Myofascial Pain SyndromesNCT05668728
Dry Needling for Myofascial Pain Syndrome
A study testing Group 1: Peppering, group 2: spin and wait and group 3: Peppering and spin and wait in people with Myofascial Pain Syndromes and Neck Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndromes, Neck Pain
- What is being tested?
- Group 1: Peppering, group 2: spin and wait and group 3: Peppering and spin and wait
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Myofascial Pain Syndromes, Neck Pain
- Being tested
- Group 1: Peppering, group 2: spin and wait, group 3: Peppering and spin and wait
- Keywords
- Dry Needling, Neck Pain, Myofascial Pain Syndromes
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: PepperingOther
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.
group 2: spin and waitOther
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.
group 3: Peppering and spin and waitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Dry needling + standard exercise program with 4 sessions of stick and pull out method at 1 week intervals Receives: Other: Group 1: Peppering |
| Group 2 | Active comparator | Dry needling + standard exercise program with 4 sessions of turn-and-wait method at 1-week intervals Receives: Other: group 2: spin and wait |
| Group 3 | Active comparator | Dry needling + standard exercise program with 4 sessions of stick and turn and wait method 1-week intervals Receives: Other: group 3: Peppering and spin and wait |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (2)
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
Measured: one month
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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Jan 2023
- Primary completion15 Feb 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 GROUPS DİFFERENT TYPES OF DRY NEEDLİNG
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Ata, Assoc Prof, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Emre Ata, Ass.Prof., Principal investigator, Sultan II. Abdulhamidhan Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668728
- Sponsor's protocol ID
- 2270
- Status last verified
- May 2023
- First submitted
- 6 Dec 2022
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32272030Gattie 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.
PubMed 28158962Raeissadat 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.
PubMed 29988746
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison for 3 Different Dry Needling Techniques for Myofacial Pain Syndrome Causing Servical Pain
- ClinicalTrials.gov ID
- NCT05668728
- Acronym / sponsor ID
- 2270
- Conditions
- Myofascial Pain Syndromes, Neck Pain
- Keywords
- Dry Needling, Neck Pain, Myofascial Pain Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 GROUPS DİFFERENT TYPES OF DRY NEEDLİNG
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Group 1: PepperingDry needling + standard exercise program with 4 sessions of stick and pull out method at 1 week intervals |
| Group 2 | Active comparator | Other: group 2: spin and waitDry needling + standard exercise program with 4 sessions of turn-and-wait method at 1-week intervals |
| Group 3 | Active comparator | Other: group 3: Peppering and spin and waitDry needling + standard exercise program with 4 sessions of stick and turn and wait method 1-week intervals |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1: PepperingBefore 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. | Other | Group 1 |
| group 2: spin and waitJust 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. | Other | Group 2 |
| group 3: Peppering and spin and waitJust 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. | Other | Group 3 |
Primary outcome
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.
2 secondary outcomes
Neck Disability Index
Time frame: one month
European Quality of Life 5 Dimensions 3 Level Version
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Results publication: PubMed 32272030Stieven 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 publication: PubMed 28158962Gattie 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 publication: PubMed 29988746Raeissadat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emre Ata, Ass.Prof. principal investigator
Sultan II. Abdulhamidhan Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: Peppering, group 2: spin and wait and group 3: Peppering and spin and wait in people with Myofascial Pain Syndromes and Neck Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visuel Analog Scale (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668728, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.