Myofascial Pain SyndromesNCT07410221
Pain Neuroscience Education in Myofascial Pain Syndrome
A study testing Conventional physiotherapy, Exercise and Pain neuroscience education (PNE) in people with Myofascial Pain Syndromes and Neuroscience Pain Education, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Background This study aimed to evaluate the additive effect of Pain Neuroscience Education (PNE), which addresses the biopsychosocial and neurophysiological foundations of pain, on conventional physiotherapy in myofascial pain syndrome (MPS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndromes, Neuroscience Pain Education, Physical Therapy Modalities
- What is being tested?
- Conventional physiotherapy, Exercise and Pain neuroscience education (PNE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2022to 10 Jul 2023
- 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
- Diagnosis of myofascial pain syndrome by a physician
- Presence of a taut band detected by palpation
- Referred pain elicited by compression of trigger points
- Local twitch response induced by transverse palpation of the taut band
- Age between 18-65 years
- Voluntary patients with symptoms lasting at least 6 months
Who cannot join
- Skin lesions or history of head trauma preventing study participation
- Ongoing or previous cancer treatment
- Uncontrolled hypertension or diabetes mellitus
- History of fracture involving the upper extremities or cervical region
- History of trauma or surgery in the cervical or upper extremity region
- Known rheumatological disease
Show all 9Show fewer
- Receipt of physical therapy within the last 6 months
- Presence of other cervical pathologies causing neck or back pain apart from MPS
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF NEUROSCIENCE PAIN EDUCATION IN ADDITION TO CONVENTIONAL PHYSIOTHERAPY AND REHABILITATION PROGRAMME IN INDIVIDUALS WITH MYOFASCIAL PAIN SYNDROME
Background This study aimed to evaluate the additive effect of Pain Neuroscience Education (PNE), which addresses the biopsychosocial and neurophysiological foundations of pain, on conventional physiotherapy in myofascial pain syndrome (MPS).
Methods Forty individuals with MPS aged between 18-50 years participated in the study. The participants were divided into two groups as study group (n=20) and control group (n=20). The control group received a conventional physiotherapy and rehabilitation program three times a week 6 weeks. In the Study group, PNE was given once a week for 6 weeks in addition to the conventional physiotherapy and rehabilitation programme. Short Form Mc-Gill Pain Questionnaire (SF-MPQ), Algometer, Pain Catastrophising Scale (PCS), Tampa Scale of Kinesiophobia (TSK) and Depression-Anxiety-Stress Scale (DASS), Pittsburg Sleep Quality Index (PSQI) and Myotonometry were used in the evaluation.
- Being tested
- Conventional physiotherapy, Exercise, Pain neuroscience education (PNE)
- Keywords
- Pain Management, Kinesiophobia, Myofascial Pain Syndromes, Neuroscience Pain Education, Physical Therapy Modalities
- Medical subject headings
- Myofascial Pain Syndromes, Agnosia, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapyOther
Transcutaneous electrical nerve stimulation (TENS); The negative electrode was placed on the trigger point and the positive electrode was placed on the insertion of the acromial tendon of the trapezius muscle. Conventional type TENS with a frequency of 50-100 Hz and a current duration of 100 μsec was applied for 20 minutes by adjusting the current intensity to the value that the patient could tolerate. US; Chattanooga® (Mexico) with 1.5 Watt/ cm² current intensity, 1 MHz frequency and continuous mode was applied to the right and left sides for 4 minutes each. It was performed by drawing circles on the trigger point and surrounding tissues with the US probe. HP; was applied for 20 minutes to the area covering the muscle with trigger point and surrounding tissues
ExerciseOther
An exercise programme consisting of stretching exercises for tense muscles which are effective in the formation of Myofascial Pain Syndrome (MPS) and trunk stabilisation exercises to provide deep postural muscle activation was applied. Abdominal hallowing exercise, shoulder bridge exercise, swimming exercise and stretching exercises were performed as 10 repetitions. In addition, scapular stabilisation exercises were also included in the programme because myofascial pain often leads to immobilisation. The 6-week exercise programme was planned to be progressively revised every 2 weeks. In this case, other extremities were included, new exercises were added, and progressive difficulty level was provided with the help of a medicine ball or resistance band. Patients were asked to perform this exercise programme, which was applied in the clinic, at home once a day for 10 repetitions. Whether the exercises were performed regularly at home was followed up with verbal feedback
Pain neuroscience education (PNE)Other
Pain Neuroscience Education (PNE) was delivered to the study group through individual, face-to-face sessions focusing on pain neurophysiology. The content was based on the book Explain Pain and supported by a PowerPoint presentation incorporating metaphors, examples, and visual materials to enhance comprehension. Considering reduced attention span in individuals with chronic pain, PNE was provided once weekly for 6 weeks, with each session lasting approximately 15 minutes, resulting in a total duration of 90 minutes. Conventional physiotherapy interventions were initiated immediately after each PNE session. Patients were encouraged to ask questions during treatment to reinforce the educational content through their own pain experiences and to promote active engagement in subsequent sessions.
| Study group | Role | What they receive |
|---|---|---|
| Study Gruop | Experimental | Not described Receives: Other: Conventional physiotherapy; Other: Exercise; Other: Pain neuroscience education (PNE) |
| Control group | Active comparator | Not described Receives: Other: Conventional physiotherapy; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form Mc-Gill Pain Questionnaire (SF-MPQ)
Because pain is a multidimensional experience involving sensory and emotional components and is often difficult to describe, standardized pain assessment tools are essential in clinical practice. Due to the length and time required to complete the McGill Pain Questionnaire, pain was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ), developed by Melzack in 1987. The SF-MPQ consists of three sections. The first section includes 15 pain descriptors (11 sensory and 4 affective), each scored from 0 (none) to 3 (severe), providing total, sensory, and affective pain scores. The second section assesses overall pain intensity using a Likert-type scale ranging from 0 (no pain) to 5 (unbearable pain). The third section evaluates current pain intensity using a 10 cm Visual Analog Scale, scored from 0 (no pain) to 10 (severe pain).
Measured: Baseline and end of Week 6
Pressure Pain Threshold Assessment
Pressure pain threshold is explained as the minimum amount of pressure measured at the first moment when the applied pressure sensation turns into pain. BASELINE® (USA) brand algometer, which can measure the pressure pain thresholds of trigger points, was used in the study. The pressure value is obtained by pressing a dynamic metal piston with a round disc with a surface area of 1 cm² at its tip to the relevant area. In our study, the pressure pain threshold of the sternocleidomastoid (SCM), upper trapezius (UT), levator scapula (LS), pectoralis major (PM) muscles, which are specified as overstrained muscle groups in the definition of 'Upper Cross Syndrome'
Measured: Baseline and end of Week 6
Secondary outcomes (5)
Pain Catastrophising Scale (PCS)
It was developed to determine the thoughts and feelings of patients about pain when they experience pain. The scale, which consists of three sub-sections as magnification, rumination and helplessness, has 13 items in total. The total score varies between 0 and 52. A high total score means that patients have a high level of catastrophising pain.
Measured: Baseline and end of Week 6
Tampa Scale of Kinesiophobia (TSK)
The Tampa Kinesiophobia Scale is a 17-item scale designed to assess the fear of re-injury or pain with movement. Each item of the TSK is answered using a scoring method consisting of 4 values. High scores indicate that the person has high kinesiophobia.
Measured: Baseline and end of Week 6
Depression Anxiety Stress Scale (DASS)
The DASS is the 21-item short version of the original 42-item scale designed to evaluate individuals' levels of depression, anxiety, and stress. This version consists of three subscales-depression, anxiety, and stress-each comprising seven items. All items are rated on a 4-point Likert scale (0 = not suitable at all, 1 = somewhat suitable, 2 = generally suitable, and 3 = completely suitable). Scores for each subscale are calculated by summing the responses to the relevant seven items, resulting in a raw score between 0 and 21. For consistency with the original 42-item form, subscale scores are multiplied by two, with higher scores reflecting greater severity of depressive, anxious, or stress-related symptoms
Measured: Baseline and end of Week 6
Pittsburgh Sleep Quality Index (PSQI)
Pittsburg Sleep Quality Index is a 24-question sleep questionnaire used to evaluate the sleep quality of individuals in the last one month period. The questions answered by the person consist of 7 sub-sections. A total score above 5 means poor sleep quality.
Measured: Baseline and end of Week 6
Myotonometric Evaluation
MyotonPRO® (Estonia) is a noninvasive digital device used to objectively assess the mechanical properties of muscles. A brief (15 ms) and low-intensity (0.58 N) mechanical oscillation is applied perpendicular to the skin via the probe, which also records the tissue's response. Muscle response reflects the viscoelastic properties of the tissue, including oscillation frequency (Hz), stiffness (N/m), and elasticity (logarithmic decrement). Oscillation frequency represents resting muscle tone, elasticity indicates the muscle's ability to return to its original shape after deformation, and stiffness reflects resistance to an external force. Using MyotonPRO®, muscle properties of the sternocleidomastoid, upper trapezius, and pectoralis major muscles associated with Upper Cross Syndrome were evaluated.
Measured: Baseline and end of Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start10 Jun 2022
- Primary completion1 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Çağlıyan Erdoğan, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410221
- Sponsor's protocol ID
- Protocol No: 21-112
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan Description: Individual participant data will not be shared. Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF NEUROSCIENCE PAIN EDUCATION IN ADDITION TO CONVENTIONAL PHYSIOTHERAPY AND REHABILITATION PROGRAMME IN INDIVIDUALS WITH MYOFASCIAL PAIN SYNDROME
- ClinicalTrials.gov ID
- NCT07410221
- Acronym / sponsor ID
- Protocol No: 21-112
- Keywords
- Pain Management, Kinesiophobia, Myofascial Pain Syndromes, Neuroscience Pain Education, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 13 Feb 2026 (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.
Background This study aimed to evaluate the additive effect of Pain Neuroscience Education (PNE), which addresses the biopsychosocial and neurophysiological foundations of pain, on conventional physiotherapy in myofascial pain syndrome (MPS).
Methods Forty individuals with MPS aged between 18-50 years participated in the study. The participants were divided into two groups as study group (n=20) and control group (n=20). The control group received a conventional physiotherapy and rehabilitation program three times a week 6 weeks. In the Study group, PNE was given once a week for 6 weeks in addition to the conventional physiotherapy and rehabilitation programme. Short Form Mc-Gill Pain Questionnaire (SF-MPQ), Algometer, Pain Catastrophising Scale (PCS), Tampa Scale of Kinesiophobia (TSK) and Depression-Anxiety-Stress Scale (DASS), Pittsburg Sleep Quality Index (PSQI) and Myotonometry were used in the evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Gruop | Experimental | Other: Conventional physiotherapy, Other: Exercise, Other: Pain neuroscience education (PNE) |
| Control group | Active comparator | Other: Conventional physiotherapy, Other: Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of myofascial pain syndrome by a physician
- Presence of a taut band detected by palpation
- Referred pain elicited by compression of trigger points
- Local twitch response induced by transverse palpation of the taut band
- Age between 18-65 years
Key exclusion criteria (9 listed)
- Skin lesions or history of head trauma preventing study participation
- Ongoing or previous cancer treatment
- Uncontrolled hypertension or diabetes mellitus
- History of fracture involving the upper extremities or cervical region
- History of trauma or surgery in the cervical or upper extremity region
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 |
|---|---|---|
| Conventional physiotherapyTranscutaneous electrical nerve stimulation (TENS); The negative electrode was placed on the trigger point and the positive electrode was placed on the insertion of the acromial tendon of the trapezius muscle. Conventional type TENS with a frequency of 50-100 Hz and a current duration of 100 μsec was applied for 20 minutes by adjusting the current intensity to the value that the patient could tolerate. US; Chattanooga® (Mexico) with 1.5 Watt/ cm² current intensity, 1 MHz frequency and continuous mode was applied to the right and left sides for 4 minutes each. It was performed by drawing circles on the trigger point and surrounding tissues with the US probe. HP; was applied for 20 minutes to the area covering the muscle with trigger point and surrounding tissues | Other | Control group, Study Gruop |
