ClinicalTrials.gg
RecruitingNCT06338488Updated Aug 24, 2026

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

An interventional study of Real dry needling and Sham dry needling in Shoulder Pain, sponsored by Kutahya Health Sciences University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 167 studies in Shoulder Pain with a site in Turkey — 42 open to participants now, 45 under way, none of them phase 3. Shoulder Pain · Turkey.

Planned enrollment
63rd of 126
50 · median 50
Started
2024
with 17 others
No phase
124 of 167
34 open now
Primary completion
2026-11
later than 28 of 44 live
Registered
92nd of 167
by date

Among the 167 studies in Shoulder Pain with a site in Turkey, this one is the 63rd largest by planned enrollment of the 126 interventional ones, is one of 18 that started in 2024, is one of 124 with no phase, reaches primary completion later than 28 of the 44 other live ones, and was the 92nd registered.

By phase

167 studies; the count open now beside each. This study's row is marked.

No phasethis study124 · 34 open
Observational41 · 8 open
Phase 42 · 0 open

By the year they started

First in 2015; this study’s year is marked. 18 started in 2024.

Size and results

Median enrollment 50 across the 126 interventional studies, 90 across the 41 observational. Of the 115 that completed or were terminated, 1 (1%) have results posted.

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02

Study 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.

Read the detailed description

It is planned to enroll 50 patients aged between 18 and 80 years who have been diagnosed with Shoulder Myofascial Pain Syndrome into the study. After signing informed consent forms, eligible patients will be randomized into two different groups using a random number table (randomizer.org) according to inclusion and exclusion criteria. In the study, neither the patient nor the evaluator will know which group they are in; only the physician administering the dry needling treatment will be aware. At the beginning of the study, during weekly follow-ups, and at the end of the study, non-interventional assessment tests will be conducted. Minimal intervention, drug-free dry needling treatment will be administered to patients twice in total, once a week, each session lasting approximately 10-20 minutes with ultrasonographic guidance. Throughout the study period, all patients in both groups will be instructed in detail on the daily exercises they need to perform (trapezius stretching and infraspinatus stretching exercises), as well as on important considerations (avoiding prolonged static positions, etc.). They will be encouraged to perform these exercises daily and mark their completion. Additionally, they will be informed about the selection and usage of medications (only paracetamol) that they can use when necessary, along with instructions on adherence and marking on the provided follow-up form. The entire process will be monitored weekly through the follow-up form provided to the patients.

03

Conditions studied

  • Shoulder Pain

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04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Dry needling group (study group)

    Real dry needling into the muscle under ultrasound guidance.

    Other: Real dry needling

  • Sham comparator
    Sham dry needling group (control group)

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

    Other: Sham dry needling

Interventions

  • OtherReal dry needling

    dry needling into the muscle under ultrasound guidance.

  • OtherSham dry needling

    dry needling into the subcutaneous fatty tissue under ultrasound guidance.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. The Shoulder Pain and Disability Index (SPADI)

    The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. Overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction.

    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

  2. The Quick DASH Outcome Measure

    The Quick DASH is an 11-item measure of the magnitude of disability and symptoms specific to the upper extremity. What is the highest score on QuickDASH? To calculate a QuickDASH score, at least 10 of the 11 items must be completed. Similar to the DASH, each item has 5 response options and, from the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).

    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

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

    The SF-12v2 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). What is the maximum score for SF-12? Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning

    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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Nov 2026, 30 months after the start.

Of 349 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 30 months is above that.

Counting every sponsor, half of 354 studies reached it within 11 months; a quarter within 4 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2024
First posted
Mar 29, 2024
StartActual
Apr 25, 2024
Primary completionEst.
Nov 15, 2026
CompletionEst.
Dec 15, 2026
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06338488
Responsible party
Hasan Hüseyin Gökpınar (Assistant Professor, Kutahya Health Sciences University) — Principal investigator
First posted
Mar 29, 2024
Start date
Apr 25, 2024
Primary completion
Nov 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Aug 24, 2026

Study contacts

Hasan H Gökpınar, Ass. Prof.
Contact
hasanhuseyin.gokpinar@ksbu.edu.tr
05052842222
Hasan H Gökpınar, Ass. Prof.
principal investigator · Kutahya Health Sciences University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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