Focused Shockwave Therapy for Neck and Shoulder Myofascial Pain

NCT07660523 | Not Yet Recruiting

• 1 other identifier: CHIS-2026-02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Myofascial pain syndrome of the neck and shoulder is a common condition characterized by persistent muscle pain, tenderness, stiffness, and limitations in daily activities. Focused extracorporeal shockwave therapy is a noninvasive treatment that may reduce pain and improve muscle function. However, additional clinical evidence is needed regarding the effectiveness of second-generation focused shockwave therapy and whether ultrasound imaging can objectively detect changes in muscle function after treatment. This pilot randomized controlled trial will enroll 60 adults with chronic neck and shoulder myofascial pain syndrome. Participants will be randomly assigned to either a focused shockwave therapy group or a home-based neck exercise group. Participants in the focused shockwave therapy group will receive one treatment session per week for three consecutive weeks. Participants in the control group will perform a standardized home exercise program designed to improve neck mobility and reduce muscle tightness. Assessments will be performed before the intervention, after the intervention, and at follow-up. Study outcomes will include pain intensity measured using the Visual Analogue Scale, neck-related disability measured using the Neck Disability Index, pressure pain threshold measured using an algometer, and upper trapezius muscle thickness and contraction-related changes measured using ultrasound imaging. The primary objective is to determine whether focused shockwave therapy is more effective than a home-based neck exercise program in reducing pain and improving neck function. The study will also evaluate whether ultrasound-derived muscle measurements are associated with changes in pain, pressure sensitivity, and functional disability.

Conditions

Myofascial Pain Syndrome

Keywords

Myofascial Pain Syndrome; Focused Extracorporeal Shockwave Therapy; Neck and Shoulder Pain; Upper Trapezius Muscle; Pressure Pain Threshold; Ultrasound Imaging; Muscle Thickness; Neck Disability

Outcome Measures

Primary Outcomes (2)

• Change in Neck and Shoulder Pain Intensity

  Pain intensity will be assessed using a 100-mm Visual Analogue Scale. Participants will mark their current neck and shoulder pain on a horizontal line ranging from 0 mm, representing no pain, to 100 mm, representing the worst imaginable pain. Higher scores indicate greater pain intensity. Changes from baseline will be compared between the focused extracorporeal shockwave therapy group and the home-based neck exercise group.

  Baseline, immediately after completion of the 3-week intervention, and Week 8 after enrollment

• Change in Pressure Pain Threshold

  Pressure pain threshold will be measured using an electronic pressure algometer at the clinically identified painful region of the upper trapezius and levator scapulae muscles. Pressure will be gradually increased at approximately 5 newtons per second until the participant first reports discomfort or pain. Two measurements will be obtained and averaged. Higher values indicate lower pressure sensitivity and greater tolerance to mechanical pressure. Unit of Measure: N/cm²

  Baseline, immediately after completion of the 3-week intervention, and Week 8 after enrollment

Secondary Outcomes (4)

• Change in Neck-Related Disability

  Baseline, immediately after completion of the 3-week intervention, and Week 8 after enrollment

• Change in Resting Upper Trapezius Muscle Thickness

  Baseline, immediately after completion of the 3-week intervention, and Week 8 after enrollment

• Change in Upper Trapezius Thickness During Anti-Gravity Contraction

  Baseline, immediately after completion of the 3-week intervention, and Week 8 after enrollment

• Change in Upper Trapezius Thickness During Maximal Voluntary Contraction

  Baseline, immediately after completion of the 3-week intervention, and Week 8 after enrollment

Study Arms (2)

Focused Extracorporeal Shockwave Therapy

EXPERIMENTAL

Participants assigned to this arm will receive second-generation focused extracorporeal shockwave therapy applied to clinically identified tight and painful regions of the upper trapezius and levator scapulae muscles. Treatment will be administered once weekly for 3 consecutive weeks using the Richard Wolf PiezoWave system. Each treatment session will include approximately 3,000 shockwave pulses at a treatment depth of 20 to 25 mm and a frequency of 2 to 4 Hz. The energy level will begin at level 4 and may be gradually increased to a maximum of level 15 according to the participant's clinical response and tolerance.

