Myofacial Pain SyndromesNCT06498466
EFFECT OF MYOFASCIAL RELEASE THERAPY IN PATIENTS WITH CERVICAL MYOFASCIAL PAIN SYNDROME
An observational study of Myofacial Pain Syndromes, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: To investigate the effects of myofascial release therapy (MRT) on pain, number of trigger points (TP), pressure pain threshold (PPT), cervical range of motion (ROM), neck disability, and quality of life in the neck pain due to cervical myofascial pain syndrome (MPS). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofacial Pain Syndromes
- What is being tested?
- myofascial release
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jul 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 volunteer patients between the ages of 18-65 who complained of neck pain lasting more than 1 month and met the Travell and Simons criteria for the diagnosis of Myofascial pain syndrome.
Who may be able to join
- volunteer patients between the ages of 18-65 who complained of neck pain lasting more than 1 month and met the Travell and Simons criteria for the diagnosis of Myofascial pain syndrome
Who cannot join
- presence of known infectious, inflammatory, tumoral, and advanced degenerative diseases that may cause neck pain, presence of pain reflected from internal organs, history of spine or shoulder fracture or surgery, presence of nerve root involvement findings due to cervical discopathy, having a history of neck manipulation or invasive procedures in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: To investigate the effects of myofascial release therapy (MRT) on pain, number of trigger points (TP), pressure pain threshold (PPT), cervical range of motion (ROM), neck disability, and quality of life in the neck pain due to cervical myofascial pain syndrome (MPS).
In this prospective study, patients in Group I (n=30) underwent a standard physical therapy program. Patients in Group II (n=30) additionally underwent MRT 3 days a week. Before and on the 15th day after treatment, patients' pain was measured by visual analog scale (VAS), TP numbers by palpation, PPTs by pressure algometer, cervical ROM by goniometer, disability by Neck Disability Index (NDI) and quality of life by Nottingham Health Profile (NHP) was evaluated.
- Conditions
- Myofacial Pain Syndromes
- Being tested
- myofascial release
- Medical subject headings
- Facial Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial releaseOther
Myofascial release therapy (MRT) is a manual therapy technique that involves gradual stretching by a therapist or the individual, acting on the muscles and surrounding fascia. Its effects include increasing joint range of motion and mobility of soft tissues, eliminating imbalances in muscle tone, reducing muscle pain, reducing stress on joints, and increasing neuromuscular efficiency.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
The patients were asked to mark the severity of their neck pain at rest and with movement on a 10-centimeter (cm) line on the 1st and 15th days (0: minimum 10: maximum). The higher the measured value, the greater the pain intensity.
Measured: 2 weeks
Trigger Point Numbers
In order to detect the trigger points, the neck and back regions of the patients were evaluated by palpation by the physician.
Measured: 2 weeks
Pressure Pain Threshold
Pressure pain threshold (PPT) was measured with a pressure algometer (Commander[JTECH medical]). The disc head of the pressure algometer was placed on the trigger point at a 90° angle. Before the application, the patient was asked to describe the pain when he/she first felt it.
Measured: 2 weeks.
Cervical Joint Range of Motion (ROM)
Cervical ROM measurements were evaluated actively and passively with a goniometer.
Measured: 2 weeks
Neck Disability Index
Disability was evaluated with the Neck Disability Index. This questionnaire, which evaluates subjective symptoms and daily living activities, consists of a total of 10 sections (pain intensity, personal care, lifting, reading, headache, concentration, work life, driving, sleep, and leisure activities).
Measured: 2 weeks
Nottingham Health Profile
Quality of life was assessed with the Nottingham Health Profile. The scale consists of two parts. The first part consists of a total of 38 items, where each item is answered yes or no. This section has a total of 6 sub-dimensions: pain, emotional reactions, sleep, social isolation, physical activity, and energy. The second part consists of 7 items that question whether there are problems in business life, housework, social life, interpersonal relationships, sexual life, hobbies, and holidays, which are the areas of daily life that are most likely to be affected due to the person's health condition, and each item is answered yes or no.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jan 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofacial Pain SyndromesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem Bolkan Günaydın, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498466
- Sponsor's protocol ID
- 12024861-88
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF MYOFASCIAL RELEASE THERAPY IN PATIENTS WITH CERVICAL MYOFASCIAL PAIN SYNDROME
- ClinicalTrials.gov ID
- NCT06498466
- Acronym / sponsor ID
- 12024861-88
- Conditions
- Myofacial Pain Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 12 Jul 2024 (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.
