Myofascial Pain Syndrome - NeckNCT06809790
Dry Needling Combined With a Therapeutic Exercise Program in Myofascial Pain Syndrome: Sonographic Evaluation of Cervical Muscles
A study testing Therapeutic Exercise Program and Dry Needling in people with Myofascial Pain Syndrome - Neck and Myofascial Pain of Upper Trapezius Muscle, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients between the ages of 20-65 years who present to the Physical Medicine and Rehabilitation outpatient clinics of our hospital with complaints of back and neck pain and are diagnosed with myofascial pain syndrome will be referred to the physicians responsible for the study to be included in the study. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome - Neck, Myofascial Pain of Upper Trapezius Muscle
- What is being tested?
- Therapeutic Exercise Program and Dry Needling
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Feb 2025to 15 Aug 2025
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20-65 years with neck pain for more than 12 weeks
- Active trigger point in the unilateral upper trapezius muscle on physical examination
- Who agreed not to receive anti-inflammatory and myorelaxant treatment during the study period
Who cannot join
- Patients diagnosed with rheumatologic diseases
- Patients with radiculopathy
- Patients with a history of previous surgery in the shoulder, back, and neck region
- Patients with polyneuropathy
- Patients with severe cervical spondylosis
- Patients with cerebrovascular events
Show all 13Show fewer
- Patients with malignancies
- Those with cognitive impairment
- Those with bleeding disorders
- Patients diagnosed with fibromyalgia
- Patients with thyroidectomy
- Anti-inflammatory-analgesic or myorelaxant treatment within the last 1 month
- Patients with a history of injection into the upper trapezius muscle or cervical region within the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, Fatih, 34093
About this study
Official title: The Effect of Dry Needling of the Upper Trapezius Muscle Added to Therapeutic Exercise Therapy on the Thickness of the Cervical Muscles in Myofascial Pain Syndrome
Patients between the ages of 20-65 years who present to the Physical Medicine and Rehabilitation outpatient clinics of our hospital with complaints of back and neck pain and are diagnosed with myofascial pain syndrome will be referred to the physicians responsible for the study to be included in the study. Exclusion criteria will be reviewed, and patients with chronic pain for more than 3 months and an active trigger point in the unilateral upper trapezius muscle will be included in the study. Patients will be randomly divided into two groups; the first group will receive only exercise therapy (including cervical range of motion and trapezius stretching), and the second group will receive exercise and dry needling therapy (1 time per week, 3 sessions in total). Demographic data (age, gender, body mass index, occupation) of all patients included in the study will be recorded. The relationship between pain and loss of function according to the Visual Analog Scale (VAS), Short Form 36 (SF-36), and Neck Disability Index (NDI) scales will be recorded. Bilateral upper trapezius, sternocleidomastoideus, and total cervical extensor muscle thickness (upper trapezius, splenius capitis, semispinalis capitis, semispinalis cervicis, and multifidus) and longus colli muscle thickness measurements will be made with the ultrasonography device in our clinic. The first group will receive only exercise therapy after the measurements. Patients in the second group will receive a total of 3 sessions of dry needling treatment to the trapezius muscle for active trigger points at 0, 1, and 2 weeks in addition to exercise therapy. After the initial examination, control VAS, SF-36, NDI, and control ultrasonographic measurements will be performed in all patients at the 3rd week and 6th week. Using data analysis methods, the effect of dry needling treatment for active trigger points in the trapezius muscle on pain and functionality as well as the thickness of the cervical muscles will be investigated.
- Being tested
- Therapeutic Exercise Program, Dry Needling
- Keywords
- myofascial pain syndrome, trigger point, dry needling, upper trapezius muscle, Therapeutic Exercise
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Exercise ProgramBehavioural
Participants in this group will receive a therapeutic exercise program (including cervical range of motion and trapezius stretching) during the study period.
Dry NeedlingProcedure or surgery
Participants in this group will receive dry needling treatment for active trigger points in addition to the therapeutic exercise program. Dry needling treatment will be applied in a total of 3 sessions at 0, 1, and 2. weeks, one week apart.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Therapeutic Exercise | Active comparator | Not described Receives: Behavioral: Therapeutic Exercise Program |
| Group 2: Therapeutic Exercise and Dry Needling | Active comparator | Not described Receives: Behavioral: Therapeutic Exercise Program; Procedure: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic evaluation for muscle thickness assessment
Bilateral upper trapezius, sternocleidomastoid, total cervical extensor muscle thickness (upper trapezius, splenius capitis, semispinalis capitis, semispinalis cervicis, and multifidus), and longus colli muscle thickness measurements will be made with the ultrasonography device.
Measured: It will be evaluated in the baseline, third, and sixth weeks.
Secondary outcomes (3)
Pain will be assessed with Visual Analog Scale.
Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.
Measured: It will be evaluated in the baseline, third, and sixth weeks.
Functional status will be assessed with the Neck Disability Index.
Neck Disability Index (NDI) consists of 10 questions in total. Each question receives a score ranging from 0 to 5. Totals can have a minimum score of 0 and a maximum score of 50. Higher scores indicate more severe disability.
Measured: It will be evaluated in the baseline, third, and sixth weeks.
General health status will be assessed with Short Form 36.
Short Form 36 (SF-36) is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: It will be evaluated in the baseline, third, and sixth weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start9 Feb 2025
- Primary completion25 Jul 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome - NeckStudies 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
- Model description
- Participants will be randomly divided into two groups; the first group will receive only exercise therapy, and the second group will receive exercise therapy as well as dry needling treatment.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammed Oğuz, Istanbul Training and Research Hospital
- Investigators
- Muhammed Oğuz, Principal investigator, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809790
- Sponsor's protocol ID
- 18/09/2024;2024-KAEK-30;114
- Status last verified
- Aug 2025
- First submitted
- 26 Jan 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dry Needling of the Upper Trapezius Muscle Added to Therapeutic Exercise Therapy on the Thickness of the Cervical Muscles in Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06809790
- Acronym / sponsor ID
- 18/09/2024;2024-KAEK-30;114
- Keywords
- myofascial pain syndrome, trigger point, dry needling, upper trapezius muscle, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 9 Feb 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 5 Feb 2025 (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.
