Back to resultsDry Needling Versus Ozone in Myofascial Pain Syndrome
Primary Purpose
Dry Needling, Ozone, Trapezius
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry Needling
Ozone Injection
Sponsored by
About this trial
This is an interventional treatment trial for Dry Needling
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control Group
Dry Needling Group
Ozone Group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05995639
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar State Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Needling, Ozone, Trapezius, Trigger Point Pain, Myofascial, Myofascial Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigators and outcomes assessors will be blinded to the procedures.
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Dry Needling Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ozone Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dry Needling
Intervention Description
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
Intervention Name(s)
Ozone Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain measured by Visual Analog Scale
Description
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.
Time Frame
First day, after first week, after three weeks, after one month
Title
Quality of Life Measured by Neck Disability Index
Description
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.
Time Frame
First day, after first week, after three weeks, after one month
Secondary Outcome Measure Information:
Title
Range of Motion Measured by Goniometer
Description
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.
Time Frame
First day, after first week, after three weeks, after one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa H Temel, M.D.
Phone
+905342714872
Email
mhuseyintemel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa H Temel, M.D.
Organizational Affiliation
Uskudar State Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual participant data will be shared upon reasonable request by the principal investigator upon reasonable request.
IPD Sharing Time Frame
1 day
IPD Sharing Access Criteria
The individual participant data will be shared upon reasonable request by the principal investigator upon reasonable request.
Learn more about this trial
Dry Needling Versus Ozone in Myofascial Pain Syndrome
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