Cervicogenic HeadacheTPI-MFR-CGHNCT07910877
Trigger Point Injection and Myofascial Release for Cervicogenic Headache
A study testing Trigger Point Injection + Home Exercise, Experimental: Myofascial Release + Home Exercise and Combined Trigger Point Injection and Myofascial Release in people with Cervicogenic Headache, run by Konya Beyhekim Training and Research Hospital.
Trial summary
Cervicogenic headache is a type of headache associated with problems in the neck. This study aims to compare the effects of trigger point injection, myofascial release, and their combination in patients with cervicogenic headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Trigger Point Injection + Home Exercise, Experimental: Myofascial Release + Home Exercise and Combined Trigger Point Injection and Myofascial Release
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 31 Dec 2027
- 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
- Adults aged 18-65 years.
- Neck pain or headache for at least 3 months.
- Fulfillment of the study's clinical criteria for cervicogenic headache:
- Unilateral pain.
- Reduced cervical range of motion.
- Ipsilateral shoulder discomfort.
- Ipsilateral arm discomfort.
- Pain exacerbated by different neck movements and pain on palpation.
Who cannot join
- Migraine.
- Cluster headache.
- Cervical radiculopathy.
- Entrapment neuropathy.
- Myelopathy.
- Rheumatoid arthritis.
Show all 12Show fewer
- History of cervical spine surgery.
- Pregnancy.
- Receipt of physical therapy within the previous 6 months.
- History of major psychiatric illness.
- Uncontrolled systemic disease, including cardiovascular, pulmonary, hepatic, renal, or hematologic disease.
- Uncontrolled systemic endocrine
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Trigger Point Injection and Myofascial Release in Cervicogenic Headache: A Randomized Controlled Trial
Cervicogenic headache is a type of headache associated with problems in the neck. This study aims to compare the effects of trigger point injection, myofascial release, and their combination in patients with cervicogenic headache.
A total of 120 adults aged 18-65 years with cervicogenic headache are planned to be included and randomly assigned to one of four groups: trigger point injection with home exercises, myofascial release with home exercises, combined trigger point injection and myofascial release with home exercises, or home exercises alone.
Trigger point injections will be performed using 0.5% lidocaine once weekly for four sessions. Myofascial release will also be provided once weekly for four sessions in the relevant groups. The home exercise program will include neck range-of-motion exercises, stretching, and is
- Conditions
- Cervicogenic Headache
- Being tested
- Trigger Point Injection + Home Exercise, Experimental: Myofascial Release + Home Exercise, Combined Trigger Point Injection and Myofascial Release, Home Exercise Program
- Keywords
- Cervicogenic Headache, Trigger Point Injection, Myofascial Release, Home Exercise Program
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger Point Injection + Home ExerciseDrug
Participants will receive trigger point injections using 0.5% lidocaine, administered once weekly for four weeks. A volume of 0.5 mL will be injected into each active trigger point, targeting the upper trapezius, sternocleidomastoid, and splenius capitis muscles as clinically appropriate. A maximum of four trigger points will be treated per session, with a maximum total lidocaine dose of 20 mg per session. Participants will also perform a home exercise program consisting of cervical range-of-motion exercises, trapezius stretching, and isometric strengthening exercises, prescribed as three sets of 10 repetitions daily for four weeks.
Experimental: Myofascial Release + Home ExerciseProcedure or surgery
Participants will receive myofascial release therapy targeting the cervical and suboccipital muscles, administered once weekly for four weeks. Participants will also perform a home exercise program consisting of cervical range-of-motion exercises, trapezius stretching, and isometric strengthening exercises, prescribed as three sets of 10 repetitions daily for four weeks.
