Clinical trial NCT06338514: The Effectiveness of Dry Needling Treatment in Patients Diagnosed With Dorsal Myofascial Pain Syndrome.
Official title: The Effectiveness of Dry Needling Treatment in Patients Diagnosed With Dorsalgia Accompanied by Myofascial Pain Syndrome.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myofascial Trigger Point 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: A two-group, sham-controlled, double-blind, prospective, randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: The study aims to enroll 60 patients aged between 18 and 80 years who present to the Physical Therapy and Rehabilitation Clinic of KSBÜ Evliya Çelebi Training and Research Hospital with complaints of dorsalgia and clinically diagnosed with Dorsal Myofascial Pain Syndrome. 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. This study will be a two-group, sham-controlled, double-blind, prospective, randomized controlled trial. Patients and the evaluator will be blinded to group allocation, with only the physician administering the dry needling treatment being aware of the assignment.

In the dry needling application, thinner needles with a gauge of 27 and a length of 5 cm, which are significantly finer than conventional standard injection needles, will be used in both the study and sham groups. These needles minimize tissue irritation due to their finer tip, targeting the trigger points in the trapezius and rhomboid muscles on the standard painful side in the study group and the subcutaneous fatty tissue in the same regions in the sham group.

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 rhomboid 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 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: [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]
measure: Patient-Specific Functional Scale
timeFrame: [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]
measure: Pressure Pain Threshold Measurement
timeFrame: [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:
measure: What does Oswestry stand for? The Oswestry Disability Index (ODI)
timeFrame: [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]
measure: The 12-item Short-Form Health Survey version 2 (SF-12v2)
timeFrame: [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]
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kütahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Hasan H Gökpınar, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References: