Neck PainNCT07058636
Efficacy of Adding Greater Occipital Nerve Block to Trigger Point Injection in Patients With Neck Pain
A study testing 2% Lidocaine HCl + saline and Steroid+lidocaine in people with Neck Pain and Myofacial Pain Syndrome, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Myofacial Pain Syndrome, Trigger Point Pain, Myofascial
- What is being tested?
- 2% Lidocaine HCl + saline and Steroid+lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, 06170
İlayda Gerdan, Resident doctor, +5077136219, ilaydagerdan@gmail.com
İlayda Gerdan, resident doctor, +5077136219
About this study
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
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
Read more
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
- Being tested
- 2% Lidocaine HCl + saline, Steroid+lidocaine
- Keywords
- neck pain, myofascial pain syndrome, trigger point injection, ultrasound guided occipital nerve block, upper trapezius trigger point
- Medical subject headings
- Neck Pain, Facial Neuralgia, Myofascial Pain Syndromes, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Lidocaine HCl + salineDrug
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+lidocaineDrug
The GON block involves injecting a mixture of 1 ml 2% lidocaine and 1 ml betamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Trigger Point Injection Group | Active comparator | 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 Receives: Drug: 2% Lidocaine HCl + saline |
| Trigger Point Injection Plus Ultrasound-Guided Greater Occipital Nerve Block Group | Active comparator | 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. Receives: Drug: 2% Lidocaine HCl + saline; Drug: Steroid+lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
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.
Measured: Baseline, Week 1 and Week 4 post-intervention.
Secondary outcomes (5)
McGill-Melzack Pain Questionnaire
A tool assessing qualitative and quantitative aspects of pain, including sensory, affective, and overall pain components.
Measured: Baseline, Week 1 and Week 4 post-intervention.
Neck Disability Index (NDI)
A 10-item questionnaire evaluating functional limitations and disability caused by neck pain in daily activities.
Measured: Baseline, Week 1, and Week 4 post-intervention.
Nottingham Health Profile (NHP)
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.
Measured: Baseline, Week 1 and Week 4 post-intervention.
Cervical Joint Position Error Test (Proprioception Assessment)
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.
Measured: Baseline, Week 1 and Week 4 post-intervention.
Cervical Range of Motion (CROM) Measurement
Objective measurement of cervical spine active range of motion in degrees using a goniometer.
Measured: Baseline, Week 1 and Week 4 post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start3 Apr 2025
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Our study was designed as a prospective, single-blind, randomized controlled trial. Patients who presented to the PMR outpatient clinic and were diagnosed with myofascial pain syndrome will be included in the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Başak Mansız-Kaplan, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058636
- Sponsor's protocol ID
- AEŞH-EK-2025-013
- Status last verified
- Mar 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07058636
- Acronym / sponsor ID
- AEŞH-EK-2025-013
- Conditions
- Neck Pain, Myofacial Pain Syndrome, Trigger Point Pain, Myofascial, Trigger Points, Upper Trapezius Trigger Points, Cervicogenic Headache
- Keywords
- neck pain, myofascial pain syndrome, trigger point injection, ultrasound guided occipital nerve block, upper trapezius trigger point
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Our study was designed as a prospective, single-blind, randomized controlled trial. Patients who presented to the PMR outpatient clinic and were diagnosed with myofascial pain syndrome will be included in the study.
| Arm | Type | Receives |
|---|---|---|
| Trigger Point Injection Group | Active comparator | Drug: 2% Lidocaine HCl + salinePatients 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 |
| Trigger Point Injection Plus Ultrasound-Guided Greater Occipital Nerve Block Group | Active comparator | Drug: 2% Lidocaine HCl + saline, Drug: Steroid+lidocainePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% Lidocaine HCl + salineThe 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 | Trigger Point Injection Group, Trigger Point Injection Plus Ultrasound-Guided Greater Occipital Nerve Block Group |
| Steroid+lidocaineThe GON block involves injecting a mixture of 1 ml 2% lidocaine and 1 ml betamethasone. | Drug | Trigger Point Injection Plus Ultrasound-Guided Greater Occipital Nerve Block Group |
Primary outcome
Visual Analog Scale (VAS)
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.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Lidocaine HCl + saline and Steroid+lidocaine in people with Neck Pain and Myofacial Pain Syndrome, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İlayda Gerdan, Resident Doctor (+905077136219, ilaydagerdan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline, Week 1 and Week 4 post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.