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Cervicogenic HeadacheNCT06690411

Comparison of Myofascial Release and Mulligan Concept Techniques in Patients With Cervicogenic Headache

A study testing Mulligan Concept and Myofascial Release Technique in people with Cervicogenic Headache and Cervicogenic Headaches, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The International Headache Society classifies cervicogenic headache as a secondary headache caused by a disorder of the cervical spine and its components. Mulligan Concept (SNAG) is a gentle manual therapy that can be applied to the neck area. Read more about this study

Who is it for?
Ages 25 to 60 years
Conditions the study is for
Cervicogenic Headache, Cervicogenic Headaches
What is being tested?
Mulligan Concept and Myofascial Release Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
13 Nov 2024to 18 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

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 25 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Having been diagnosed with cervicogenic headache according to the International Classification of Headache Disorder-III diagnostic criteria
  • Having been diagnosed with cervicogenic headache for more than 3 months
  • Having a headache accompanying neck pain
  • Having restricted neck joint movement according to the Flexion-Rotation Test
  • Having pain between 3 and 8 according to the Visual Analog Scale
  • Being between 25-60 years of age
  • Agreeing to participate in the study voluntarily

Who cannot join

  • Previous cervical surgery
  • Previous cervical trauma
  • Having received diagnosis-related physiotherapy in the last 6 months
  • Diagnosis of tumor or cancer
  • Having other types of headache
  • Serious cardiovascular, cerebrovascular, hematological, metabolic, neurological or mental disease
Show all 11Show fewer
  • Being pregnant or breastfeeding
  • Having red flags for manual therapy
  • Dizziness with headache, visual disturbance
  • Congenital cervical disorder
  • Rheumatoid arthritis, cervical spondylolisthesis, cervical instability, infection

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sefakoy Medipol University Hospital

    Istanbul, Istanbul, 34295

Other trials in Turkey (Türkiye)

About this study

Official title: Effectiveness of Myofascial Release and Mulligan Concept Techniques in Patients With Cervicogenic Headache: A Single Blind-Randomized Clinical Trial

The International Headache Society classifies cervicogenic headache as a secondary headache caused by a disorder of the cervical spine and its components. Mulligan Concept (SNAG) is a gentle manual therapy that can be applied to the neck area. The myofascial release technique is also a massage-type manual therapy technique that is widely used in physiotherapy to relieve pain and tension in the relevant muscle group.

This clinical trial aims to investigate the effectiveness of the Mulligan Concept and myofascial release technique in patients with cervicogenic headaches. The main questions it aims to answer are:

Read more
  1. Does the Mulligan Concept improve hand grip strength, pressure pain threshold, range of motion, pain frequency, pain intensity, pain duration, number of medications used, daily living activities, and disability in patients with cervicogenic headache?
  2. Does myofascial release technique improve hand grip strength, pressure pain threshold, range of motion, pain frequency, pain intensity, pain duration, number of medications used, daily living activities, and disability in patients with cervicogenic headache?

Researchers will compare the Mulligan Concept to a myofascial release technique to see which physiotherapy method has more significant results in treating cervicogenic headaches.

Participants will:

  • Undergo the evaluations mentioned above before and after interventions
  • Undergo Mulligan Concept applications or the myofascial release technique 3 times a week for 4 weeks
  • Keep a diary of their symptoms and the number of times they use a drug
Read the detailed description

Although headache is one of the most common neurological symptoms, it is still not fully recognized and treated worldwide. The International Headache Society divides headaches into primary and secondary categories. The International Headache Society classifies cervicogenic headache as a secondary headache caused by a disorder of the cervical spine and its components. The prevalence in the general population is estimated to be approximately 0.17% to 4.1%.

Cervicogenic headache features are as follows;

  1. observed in adulthood,
  2. unilateral and does not change sides,
  3. radiating from the back of the head and neck to the ear and cheekbone,
  4. can be triggered mechanically by maneuvers,
  5. characterized by compressive pain that starts seconds or 30 minutes after the maneuver and lasts for several days to weeks

The diagnostic criteria for cervicogenic headache are as follows:

  1. The headache developed at a time similar to the onset of the cervical disorder or the appearance of the lesion
  2. The headache has significantly decreased or disappeared in parallel with the regression or complete healing of the cervical disorder or lesion
  3. The cervical range of motion is reduced and the headache worsens significantly with stimulating maneuvers
  4. The headache disappears after the cervical structure or nerve source is blocked for diagnosis

Studies show that physiotherapy and rehabilitation approaches such as manual therapy, exercise training, and dry needling are effective in treating headaches.

