Myofascial Pain SyndromeNCT06546124
Treatment of Upper Trapezius Muscle Myofascial Pain Syndrome
A study testing Deep Fascia Dry needling Technique and Intramuscular Trigger Point Dry Needling Technique in people with Myofascial Pain Syndrome, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of superficial and deep dry needling techniques, guided by ultrasound, on pain, disability, functional impairment, and quality of life in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Deep Fascia Dry needling Technique and Intramuscular Trigger Point Dry Needling Technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Aug 2024to 1 Apr 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of MPS in the upper trapezius muscle in accordance with criteria defined by Travell and Simons
- Ages between 20 and 50 years
- No treatment, including injections, dry needling, and physical methods, applied to the cervical region in the last three months
Who cannot join
- Bleeding Tendency
- History of Neck and Shoulder Trauma
- Other Conditions Affecting Neck and Shoulder Pain: including malignancy, infection, rheumatic diseases, degenerative joint disease, fibromyalgia, cervical radiculopathy, neuropathy, myelopathy, myopathy, adhesive capsulitis, etc.
- Cases Where Evaluation Could Not Be Completed for Any Reason
- Patients Who Refuse to Complete the Evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Upper Trapezius Muscle Myofascial Pain Syndrome: Comparison of Ultrasound- Guided Dry Needling Techniques
The aim of this study is to compare the effects of superficial and deep dry needling techniques, guided by ultrasound, on pain, disability, functional impairment, and quality of life in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle.
Read the detailed description
Myofascial Pain Syndrome (MAS) is a common condition encountered in the daily practice of musculoskeletal medicine. Dry needling is a commonly used technique by clinicians in the treatment of myofascial trigger points. Dry needling can be classified into two main categories based on the depth of needle insertion: superficial and deep dry needling. Dry needling can be performed using either manual palpation techniques or ultrasonographic imaging. Ultrasound allows for more precise needle placement. It must be recognized that the depth of needling (superficial insertion vs. deep insertion) varies for every structure and that without ultrasound guidance, differentiation between needling into the superficial fascia and beyond the deep fascia maybe difficult. In clinical settings, using ultrasound can help visualize the different layers and guide the needle to the appropriate depth. The aim of this study is to compare the effectiveness of deep fascia and intramuscular trigger point dry needling techniques, guided by ultrasound, on pain, disability, functional impairment, and quality of life in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Deep Fascia Dry needling Technique, Intramuscular Trigger Point Dry Needling Technique
- 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.
Deep Fascia Dry needling TechniqueOther
"Participants will undergo a single session of dry needling on the painful area of the upper trapezius muscle on the right and/or left side of the neck, either unilaterally or bilaterally. All participants will be positioned upright in a chair with their backs supported, heads in a neutral position, and arms at their sides. A myofascial trigger point on the upper trapezius muscle will be marked. A sterile acupuncture needle, 0.25 mm in diameter and 40 mm in length, will be used. Under ultrasound guidance, the needle will be inserted at three points, including 1 cm lateral and medial to the marked point, penetrating subcutaneously to the deep fascia. After leaving the needle in place for 5 minutes, it will be rotated clockwise and left in place for an additional 5 minutes. The needles will be removed after a total of 10 minutes. Participants will be advised to perform upper trapezius stretching exercises."
Intramuscular Trigger Point Dry Needling TechniqueOther
"Participants will undergo a single session of dry needling on the painful area of the upper trapezius muscle on the right and/or left side of the neck, either unilaterally or bilaterally. All participants will be positioned upright in a chair with their backs supported, heads in a neutral position, and arms at their sides. A myofascial trigger point on the upper trapezius muscle will be marked. A sterile acupuncture needle, 0.25 mm in diameter and 40 mm in length, will be used. Under ultrasound guidance, the needle will be inserted at three points, including 1 cm lateral and medial to the marked point, penetrating through the deep fascia into the upper trapezius muscle. After leaving the needle in place for 5 minutes, it will be rotated clockwise and left in place for an additional 5 minutes. The needles will be removed after a total of 10 minutes. Participants will be advised to perform upper trapezius stretching exercises."
| Study group | Role | What they receive |
|---|---|---|
| Deep fascia dry needling technique | Active comparator | Deep fascia dry needling technique Receives: Other: Deep Fascia Dry needling Technique |
| İntramuscular trigger point dry needling technique | Active comparator | İntramuscular trigger point dry needling technique Receives: Other: Intramuscular Trigger Point Dry Needling Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Pain Rating Scale
It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain. In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.
Measured: Before treatment
The Numerical Pain Rating Scale
It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain. In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.
Measured: 1 week after treatment
Pressure Pain Threshold
A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception. It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (Baseline® Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.
Measured: Before treatment
Pressure Pain Threshold
A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception. It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (Baseline® Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.
Measured: 1 week after treatment
Neck disability index
The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.
Measured: Before treatment
Neck disability index
The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.
Measured: 1 week after treatment
Neck bournemouth questionnaire
Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.
Measured: Before treatment
Neck bournemouth questionnaire
Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.
Measured: 1 week after treatment
Joint range of Motion Measurement
Joint range of motion is measured using a goniometric protractor with the Neutral-0 Method. While the person sits upright in a chair, the goniometer is used to measure the range of motion of the neck in the directions of flexion, extension, lateral flexion, and rotation.
Measured: Before treatment
Joint range of Motion Measurement
Joint range of motion is measured using a goniometric protractor with the Neutral-0 Method. While the person sits upright in a chair, the goniometer is used to measure the range of motion of the neck in the directions of flexion, extension, lateral flexion, and rotation.
Measured: 1 week after treatment
Secondary outcomes (2)
Advers event
Follow-up will include assessment of pain-burning sensation, nausea, dizziness, and pain experienced during the procedure.
Measured: 1 week after treatment
Cutaneous and subcutaneous thickness
Cutaneous and subcutaneous tissue thickness will be measured with ultrasound at the site of the trigger point in the upper trapezius muscle.
Measured: Before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start11 Aug 2024
- Primary completion1 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kilinc, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546124
- Sponsor's protocol ID
- AIBU-FTR-SK-07
- Status last verified
- Sep 2025
- First submitted
- 7 Aug 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Upper Trapezius Muscle Myofascial Pain Syndrome: Comparison of Ultrasound- Guided Dry Needling Techniques
- ClinicalTrials.gov ID
- NCT06546124
- Acronym / sponsor ID
- AIBU-FTR-SK-07
- Conditions
- Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 11 Aug 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 9 Aug 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.
The aim of this study is to compare the effects of superficial and deep dry needling techniques, guided by ultrasound, on pain, disability, functional impairment, and quality of life in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle.
Detailed description
Myofascial Pain Syndrome (MAS) is a common condition encountered in the daily practice of musculoskeletal medicine. Dry needling is a commonly used technique by clinicians in the treatment of myofascial trigger points. Dry needling can be classified into two main categories based on the depth of needle insertion: superficial and deep dry needling. Dry needling can be performed using either manual palpation techniques or ultrasonographic imaging. Ultrasound allows for more precise needle placement. It must be recognized that the depth of needling (superficial insertion vs. deep insertion) varies for every structure and that without ultrasound guidance, differentiation between needling into the superficial fascia and beyond the deep fascia maybe difficult. In clinical settings, using ultrasound can help visualize the different layers and guide the needle to the appropriate depth. The aim of this study is to compare the effectiveness of deep fascia and intramuscular trigger point dry needling techniques, guided by ultrasound, on pain, disability, functional impairment, and quality of life in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep fascia dry needling technique | Active comparator | Other: Deep Fascia Dry needling TechniqueDeep fascia dry needling technique |
| İntramuscular trigger point dry needling technique | Active comparator | Other: Intramuscular Trigger Point Dry Needling Techniqueİntramuscular trigger point dry needling technique |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of MPS in the upper trapezius muscle in accordance with criteria defined by Travell and Simons
- Ages between 20 and 50 years
- No treatment, including injections, dry needling, and physical methods, applied to the cervical region in the last three months
Key exclusion criteria (5 listed)
- Bleeding Tendency
- History of Neck and Shoulder Trauma
- Other Conditions Affecting Neck and Shoulder Pain: including malignancy, infection, rheumatic diseases, degenerative joint disease, fibromyalgia, cervical radiculopathy, neuropathy, myelopathy, myopathy, adhesive capsulitis, etc.