Device: Second-Generation Focused Extracorporeal Shockwave Therapy

Home-Based Neck Exercise Program

ACTIVE COMPARATOR

Participants assigned to this arm will receive instruction in a standardized home-based neck exercise program for 3 weeks. The program includes cervical flexion, extension, right and left rotation, right and left lateral flexion, and right and left upper cervical rotation performed with the neck in a flexed position. Participants will receive initial instruction and movement correction from a qualified physical therapist, together with written educational materials. Adherence and exercise-related difficulties will be monitored during the study.

Behavioral: Home-Based Neck Exercise Program

Interventions

Second-Generation Focused Extracorporeal Shockwave Therapy DEVICE

Second-generation focused extracorporeal shockwave therapy will be applied to clinically identified tight and painful regions of the upper trapezius and levator scapulae muscles. Treatment will be administered using the Richard Wolf PiezoWave system once weekly for 3 consecutive weeks. Each session will include approximately 3,000 shockwave pulses at a treatment depth of 20 to 25 mm and a frequency of 2 to 4 Hz. The treatment energy level will begin at level 4 and may be gradually increased to a maximum of level 15 according to the participant's clinical response and tolerance.

Focused Extracorporeal Shockwave Therapy

Home-Based Neck Exercise Program BEHAVIORAL

Participants will perform a standardized home-based neck exercise program for 3 weeks. The program includes cervical flexion, extension, right and left rotation, right and left lateral flexion, and right and left upper cervical rotation performed with the neck in a flexed position. Each exercise will be performed for 20 repetitions per set, for 3 sets, 5 times per day. Participants will receive initial instruction and movement correction from a qualified physical therapist, together with written educational materials. Adherence and exercise-related difficulties will be monitored during the study.

Home-Based Neck Exercise Program

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults older than 20 years.
• Clinical diagnosis of nonspecific neck and shoulder pain primarily arising from muscles and soft tissues in the upper trapezius or levator scapulae region, as determined by a physical medicine and rehabilitation physician.
• Neck and shoulder pain lasting for at least 3 months.
• Neck Disability Index score greater than 5.
• No use of analgesic medication or muscle relaxants within the previous month.
• No injection therapy, physical therapy, or other treatment for neck and shoulder pain within the previous month.
• Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

• Neck or shoulder pain caused by a neurologic disorder, including cervical radiculopathy.
• Clinical or imaging diagnosis of cervical degenerative joint disease.
• History of a rheumatic disease, including rheumatoid arthritis or systemic lupus erythematosus.
• History of head or neck trauma.
• History of cervical spine surgery.
• History of whiplash injury.
• Pregnancy.
• Current or previous malignancy considered clinically relevant to shockwave therapy.
• Bleeding disorder.
• Current use of anticoagulant medication, including warfarin.
• Acute inflammation or infection at the treatment site.
• Implanted cardiac pacemaker or implantable cardioverter-defibrillator.
• Any other condition judged by the study physician to make participation or focused shockwave therapy inappropriate or unsafe.

Sponsors & Collaborators

• Cishan Hospital, Ministry of Health and Welfare: lead

Related Publications (17)

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• Ezzati K, Khani S, Moladoust H, Takamjani IE, Nasiri E, Ettehad H. Comparing muscle thickness and function in healthy people and subjects with upper trapezius myofascial pain syndrome using ultrasonography. J Bodyw Mov Ther. 2021 Apr;26:253-256. doi: 10.1016/j.jbmt.2020.12.016. Epub 2020 Dec 15.

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• Salavati M, Akhbari B, Ebrahimi Takamjani I, Ezzati K, Haghighatkhah H. Reliability of the Upper Trapezius Muscle and Fascia Thickness and Strain Ratio Measures by Ultrasonography and Sonoelastography in Participants With Myofascial Pain Syndrome. J Chiropr Med. 2017 Dec;16(4):316-323. doi: 10.1016/j.jcm.2017.06.003. Epub 2017 Oct 11.

  PMID: 29276464 RESULT

• Fiani B, Davati C, Griepp DW, Lee J, Pennington E, Moawad CM. Enhanced Spinal Therapy: Extracorporeal Shock Wave Therapy for the Spine. Cureus. 2020 Oct 27;12(10):e11200. doi: 10.7759/cureus.11200.

  PMID: 33269131 RESULT

• Zhang Q, Fu C, Huang L, Xiong F, Peng L, Liang Z, Chen L, He C, Wei Q. Efficacy of Extracorporeal Shockwave Therapy on Pain and Function in Myofascial Pain Syndrome of the Trapezius: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2020 Aug;101(8):1437-1446. doi: 10.1016/j.apmr.2020.02.013. Epub 2020 Mar 28.

  PMID: 32234411 RESULT

• Ismail Hassan M, Shafiek Mustafa Saleh M, Hesham Sallam M, Hesham Elkhodary H, Mohamed Sayed M, Samy H, Hesham Mohamed A, Said Ashour A, Mohamed Mosaid E, Hassan Zaghloul M, Ramadan Elbathesh E, Vaish H, Mohammed Abdullah A A, Ibrahim Abdelhamed A. Extracorporeal Shock Wave Therapy versus laser therapy in treating musculoskeletal disorders: a systematic review and meta-analysis. Lasers Med Sci. 2025 Apr 15;40(1):194. doi: 10.1007/s10103-025-04392-0.

  PMID: 40232318 RESULT

• Yoo JI, Oh MK, Chun SW, Lee SU, Lee CH. The effect of focused extracorporeal shock wave therapy on myofascial pain syndrome of trapezius: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Feb;99(7):e19085. doi: 10.1097/MD.0000000000019085.

  PMID: 32049811 RESULT

• Muller-Ehrenberg H, Giordani F, Muller-Ehrenberg A, Stange R. The Use and Benefits of Focused Shockwaves for the Diagnosis of Myofascial Pain Syndrome by Examining Myofascial Trigger Points in Low Back Pain. Biomedicines. 2024 Dec 20;12(12):2909. doi: 10.3390/biomedicines12122909.

  PMID: 39767813 RESULT

• 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: 32520797 RESULT

• Ughreja RA, Venkatesan P, Balebail Gopalakrishna D, Singh YP. Effectiveness of myofascial release on pain, sleep, and quality of life in patients with fibromyalgia syndrome: A systematic review. Complement Ther Clin Pract. 2021 Nov;45:101477. doi: 10.1016/j.ctcp.2021.101477. Epub 2021 Aug 27.

  PMID: 34507243 RESULT

• Badil Guloglu S, Tunc S. The assessment of affective temperament and life quality in myofascial pain syndrome patients. Int J Psychiatry Clin Pract. 2022 Mar;26(1):79-84. doi: 10.1080/13651501.2020.1833039. Epub 2020 Oct 21.

  PMID: 33084454 RESULT

• Lee CH, Lee SU. Usefulness of Extracorporeal Shockwave Therapy on Myofascial Pain Syndrome. Ann Rehabil Med. 2021 Aug;45(4):261-263. doi: 10.5535/arm.21128. Epub 2021 Aug 30. No abstract available.

  PMID: 34496468 RESULT

• Sciotti VM, Mittak VL, DiMarco L, Ford LM, Plezbert J, Santipadri E, Wigglesworth J, Ball K. Clinical precision of myofascial trigger point location in the trapezius muscle. Pain. 2001 Sep;93(3):259-266. doi: 10.1016/S0304-3959(01)00325-6.

  PMID: 11514085 RESULT

MeSH Terms

Conditions

Myofascial Pain Syndromes; Shoulder Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Arthralgia; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chia-Yu Wei, M.S.

CONTACT

+886-7-6613811; ivywei@chis.mohw.gov.tw

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: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician and Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the focused extracorporeal shockwave therapy group or the home-based neck exercise group. Each participant will remain in the assigned group throughout the study, with no crossover between interventions.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share