Combined Trigger Point Injection and Myofascial ReleaseProcedure or surgery
Participants will receive combined trigger point injections using 0.5% lidocaine and myofascial release therapy once weekly for four weeks. A volume of 0.5 mL of lidocaine will be injected into each active trigger point, targeting the upper trapezius, sternocleidomastoid, and splenius capitis muscles as clinically appropriate. A maximum of four trigger points will be treated per session, with a maximum total lidocaine dose of 20 mg per session. Myofascial release therapy will target the cervical and suboccipital muscles. Participants will also perform a home exercise program consisting of cervical range-of-motion exercises, trapezius stretching, and isometric strengthening exercises, prescribed as three sets of 10 repetitions daily for four weeks.
Home Exercise ProgramBehavioural
Participants will perform a home exercise program for four weeks consisting of cervical range-of-motion exercises, trapezius stretching, and isometric strengthening exercises. The exercises will be prescribed as three sets of 10 repetitions daily throughout the four-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Trigger Point Injection + Home Exercise | Experimental | Participants will receive trigger point injections using 0.5% lidocaine once weekly for four sessions. The injections will be administered to active trigger points in the upper trapezius, sternocleidomastoid, and splenius capitis muscles, as appropriate. Participants will also perform a home exercise program consisting of neck range-of-motion exercises, trapezius stretching, and isometric neck strengthening exercises. Receives: Drug: Trigger Point Injection + Home Exercise |
| Myofascial Release + Home Exercise | Experimental | Participants will receive myofascial release targeting the cervical and suboccipital muscles once weekly for four sessions. The treatment will focus on the neck muscles as described in the study protocol. Participants will also perform a home exercise program consisting of neck range-of-motion exercises, trapezius stretching, and isometric neck strengthening exercises. Receives: Procedure: Experimental: Myofascial Release + Home Exercise |
| Combined Treatment + Home Exercise | Experimental | Participants will receive both trigger point injections using 0.5% lidocaine and myofascial release once weekly for four sessions. Trigger point injections will target active trigger points in the upper trapezius, sternocleidomastoid, and splenius capitis muscles, as appropriate. Myofascial release will be applied to the cervical and suboccipital muscles according to the study protocol. Participants will also perform a home exercise program consisting of neck range-of-motion exercises, trapezius stretching, and isometric neck strengthening exercises. Receives: Procedure: Combined Trigger Point Injection and Myofascial Release |
| Home Exercise Alone | Active comparator | Participants will follow a home exercise program for four weeks. The program will include neck range-of-motion exercises, trapezius stretching, and isometric neck strengthening exercises. Participants will be instructed to perform three sets of 10 repetitions daily. Exercise instructions will be demonstrated by a physician and provided in a printed handout. Receives: Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity on the Visual Analog Scale (VAS)
Change in headache pain intensity from baseline to the end of the 4-week treatment period, measured using the Visual Analog Scale (VAS). The change will be compared among the four study groups.
Measured: Baseline, Week 4 (end of treatment), and Week 8 (1 month after treatment)
Secondary outcomes (4)
Change in Headache-Related Disability Index (HDI) Score
Change in headache-related disability measured using the Headache Disability Index (HDI). Scores will be assessed at baseline, at the end of treatment, and one month after treatment completion.
Measured: Baseline, Week 4, and Week 8
Change in Headache Impact Test (HIT-6) Score
Change in the impact of headache on daily functioning measured using the Headache Impact Test (HIT-6). Scores will be assessed at baseline, at the end of treatment, and one month after treatment completion.
Measured: Baseline, Week 4, and Week 8
Change in 12-Item Short Form Health Survey (SF-12) Score
Change in health-related quality of life measured using the 12-Item Short Form Health Survey (SF-12). Scores will be assessed at baseline, at the end of treatment, and one month after treatment completion.
Measured: Baseline, Week 4, and Week 8
Change in Number of Headache Days per Week
Change in the number of days with headache during the preceding 7 days, recorded in a headache diary. Headache days will be assessed at baseline, at the end of treatment, and one month after treatment completion.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savaş Karpuz, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910877
- Sponsor's protocol ID
- 2026/1
- Acronym
- TPI-MFR-CGH
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
PubMed 12221344Lerner-Lentz A, O'Halloran B, Donaldson M, Cleland JA. Pragmatic application of manipulation versus mobilization to the upper segments of the cervical spine plus exercise for treatment of cervicogenic headache: a randomized clinical trial. J Man Manip Ther. 2021 Oct;29(5):267-275. doi: 10.1080/10669817.2020.1834322. Epub 2020 Nov 5.
