The Effectiveness of Dry Needling Treatment in Patients Diagnosed With Dorsal Myofascial Pain Syndrome.

NCT06338514 | Recruiting

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

Brief Summary

Back pain is commonly seen in the working-age population, with the peak occurrence around the age of 40. Its frequency does not increase with age and is not associated with age-related degenerative changes in the spine. Especially when the underlying cause is conditions such as myofascial pain syndrome (MPS), where regional muscle sensitivity in the rhomboid and trapezius areas is prominent, dry needling treatment has become increasingly popular and the subject of numerous studies in recent years. In the diagnosis of MPS, two valuable findings include the detection of a taut band upon palpation and the presence of trigger points in muscle fibers with mild finger pressure. The study we are planning involves a double-blind efficacy trial where real and sham dry needling procedures will be performed under ultrasound guidance, ensuring that both the patient and the evaluator are blinded. This study design has the potential to make a significant contribution to the literature in this field.

Conditions

Myofascial Trigger Point 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: 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: 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: 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 (2)

• What does Oswestry stand for? The Oswestry Disability Index (ODI)

  [Time Frame: 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: 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 Dorsal Myofascial Pain Syndrome associated with rhomboid and trapezius 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 spinal surgery.
• Lesions, atrophy, or scars in the skin around the back.
• Undergoing physiotherapy targeting the back and lumbar region in the last 6 months.
• Undergoing an interventional procedure for back or lumbar pain in the last 3 months.
• Use of 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, 43020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

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 dorsal trapezius and rhomboid 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: A two-group, sham-controlled, double-blind, prospective, randomized controlled trial

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: March 29, 2024
• Study Start: April 25, 2024
• Primary Completion: October 10, 2025
• Study Completion: November 10, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)