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Clinical Trials/NCT06690411
NCT06690411CompletedNot Applicable

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

Istanbul Medipol University Hospital1 site in 1 country40 target enrollmentStarted: November 13, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Headache Impact Test-6

Study Overview

Brief 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. 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:

  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

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The researcher who makes the evaluations will not know which treatment the individuals received, in other words, will be blind to the groups.

Eligibility Criteria

Ages
25 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • 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

Arms & Interventions

Myofascial Release Group

Experimental

Twenty 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.

Intervention: Myofascial Release Technique (Other)

Mulligan SNAG group

Experimental

Twenty 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.

Intervention: Mulligan Concept (Other)

Outcomes

Primary Outcomes

Headache Impact Test-6

Time Frame: 10 minutes

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.

Hand Grip Strength Measurement

Time Frame: 1 minute

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.

Headache Impact Test-6

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

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.

Secondary Outcomes

  • Muscle Tone Measurement(5 minutes)
  • Cervical Range of Motion Measurement(5 minutes)
  • Pain Pressure Threshold Measurement(5 minutes)
  • Neck Disability Index(10 minutes)
  • Diary(3 minutes a day)
  • Postural Examination(3 minutes)
  • Muscle Tone Measurement(Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.)
  • Cervical Range of Motion Measurement(Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.)
  • Hand Grip Strength Measurement(Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.)
  • Pain Pressure Threshold Measurement(Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.)
  • Neck Disability Index(Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.)
  • Diary(During the 2-week pretreatment period, during the 4-week treatment period, and during the 4 weeks preceding the 24-week follow-up assessment.)
  • Postural Examination(Baseline, immediately after the 4-week treatment period, and 24 weeks after treatment completion.)

Investigators

Sponsor
Istanbul Medipol University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

fatih bali

Lecturer, Assoc. Dr.

Istanbul Medipol University Hospital

Study Sites (1)

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