The Effectiveness of Dry Needling Treatment in Patients With Shoulder Myofascial Pain Syndrome

NCT06338488 | Recruiting

• 1 other identifier: KutahyaHSU-DRYNEEDLE-SHOULDER
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Myofascial pain can be diagnosed by the presence of one or more myofascial trigger points (MTrPs), defined as hyperirritable spots in taut bands of skeletal muscle fibers palpable by hand. The treatment of myofascial pain primarily relies on the inactivation of MTrPs, often through manual pressure techniques or dry needling. In manual pressure techniques, the physiotherapist applies increasing pressure directly to the MTrP. In dry needling, acupuncture-like filiform needles are applied to the same point. There are two types of dry needling: superficial dry needling, which penetrates only the skin and superficial muscle, and deep dry needling, which involves inserting a needle directly into the MTrP. The sole or adjunct effectiveness of dry needling treatment targeting the trapezius and infraspinatus muscles has been investigated, particularly in patients with shoulder myofascial pain syndrome. In the study we are planning, a double-blinded efficacy trial will be conducted in patients with shoulder myofascial pain syndrome, where real and sham dry needling applications will be performed under ultrasound guidance, with both the patient and the evaluator blinded. This study design has the potential to make a significant contribution to the literature in this field.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale

  "Visual Analog Scale (VAS)" is a measurement instrument often used in healthcare to assess the intensity or characteristics of subjective experiences such as pain. It typically consists of a straight line, usually 10 centimeters in length, with endpoints representing extremes (e.g., "no pain" to "worst imaginable pain"). Patients mark on the line to indicate their subjective experience, and the distance from one endpoint provides a numerical score representing the intensity of the sensation being measured. The VAS is commonly employed in pain assessment but can also be adapted for various other subjective evaluations.

  Time frame 1: Up to 24 hour before the first intervention, Time frame 2: Up to 24 hour before the second intervention, Time frame 3: One week after the last intervention, Time frame 4: One month after the last intervention

• Patient-Specific Functional Scale

  "Patient-Specific Functional Scale" (PSFS). The PSFS is a self-report outcome measure commonly used in healthcare, particularly in physical therapy and rehabilitation settings. It is designed to assess the patient's perceived difficulty in performing specific activities that are relevant to their daily life and function. Identification of Activities: The patient is asked to identify and list three to five activities that they find challenging or have difficulty performing due to their condition or symptoms. Rating Scale: For each identified activity, the patient is asked to rate their current level of difficulty on a numerical scale, often ranging from 0 to 10. A score of 0 indicates no difficulty, while 10 indicates the maximum difficulty. Follow-up Assessments: The same activities and rating scale are used in follow-up assessments to track changes over time or in response to interventions.

  Time frame 1: Up to 24 hour before the first intervention, Time frame 2: Up to 24 hour before the second intervention, Time frame 3: One week after the last intervention, Time frame 4: One month after the last intervention

• Pressure Pain Threshold Measurement

  "Pressure Pain Threshold Measurement" refers to the assessment of the amount of pressure applied to a specific point on the body before the individual perceives it as painful. This measurement is commonly used in clinical settings to evaluate pain sensitivity and threshold. The process involves gradually applying pressure to a specific area until the individual signals that they begin to feel pain. It is a quantitative way to assess pain perception and is often utilized in research, physical therapy, and other healthcare disciplines to understand pain levels and responses.

  Time frame 1: Up to 24 hour before the first intervention, Time frame 2: Up to 24 hour before the second intervention, Time frame 3: One week after the last intervention, Time frame 4: One month after the last intervention

Secondary Outcomes (3)

• The Shoulder Pain and Disability Index (SPADI)

  Time frame 1: Up to 24 hour before the first intervention, Time frame 2: One week after the last intervention, Time frame 3: One month after the last intervention

• The Quick DASH Outcome Measure

  Time frame 1: Up to 24 hour before the first intervention, Time frame 2: One week after the last intervention, Time frame 3: One month after the last intervention

• The 12-item Short-Form Health Survey version 2 (SF-12v2)

  Time frame 1: Up to 24 hour before the first intervention, Time frame 2: One week after the last intervention, Time frame 3: One month after the last intervention

Study Arms (2)

Dry needling group (study group)

ACTIVE COMPARATOR

Real dry needling into the muscle under ultrasound guidance.

Other: Real dry needling

Sham dry needling group (control group)

SHAM COMPARATOR

Sham dry needling into the subcutaneous fatty tissue under ultrasound guidance.

Other: Sham dry needling

Interventions

Real dry needling OTHER

dry needling into the muscle under ultrasound guidance.

Dry needling group (study group)

Sham dry needling OTHER

dry needling into the subcutaneous fatty tissue under ultrasound guidance.

Sham dry needling group (control group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed with Shoulder Myofascial Pain Syndrome associated with Infraspinatus trigger point.
• Having a shoulder pain Visual Analog Scale (VAS) score of 6 or higher.
• Ability to read and write

You may not qualify if:

• History of shoulder surgery and frozen shoulder syndrome.
• Lesions, atrophy, or scars in the skin around the shoulder.
• Having undergone physiotherapy targeting the shoulder in the last 6 months.
• Undergoing an interventional procedure for shoulder pain in the last 3 months.
• Having used steroids in the last 1 month.
• Special conditions such as epilepsy, pregnancy, injection phobia, etc.
• Inability to comply with the restriction on the use of steroid and non-steroidal anti-inflammatory drugs during the treatment period.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University

Kütahya, Türkiye, 43020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Hasan H Gökpınar, Ass. Prof.

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan H Gökpınar, Ass. Prof.

CONTACT

05052842222; hasanhuseyin.gokpinar@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the dry needling application, patients will be blinded to the groups they are randomized into. The evaluator will also be unaware of which group the patients belong to. The practitioner will perform the procedures in both groups using ultrasound guidance, targeting the standard trigger points in the painful shoulder's trapezius and infraspinatus muscles in the study group, and targeting subcutaneous fatty tissue in the same regions in the sham group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective double-blind randomized sham-controlled study.

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: March 29, 2024
• Study Start: April 25, 2024
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

TU (1)