Patients between the ages of 20-65 years who present to the Physical Medicine and Rehabilitation outpatient clinics of our hospital with complaints of back and neck pain and are diagnosed with myofascial pain syndrome will be referred to the physicians responsible for the study to be included in the study. Exclusion criteria will be reviewed, and patients with chronic pain for more than 3 months and an active trigger point in the unilateral upper trapezius muscle will be included in the study. Patients will be randomly divided into two groups; the first group will receive only exercise therapy (including cervical range of motion and trapezius stretching), and the second group will receive exercise and dry needling therapy (1 time per week, 3 sessions in total). Demographic data (age, gender, body mass index, occupation) of all patients included in the study will be recorded. The relationship between pain and loss of function according to the Visual Analog Scale (VAS), Short Form 36 (SF-36), and Neck Disability Index (NDI) scales will be recorded. Bilateral upper trapezius, sternocleidomastoideus, and total cervical extensor muscle thickness (upper trapezius, splenius capitis, semispinalis capitis, semispinalis cervicis, and multifidus) and longus colli muscle thickness measurements will be made with the ultrasonography device in our clinic. The first group will receive only exercise therapy after the measurements. Patients in the second group will receive a total of 3 sessions of dry needling treatment to the trapezius muscle for active trigger points at 0, 1, and 2 weeks in addition to exercise therapy. After the initial examination, control VAS, SF-36, NDI, and control ultrasonographic measurements will be performed in all patients at the 3rd week and 6th week. Using data analysis methods, the effect of dry needling treatment for active trigger points in the trapezius muscle on pain and functionality as well as the thickness of the cervical muscles will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into two groups; the first group will receive only exercise therapy, and the second group will receive exercise therapy as well as dry needling treatment.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Therapeutic Exercise | Active comparator | Behavioral: Therapeutic Exercise Program |
| Group 2: Therapeutic Exercise and Dry Needling | Active comparator | Behavioral: Therapeutic Exercise Program, Procedure: Dry Needling |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 20-65 years with neck pain for more than 12 weeks
- Active trigger point in the unilateral upper trapezius muscle on physical examination
- Who agreed not to receive anti-inflammatory and myorelaxant treatment during the study period
Key exclusion criteria (13 listed)
- Patients diagnosed with rheumatologic diseases
- Patients with radiculopathy
- Patients with a history of previous surgery in the shoulder, back, and neck region
- Patients with polyneuropathy
- Patients with severe cervical spondylosis
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 |
|---|---|---|
| Therapeutic Exercise ProgramParticipants in this group will receive a therapeutic exercise program (including cervical range of motion and trapezius stretching) during the study period. | Behavioural | Group 1: Therapeutic Exercise, Group 2: Therapeutic Exercise and Dry Needling |
| Dry NeedlingParticipants in this group will receive dry needling treatment for active trigger points in addition to the therapeutic exercise program. Dry needling treatment will be applied in a total of 3 sessions at 0, 1, and 2. weeks, one week apart. | Procedure or surgery | Group 2: Therapeutic Exercise and Dry Needling |
Primary outcome
Ultrasonographic evaluation for muscle thickness assessment
Time frame: It will be evaluated in the baseline, third, and sixth weeks.
Bilateral upper trapezius, sternocleidomastoid, total cervical extensor muscle thickness (upper trapezius, splenius capitis, semispinalis capitis, semispinalis cervicis, and multifidus), and longus colli muscle thickness measurements will be made with the ultrasonography device.
3 secondary outcomes
Pain will be assessed with Visual Analog Scale.
Time frame: It will be evaluated in the baseline, third, and sixth weeks.
Functional status will be assessed with the Neck Disability Index.
Time frame: It will be evaluated in the baseline, third, and sixth weeks.
General health status will be assessed with Short Form 36.
Time frame: It will be evaluated in the baseline, third, and sixth 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 19 Aug 2025.
Related trials for Myofascial Pain Syndrome - Neck
Not yet recruiting
Focused Versus Multi-Target Trigger Point Injection for Chronic Myofascial Neck Pain
Myofacial Pain Syndrome, Chronic Neck Pain
Not yet recruiting
Kinesio Taping for Upper Trapezius Myofascial Trigger Points
Myofascial Pain Syndromes, Myofascial Trigger Point Pain
Not yet recruitingPhase 3
Effectiveness of Mitragynine Topical Patch for Pain Reduction in Myofascial Pain Syndrome
Topical Analgesia, Myofascial Pain Syndrome - Neck
Recruiting
Effectiveness of Tele-Rehabilitation in Managing Rhomboid Trigger Points in Patients With Myofascial Pain Syndrome
Myofascial Pain Syndrome
Recruiting
Effects of Different Myofascial Release Techniques on Function in Chronic Non-Specific Neck Pain
Chronic Neck Pain, Non-specific Neck Pain
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.
Muhammed Oğuz principal investigator
Istanbul 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 Therapeutic Exercise Program and Dry Needling in people with Myofascial Pain Syndrome - Neck and Myofascial Pain of Upper Trapezius Muscle, run by Istanbul Training and Research Hospital 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 13 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 19 Aug 2025. 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?
Ultrasonographic evaluation for muscle thickness assessment (time frame: It will be evaluated in the baseline, third, and sixth 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 19 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.