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RecruitingNCT06338514

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

The Effectiveness of Dry Needling Treatment in Patients Diagnosed With Dorsalgia Accompanied by Myofascial Pain Syndrome.

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Kutahya Health Sciences University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERReal dry needlingdry needling into the muscle under ultrasound guidance.
OTHERSham dry needlingdry needling into the subcutaneous fatty tissue under ultrasound guidance.

Timeline

Start date
2024-04-25
Primary completion
2025-10-10
Completion
2025-11-10
First posted
2024-03-29
Last updated
2025-09-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06338514. Inclusion in this directory is not an endorsement.