PubMed 33148134Rani M, Kaur J. Effectiveness of different physiotherapy interventions in the management of cervicogenic headache: a pilot randomized controlled trial. J Man Manip Ther. 2022 Apr;30(2):96-104. doi: 10.1080/10669817.2021.1962687. Epub 2021 Aug 10.
PubMed 34374330
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Trigger Point Injection and Myofascial Release in Cervicogenic Headache: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07910877
- Acronym / sponsor ID
- TPI-MFR-CGH / 2026/1
- Conditions
- Cervicogenic Headache
- Keywords
- Cervicogenic Headache, Trigger Point Injection, Myofascial Release, Home Exercise Program
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
Cervicogenic headache is a type of headache associated with problems in the neck. This study aims to compare the effects of trigger point injection, myofascial release, and their combination in patients with cervicogenic headache.
A total of 120 adults aged 18-65 years with cervicogenic headache are planned to be included and randomly assigned to one of four groups: trigger point injection with home exercises, myofascial release with home exercises, combined trigger point injection and myofascial release with home exercises, or home exercises alone.
Trigger point injections will be performed using 0.5% lidocaine once weekly for four sessions. Myofascial release will also be provided once weekly for four sessions in the relevant groups. The home exercise program will include neck range-of-motion exercises, stretching, and is
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trigger Point Injection + Home Exercise | Experimental | Drug: Trigger Point Injection + Home ExerciseParticipants will receive trigger point injections using 0.5% lidocaine once weekly for four sessions. The injections will be administered to active trigger points in the upper trapezius, sternocleidomastoid, and splenius capitis muscles, as appropriate. Participants will also perform a home exercise program consisting of neck range-of-motion exercises, trapezius stretching, and isometric neck strengthening exercises. |
| Myofascial Release + Home Exercise | Experimental | Procedure: Experimental: Myofascial Release + Home ExerciseParticipants will receive myofascial release targeting the cervical and suboccipital muscles once weekly for four sessions. The treatment will focus on the neck muscles as described in the study protocol. Participants will also perform a home exercise program consisting of neck range-of-motion exercises, trapezius stretching, and isometric neck strengthening exercises. |
| Combined Treatment + Home Exercise | Experimental | Procedure: Combined Trigger Point Injection and Myofascial ReleaseParticipants will receive both trigger point injections using 0.5% lidocaine and myofascial release once weekly for four sessions. Trigger point injections will target active trigger points in the upper trapezius, sternocleidomastoid, and splenius capitis muscles, as appropriate. Myofascial release will be applied to the cervical and suboccipital muscles according to the study protocol. Participants will also perform a home exercise program consisting of neck range-of-motion exercises, trapezius stretching, and isometric neck strengthening exercises. |
| Home Exercise Alone | Active comparator | Behavioral: Home Exercise ProgramParticipants will follow a home exercise program for four weeks. The program will include neck range-of-motion exercises, trapezius stretching, and isometric neck strengthening exercises. Participants will be instructed to perform three sets of 10 repetitions daily. Exercise instructions will be demonstrated by a physician and provided in a printed handout. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18-65 years.
- Neck pain or headache for at least 3 months.
- Fulfillment of the study's clinical criteria for cervicogenic headache:
- Unilateral pain.
- Reduced cervical range of motion.
Key exclusion criteria (12 listed)
- Migraine.
- Cluster headache.
- Cervical radiculopathy.
- Entrapment neuropathy.
- Myelopathy.
