跳至主要内容
临床试验/NCT06690411
NCT06690411已完成不适用

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

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Headache Impact Test-6

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: 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.

干预措施: Mulligan Concept (Other)

结局指标

主要结局

Headache Impact Test-6

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

fatih bali

Lecturer, Assoc. Dr.

Istanbul Medipol University Hospital

研究点 (1)

Loading locations...

相似试验