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NCT Number: NCT07397039

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

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.

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Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ramathibodi Hospital

Bangkok, 10400, Thailand

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

The participant who has

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Visual Analogue Scale (VAS)

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

    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.

Secondary outcomes

  1. Pain pressure threshold (PPT)

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

    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.

  2. The Neck Disability Index (NDI)

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

    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).

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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