Clinical trial NCT05995639: Dry Needling Versus Ozone in Myofascial Pain Syndrome
Official title: Comparison of the Effects of Dry Needling and Ozone Treatment on Pain and Functionality in Myofascial Pain Syndrome of the Upper Trapezius
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Needling
Ozone
Trapezius
Trigger Point Pain, Myofascial
Myofascial Pain Syndrome
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this prospective randomized study to be conducted in Üsküdar state hospital, patients diagnosed with myofascial pain syndrome in the upper part of the trapezius muscle will be divided into 3 equal groups.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of dry needling treatment (DN) and ozone treatment on pain and functionality in individuals with myofascial pain syndrome affecting the upper trapezius (UT) region.

Detailed description: In this prospective randomized study to be conducted in Üsküdar state hospital, patients diagnosed with myofascial pain syndrome in the upper part of the trapezius muscle will be divided into 3 groups. 1st group patients will be given stretching exercises for the upper part of the trapezius muscle. The exercise program will last 15 days. In addition to exercise therapy, the 2nd group will receive dry needling treatment using acupuncture needles of 0.25 x 25mm in size by a physical medicine and rehabilitation specialist with 5 years of experience in the field. Active trigger points will be treated. Trigger points will be diagnosed according to the criteria determined by Simons and Travell. Dry needling treatment will be applied in 3 sessions, one week apart. In the 3rd group, in addition to exercise therapy, 10 gamma ozone will be applied in a total of 3 sessions, one week apart to the upper part of the trapezius muscle by a physical therapist with 10 years of experience in the field. Patients will be evaluated at the beginning of the treatment, after 1 week, at the 3rd week, and after 1 month.

Eligibility criteria: Inclusion Criteria:

Adults (18-65 years) with diagnosed myofascial pain syndrome affecting the upper trapezius area Willing and able to provide informed consent Able to comprehend and complete study-related assessments Diagnosed with myofascial pain syndrome affecting the upper trapezius area, based on clinical assessment and Simons and Travell criteria No prior exposure to dry needling or ozone therapy for myofascial pain syndrome Medically stable and cleared by a physician for study participation No active musculoskeletal injuries or conditions in the upper trapezius area No participation in similar interventions within the last 6 months

Exclusion Criteria:

Individuals with known contraindications to dry needling or ozone therapy Severe cardiovascular conditions or uncontrolled hypertension Active infections or skin conditions at treatment sites Known bleeding disorders or anticoagulant use Diagnosed with any other chronic pain syndrome not related to myofascial pain syndrome Any ongoing litigation or compensation claims related to pain conditions Recent trauma or surgery in the upper trapezius area Previous adverse reactions to dry needling or ozone therapy Participation in other investigational studies within the last 3 months History of psychological conditions that might interfere with assessment Pregnant or breastfeeding History of malignancy or immunocompromised status Neurological disorders affecting upper trapezius function Severe cognitive impairments that hinder assessment Inability to commit to the study duration or follow-up assessments Any change in medication regimen that might impact pain or functionality during the study period

Primary outcomes:
measure: Pain measured by Visual Analog Scale
timeFrame: First day, after first week, after three weeks, after one month
measure: Quality of Life Measured by Neck Disability Index
timeFrame: First day, after first week, after three weeks, after one month
Secondary outcomes:
measure: Range of Motion Measured by Goniometer
timeFrame: First day, after first week, after three weeks, after one month
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: