Back to resultsDry Needling for Myofascial Pain Syndrome
Primary Purpose
Myofascial Pain Syndromes, Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group 1: Peppering
group 2: spin and wait
group 3: Peppering and spin and wait
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring Dry Needling, Neck Pain, Myofascial Pain Syndromes
Eligibility Criteria
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
Sites / Locations
- Sultan 2. Abdulhamid Han Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
Dry needling + standard exercise program with 4 sessions of stick and pull out method at 1 week intervals
Dry needling + standard exercise program with 4 sessions of turn-and-wait method at 1-week intervals
Dry needling + standard exercise program with 4 sessions of stick and turn and wait method 1-week intervals
Outcomes
Primary Outcome Measures
Visuel Analog Scale
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.
Secondary Outcome Measures
Neck Disability Index
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
European Quality of Life 5 Dimensions 3 Level Version
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.
Full Information
NCT ID
NCT05668728
First Posted
December 6, 2022
Last Updated
May 26, 2023
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT05668728
Brief Title
Dry Needling for Myofascial Pain Syndrome
Official Title
A Comparison for 3 Different Dry Needling Techniques for Myofacial Pain Syndrome Causing Servical Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndromes, Neck Pain
Keywords
Dry Needling, Neck Pain, Myofascial Pain Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 GROUPS DİFFERENT TYPES OF DRY NEEDLİNG
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Dry needling + standard exercise program with 4 sessions of stick and pull out method at 1 week intervals
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Dry needling + standard exercise program with 4 sessions of turn-and-wait method at 1-week intervals
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Dry needling + standard exercise program with 4 sessions of stick and turn and wait method 1-week intervals
Intervention Type
Other
Intervention Name(s)
Group 1: Peppering
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
group 2: spin and wait
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
group 3: Peppering and spin and wait
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visuel Analog Scale
Description
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.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
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
Time Frame
one month
Title
European Quality of Life 5 Dimensions 3 Level Version
Description
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.
Time Frame
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emre Ata, Ass.Prof.
Organizational Affiliation
Sultan II. Abdulhamidhan Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultan 2. Abdulhamid Han Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32272030
Citation
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.
Results Reference
result
PubMed Identifier
28158962
Citation
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.
Results Reference
result
PubMed Identifier
29988746
Citation
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.
Results Reference
result
Learn more about this trial
Dry Needling for Myofascial Pain Syndrome
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