Trigger Point Pain, MyofascialNCT05066529
Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome
A study testing dry-needling in people with Trigger Point Pain, Myofascial, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the short and long-term effects of dry-needling of participants with trigger points in the upper trapezius muscle. 64 participants who diagnosed with myofascial pain syndrome will be included in the study. All participants will have trigger points in the upper trapezius muscles. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- dry-needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 30 Oct 2021
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- trigger points in the upper trapezius muscle
- 18-45 years old
- no treatment in three months for myofascial pain syndrome (MPS)
- accept to participate treatment program
Who cannot join
- already treated in 3 months for MPS
- below 18 years and above 45 years old
- no acceptance to participate the trial
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34303
About this study
Official title: Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome-single Blind Randomized Controlled Trial
The aim of this study is to investigate the short and long-term effects of dry-needling of participants with trigger points in the upper trapezius muscle.
64 participants who diagnosed with myofascial pain syndrome will be included in the study. All participants will have trigger points in the upper trapezius muscles. They are randomised into two groups: dry needling (n=32) and exercise group (n=32). Ultrasonographic evaluation of trigger points (diameter, circumference and area), pain intensity and neck disability will be evaluated as primary outcome. Active cervical range of motion will be evaluated as secondary outcome.
Read the detailed description
Objective: The aim of this study is to investigate the short and long-term effects of dry-needling of participants with trigger points in the upper trapezius muscle.
Methods: 64 participants who diagnosed with myofascial pain syndrome will be included in the study. All participants will have trigger points in the upper trapezius muscles. They are randomised into two groups: dry needling (n=32) and exercise group (n=32). Ultrasonographic evaluation of trigger points (diameter, circumference and area), pain intensity and neck disability will be evaluated as primary outcome. Active cervical range of motion will be evaluated as secondary outcome.
All treatments will be applied by an investigator and a different blinded investigator will evaluated all participants. Numerical Rating Scale will be used for evaluating pain intensity and Neck Disability Index will be used for evaluating neck disability.
Dry-needling treatment will be applied once a week for three weeks. Servical stretching exercises are given to all participants. (20 repetitions in one session and 2 sessions in a day, three days a week.)
All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3 month follow-ups.
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- dry-needling
- Keywords
- trigger point, dry-needling, ultrasonography, pain intensity, neck disability
- Medical subject headings
- Myofascial Pain Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry-needlingProcedure or surgery
Also called exercise
Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues and muscles to mechanically disrupt tissue without the use of anesthesia. Treatment is often used to treat myofascial trigger points.
| Study group | Role | What they receive |
|---|---|---|
| dry-needling group | Experimental | 32 participants in this group Dry-needling treatment will be applied once a week for three weeks. Servical stretching exercises are given to all participants. (20 repetitions in one session and 2 sessions in a day, three days a week.)
All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3 month follow-ups. Receives: Procedure: dry-needling |
| exercise group | Other | 32 participants in this group Servical stretching exercises are given to all participants. (20 repetitions in one session and 2 sessions in a day, three days a week.)
All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3 month follow-ups. Receives: Procedure: dry-needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
diameter of trigger point
an ultrasonographic evaluation
Measured: 3 month follow-ups
circumference of trigger point
an ultrasonographic evaluation
Measured: 3 month follow-ups
area of trigger point
an ultrasonographic evaluation
Measured: 3 month follow-ups
Numerical Rating Scale
a questionnaire to evaluate pain intensity
Measured: 3 month follow-ups
Neck Disability index
a questionnaire to evaluate neck disability
Measured: 3 month follow-ups
Secondary outcomes (1)
active servical range of motion
active servical range of motion
Measured: 3 month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Apr 2021
- Primary completion30 Sep 2021
- Study completion30 Oct 2021
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 Trigger Point Pain, MyofascialStudies 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
- Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues and muscles to mechanically disrupt tissue without the use of anesthesia. Treatment is often used to treat myofascial trigger points.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Merve Damla Korkmaz, Study director, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066529
- Sponsor's protocol ID
- KAEK/2021.03.88
- Status last verified
- Oct 2021
- First submitted
- 28 Aug 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 28158962Gerber LH, Shah J, Rosenberger W, Armstrong K, Turo D, Otto P, Heimur J, Thaker N, Sikdar S. Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain. PM R. 2015 Jul;7(7):711-718. doi: 10.1016/j.pmrj.2015.01.020. Epub 2015 Feb 4.
PubMed 25661462Gattie ER, Cleland JA, Snodgrass SJ. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial. JMIR Res Protoc. 2017 Nov 22;6(11):e227. doi: 10.2196/resprot.7980.
PubMed 29167092
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome-single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05066529
- Acronym / sponsor ID
- KAEK/2021.03.88
- Conditions
- Trigger Point Pain, Myofascial
- Keywords
- trigger point, dry-needling, ultrasonography, pain intensity, neck disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 4 Oct 2021 (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.
The aim of this study is to investigate the short and long-term effects of dry-needling of participants with trigger points in the upper trapezius muscle.
64 participants who diagnosed with myofascial pain syndrome will be included in the study. All participants will have trigger points in the upper trapezius muscles. They are randomised into two groups: dry needling (n=32) and exercise group (n=32). Ultrasonographic evaluation of trigger points (diameter, circumference and area), pain intensity and neck disability will be evaluated as primary outcome. Active cervical range of motion will be evaluated as secondary outcome.
Detailed description
Objective: The aim of this study is to investigate the short and long-term effects of dry-needling of participants with trigger points in the upper trapezius muscle.
Methods: 64 participants who diagnosed with myofascial pain syndrome will be included in the study. All participants will have trigger points in the upper trapezius muscles. They are randomised into two groups: dry needling (n=32) and exercise group (n=32). Ultrasonographic evaluation of trigger points (diameter, circumference and area), pain intensity and neck disability will be evaluated as primary outcome. Active cervical range of motion will be evaluated as secondary outcome.
All treatments will be applied by an investigator and a different blinded investigator will evaluated all participants. Numerical Rating Scale will be used for evaluating pain intensity and Neck Disability Index will be used for evaluating neck disability.
Dry-needling treatment will be applied once a week for three weeks. Servical stretching exercises are given to all participants. (20 repetitions in one session and 2 sessions in a day, three days a week.)
All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3 month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues and muscles to mechanically disrupt tissue without the use of anesthesia. Treatment is often used to treat myofascial trigger points.
| Arm | Type | Receives |
|---|---|---|
| dry-needling group | Experimental | Procedure: dry-needling32 participants in this group Dry-needling treatment will be applied once a week for three weeks. Servical stretching exercises are given to all participants. (20 repetitions in one session and 2 sessions in a day, three days a week.) All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3 month follow-ups. |
| exercise group | Other | Procedure: dry-needling32 participants in this group Servical stretching exercises are given to all participants. (20 repetitions in one session and 2 sessions in a day, three days a week.) All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3 month follow-ups. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- trigger points in the upper trapezius muscle
- 18-45 years old
- no treatment in three months for myofascial pain syndrome (MPS)
- accept to participate treatment program
Key exclusion criteria (3 listed)
- already treated in 3 months for MPS
- below 18 years and above 45 years old
- no acceptance to participate the trial
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 |
|---|---|---|
| dry-needlingAlso: exerciseDry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues and muscles to mechanically disrupt tissue without the use of anesthesia. Treatment is often used to treat myofascial trigger points. | Procedure or surgery | dry-needling group, exercise group |
Primary outcome
diameter of trigger point
Time frame: 3 month follow-ups
an ultrasonographic evaluation
circumference of trigger point
Time frame: 3 month follow-ups
an ultrasonographic evaluation
area of trigger point
Time frame: 3 month follow-ups
an ultrasonographic evaluation
Numerical Rating Scale
Time frame: 3 month follow-ups
a questionnaire to evaluate pain intensity
Neck Disability index
Time frame: 3 month follow-ups
a questionnaire to evaluate neck disability
1 secondary outcome
active servical range of motion
Time frame: 3 month follow-ups
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 5 Nov 2021.
- 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 25661462Gerber LH, Shah J, Rosenberger W, Armstrong K, Turo D, Otto P, Heimur J, Thaker N, Sikdar S. Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain. PM R. 2015 Jul;7(7):711-718. doi: 10.1016/j.pmrj.2015.01.020. Epub 2015 Feb 4.
- Results publication: PubMed 29167092Gattie ER, Cleland JA, Snodgrass SJ. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial. JMIR Res Protoc. 2017 Nov 22;6(11):e227. doi: 10.2196/resprot.7980.
- Individual participant dataSharing planned: Yes
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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.
Merve Damla Korkmaz study director
Kanuni Sultan Suleyman 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 dry-needling in people with Trigger Point Pain, Myofascial, run by Kanuni Sultan Suleyman Training and Research Hospital 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 4 inclusion and 3 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 5 Nov 2021. 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?
diameter of trigger point (time frame: 3 month follow-ups). The study lists 5 primary outcomes in all. 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 NCT05066529, 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 5 Nov 2021.