- Cases Where Evaluation Could Not Be Completed for Any Reason
- Patients Who Refuse to Complete the Evaluations
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 |
|---|---|---|
| Deep Fascia Dry needling Technique"Participants will undergo a single session of dry needling on the painful area of the upper trapezius muscle on the right and/or left side of the neck, either unilaterally or bilaterally. All participants will be positioned upright in a chair with their backs supported, heads in a neutral position, and arms at their sides. A myofascial trigger point on the upper trapezius muscle will be marked. A sterile acupuncture needle, 0.25 mm in diameter and 40 mm in length, will be used. Under ultrasound guidance, the needle will be inserted at three points, including 1 cm lateral and medial to the marked point, penetrating subcutaneously to the deep fascia. After leaving the needle in place for 5 minutes, it will be rotated clockwise and left in place for an additional 5 minutes. The needles will be removed after a total of 10 minutes. Participants will be advised to perform upper trapezius stretching exercises." | Other | Deep fascia dry needling technique |
| Intramuscular Trigger Point Dry Needling Technique"Participants will undergo a single session of dry needling on the painful area of the upper trapezius muscle on the right and/or left side of the neck, either unilaterally or bilaterally. All participants will be positioned upright in a chair with their backs supported, heads in a neutral position, and arms at their sides. A myofascial trigger point on the upper trapezius muscle will be marked. A sterile acupuncture needle, 0.25 mm in diameter and 40 mm in length, will be used. Under ultrasound guidance, the needle will be inserted at three points, including 1 cm lateral and medial to the marked point, penetrating through the deep fascia into the upper trapezius muscle. After leaving the needle in place for 5 minutes, it will be rotated clockwise and left in place for an additional 5 minutes. The needles will be removed after a total of 10 minutes. Participants will be advised to perform upper trapezius stretching exercises." | Other | İntramuscular trigger point dry needling technique |
Primary outcome
The Numerical Pain Rating Scale
Time frame: Before treatment
It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain. In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.
The Numerical Pain Rating Scale
Time frame: 1 week after treatment
It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain. In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.
Pressure Pain Threshold
Time frame: Before treatment
A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception. It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (Baseline® Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.
Pressure Pain Threshold
Time frame: 1 week after treatment
A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception. It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (Baseline® Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.
Neck disability index
Time frame: Before treatment
The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.
Neck disability index
Time frame: 1 week after treatment
The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.
Neck bournemouth questionnaire
Time frame: Before treatment
Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.
Neck bournemouth questionnaire
Time frame: 1 week after treatment
Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.
Joint range of Motion Measurement
Time frame: Before treatment
Joint range of motion is measured using a goniometric protractor with the Neutral-0 Method. While the person sits upright in a chair, the goniometer is used to measure the range of motion of the neck in the directions of flexion, extension, lateral flexion, and rotation.
Joint range of Motion Measurement
Time frame: 1 week after treatment
Joint range of motion is measured using a goniometric protractor with the Neutral-0 Method. While the person sits upright in a chair, the goniometer is used to measure the range of motion of the neck in the directions of flexion, extension, lateral flexion, and rotation.
2 secondary outcomes
Advers event
Time frame: 1 week after treatment
Cutaneous and subcutaneous thickness
Time frame: Before treatment
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 27 Jan 2026.
- 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.
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 Deep Fascia Dry needling Technique and Intramuscular Trigger Point Dry Needling Technique in people with Myofascial Pain Syndrome, 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 5 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 27 Jan 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?
The Numerical Pain Rating Scale (time frame: Before treatment). The study lists 10 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 27 Jan 2026.