Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05995639
Other study ID # DnvsO
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date November 2, 2023

Study information

Verified date August 2023
Source Uskudar State Hospital
Contact Mustafa H Temel, M.D.
Phone +905342714872
Email mhuseyintemel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date November 2, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Procedure:
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Uskudar State Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Pain measured by Visual Analog Scale The Visual Analog Scale (VAS) is a widely used pain assessment tool in clinical settings. It involves a simple linear scale typically ranging from 0 to 10, where individuals mark a point to indicate their pain intensity level. The left end of the scale represents "no pain," assigned a value of 0, while the right end corresponds to "worst possible pain," denoted as 10. By gauging pain subjectively through this visual representation, the VAS provides a quantifiable measure of pain intensity, enabling healthcare professionals to track changes in pain over time and tailor treatment strategies accordingly. First day, after first week, after three weeks, after one month
Primary Quality of Life Measured by Neck Disability Index The Neck Disability Index (NDI) is a widely used tool to assess the impact of neck-related conditions on an individual's quality of life. It consists of a questionnaire that comprises ten items, each addressing different aspects of daily functioning and discomfort related to neck pain. Participants rate their level of difficulty in various activities such as lifting, reading, and sleeping on a scale from 0 to 5. The total score is then calculated and expressed as a percentage, providing valuable insights into the extent of neck-related disability and its effect on overall quality of life. The NDI aids clinicians in evaluating treatment outcomes, designing intervention plans, and monitoring improvements in neck-related functionality. First day, after first week, after three weeks, after one month
Secondary Range of Motion Measured by Goniometer A goniometer is a standard instrument used to measure the range of motion (ROM) of the neck joints. It consists of arms and a protractor that allows clinicians to precisely quantify the angles achieved during various neck movements. During assessment, the patient is guided through specific motions like flexion, extension, rotation, and lateral bending, while the goniometer's arms are aligned with the corresponding body landmarks. The resulting measurements provide objective data about the neck's flexibility and mobility, aiding healthcare professionals in diagnosing musculoskeletal conditions, planning treatment strategies, and tracking progress over time. First day, after first week, after three weeks, after one month
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03161210 - Evaluation of Pain Regression in Patients With Myofascial Facial Pain Using Dextrose, Local Anaesthesia and Saline. N/A
Completed NCT01418170 - Dose Response Effects of Cervical Spinal Manipulative Therapy (SMT) on Pressure Sensitivity of Myofascial Trigger Points Phase 2
Not yet recruiting NCT01174667 - Massage of the Low Back Muscles Assessed With Ultrasound Scanning Phase 1/Phase 2
Completed NCT01167036 - Effectiveness of a Massage Instrument Compared to Placebo for Upper Trapezius Muscle Pain N/A
Completed NCT03273985 - Effectiveness of Dry Needling in Shortened Triceps Surae Muscle N/A
Completed NCT05776199 - Myofascial Trigger Points of the Levator Scapulae Muscle N/A
Completed NCT05225571 - The Relationship of Cervical Sagittal Parameters With Pain and Disability in Cervical Myofascial Pain Syndrome
Completed NCT06258070 - Clinical Performance of Therapeutic Use of BTX for Bruxism N/A
Completed NCT03619889 - The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder N/A
Completed NCT02029391 - Kinesio Taping in Subjects With Myofascial Pain Syndrome: a Randomized Controlled Trial N/A
Not yet recruiting NCT03088215 - Shock-Waves to Treat Fibromyalgia Pain N/A
Completed NCT05185050 - Prevalence of Myofascial Pain Syndrome in Adolescent Idiopathic Scoliosis
Recruiting NCT03709797 - Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients N/A
Withdrawn NCT00795106 - Trial to Evaluate the Efficacy of Topical Capsaicin to Reduce Pain and Improve Health-related Quality of Life in Adults With Chronic Myofascial Neck Pain Phase 2
Completed NCT04628312 - Foot Plantar Pressure Changes After Plantar Dry Needling N/A
Completed NCT04640558 - Gluteus Medius Latent Trigger Point and Muscle Strength in Healthy Subjects
Recruiting NCT05627830 - Ultrasound Guided Versus Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. N/A
Not yet recruiting NCT05882838 - The Level of Knowledge and Awareness of Myofascial Pain Syndrome in the Turkish Population
Completed NCT04260906 - Auricular Vagus Nerve Stimulation For Fibromyalgia Syndrome N/A
Completed NCT04832074 - Immediate Stiffness Changes in Myofascial Trigger Points After Dry Needling N/A