Myofascial Pain of Upper Trapezius MuscleNCT07490366
Comparison of the Effectiveness of Exercise, Dry Needling and Interfascial Block Treatments in the Treatment of Myofascial Pain Syndrome
A study testing Exercise, Dry Needling + Exercise and Exercise + interfascial block in people with Myofascial Pain of Upper Trapezius Muscle, run by Eren Başıbüyük at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare interfascial block therapy with commonly used exercise therapy and conventional invasive dry needling therapy, and to evaluate its effectiveness and superiority. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Myofascial Pain of Upper Trapezius Muscle
- What is being tested?
- Exercise, Dry Needling + Exercise and Exercise + interfascial block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Myofascial pain in the upper trapezius muscle that has lasted for at least 3 months
- VAS score of 4 or higher for the current pain
- Clinically diagnosed with myofascial pain in the trapezius muscle
- Ages 18 to 55
- Patients who can follow verbal instructions and have no cognitive deficits
Who cannot join
- Having received interventional injections in the neck and shoulder area within the last 3 months
- Having received physical therapy within the last 3 months
- Having received regular nonsteroidal anti-inflammatory and myorelaxant treatment within the last month
- History of surgery on the affected side (neck or shoulder)
- Chronic inflammatory disease
- Acute infection
Show all 11Show fewer
- History of malignancy
- Coagulation disorders
- Pregnancy
- Liver and kidney pathologies
- Drug allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Haydarpaşa Training and Research Hospital
Istanbul, Istanbul, 34668
Eren Başıbüyük, M.D., +905344844832, erenbasiboyuk@gmail.com
About this study
This study aimed to compare interfascial block therapy with commonly used exercise therapy and conventional invasive dry needling therapy, and to evaluate its effectiveness and superiority. Another objective of this study was to evaluate and compare the short-term and long-term effectiveness of interfascial block, dry needling, and exercise therapies on pain, disability, and quality of life in patients with myofascial pain syndrome. In this respect, our study is important in terms of its contribution to the literature.
Read the detailed description
The study will include patients who present to the Physical Medicine and Rehabilitation outpatient clinic between July 2025 and May 2026 with clinical symptoms consistent with myofascial pain syndrome in the trapezius muscle. Patients referred to our injection clinic (treatment room) for routine myofascial stretching exercises, dry needling, and interfascial block treatments will be included if they meet the inclusion and exclusion criteria specified below. Demographic data such as age, gender, height, and weight will be recorded. At the initial assessment, patients' VAS (Visual Analog Scale), range of motion in the neck, neck disability scale, pressure pain threshold (PPT) measurements with an algometer, central sensitization scale, and Short Form 12 (SF-12) results will be noted. A total of 78 patients will be included in the study and randomly divided into three groups: Group 1 (Exercise group), Group 2 (Exercise + dry needling group), and Group 3 (Exercise + interfascial block group). Randomization will be done using a sealed envelope method. Group 1 will perform cervical ROM and trapezius facial stretching exercises. Group 2 will perform cervical ROM, trapezius facial stretching exercises, and dry needling of the relevant fascia using Hua Long brand 0.25x25 mm disposable sterile steel acupuncture needles under ultrasound guidance. Group 3 will perform cervical ROM and trapezius facial stretching exercises, and interfascial application of a mixture of 1 cc of 2% lidocaine and 4 cc of 0.9% saline under ultrasound guidance. Patients will receive a total of 3 treatment sessions, once a week for 3 weeks. All evaluation parameters will be performed before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment. Within-group and between-group differences will be examined statistically.
- Being tested
- Exercise, Dry Needling + Exercise, Exercise + interfascial block
- Keywords
- myofascial pain, hydrodissection, dry needling, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Cervical range of motion and trapezius fascial stretching exercises
Dry Needling + ExerciseOther
Cervical ROM, fascial stretching exercises for the trapezius muscles, and dry needling of the relevant fascia with Hua Long brand 0.25x25 mm disposable sterile steel acupuncture needles under ultrasound guidance.
Exercise + interfascial blockOther
Cervical range of motion (ROM) and trapezius muscles are treated with fascial stretching exercises and ultrasound-guided interfascial injection of 1 cc of 2% lidocaine + 4 cc of 0.9% saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Not described Receives: Other: Exercise |
| Exercise + Dry Needling Group | Experimental | Not described Receives: Other: Dry Needling + Exercise |
| Exercise + interfascial block group | Experimental | Not described Receives: Other: Exercise + interfascial block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
0-10 scale. Higher scores represent more severe pain.
Measured: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Cervical Range of Motion
Will measure flexion/extension, lateral bending, rotation, protraction/retraction in degrees.
Measured: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a widely used self-report questionnaire that measures functional disability associated with neck pain. It consists of 10 items scored from 0 to 5, covering pain intensity and daily activities. Higher scores indicate greater disability. The NDI is commonly used in clinical practice and research to assess baseline status and monitor treatment outcomes.
Measured: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Pressure Pain Threshold (PPT)
Pressure Pain Threshold (PPT) is a quantitative measure of pain sensitivity assessed using a pressure algometer. It represents the minimum amount of pressure that evokes pain. PPT is widely used in clinical and research settings to evaluate mechanical pain sensitivity, detect hyperalgesia, and monitor treatment effects. Lower PPT values indicate increased pain sensitivity, while higher values reflect reduced sensitivity.
Measured: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Secondary outcomes (2)
12-Item Short Form Survey (SF-12)
The 12-Item Short Form Survey (SF-12) is a brief, validated questionnaire used to assess overall health-related quality of life. It measures physical and mental health through 12 questions derived from the SF-36. The survey generates two main scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better health status. The SF-12 is widely used in clinical practice and research due to its brevity, reliability, and ability to capture general functional health.
Measured: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Central Sensitisation Inventory
A self-report inventory, the Central Sensitization Inventory (CSI), will be used to assess the overlapping symptom dimensions of Central Sensitivity Syndromes. This measure is intended as a screening instrument to help identify the presence of a Central Sensitivity Syndrome, and to alert clinicians that presenting symptoms may be related to central sensitisation. Part A of the Central Sensitisation Inventory assesses 25 health-related symptoms that are common to Central Sensitivity Syndrome, with total scores ranging from 0-100. Part B (which is not scored) asks if one has previously been diagnosed with one or more specific disorders, including seven separate Central Sensitivity Syndromes
Measured: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain of Upper Trapezius MuscleStudies 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
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eren Başıbüyük
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eren Başıbüyük, Haydarpasa Numune Training and Research Hospital
- Investigators
- Sibel Süzen Özbayrak, Study director, Haydarpaşa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490366
- Sponsor's protocol ID
- 2024KAEK18
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Safety concerns
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Exercise, Dry Needling and Interfascial Block Treatments in the Treatment of Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT07490366
- Acronym / sponsor ID
- 2024KAEK18
- Keywords
- myofascial pain, hydrodissection, dry needling, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Eren BaşıbüyükUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 24 Mar 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.
This study aimed to compare interfascial block therapy with commonly used exercise therapy and conventional invasive dry needling therapy, and to evaluate its effectiveness and superiority. Another objective of this study was to evaluate and compare the short-term and long-term effectiveness of interfascial block, dry needling, and exercise therapies on pain, disability, and quality of life in patients with myofascial pain syndrome. In this respect, our study is important in terms of its contribution to the literature.
