Efficacy of Adding Greater Occipital Nerve Block to Trigger Point Injection in Patients With Neck Pain

NCT ID: NCT07058636

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2026-04-30

Brief Summary

Study Title:

Evaluation of the Effectiveness of Adding Greater Occipital Nerve Block to Trigger Point Injection in Patients with Neck Pain Due to Upper Trapezius Trigger Points: A Single-Blind Randomized Controlled Trial

Purpose of the Study:

This study aims to evaluate whether adding a Greater Occipital Nerve (GON) block to the standard trigger point injection treatment provides better pain relief and improves daily function in patients with neck pain caused by trigger points in the upper trapezius muscle. Trigger points are small, sensitive spots in muscles that can cause significant pain and discomfort. While both trigger point injections and GON blocks are common treatments for neck and head pain, it is not yet clear if combining these two methods offers better results.

Why is this study important? Neck pain related to trigger points in the upper trapezius muscle is a frequent problem, but there is limited research on the effectiveness of combining trigger point injections with GON blocks. This study will provide important information on whether the combination therapy can reduce pain more effectively and improve patients' quality of life and ability to perform daily activities.

Who can participate?

Adults aged 18 to 65 years old

Diagnosed with myofascial pain syndrome (MAS) based on specific clinical criteria, including the presence of trigger points in the upper trapezius muscle

Experiencing neck pain lasting longer than 3 months

Pain intensity rated 5 or higher on a scale of 0 to 10

Who cannot participate?

Pregnant or breastfeeding women, children, elderly people, unconscious or critically ill patients

Patients with allergies to local anesthetics or steroids

Individuals with bleeding disorders or infections near the injection site

Patients with serious psychiatric or neurological diseases, or other medical conditions that may affect study results

Those who have recently received similar treatments or surgery for neck or shoulder problems

Study Design and Procedures:

The study will include 60 patients meeting the criteria, randomly assigned to two groups using a balanced randomization method.

Group A will receive only trigger point injections into the upper trapezius muscle using a mixture of lidocaine and saline solution.

Group B will receive both trigger point injections and an ultrasound-guided GON block, which involves injecting a combination of local anesthetics and steroid near the greater occipital nerve to reduce pain signals.

Both groups will receive the same home exercise program focusing on stretching and strengthening neck muscles to support recovery. Patients will be encouraged to perform these exercises regularly and will be followed up weekly by phone to check their progress.

The doctor assessing patients' progress will not know which treatment the patient received, to ensure unbiased results.

Assessments:

Patients will be evaluated at three different times: before treatment, 1 week after treatment, and 4 weeks after treatment. Assessments include:

Pain intensity and quality (using Visual Analog Scale and McGill Pain Questionnaire)

Neck disability and ability to perform daily activities (Neck Disability Index)

Quality of life (Nottingham Health Profile)

Neck joint movement and position sense (using clinical tests with special equipment)

Posture evaluation (measuring head position using photography)

Expected Outcomes:

The main goal is to determine if the combined treatment of trigger point injection plus GON block is more effective than trigger point injection alone in reducing pain, improving neck function, and enhancing quality of life.

Duration and Follow-Up:

The study is planned to last 12 months. Patients will be closely monitored during and after treatment to ensure safety and to collect necessary data.

Potential Benefits and Risks:

Participants may experience pain relief and improved function if the combined treatment is effective. Risks include mild discomfort or side effects related to injections, which will be minimized by experienced medical staff.

Conditions

Neck Pain; Myofacial Pain Syndrome; Trigger Point Pain, Myofascial; Trigger Points; Upper Trapezius Trigger Points; Cervicogenic Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Trigger Point Injection Group

Patients in this arm will receive trigger point injections only. The injection solution consists of 1 ml of 2% lidocaine mixed with 1 ml of normal saline

Group Type: ACTIVE_COMPARATOR

2% Lidocaine HCl + saline

Intervention Type: DRUG

The intervention consists of injecting a mixture of 1 ml 2% lidocaine and 1 ml normal saline into trigger points located in the upper trapezius muscle.

Trigger Point Injection Plus Ultrasound-Guided Greater Occipital Nerve Block Group

Patients in this arm will receive the same trigger point injection protocol plus an ultrasound-guided greater occipital nerve (GON) block. The GON block solution consists of a mixture of 1 ml of 2% lidocaine, and 1 ml of betamethasone.

Group Type: ACTIVE_COMPARATOR

2% Lidocaine HCl + saline

Intervention Type: DRUG

The intervention consists of injecting a mixture of 1 ml 2% lidocaine and 1 ml normal saline into trigger points located in the upper trapezius muscle.

Steroid+lidocaine

Intervention Type: DRUG

The GON block involves injecting a mixture of 1 ml 2% lidocaine and 1 ml betamethasone.

Interventions

2% Lidocaine HCl + saline

The intervention consists of injecting a mixture of 1 ml 2% lidocaine and 1 ml normal saline into trigger points located in the upper trapezius muscle.

Intervention Type: DRUG

Steroid+lidocaine

The GON block involves injecting a mixture of 1 ml 2% lidocaine and 1 ml betamethasone.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged between 18 and 65 years.
• Diagnosed with myofascial pain syndrome (MPS) based on the major and minor criteria described by Travell and Simons (a diagnosis requires all 5 major and at least 1 minor criterion)
• Presence of active trigger points in the upper trapezius muscle.
• Patients with neck pain lasting longer than 3 months.
• Pain intensity of ≥5 on the Visual Analog Scale (VAS).

Exclusion Criteria

• Elderly, pediatric, pregnant, postpartum, or breastfeeding individuals; patients in intensive care; unconscious individuals; or legally incapacitated persons.
• Known allergy to local anesthetics used in trigger point injection (e.g., lidocaine, bupivacaine) or to other drugs used (e.g., corticosteroids).
• Patients with bleeding disorders (e.g., hemophilia, thrombocytopenia) or those currently on anticoagulant therapy.
• Presence of active infection at or near the injection site, or any systemic infection; impaired skin integrity.
• Patients with psychiatric disorders that may interfere with treatment response or affect study outcomes.
• Patients with severe neurological or cardiovascular disorders, or with uncontrolled diabetes.
• Patients with cervical disc pathologies with radiculopathy.
• History of receiving shoulder injection, trigger point injection, dry needling, manual therapy, or electrotherapy within the past 3 months.
• History of cervical or shoulder surgery.
• Patients diagnosed with adhesive capsulitis, rotator cuff tendinopathy, or shoulder impingement syndrome.
• Diagnosis of fibromyalgia.
• Presence of active trigger points in other back muscles.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Başak Mansız-Kaplan

Principal İnvestigator ,specialist doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Etlik City Hospital

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

İlayda Gerdan, Resident Doctor

Role: CONTACT

ilaydagerdan@gmail.com

+905077136219

Facility Contacts

İlayda Gerdan, Resident doctor

Role: primary

ilaydagerdan@gmail.com

+5077136219

İlayda Gerdan, resident doctor

Role: backup

+5077136219

Other Identifiers

AEŞH-EK-2025-013

Identifier Type: -

Identifier Source: org_study_id