Dry Needling Versus Ozone in Myofascial Pain Syndrome

NCT ID: NCT05995639

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-11-02

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.

Conditions

Dry Needling; Ozone; Trapezius; Trigger Point Pain, Myofascial; Myofascial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Patients who will undergo an exercise treatment for the UT. The exercise therapy will focus on stretching exercises for the UT. Exercise therapy will undergo 2 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Dry Needling Group

Patients who will undergo DN treatment for the UT. A clinician with 5 years of DN experience will assess patients and apply DN treatment. The active trigger points will be diagnosed by the criteria described by Simons and Travell. 0.25x25mm acupuncture needles will be used. DN will be performed with fast in fast out technique and needling will continue until a local twitch response is elicited. Treatment will be applied 3 times, one week apart.

Group Type: ACTIVE_COMPARATOR

Dry Needling

Intervention Type: PROCEDURE

Dry needling is an evidence-based therapeutic procedure used primarily in musculoskeletal rehabilitation. It involves inserting thin needles into specific trigger points in muscles, tendons, or fascia, aiming to alleviate pain and improve musculoskeletal function. Unlike acupuncture, dry needling focuses on resolving myofascial pain and dysfunction by directly targeting trigger points, often identified through palpation and anatomical understanding. Academic exploration of dry needling delves into its physiological mechanisms, clinical effectiveness, and potential integration into comprehensive treatment strategies.

Ozone Group

Patients who will undergo ozone treatment for the UT. A clinician with 10 years of ozone experience will assess patients and apply ozone treatment. 12 gamma ozone will be used. Patients will be injected with ozone in UT with most sensitive parts. Treatment will be applied 3 times, one week apart.

Group Type: ACTIVE_COMPARATOR

Ozone Injection

Intervention Type: PROCEDURE

Intramuscular ozone injection is a therapeutic intervention utilized within the context of musculoskeletal care, particularly for individuals grappling with conditions such as myofascial pain syndrome and related neuromuscular issues. This technique involves the controlled introduction of ozone gas, a chemically reactive form of oxygen, directly into targeted muscle tissue through an injection. This intramuscular administration is guided by precise anatomical knowledge and is designed to harness the potential therapeutic benefits of ozone's reactive properties.

Interventions

Dry Needling

Dry needling is an evidence-based therapeutic procedure used primarily in musculoskeletal rehabilitation. It involves inserting thin needles into specific trigger points in muscles, tendons, or fascia, aiming to alleviate pain and improve musculoskeletal function. Unlike acupuncture, dry needling focuses on resolving myofascial pain and dysfunction by directly targeting trigger points, often identified through palpation and anatomical understanding. Academic exploration of dry needling delves into its physiological mechanisms, clinical effectiveness, and potential integration into comprehensive treatment strategies.

Intervention Type: PROCEDURE

Ozone Injection

Intramuscular ozone injection is a therapeutic intervention utilized within the context of musculoskeletal care, particularly for individuals grappling with conditions such as myofascial pain syndrome and related neuromuscular issues. This technique involves the controlled introduction of ozone gas, a chemically reactive form of oxygen, directly into targeted muscle tissue through an injection. This intramuscular administration is guided by precise anatomical knowledge and is designed to harness the potential therapeutic benefits of ozone's reactive properties.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uskudar State Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mustafa Hüseyin Temel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa H Temel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Uskudar State Hospital

Central Contacts

Mustafa H Temel, M.D.

Role: CONTACT

mhuseyintemel@gmail.com

+905342714872

Other Identifiers

DnvsO

Identifier Type: -

Identifier Source: org_study_id