Detailed description
The study will include patients who present to the Physical Medicine and Rehabilitation outpatient clinic between July 2025 and May 2026 with clinical symptoms consistent with myofascial pain syndrome in the trapezius muscle. Patients referred to our injection clinic (treatment room) for routine myofascial stretching exercises, dry needling, and interfascial block treatments will be included if they meet the inclusion and exclusion criteria specified below. Demographic data such as age, gender, height, and weight will be recorded. At the initial assessment, patients' VAS (Visual Analog Scale), range of motion in the neck, neck disability scale, pressure pain threshold (PPT) measurements with an algometer, central sensitization scale, and Short Form 12 (SF-12) results will be noted. A total of 78 patients will be included in the study and randomly divided into three groups: Group 1 (Exercise group), Group 2 (Exercise + dry needling group), and Group 3 (Exercise + interfascial block group). Randomization will be done using a sealed envelope method. Group 1 will perform cervical ROM and trapezius facial stretching exercises. Group 2 will perform cervical ROM, trapezius facial stretching exercises, and dry needling of the relevant fascia using Hua Long brand 0.25x25 mm disposable sterile steel acupuncture needles under ultrasound guidance. Group 3 will perform cervical ROM and trapezius facial stretching exercises, and interfascial application of a mixture of 1 cc of 2% lidocaine and 4 cc of 0.9% saline under ultrasound guidance. Patients will receive a total of 3 treatment sessions, once a week for 3 weeks. All evaluation parameters will be performed before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment. Within-group and between-group differences will be examined statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise |
| Exercise + Dry Needling Group | Experimental | Other: Dry Needling + Exercise |
| Exercise + interfascial block group | Experimental | Other: Exercise + interfascial block |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Myofascial pain in the upper trapezius muscle that has lasted for at least 3 months
- VAS score of 4 or higher for the current pain
- Clinically diagnosed with myofascial pain in the trapezius muscle
- Ages 18 to 55
- Patients who can follow verbal instructions and have no cognitive deficits
Key exclusion criteria (11 listed)
- Having received interventional injections in the neck and shoulder area within the last 3 months
- Having received physical therapy within the last 3 months
- Having received regular nonsteroidal anti-inflammatory and myorelaxant treatment within the last month
- History of surgery on the affected side (neck or shoulder)
- Chronic inflammatory disease
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 |
|---|---|---|
| ExerciseCervical range of motion and trapezius fascial stretching exercises | Other | Exercise group |
| Dry Needling + ExerciseCervical ROM, fascial stretching exercises for the trapezius muscles, and dry needling of the relevant fascia with Hua Long brand 0.25x25 mm disposable sterile steel acupuncture needles under ultrasound guidance. | Other | Exercise + Dry Needling Group |
| Exercise + interfascial blockCervical range of motion (ROM) and trapezius muscles are treated with fascial stretching exercises and ultrasound-guided interfascial injection of 1 cc of 2% lidocaine + 4 cc of 0.9% saline solution. | Other | Exercise + interfascial block group |
Primary outcome
Visual Analog Scale
Time frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
0-10 scale. Higher scores represent more severe pain.
Cervical Range of Motion
Time frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Will measure flexion/extension, lateral bending, rotation, protraction/retraction in degrees.
Neck Disability Index (NDI)
Time frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
The Neck Disability Index (NDI) is a widely used self-report questionnaire that measures functional disability associated with neck pain. It consists of 10 items scored from 0 to 5, covering pain intensity and daily activities. Higher scores indicate greater disability. The NDI is commonly used in clinical practice and research to assess baseline status and monitor treatment outcomes.
Pressure Pain Threshold (PPT)
Time frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Pressure Pain Threshold (PPT) is a quantitative measure of pain sensitivity assessed using a pressure algometer. It represents the minimum amount of pressure that evokes pain. PPT is widely used in clinical and research settings to evaluate mechanical pain sensitivity, detect hyperalgesia, and monitor treatment effects. Lower PPT values indicate increased pain sensitivity, while higher values reflect reduced sensitivity.
2 secondary outcomes
12-Item Short Form Survey (SF-12)
Time frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Central Sensitisation Inventory
Time frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No. Safety concerns
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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.
Sibel Süzen Özbayrak study director
Haydarpaşa Numune Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Dry Needling + Exercise and Exercise + interfascial block in people with Myofascial Pain of Upper Trapezius Muscle, run by Eren Başıbüyük 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 24 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eren Başıbüyük, M.D. (+905344844832, erenbasiboyuk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.). The study lists 4 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 24 Mar 2026.