Studies have shown that people with cervicogenic headaches have a high rate of C1-C2 dysfunction. The mechanism of Mulligan's movement mobilization technique (SNAG) is based on the correction of joint position. Mulligan's SNAG technique is a gentle manual therapy method. Some studies have shown that Mulligan mobilization increases the range of motion and significantly reduces pain intensity and frequency in patients with cervicogenic headaches

Another form of massage-type manual therapy, myofascial release, is widely used in clinical practice. Previous studies have found that active myofascial trigger points often trigger tension-type headaches and migraines with palpation. Therefore, treatment of these myofascial trigger points may be an effective headache management.

In light of the literature data, this study aims to investigate and compare the effectiveness of physiotherapy methods such as Mulligan Concept applications and myofascial release technique on hand grip strength, pressure pain threshold, range of motion, pain frequency, pain intensity, pain duration, number of medication use, daily living activities and disability in patients with cervicogenic headache.

Hypotheses of this study are;

H0: There is no significant difference in favor of myofascial release technique or Mulligan concept applications in terms of pressure pain threshold, neck joint range of motion, handgrip strength, pain intensity, frequency and duration, number of medications used, disability and daily living activities between myofascial release technique and Mulligan concept applications in cervicogenic headache.

H1: There is a significant difference in favor of myofascial release technique between myofascial release technique and Mulligan concept applications in terms of pressure pain threshold, neck joint range of motion, handgrip strength, pain intensity, frequency and duration, number of medications used, disability and daily living activities between myofascial release technique and Mulligan concept applications in cervicogenic headache.

H2: There is a significant difference in favor of Mulligan concept applications between myofascial release technique and Mulligan concept applications in terms of pressure pain threshold, neck joint range of motion, handgrip strength, pain intensity, frequency and duration, number of medications used, disability and daily living activities.

To determine whether the physiotherapy approach produces greater significant outcomes for treating cervicogenic headaches, researchers will compare the Mulligan Concept with a myofascial release technique.

The 40 individuals, consisting of women and men, who will participate in the study will be randomly divided into two groups. These groups will consist of individuals who receive the myofascial release method or the Mulligan concept technique. After the initial evaluations, both groups will be applied to a 4-week treatment program consisting of 3 sessions per week and the evaluations will be repeated at the end of the 4 weeks. The researcher who makes the evaluations will not know which treatment the individuals received, in other words, will be blind to the groups.

The participants will be evaluated on their neck joint range of motion, pressure pain threshold, hand grip strength, headache and functionality, and disability due to neck problems. In addition, they will be evaluated on their pain frequency, intensity, and duration. Participants will keep a diary of their symptoms and the number of times they use a medication.

Being tested
Mulligan Concept, Myofascial Release Technique
Keywords
Cervicogenic headache, Mulligan SNAG, Myofascial Release, Physiotherapy, Headache, Manual Therapy
Medical subject headings
Post-Traumatic Headache, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mulligan ConceptOther

    The participants of the Mulligan SNAG group will undergo the Mulligan SNAG technique. Mulligan's SNAG technique is a gentle manual therapy method. This technique is based on the correction of the joint position. There are 3 techniques specified for headache; Headache SNAG, Reverse Headache SNAG, and C1-C2 SNAG.

  • Myofascial Release TechniqueOther

    Myofascial therapy can be described as massage-type manual therapy. The participants of the Myofascial Release Group will undergo the myofascial release technique.

Study groups in NCT06690411
Study groupRoleWhat they receive
Myofascial Release GroupExperimentalTwenty participants who will be randomized into the myofascial release group will undergo the myofascial release technique by an experienced physiotherapist 3 times a week for 4 weeks.
Receives: Other: Myofascial Release Technique
Mulligan SNAG groupExperimentalTwenty participants who will be randomized into the Mulligan SNAG group will undergo the Mulligan SNAG technique by an experienced physiotherapist 3 times a week for 4 weeks.
Receives: Other: Mulligan Concept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache Impact Test-6

    Headache Impact Test-6 (HIT-6) evaluates the effects of headaches on daily living activities. HIT-6 shows good internal consistency, retest reliability, validity and responsiveness. A total score of 36 is the best in terms of headache, and 78 is the worst. In this study, HIT-6 will be used to evaluate how headache affects individuals' daily living activities.

    Measured: Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.

Secondary outcomes (7)
  1. Muscle Tone Measurement

    In this study, MyotonPro will be used to evaluate the effect of physiotherapy techniques on muscle tone. MyotonPRO offers a non-invasive, reliable and accurate solution for digital palpation of soft biological tissues. The device measures superficial skeletal muscles, tendons, ligaments, adipose tissue and skin. MyotonPRO is a hand-held, smartphone-sized device which is quick and easy to use. Scientific research has proven its practicality and versatility.

    Measured: Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.

  2. Cervical Range of Motion Measurement

    A reduction in the cervical joint range of motion is frequently observed in cervicogenic headaches. A digital goniometer is a valid and reliable tool for measuring joint range of motion in individuals. In this study, digital goniometer; C1-C2 Flexion-Rotation Test will be used to evaluate flexion-extension, right and left rotation neck joint range of motion.

    Measured: Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.

  3. Hand Grip Strength Measurement

    To the best of our knowledge, no previous study has evaluated the effect of headache on handgrip strength. However, studies have shown a negative correlation between neck pain and handgrip strength. The Jamar Hand Dynamometer is the gold standard tool for handgrip strength assessment in clinical and research settings with its validity and reliability. In this study, Jamar dynamometer will be used to evaluate the hand grip strength of patients on the affected side.

    Measured: Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.

  4. Pain Pressure Threshold Measurement

    Pain pressure threshold measurement will be performed to assess pain sensitivity and determine pressure perception. The algometer is the gold standard tool for pain pressure threshold measurement. In this study, pressure pain threshold assessment will be performed on the trapezius muscle and suboccipital muscles on the affected side of the patients.

    Measured: Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.

  5. Neck Disability Index

    Neck Disability Index is a ten-part test that determines how neck pain affects daily living activities. The Neck Disability Index is a self-scored disability instrument used in patients with cervical musculoskeletal disorders but is increasingly being used to assess neck pain-related disability in individuals with headaches. In this study, NDI will be used to evaluate how patients' neck problems affect their daily living activities. The minimum score is 0, maximum score is 100. High scores show worse results, while low scores show better results.

    Measured: Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.

  6. Diary

    The diary helps both users and healthcare professionals assess the impact of headaches, make diagnoses, and inform healthcare decision-making. In this study, a headache diary will be used to assess patients' headache intensity, frequency, duration, and medication use.

    Measured: During the 2-week pretreatment period, during the 4-week treatment period, and during the 4 weeks preceding the 24-week follow-up assessment.

  7. Postural Examination

    Anterior translations of the head or shoulder may contribute to pain in the upper half of the body. In this study, head and neck translations will be evaluated by measuring the wall-tragus distance and the craniovertebral angle (C7-tragus horizontal angle). Optimal angle of the craniovertebral angle is 48-50.

    Measured: Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2024
  2. Study start13 Nov 2024
  3. Primary completion1 Feb 2026
  4. Study completion18 Feb 2026

Resources

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
This study will be a single blind-randomized clinical trial. The researcher who makes the evaluations will not know which treatment the individuals received, in other words, will be blind to the groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06690411
Sponsor's protocol ID
E-10840098-202.3.02-4329
Status last verified
Feb 2025
First submitted
13 Nov 2024
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Correll S, Field J, Hutchinson H, Mickevicius G, Fitzsimmons A, Smoot B. RELIABILITY AND VALIDITY OF THE HALO DIGITAL GONIOMETER FOR SHOULDER RANGE OF MOTION IN HEALTHY SUBJECTS. Int J Sports Phys Ther. 2018 Aug;13(4):707-714.

    PubMed 30140564
  • Corum M, Aydin T, Medin Ceylan C, Kesiktas FN. The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: A randomized controlled trial. Complement Ther Clin Pract. 2021 May;43:101319. doi: 10.1016/j.ctcp.2021.101319. Epub 2021 Jan 24.

    PubMed 33517104
  • Liang Z, Thomas L, Jull G, Treleaven J. The Neck Disability Index Reflects Allodynia and Headache Disability but Not Cervical Musculoskeletal Dysfunction in Migraine. Phys Ther. 2022 May 5;102(5):pzac027. doi: 10.1093/ptj/pzac027.

    PubMed 35230421

Questions about this trial

What is this clinical trial studying?

A study testing Mulligan Concept and Myofascial Release Technique in people with Cervicogenic Headache and Cervicogenic Headaches, run by Istanbul Medipol University 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 31 Jul 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache Impact Test-6 (time frame: Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.). 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 NCT06690411, 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 31 Jul 2026.

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