| ExerciseAn exercise programme consisting of stretching exercises for tense muscles which are effective in the formation of Myofascial Pain Syndrome (MPS) and trunk stabilisation exercises to provide deep postural muscle activation was applied. Abdominal hallowing exercise, shoulder bridge exercise, swimming exercise and stretching exercises were performed as 10 repetitions. In addition, scapular stabilisation exercises were also included in the programme because myofascial pain often leads to immobilisation. The 6-week exercise programme was planned to be progressively revised every 2 weeks. In this case, other extremities were included, new exercises were added, and progressive difficulty level was provided with the help of a medicine ball or resistance band. Patients were asked to perform this exercise programme, which was applied in the clinic, at home once a day for 10 repetitions. Whether the exercises were performed regularly at home was followed up with verbal feedback | Other | Control group, Study Gruop |
| Pain neuroscience education (PNE)Pain Neuroscience Education (PNE) was delivered to the study group through individual, face-to-face sessions focusing on pain neurophysiology. The content was based on the book Explain Pain and supported by a PowerPoint presentation incorporating metaphors, examples, and visual materials to enhance comprehension. Considering reduced attention span in individuals with chronic pain, PNE was provided once weekly for 6 weeks, with each session lasting approximately 15 minutes, resulting in a total duration of 90 minutes. Conventional physiotherapy interventions were initiated immediately after each PNE session. Patients were encouraged to ask questions during treatment to reinforce the educational content through their own pain experiences and to promote active engagement in subsequent sessions. | Other | Study Gruop |
Primary outcome
Short Form Mc-Gill Pain Questionnaire (SF-MPQ)
Time frame: Baseline and end of Week 6
Because pain is a multidimensional experience involving sensory and emotional components and is often difficult to describe, standardized pain assessment tools are essential in clinical practice. Due to the length and time required to complete the McGill Pain Questionnaire, pain was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ), developed by Melzack in 1987. The SF-MPQ consists of three sections. The first section includes 15 pain descriptors (11 sensory and 4 affective), each scored from 0 (none) to 3 (severe), providing total, sensory, and affective pain scores. The second section assesses overall pain intensity using a Likert-type scale ranging from 0 (no pain) to 5 (unbearable pain). The third section evaluates current pain intensity using a 10 cm Visual Analog Scale, scored from 0 (no pain) to 10 (severe pain).
Pressure Pain Threshold Assessment
Time frame: Baseline and end of Week 6
Pressure pain threshold is explained as the minimum amount of pressure measured at the first moment when the applied pressure sensation turns into pain. BASELINE® (USA) brand algometer, which can measure the pressure pain thresholds of trigger points, was used in the study. The pressure value is obtained by pressing a dynamic metal piston with a round disc with a surface area of 1 cm² at its tip to the relevant area. In our study, the pressure pain threshold of the sternocleidomastoid (SCM), upper trapezius (UT), levator scapula (LS), pectoralis major (PM) muscles, which are specified as overstrained muscle groups in the definition of 'Upper Cross Syndrome'
5 secondary outcomes
Pain Catastrophising Scale (PCS)
Time frame: Baseline and end of Week 6
Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline and end of Week 6
Depression Anxiety Stress Scale (DASS)
Time frame: Baseline and end of Week 6
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and end of Week 6
Myotonometric Evaluation
Time frame: Baseline and end of Week 6
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 13 Feb 2026.
- Individual participant dataSharing planned: No. Plan Description: Individual participant data will not be shared. Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.
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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 Conventional physiotherapy, Exercise and Pain neuroscience education (PNE) in people with Myofascial Pain Syndromes and Neuroscience Pain Education, run by Istinye 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 6 inclusion and 9 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 13 Feb 2026. 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?
Short Form Mc-Gill Pain Questionnaire (SF-MPQ) (time frame: Baseline and end of Week 6). The study lists 2 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 13 Feb 2026.