Myofacial Pain SyndromeNCT07876739
Focused Versus Multi-Target Trigger Point Injection for Chronic Myofascial Neck Pain
A study testing Lidocaine 1% Trigger Point Injection in people with Myofacial Pain Syndrome and Chronic Neck Pain, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
Myofascial neck pain may involve several active trigger points in the neck and shoulder muscles. In clinical practice, it is not clear whether treating only the main trigger point that best reproduces the patient's pain is sufficient, or whether treating several active trigger points provides additional benefit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofacial Pain Syndrome, Chronic Neck Pain
- What is being tested?
- Lidocaine 1% Trigger Point Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2027to 20 Feb 2028
- Phase
- Interventional
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
- Age 18 to 65 years
- Chronic myofascial neck or cervicoscapular pain for at least 3 months
- Average pain intensity during the previous 7 days of at least 4/10 on the Numeric Rating Scale
- Presence of active myofascial trigger points in at least two different muscles among the upper trapezius, levator scapulae, and infraspinatus muscles
- Willingness to participate in the study and provide written informed consent
Who cannot join
- Cervical radiculopathy or myelopathy
- Fibromyalgia
- Neurological, rheumatological, or structural disease that may explain the neck or cervicoscapular pain
- History of major surgery involving the neck or shoulder girdle, or trauma that may significantly affect clinical assessment
- Trigger point injection or dry needling in the cervicoscapular region within the previous 3 months
- Active infection, open wound, or significant skin lesion at the injection site
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- Active systemic infection
- Known allergy to lidocaine or other amide-type local anesthetics
- Known bleeding disorder, clinically significant thrombocytopenia, or anticoagulant treatment associated with an unacceptable bleeding risk for injection
- Pregnancy
- Severe cognitive or communication impairment that would prevent reliable completion of study assessments
- Inability or unwillingness to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mardin Training and Research Hospital
Mardin, 47100
Taha Yasin YILDIRIM, M.D., +90 534 220 77 17, tyasinyildirim.ftr@gmail.com
About this study
Official title: Focused Versus Multi-Target Trigger Point Injection in Chronic Myofascial Neck Pain: A Participant- and Assessor-Blinded Randomized Controlled Trial
Myofascial neck pain may involve several active trigger points in the neck and shoulder muscles. In clinical practice, it is not clear whether treating only the main trigger point that best reproduces the patient's pain is sufficient, or whether treating several active trigger points provides additional benefit.
This randomized controlled trial will compare two trigger point injection strategies in adults with chronic myofascial neck or cervicoscapular pain and active trigger points in at least two different muscles. Participants will receive either a focused injection to the dominant active trigger point or multi-target injections to the active trigger points identified within the study protocol. All injections will be performed under ultrasound guidance using the same local anesthetic and injection technique.
Read more
The main outcome will be average pain intensity at 4 weeks. The study will also evaluate early pain response, neck-related disability, global improvement, procedure duration, pain after the procedure, and adverse events.
The study aims to determine whether treating several active trigger points provides enough additional clinical benefit to justify the greater number of injections and increased procedure burden.
Read the detailed description
Myofascial pain involving the neck and cervicoscapular region may be associated with more than one active myofascial trigger point. Although local anesthetic trigger point injection is used in clinical practice, the optimal extent of treatment is uncertain. Previous studies have mainly compared different injectates, dry needling, physical therapy, or different injection techniques. There is limited evidence directly addressing how many active trigger points should be treated during the same treatment session.
The clinical question of this study is whether treatment should be focused on the dominant active trigger point or extended to other active trigger points identified in predefined cervicoscapular muscles. Treating more trigger points may provide greater pain relief and functional improvement. However, it also requires more needle insertions, a greater total volume of local anesthetic, a longer procedure, and potentially greater post-procedure discomfort. If focused treatment provides similar clinical benefit, additional injections may represent unnecessary treatment burden.
Participants with chronic myofascial neck or cervicoscapular pain and active trigger points in at least two different muscles will be randomized in a 1:1 ratio to a focused injection group or a multi-target injection group. The upper trapezius, levator scapulae, and infraspinatus muscles will be evaluated bilaterally before randomization. Active trigger points and the dominant active trigger point will be identified before group allocation is revealed.
In the focused injection group, the dominant active trigger point that best reproduces the participant's usual clinical pain will be treated. In the multi-target injection group, the active trigger points identified in the muscles included in the study protocol will be treated. Latent trigger points will not be injected.
All procedures will be performed under ultrasound guidance using the same injection technique. Each treated trigger point will receive 1 mL of 1% lidocaine. Only one injection session will be performed. Participants will not be informed of their treatment allocation, and follow-up assessments will be performed by an assessor who is blinded to group assignment.