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 |
|---|---|---|
| Trigger Point Injection + Home ExerciseParticipants will receive trigger point injections using 0.5% lidocaine, administered once weekly for four weeks. A volume of 0.5 mL will be injected into each active trigger point, targeting the upper trapezius, sternocleidomastoid, and splenius capitis muscles as clinically appropriate. A maximum of four trigger points will be treated per session, with a maximum total lidocaine dose of 20 mg per session. Participants will also perform a home exercise program consisting of cervical range-of-motion exercises, trapezius stretching, and isometric strengthening exercises, prescribed as three sets of 10 repetitions daily for four weeks. | Drug | Trigger Point Injection + Home Exercise |
| Experimental: Myofascial Release + Home ExerciseParticipants will receive myofascial release therapy targeting the cervical and suboccipital muscles, administered once weekly for four weeks. Participants will also perform a home exercise program consisting of cervical range-of-motion exercises, trapezius stretching, and isometric strengthening exercises, prescribed as three sets of 10 repetitions daily for four weeks. | Procedure or surgery | Myofascial Release + Home Exercise |
| Combined Trigger Point Injection and Myofascial ReleaseParticipants will receive combined trigger point injections using 0.5% lidocaine and myofascial release therapy once weekly for four weeks. A volume of 0.5 mL of lidocaine will be injected into each active trigger point, targeting the upper trapezius, sternocleidomastoid, and splenius capitis muscles as clinically appropriate. A maximum of four trigger points will be treated per session, with a maximum total lidocaine dose of 20 mg per session. Myofascial release therapy will target the cervical and suboccipital muscles. Participants will also perform a home exercise program consisting of cervical range-of-motion exercises, trapezius stretching, and isometric strengthening exercises, prescribed as three sets of 10 repetitions daily for four weeks. | Procedure or surgery | Combined Treatment + Home Exercise |
| Home Exercise ProgramParticipants will perform a home exercise program for four weeks consisting of cervical range-of-motion exercises, trapezius stretching, and isometric strengthening exercises. The exercises will be prescribed as three sets of 10 repetitions daily throughout the four-week intervention period. | Behavioural | Home Exercise Alone |
Primary outcome
Change in Pain Intensity on the Visual Analog Scale (VAS)
Time frame: Baseline, Week 4 (end of treatment), and Week 8 (1 month after treatment)
Change in headache pain intensity from baseline to the end of the 4-week treatment period, measured using the Visual Analog Scale (VAS). The change will be compared among the four study groups.
4 secondary outcomes
Change in Headache-Related Disability Index (HDI) Score
Time frame: Baseline, Week 4, and Week 8
Change in Headache Impact Test (HIT-6) Score
Time frame: Baseline, Week 4, and Week 8
Change in 12-Item Short Form Health Survey (SF-12) Score
Time frame: Baseline, Week 4, and Week 8
Change in Number of Headache Days per Week
Time frame: Baseline, Week 4, and Week 8
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 2 Nov 2026.
- Background: PubMed 12221344Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
- Background: PubMed 33148134Lerner-Lentz A, O'Halloran B, Donaldson M, Cleland JA. Pragmatic application of manipulation versus mobilization to the upper segments of the cervical spine plus exercise for treatment of cervicogenic headache: a randomized clinical trial. J Man Manip Ther. 2021 Oct;29(5):267-275. doi: 10.1080/10669817.2020.1834322. Epub 2020 Nov 5.
- Background: PubMed 34374330Rani M, Kaur J. Effectiveness of different physiotherapy interventions in the management of cervicogenic headache: a pilot randomized controlled trial. J Man Manip Ther. 2022 Apr;30(2):96-104. doi: 10.1080/10669817.2021.1962687. Epub 2021 Aug 10.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Trigger Point Injection + Home Exercise, Experimental: Myofascial Release + Home Exercise and Combined Trigger Point Injection and Myofascial Release in people with Cervicogenic Headache, run by Konya Beyhekim Training and Research Hospital.
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 8 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 savaş Karpuz (+905552057860, svskrpz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity on the Visual Analog Scale (VAS) (time frame: Baseline, Week 4 (end of treatment), and Week 8 (1 month after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07910877, which also lists 3 linked publications.
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 2 Nov 2026.