Ankara Etlik City Hospital
Ankara, 06170, Turkey (Türkiye)
Location status: Recruiting
Location contact
İlayda Gerdan, Resident doctor
CONTACT
İlayda Gerdan, resident doctor
CONTACT
NCT Number: NCT07058636
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Ankara, 06170, Turkey (Türkiye)
Location status: Recruiting
İlayda Gerdan, Resident doctor
CONTACT
İlayda Gerdan, resident doctor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The GON block involves injecting a mixture of 1 ml 2% lidocaine and 1 ml betamethasone.
Time frame: Baseline, Week 1 and Week 4 post-intervention.
Global pain assessment using a Visual Analog Scale ranging from 0 ("no pain") to 10 ("unbearable pain"). Patients rate their pain intensity on this scale.
Time frame: Baseline, Week 1 and Week 4 post-intervention.
A tool assessing qualitative and quantitative aspects of pain, including sensory, affective, and overall pain components.
Time frame: Baseline, Week 1, and Week 4 post-intervention.
A 10-item questionnaire evaluating functional limitations and disability caused by neck pain in daily activities.
Time frame: Baseline, Week 1 and Week 4 post-intervention.
A patient-reported questionnaire measuring subjective health status and quality of life across six dimensions: energy, pain, emotional reactions, sleep, social isolation, and physical mobility.
Time frame: Baseline, Week 1 and Week 4 post-intervention.
Measurement of cervical proprioception errors during head and neck movements using a laser pointer and target board system. The average error in centimeters over six repetitions per movement will be recorded.
Time frame: Baseline, Week 1 and Week 4 post-intervention.
Objective measurement of cervical spine active range of motion in degrees using a goniometer.
Time frame: Baseline only
Assessment of forward head posture using photogrammetric measurement of the craniovertebral angle. The angle is formed between a horizontal line passing through the C7 spinous process and a line connecting the tragus of the ear to C7. Smaller angles indicate a more pronounced forward head posture.
Contact information is provided by the study sponsor or research team.
Ankara Etlik City Hospital
Other Gov
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07503574
Muscular Diseases, Musculoskeletal Diseases
Ankara, Turkey (Türkiye)
View Trial DetailsNCT05870904
Muscle Tightness, Muscular Diseases
Islamabad, Pakistan
View Trial DetailsNCT05265468
Muscular Diseases, Musculoskeletal Diseases
Murcia, Spain
View Trial DetailsNCT04832074
Muscular Diseases, Musculoskeletal Diseases
Pozuelo de Alarcón, Madrid, Spain
View Trial Details