Objectives: To investigate the effects of myofascial release therapy (MRT) on pain, number of trigger points (TP), pressure pain threshold (PPT), cervical range of motion (ROM), neck disability, and quality of life in the neck pain due to cervical myofascial pain syndrome (MPS).
In this prospective study, patients in Group I (n=30) underwent a standard physical therapy program. Patients in Group II (n=30) additionally underwent MRT 3 days a week. Before and on the 15th day after treatment, patients' pain was measured by visual analog scale (VAS), TP numbers by palpation, PPTs by pressure algometer, cervical ROM by goniometer, disability by Neck Disability Index (NDI) and quality of life by Nottingham Health Profile (NHP) was evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 volunteer patients between the ages of 18-65 who complained of neck pain lasting more than 1 month and met the Travell and Simons criteria for the diagnosis of Myofascial pain syndrome.
Key inclusion criteria (1 listed)
- volunteer patients between the ages of 18-65 who complained of neck pain lasting more than 1 month and met the Travell and Simons criteria for the diagnosis of Myofascial pain syndrome
Key exclusion criteria (1 listed)
- presence of known infectious, inflammatory, tumoral, and advanced degenerative diseases that may cause neck pain, presence of pain reflected from internal organs, history of spine or shoulder fracture or surgery, presence of nerve root involvement findings due to cervical discopathy, having a history of neck manipulation or invasive procedures in the last 3 months.
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 releaseMyofascial release therapy (MRT) is a manual therapy technique that involves gradual stretching by a therapist or the individual, acting on the muscles and surrounding fascia. Its effects include increasing joint range of motion and mobility of soft tissues, eliminating imbalances in muscle tone, reducing muscle pain, reducing stress on joints, and increasing neuromuscular efficiency. | Other | – |
Primary outcome
Visual analog scale (VAS)
Time frame: 2 weeks
The patients were asked to mark the severity of their neck pain at rest and with movement on a 10-centimeter (cm) line on the 1st and 15th days (0: minimum 10: maximum). The higher the measured value, the greater the pain intensity.
Trigger Point Numbers
Time frame: 2 weeks
In order to detect the trigger points, the neck and back regions of the patients were evaluated by palpation by the physician.
Pressure Pain Threshold
Time frame: 2 weeks.
Pressure pain threshold (PPT) was measured with a pressure algometer (Commander[JTECH medical]). The disc head of the pressure algometer was placed on the trigger point at a 90° angle. Before the application, the patient was asked to describe the pain when he/she first felt it.
Cervical Joint Range of Motion (ROM)
Time frame: 2 weeks
Cervical ROM measurements were evaluated actively and passively with a goniometer.
Neck Disability Index
Time frame: 2 weeks
Disability was evaluated with the Neck Disability Index. This questionnaire, which evaluates subjective symptoms and daily living activities, consists of a total of 10 sections (pain intensity, personal care, lifting, reading, headache, concentration, work life, driving, sleep, and leisure activities).
Nottingham Health Profile
Time frame: 2 weeks
Quality of life was assessed with the Nottingham Health Profile. The scale consists of two parts. The first part consists of a total of 38 items, where each item is answered yes or no. This section has a total of 6 sub-dimensions: pain, emotional reactions, sleep, social isolation, physical activity, and energy. The second part consists of 7 items that question whether there are problems in business life, housework, social life, interpersonal relationships, sexual life, hobbies, and holidays, which are the areas of daily life that are most likely to be affected due to the person's health condition, and each item is answered yes or no.
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 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Myofacial Pain Syndromes, run by Ufuk 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 1 inclusion and 1 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 12 Jul 2024. 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. 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?
Visual analog scale (VAS) (time frame: 2 weeks). The study lists 6 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 12 Jul 2024.