NCT07397039

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

November 7, 2022

Last Update Submit

February 6, 2026

Conditions

Keywords

Extracorporeal shockwave therapy, Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • Pain pressure threshold (PPT)

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

  • The Neck Disability Index (NDI)

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

Study Arms (2)

Focused Extracorporeal Shockwave Therapy (fESWT)

EXPERIMENTAL

The participant will be treated by fESWT plus conservative treatment. fESWT will be applied once a week, for a total of 3 sessions.

Device: Focused Extracorporeal Shockwave Therapy (fESWT)

Dry needling (DN)

ACTIVE COMPARATOR

The participant will be treated by DN plus conservative treatment. DN will be done as a single session.

Other: Dry needling (DN)

Interventions

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.

Focused Extracorporeal Shockwave Therapy (fESWT)

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.

Dry needling (DN)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (6)

  • 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.

    PMID: 25135034BACKGROUND
  • 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.

    PMID: 32523286BACKGROUND
  • 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.

    PMID: 32520797BACKGROUND
  • 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.

    PMID: 29995794BACKGROUND
  • Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

    PMID: 1834753BACKGROUND
  • 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.

    PMID: 19130648BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Thitiporn Phakdepiboon, MD

    Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

February 9, 2026

Study Start

December 1, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations