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Myofascial Pain SyndromeNCT07397039

Efficacy of Focused ESWT and Dry Needling Among Patients With Myofascial Pain Syndrome of the Upper Trapezius Muscle

A study testing Focused Extracorporeal Shockwave Therapy (fESWT) and Dry needling (DN) in people with Myofascial Pain Syndrome, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Myofascial pain syndrome (MPS) is one of the most common causes of musculoskeletal pain. Among patients with MPS, the upper trapezius muscle appears to be the common muscle that generates pain in the area of upper extremity. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Myofascial Pain Syndrome
What is being tested?
Focused Extracorporeal Shockwave Therapy (fESWT) and Dry needling (DN)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteThailand
Study dates
1 Dec 2022to 31 May 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The participant who is diagnosed with myofascial pain syndrome based on the criteria listed below:
  • The trigger point must be in a taut band of the upper trapezius muscle. The trigger point in the muscle is hypersensitivity to pain. Pain radiates to the specific pattern of the upper trapezius muscle. When pressure is applied to the trigger point, the participant perceives the same pain sensation as their pain complaint.
  • The participant who has a VAS score of > or = 5 points
  • The participant who has had myofascial pain for > or = 3 months

Who cannot join

  • Unresolved neurological or musculoskeletal problems, such as fibromyalgia, cervical radiculopathy, and cervical spine fracture.
  • History of cervical spine or shoulder surgery
  • Uncontrolled underlying diseases, such as psychological problems, cancer, or acute renal or hepatic failure
  • Received treatment by other physical modalities or steroid injection into the trigger point within 3 months, or was treated by analgesic drugs within 2 weeks.
  • Contraindicated to ESWT or DN
  • Refuse to attend the study

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Ramathibodi Hospital

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: The Comparative Efficacy of Focused Extracorporeal Shockwave Therapy and Dry Needling Among Patients With Myofascial Pain Syndrome of the Upper Trapezius Muscle, a Randomized Controlled Trial.

Myofascial pain syndrome (MPS) is one of the most common causes of musculoskeletal pain. Among patients with MPS, the upper trapezius muscle appears to be the common muscle that generates pain in the area of upper extremity. The main target treatment for MPS is to eradicate the painful trigger points by using treatment options, such as ultrasound, laser, and dry needling (DN). In the past decade, focused extracorporeal shockwave therapy (fESWT) has become the well-known treatment for pain relief in various musculoskeletal pain conditions. The main advantages of this non-invasive treatment modality are reducing pain, inflammation and promoting tissue healing. However, there were no previous studies compared effects of fESWT to dry needling. Therefore, the present study aims to compare the efficacy of the two treatments in terms of pain reduction and functional improvement.

Read the detailed description
  • This study is a single-blinded non-inferiority randomized controlled trial that will compare the efficacy of fESWT to DN in terms of pain reduction and functional improvement in patients with MPS of the upper trapezius.
  • 58 patients will be recruited for the study and randomly allocated to 2 groups, mainly fESWT and DN.
  • For the fESWT group, the participants will receive fESWT once a week, for a total of 3 sessions, consecutively. While the participants in the DN group will receive DN at the painful trigger point for 1 session. Moreover, both groups will receive the same conservative treatment, for example, education, exercise, and behavioral modification advice.
  • The primary outcome is Visual Analogue Scale (VAS) and the secondary outcomes are Pain Pressure Threshold (PPT) and Neck Disability Index (NDI) which will be recorded at baseline, 1 week, 3 week, and 6 week from baseline.
  • Statistical analysis will be performed using Stata to detect statistically significant changes in the same group and differences between the two groups.
Being tested
Focused Extracorporeal Shockwave Therapy (fESWT), Dry needling (DN)
Keywords
Extracorporeal shockwave therapy, Myofascial Pain Syndrome
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.

  • Focused Extracorporeal Shockwave Therapy (fESWT)Device

    fESWT will be done using an energy flux density of 0.20 - 0.25 millijoule (mJ)/mm2, a frequency of 4 Hz, and 1000 shocks per session which will be done one session per week, for a total of 3 sessions, consecutively.

  • Dry needling (DN)Other

    DN will be done by using a sterile technique with a sterile acupuncture needle, a diameter of 0.25 mm, and a length of 30-40 mm.

    The needle will be applied to the painful active trigger point using fan-shaped movements and the fast-in and fast-out technique until the twitching response disappears.

Study groups in NCT07397039
Study groupRoleWhat they receive
Focused Extracorporeal Shockwave Therapy (fESWT)ExperimentalThe participant will be treated by fESWT plus conservative treatment. fESWT will be applied once a week, for a total of 3 sessions.
Receives: Device: Focused Extracorporeal Shockwave Therapy (fESWT)
Dry needling (DN)Active comparatorThe participant will be treated by DN plus conservative treatment. DN will be done as a single session.
Receives: Other: Dry needling (DN)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Scale (VAS)

    VAS is a subjective tool that is used to measure pain scores. In this study, the 100-numerical scale will be used, in which 0 means "no pain," whereas 100 means "the worst pain." Patients mark the scale to rate the pain score based on their pain perception.

    Measured: Changes in VAS were assessed at baseline, and at 4 and 6 weeks following baseline.

Secondary outcomes (2)

  1. Pain pressure threshold (PPT)

    PPT is used to assess the strength of a physical stimulus that causes pain. A mechanical pressure is applied over the measured area, such as a muscle. The minimum force that provokes pain is determined as the pain threshold.

    Measured: Changes in PPT were assessed at baseline, and at 4 and 6 weeks following baseline.

  2. The Neck Disability Index (NDI)

    The Neck Disability Index (NDI) is a self-report questionnaire intended to evaluate patients' disabilities and how much their neck pain impacts their lives. This questionnaire consists of 10 items; 5 points for each item (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation).

    Measured: Changes in NDI were assessed at baseline and 6 weeks following baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start1 Dec 2022
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

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
Investigator, Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397039
Sponsor's protocol ID
MURA2022/525
Status last verified
Feb 2026
First submitted
7 Nov 2022
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Desai MJ, Saini V, Saini S. Myofascial pain syndrome: a treatment review. Pain Ther. 2013 Jun;2(1):21-36. doi: 10.1007/s40122-013-0006-y. Epub 2013 Feb 12.

    PubMed 25135034

  • Simplicio CL, Purita J, Murrell W, Santos GS, Dos Santos RG, Lana JFSD. Extracorporeal shock wave therapy mechanisms in musculoskeletal regenerative medicine. J Clin Orthop Trauma. 2020 May;11(Suppl 3):S309-S318. doi: 10.1016/j.jcot.2020.02.004. Epub 2020 Feb 12.

    PubMed 32523286

  • Jun JH, Park GY, Chae CS, Suh DC. The Effect of Extracorporeal Shock Wave Therapy on Pain Intensity and Neck Disability for Patients With Myofascial Pain Syndrome in the Neck and Shoulder: A Meta-Analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2021 Feb 1;100(2):120-129. doi: 10.1097/PHM.0000000000001493.

    PubMed 32520797

  • Park KD, Lee WY, Park MH, Ahn JK, Park Y. High- versus low-energy extracorporeal shock-wave therapy for myofascial pain syndrome of upper trapezius: A prospective randomized single blinded pilot study. Medicine (Baltimore). 2018 Jul;97(28):e11432. doi: 10.1097/MD.0000000000011432.

    PubMed 29995794

  • Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

    PubMed 1834753

  • Kinser AM, Sands WA, Stone MH. Reliability and validity of a pressure algometer. J Strength Cond Res. 2009 Jan;23(1):312-4. doi: 10.1519/jsc.0b013e31818f051c.

    PubMed 19130648

Questions about this trial

What is this clinical trial studying?

A study testing Focused Extracorporeal Shockwave Therapy (fESWT) and Dry needling (DN) in people with Myofascial Pain Syndrome, run by Mahidol University at 1 site in Thailand.

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 4 inclusion and 6 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 9 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 Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) (time frame: Changes in VAS were assessed at baseline, and at 4 and 6 weeks following baseline.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07397039, which also lists 6 linked publications.

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 9 Feb 2026.

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