Focused Versus Multi-Target Trigger Point Injection in Chronic Myofascial Neck Pain: A Participant- and Assessor-Blinded Randomized Controlled Trial
| Registry | NCT07876739 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Mardin Artuklu University (Other); collaborators: Mardin Training and Research Hospital |
| Conditions | Myofacial Pain Syndrome, Chronic Neck Pain |
| Interventions | Lidocaine 1% Trigger Point Injection (Drug) |
| Dates | start 2027-04-01 (estimated), primary completion 2028-01-15 (estimated), completion 2028-02-20 (estimated), first posted 2026-10-15, last updated 2026-10-20 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Myofacial Pain Syndrome All trials for Chronic Neck Pain All trials of Lidocaine 1% Trigger Point Injection
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.
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Focused Trigger Point Injection | Experimental | Drug: Lidocaine 1% Trigger Point Injection | 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. |
| Multi-Target Trigger Point Injection | Experimental | Drug: Lidocaine 1% Trigger Point Injection | 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. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Mardin Training and Research Hospital | Mardin | Turkey (Türkiye) |