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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Visual Analog Scale (VAS) [Time frame: Baseline, Week 1 and Week 4 post-intervention.]

Secondary outcome measures (5)

• McGill-Melzack Pain Questionnaire [Time frame: Baseline, Week 1 and Week 4 post-intervention.]
• Neck Disability Index (NDI) [Time frame: Baseline, Week 1, and Week 4 post-intervention.]
• Nottingham Health Profile (NHP) [Time frame: Baseline, Week 1 and Week 4 post-intervention.]
• Cervical Joint Position Error Test (Proprioception Assessment) [Time frame: Baseline, Week 1 and Week 4 post-intervention.]
• Cervical Range of Motion (CROM) Measurement [Time frame: Baseline, Week 1 and Week 4 post-intervention.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara Etlik City Hospital — Ankara

Identifiers

NCT: NCT07058636 · AEŞH-EK-2025-013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