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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).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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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
Show all 12Show fewer
  • 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.

Taha Yasin YILDIRIM, M.D. contact

+90 534 220 77 17

tyasinyildirim.ftr@gmail.com

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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07876739
Study groupRoleWhat they receive
Focused Trigger Point InjectionExperimentalParticipants 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 InjectionExperimentalParticipants 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. Procedure Duration

    Procedure duration will be recorded as the time from the first needle insertion to removal of the final needle.

    Measured: Baseline

  5. 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

  6. 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.

  1. First posted15 Oct 2026
  2. Study start1 Apr 2027 (estimated)
  3. Primary completion15 Jan 2028 (estimated)
  4. Study completion20 Feb 2028 (estimated)

Resources

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)
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 35173837
  • Suputtitada 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 35454318
  • Lugo 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

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