema Serrano-Hernanz, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619889
- Sponsor's protocol ID
- Geseher
- Acronym
- TrP-TMD
- Status last verified
- Mar 2020
- First submitted
- 27 May 2018
- Last updated
- 20 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serrano-Hernanz G, Angulo-Carrere T, Ardizone-Garcia I, Svensson P, Alvarez-Mendez AM. Pressure release technique versus placebo applied to cervical and masticatory muscles in patients with chronic painful myofascial temporomandibular disorder: A randomised clinical trial. J Oral Rehabil. 2023 Sep;50(9):782-791. doi: 10.1111/joor.13490. Epub 2023 May 25.
PubMed 37163204
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Pressure Release Technique on Masticatory and Neck Muscle Trigger Points in Patients With Chronic Myofascial Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT03619889
- Acronym / sponsor ID
- TrP-TMD / Geseher
- Keywords
- Chronic Pain, Physical Therapy modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Posted 24 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants with chronic orofacial pain caused by masticatory and neck muscles will be distributed in two groups, both followed with the same occlusal and self-care treatment. The experimental group will receive 5 sessions of physiotherapy applying a specific pressure on the trigger points while the control group will receive placebo through a simulation of the same technique. Orofacial perceived pain, pain pressure thresholds, catastrophizing, kinesiophobia, cervical disability, depression and anxiety will be evaluated at baseline, immediately after treatment and 3 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- clinical trial, prospective, randomized and experimental with masking of the statistician and the participants
| Arm | Type | Receives |
|---|---|---|
| Sham simulation group | Sham comparator | Other: ShamA simulation of the pressure release technique, applying a soft pressure or contact in the same muscles sites or trigger points than in the intervention group. |
| Pressure release technique group | Experimental | Other: Manual pressure release technique on trigger points.The release pressure technique is applied in the trigger points of masticatory and neck muscles (upper trapezius, sternal and clavicular sternocleidomastoid, deep and superficial masseter, posterior, medium and anterior temporalis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥18 years.
- Patients diagnosed of myofascial TMD with at least one TrP with referred pain.
- TMD patients with a current complaint of myofascial pain with more than 6 months of evolution.
- Patients with myofascial TMD initially treated with splint currently used, that has not been modified in the last 6 months, without improvement.
Key exclusion criteria (6 listed)
- Patients treated with occlusal splint recently modified.
- Patients with acute TMJ diseases.
- Patients with systemic disease, neurological and muscular diseases.
- Patients with psychiatric or psychological disorders.
- Patients with cervical disc hernia and acute whiplash injury.
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 |
|---|---|---|
| Manual pressure release technique on trigger points.Also: Myofascial releaseA specific pressure is applied on trigger points of masticatory and neck muscles between pain pressure threshold and pain tolerance (7-8 visual analog scale). | Other | Pressure release technique group |
| ShamAlso: PlaceboA simulated pressure release technique is applied around masticatory and neck muscles. | Other | Sham simulation group |
Primary outcome
Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique)
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
The Visual Analogue Scale (0-10) was used, 0 representing no pain/better outcome, and 10 representing unbearable pain/worst outcome. the clinical minimum relevance outcome is at least a change of 1.2 points in the scale.
12 secondary outcomes
Changes of Pain Pressure Thresholds Anterior Temporalis
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Range of the Opening of the Mouth
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Neck Disability
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Kinesiophobia
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Catastrophizing
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the State Anxiety
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the State Depression
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Trait Anxiety
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes in the Trait Depression
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes of Pain Pressure Thresholds Upper Trapezius
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Changes of Pain Pressure Thresholds Superficial Masseter
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37163204Serrano-Hernanz G, Angulo-Carrere T, Ardizone-Garcia I, Svensson P, Alvarez-Mendez AM. Pressure release technique versus placebo applied to cervical and masticatory muscles in patients with chronic painful myofascial temporomandibular disorder: A randomised clinical trial. J Oral Rehabil. 2023 Sep;50(9):782-791. doi: 10.1111/joor.13490. Epub 2023 May 25.
- Individual participant dataSharing planned: No
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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.
Gema Serrano-Hernanz principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual pressure release technique on trigger points. in people with Myofascial Pain Syndrome and Temporomandibular Disorder, run by Universidad Complutense de Madrid 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 4 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 20 Mar 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 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique) (time frame: Change from baseline in the scale at post-treatment and at 3 months later). 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 NCT03619889, 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 20 Mar 2020.