- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05668728
Dry Needling for Myofascial Pain Syndrome
May 26, 2023 updated by: Emre Ata, Assoc Prof, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
A Comparison for 3 Different Dry Needling Techniques for Myofacial Pain Syndrome Causing Servical Pain
Myofascial pain syndrome (MAS) is defined as a regional painful syndrome characterized by pain and tenderness in a muscle group or a muscle, a taut band within the muscle, pain reflected by pressing, and the presence of trigger points.
It causes localized muscle pain in the shoulder and neck.
The frequency of mas is around 12% in the normal population, and its frequency increases in those with chronic diseases.
It is more common in the 30-60 age range and in the female population.
Mechanical causes such as micro-macro trauma, nociceptive disorders, physical fatigue, psychological stress and genetic factors are blamed in its etiopathogenesis.
Painful myofascial trigger points may occur by pressing on all muscles in the body, although it is more common in the trazius muscle, especially in those who work at a desk, who are constantly in a certain position, and who are sedentary.
Myofascial trigger points are often detected by examination.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is a difference between the pain, neck extension range of motion, neck functional status of 3 different dry needling methods used in routine treatment in patients with myofascial pain syndrome.
The investigators set out by thinking which method is more appropriate to choose in our practice.
When the investigators examined the literature, the investigators could not find a study comparing these methods.
However, at the points where sham needling, lidocaine administration, ozone cost, kinesiotaping methods and dry needling are compared by using these methods separately, regardless of the method of dry needling, there is a significant improvement in functional status, pain score, attachments, improvement expenses in the range of motion.
However, the investigators think that it will contribute to a study literature on the protection of these purposes more clearly.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Sultan 2. Abdulhamid Han Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Among the patients who applied to Sultan 2. Abdulhamid Han Hospital Physical Medicine and Rehabilitation Department and were diagnosed with myofascial pain syndrome
- Decided to receive dry needling treatment
- Between the ages of 18 and 65
- At least 1 painful myofascial trigger point in the m.trapezius, m.levator scapula muscles
- Patients with neck pain lasting less than 6 months
Exclusion Criteria:
- Those with a history of cervical operation
- Those who have a history of shoulder operation
- Patients with radiculopathy as a result of the examination
- Those who have been injected into the determined area in the last 3 months
- Those diagnosed with fibromyalgia according to the 2018 fibromyalgia scale
- Those with cervical disc herniation in the MR imaging taken within the last 1 year
- Pregnant/pregnant women
- Those who are allergic to silver
- Those with a history of malignancy
- Those with positive red flags
- Those with known rheumatological disease
- Those who do not accept dry needling
- Those with cognitive impairment
- Those who have local infection in the application area
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Dry needling + standard exercise program with 4 sessions of stick and pull out method at 1 week intervals
|
Before injection we will palpate the muscles of trapezius, m. rhomboideus, m. levator scapula for finding painful trigger points, and we will mark the point.
the skin will be cleaned with an appropriate antiseptic.
Before the needle is inserted, the area to be applied will be palpated once again to detect the painful trigger point between the thumb and index fingers.
The needle will be guided to painful trigger points detected by palpation.
Stainless steel 25x25 mm needles will be used for dry needling.
The needle will be inserted and removed until the local twitch response disappears, at least 10 times at each point found.
Afterwards, the patient will be given a standard exercise program for the neck muscles.
With this method, dry needling will be applied to the patient 4 times a week, once a week.
|
Active Comparator: Group 2
Dry needling + standard exercise program with 4 sessions of turn-and-wait method at 1-week intervals
|
Just before the injection, painful trigger points in the bilateral muscles of trapezius, m. rhomboideus, and m. levator scapula will be identified and marked by palpation, and the skin will be cleaned with an appropriate antiseptic.
Before the needle is inserted, the area to be applied will be palpated once again to detect the painful trigger point between the thumb and index fingers.
The needle will be guided to painful trigger points detected by palpation.
Stainless steel 25x25 mm needles will be used for dry needling.
After the dry needle is inserted at each point found, it will be spinned counterclockwise and left.
Waiting time for each patient will be limited to 15 minutes.
Afterwards, the patient will be given a standard exercise program for the neck muscles.
With this method, dry needling will be applied to the patient 4 times a week, once a week.
|
Active Comparator: Group 3
Dry needling + standard exercise program with 4 sessions of stick and turn and wait method 1-week intervals
|
Just before the injection, painful trigger points in the bilateral muscles of trapezius, m. rhomboideus, and m. levator scapul will be identified and marked with palpation, and the skin will be cleaned with an appropriate antiseptic.
Before the needle is inserted, the area to be applied will be palpated once again to detect the painful trigger point between the thumb and index fingers.
The needle will be guided to painful trigger points detected by palpation.
Stainless steel 25x25 mm needles will be used for dry needling.
After the needle is inserted and removed, it will be spinned counterclockwise for 15 minutes in each patient until the local twitch response disappears, at least 10 times at each point found.
Afterwards, the patient will be given a standard exercise program.
With this method, dry needling will be applied to the patient 4 times a week, once a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visuel Analog Scale
Time Frame: one month
|
It is used to convert some values that cannot be measured numerically into numeric.
Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.
For example, for pain, I have no pain at one end and very severe pain at the other end, and the patient marks his/her current state on this line.
The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
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one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index
Time Frame: one month
|
It is a questionnaire consisting of 10 questions and questions how neck pain affects the patient's ability to perform daily life activities such as sleep, personal care, driving, reading, and concentration.
Each question is answered between 0-5 points.
The minimum score can be 0, the maximum score can be 50.
0-4 points: no disability 5-14 points: mild disability 15-24 points: moderate disability 25-34 points: severe disability A score of 35 and above means complete disability
|
one month
|
European Quality of Life 5 Dimensions 3 Level Version
Time Frame: One month
|
It is a scale developed to evaluate health-related quality of life.
It consists of two parts; one .
The department defines the health profile in 5 dimensions (mobility, self-care, social life, pain, psychological state).
Each dimension contains three statements according to the degree of difficulty (1: some problem, 2: moderate, 3: a lot of problems), the second part includes a visual analog scale (VAS) on which respondents rate their current health status from 0 to 100.
It is easy to apply and is completed in a short time.
100 describes best functional stiuation, 0 describes worst developed to evaluate health-related quality of life.
|
One month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Emre Ata, Ass.Prof., Sultan II. Abdulhamidhan Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stieven FF, Ferreira GE, Wiebusch M, de Araujo FX, da Rosa LHT, Silva MF. Dry Needling Combined With Guideline-Based Physical Therapy Provides No Added Benefit in the Management of Chronic Neck Pain: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2020 Aug;50(8):447-454. doi: 10.2519/jospt.2020.9389. Epub 2020 Apr 9.
- Gattie E, Cleland JA, Snodgrass S. The Effectiveness of Trigger Point Dry Needling for Musculoskeletal Conditions by Physical Therapists: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Mar;47(3):133-149. doi: 10.2519/jospt.2017.7096. Epub 2017 Feb 3.
- Raeissadat SA, Rayegani SM, Sadeghi F, Rahimi-Dehgolan S. Comparison of ozone and lidocaine injection efficacy vs dry needling in myofascial pain syndrome patients. J Pain Res. 2018 Jun 29;11:1273-1279. doi: 10.2147/JPR.S164629. eCollection 2018.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
February 15, 2023
Study Completion (Actual)
April 15, 2023
Study Registration Dates
First Submitted
December 6, 2022
First Submitted That Met QC Criteria
December 19, 2022
First Posted (Actual)
December 30, 2022
Study Record Updates
Last Update Posted (Actual)
May 30, 2023
Last Update Submitted That Met QC Criteria
May 26, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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