An interventional study of Lidocaine 1% Trigger Point Injection in Myofacial Pain Syndrome and Chronic Neck Pain, sponsored by Mardin Artuklu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Mardin Artuklu University · Not applicable, Interventional, and Treatment
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.
29 studies on the registry are indexed under Facial Neuralgia; 9 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 23 interventional studies indexed under Facial Neuralgia.
Browse Facial Neuralgia studies →Mardin Artuklu University is the lead sponsor of 32 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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.
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.
Drug: Lidocaine 1% Trigger Point Injection
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.
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.
Time frame: 4 weeks after the injection
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after the injection
Adverse Events
Adverse events related to the injection procedure will be recorded throughout the follow-up period.
Time frame: From the injection procedure through 4 weeks after the injection
Plan to share: No
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Studies of the drug tested here: Lidocaine
Mardin Artuklu University