Clinical trial NCT06338488: The Effectiveness of Dry Needling Treatment in Patients With Shoulder Myofascial Pain Syndrome
Official title: The Effectiveness of Dry Needling Treatment in Patients With Shoulder Myofascial Pain Syndrome: Double-blind Randomized Sham-controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective double-blind randomized sham-controlled study.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 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
measure: Patient-Specific Functional Scale
timeFrame: 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
measure: Pressure Pain Threshold Measurement
timeFrame: 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:
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: 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
measure: The Quick DASH Outcome Measure
timeFrame: 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
measure: The 12-item Short-Form Health Survey version 2 (SF-12v2)
timeFrame: 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
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kütahya Health Sciences University
state: Türkiye
Study officials:
affiliation: Kutahya Health Sciences University
name: Hasan H Gökpınar, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References: