Trigger Point Pain, MyofascialNCT03585283
Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points
A study testing Myofascial Group in people with Trigger Point Pain, Myofascial and Neck Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Aim of this study is to investigate effectiveness of myofascial releasing on neck pain related to trigger points located on upper cervical region. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trigger Point Pain, Myofascial, Neck Pain
- What is being tested?
- Myofascial Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2018to 20 Mar 2019
- 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
- Non specific cervical pain
- Symptoms should last longer than 4 weeks
- Palpable trigger points on upper thoracic region
Who cannot join
- Cervical radiculopathy
- Previous manual therapy treatment history
- Sensory or motor function loss
- Rheumatologic diseases
- Structural damage on cervical spina
- Trauma history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points: A Single Blinded, Randomized Controlled Trial
Aim of this study is to investigate effectiveness of myofascial releasing on neck pain related to trigger points located on upper cervical region.
Read the detailed description
Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is 27.2% female and 17.4% in male population. Approximately 1/3 of acute onset neck aches become chronic. It causes increasing the cost of treatment and also the loss of labor.
Myofascial pain is usually considered caused by myofascial trigger points. The trigger points in the neck muscles have been associated with a possible source of referred facial and cranial pain. Mechanical neck pain is a non-radicular pain caused by local musculoskeletal structures and is characterized by a spasm of the cervical muscles. Posture, emotional stress, cold and fatigue are etiologic causes, and pain is also reflected to the cervical, occipital and scapular regions depending on the severity of muscle spasm and the presence of trigger point in myofascial pain syndrome.
Myofascial releasing is a specific type of passive soft tissue mobilization. Triggers points often considered as a pathology that occurs after excessive load or trauma on soft tissue which disturbs blood circulation. Fascial restriction can be found with triggers points and taut band.
In this study effects of myofascial release on triggers points will be investigated.
- Conditions
- Trigger Point Pain, Myofascial, Neck Pain
- Being tested
- Myofascial Group, Sham Group
- Keywords
- Myofascial Release, Manual Therapies
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial GroupOther
Manual myofascial release will be applied at prone position. Patient's upper thoracic and cervical region will be undressed. Researcher will use direct and indirect myofascial release techniques on upper thoracic and cervical region focusing on trigger point located muscles (most frequently m. trapezius)
Sham GroupOther
Patient's upper thoracic and cervical region will be undressed. Researcher will place his hands on points that used for myofascial release however no pressure or release techniques will be used.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Group | Experimental | Myofascial release will be applied by physiotherapist two times a week for four weeks which is a manual therapy technique includes stretching and compression of soft tissues according to fascial chains.Each session will be approximately 45 min long. Participant will be reevaluated 8 week later after last session for a follow-up assessment. Receives: Other: Myofascial Group |
| Sham Group | Sham comparator | Sham application will be applied two times a week for four weeks. Each session will be approximately 45 min long. Participant will be reevaluated 8 week later after last session for a follow-up assessment. Receives: Other: Sham Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain Pressure Threshold on Trigger Points with Algometer
Trigger points will be located with palpation and with slight pressure most painful one will be marked. Pressure will be applied by researcher and patient will be informed to notify researcher immediately after starting to feel pain from pressure.
Measured: 12 weeks
Secondary outcomes (4)
Neck Disability Index
The Neck Disability Index will be used to record perceived disability according to patients with neck pain. Neck disability index is a 10 question self administrated questionaire. Each question scored from 0-5 for a total of 50 point.
Measured: 12 weeks
Assessment of Perceived Pain on Cervical Region
Visual analog scale (VAS) will be used to assess patients' pain while doing neck rotations. Patients will mark their perceived pain on a 10 cm horizontal line. Left side of line considered as 0 (no pain at all) and right side considered as 10 (most intense pain experienced so far).
Measured: 12 weeks
Global Rating of Change Scale-Turkish Version
Patients global perception on effects of treatment will be assessed with a 9 aspect scale. 5 was considered as no change from the baseline and 1-4 indicate decline in symptoms and 6-9 indicate improvement.
Measured: 12 weeks
Assessment of Cervical Active Range of Motion (ROM)
Patients cervical flexion, lateral flexin and rotation ROM's will be assessed with a goniometer.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start12 Aug 2018
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Point Pain, MyofascialStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Patients' information and contact will be obtained from physiatrist and willing participant's gender, age and pain onset data will be processed with a random number generator in order to form groups. Patients will divide randomly into two groups as intervention and control with a normal distribution of gender, age and pain onset.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Şebnem Avcı, Ph.D, Study director, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585283
- Sponsor's protocol ID
- AbantIBU-Phys2
- Status last verified
- Mar 2019
- First submitted
- 20 Jun 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Releasing on Neck Pain in Patients With Trigger Points: A Single Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03585283
- Acronym / sponsor ID
- AbantIBU-Phys2
- Conditions
- Trigger Point Pain, Myofascial, Neck Pain
- Keywords
- Myofascial Release, Manual Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 12 Aug 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 13 Jul 2018 (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.
Aim of this study is to investigate effectiveness of myofascial releasing on neck pain related to trigger points located on upper cervical region.
Detailed description
Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is 27.2% female and 17.4% in male population. Approximately 1/3 of acute onset neck aches become chronic. It causes increasing the cost of treatment and also the loss of labor.
Myofascial pain is usually considered caused by myofascial trigger points. The trigger points in the neck muscles have been associated with a possible source of referred facial and cranial pain. Mechanical neck pain is a non-radicular pain caused by local musculoskeletal structures and is characterized by a spasm of the cervical muscles. Posture, emotional stress, cold and fatigue are etiologic causes, and pain is also reflected to the cervical, occipital and scapular regions depending on the severity of muscle spasm and the presence of trigger point in myofascial pain syndrome.
Myofascial releasing is a specific type of passive soft tissue mobilization. Triggers points often considered as a pathology that occurs after excessive load or trauma on soft tissue which disturbs blood circulation. Fascial restriction can be found with triggers points and taut band.
In this study effects of myofascial release on triggers points will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients' information and contact will be obtained from physiatrist and willing participant's gender, age and pain onset data will be processed with a random number generator in order to form groups. Patients will divide randomly into two groups as intervention and control with a normal distribution of gender, age and pain onset.
| Arm | Type | Receives |
|---|---|---|
| Myofascial Group | Experimental | Other: Myofascial GroupMyofascial release will be applied by physiotherapist two times a week for four weeks which is a manual therapy technique includes stretching and compression of soft tissues according to fascial chains.Each session will be approximately 45 min long. Participant will be reevaluated 8 week later after last session for a follow-up assessment. |
| Sham Group | Sham comparator | Other: Sham GroupSham application will be applied two times a week for four weeks. Each session will be approximately 45 min long. Participant will be reevaluated 8 week later after last session for a follow-up assessment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non specific cervical pain
- Symptoms should last longer than 4 weeks
- Palpable trigger points on upper thoracic region
Key exclusion criteria (6 listed)
- Cervical radiculopathy
- Previous manual therapy treatment history
- Sensory or motor function loss
- Rheumatologic diseases
- Structural damage on cervical spina
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 |
|---|---|---|
| Myofascial GroupManual myofascial release will be applied at prone position. Patient's upper thoracic and cervical region will be undressed. Researcher will use direct and indirect myofascial release techniques on upper thoracic and cervical region focusing on trigger point located muscles (most frequently m. trapezius) | Other | Myofascial Group |
| Sham GroupPatient's upper thoracic and cervical region will be undressed. Researcher will place his hands on points that used for myofascial release however no pressure or release techniques will be used. | Other | Sham Group |
Primary outcome
Assessment of Pain Pressure Threshold on Trigger Points with Algometer
Time frame: 12 weeks
Trigger points will be located with palpation and with slight pressure most painful one will be marked. Pressure will be applied by researcher and patient will be informed to notify researcher immediately after starting to feel pain from pressure.
4 secondary outcomes
Neck Disability Index
Time frame: 12 weeks
Assessment of Perceived Pain on Cervical Region
Time frame: 12 weeks
Global Rating of Change Scale-Turkish Version
Time frame: 12 weeks
Assessment of Cervical Active Range of Motion (ROM)
Time frame: 12 weeks
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 21 Mar 2019.
- 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.
Şebnem Avcı, Ph.D study director
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Group in people with Trigger Point Pain, Myofascial and Neck Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 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 21 Mar 2019. 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 Turkey (Türkiye). 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?
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?
Assessment of Pain Pressure Threshold on Trigger Points with Algometer (time frame: 12 weeks). 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 21 Mar 2019.