The primary outcome is average neck and cervicoscapular pain intensity during the previous 7 days, measured using a 0-10 Numeric Rating Scale at 4 weeks. Secondary outcomes include pain at 1 week, Neck Disability Index score at 4 weeks, global improvement, procedure duration, pain 24 hours after the procedure, and adverse events.
The main objective is to determine whether a multi-target injection strategy provides additional clinical benefit compared with a focused injection strategy and whether any additional benefit is sufficient to justify the increased procedural burden.
- Conditions
- Myofacial Pain Syndrome, Chronic Neck Pain
- Being tested
- Lidocaine 1% Trigger Point Injection
- Keywords
- Myofascial Pain Syndrome, Myofascial Trigger Point, Trigger Point Injection, Neck Pain, Ultrasound-Guided Injection
- Medical subject headings
- Facial Neuralgia, Myofascial Pain Syndromes, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1% Trigger Point InjectionDrug
Ultrasound-guided trigger point injection with 1 mL of 1% lidocaine per treated active myofascial trigger point. Each trigger point will receive a single needle insertion and a single injection. No additional needle movement or redirection will be performed to elicit a local twitch response.
| Study group | Role | What they receive |
|---|---|---|
| Focused Trigger Point Injection | Experimental | Participants assigned to this group will receive ultrasound-guided injection of the dominant active myofascial trigger point, defined as the active trigger point that best reproduces the participant's usual clinical pain. A single injection session will be performed. Receives: Drug: Lidocaine 1% Trigger Point Injection |
| Multi-Target Trigger Point Injection | Experimental | Participants assigned to this group will receive ultrasound-guided injection of the active myofascial trigger points identified in the predefined study muscles. Latent trigger points will not be treated. A single injection session will be performed. Receives: Drug: Lidocaine 1% Trigger Point Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Neck and Cervicoscapular Pain Intensity
Average pain intensity over the previous 7 days will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: 4 weeks after the injection
Secondary outcomes (6)
Average Neck and Cervicoscapular Pain Intensity at 1 Week
Average pain intensity over the previous 7 days will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: 1 week after the injection
Neck Disability Index Score
Neck-related disability will be assessed using the Neck Disability Index (NDI), a 10-item questionnaire evaluating pain and limitations in daily activities. Each item is scored from 0 to 5, yielding a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability.
Measured: 4 weeks after the injection
Global Improvement
Participants will rate their overall perceived change in symptoms compared with their condition before treatment using a 7-point Patient Global Impression of Change (PGIC) scale. The scale ranges from 1 (very much improved) to 7 (very much worse), with 4 indicating no change. Lower scores indicate greater perceived improvement.
Measured: 4 weeks after the injection
Procedure Duration
Procedure duration will be recorded as the time from the first needle insertion to removal of the final needle.
Measured: Baseline
Post-Procedural Pain
Pain related to the injection procedure will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: 24 hours after the injection
Adverse Events
Adverse events related to the injection procedure will be recorded throughout the follow-up period.
Measured: From the injection procedure through 4 weeks after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Apr 2027 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion20 Feb 2028 (estimated)
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 Myofacial Pain SyndromeStudies 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
- Participants will be randomly assigned in a 1:1 ratio to either a focused trigger point injection strategy or a multi-target trigger point injection strategy. Both groups will receive ultrasound-guided trigger point injection using the same local anesthetic and injection technique.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Responsible party
- Principal investigator, Taha Yasin YILDIRIM, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876739
- Sponsor's protocol ID
- MEAH-PMR-TYY2
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anwar N, Li S, Long L, Zhou L, Fan M, Zhou Y, Wang S, Yu L. Combined effectiveness of extracorporeal radial shockwave therapy and ultrasound-guided trigger point injection of lidocaine in upper trapezius myofascial pain syndrome. Am J Transl Res. 2022 Jan 15;14(1):182-196. eCollection 2022.
PubMed 35173837Suputtitada A, Chen CPC, Ngamrungsiri N, Schmitz C. Effects of Repeated Injection of 1% Lidocaine vs. Radial Extracorporeal Shock Wave Therapy for Treating Myofascial Trigger Points: A Randomized Controlled Trial. Medicina (Kaunas). 2022 Mar 26;58(4):479. doi: 10.3390/medicina58040479.
PubMed 35454318Lugo LH, Garcia HI, Rogers HL, Plata JA. Treatment of myofascial pain syndrome with lidocaine injection and physical therapy, alone or in combination: a single blind, randomized, controlled clinical trial. BMC Musculoskelet Disord. 2016 Feb 24;17:101. doi: 10.1186/s12891-016-0949-3.
PubMed 26911981