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临床试验/NCT06703385
NCT06703385尚未招募不适用

Effect of Suboccipital Release Versus Instrument- Assisted Soft Tissue Mobilization on Tension Type Headache

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
assessment of pain intensity using numeric pain rating scale

研究概览

简要总结

The study aims to explore the impact of suboccipital release versus instrument-assisted soft tissue mobilization on pain intensity, pressure pain threshold, headache impact test, and headache frequency in patients with tension headache. The research will also examine the effects of these methods on headache impact tests and frequency.

详细描述

Headache prevalence ranges from 38.2 to 59.4%, with a lifetime prevalence of 26.1-45%. Tension Type Headache can be episodic or chronic, with 78% occurring less than 15 times/month and 6% occurring more than 15 times/month. Tension Type Headache has a greater socioeconomic burden, leading to lower productivity and workday loss. Tension Type Headache is linked to myofascial pain and trigger points, which can cause sensory changes and reduced pain threshold. Studies show that referred pain from myofascial trigger points reproduces headache in patients with , leading to increased symptom severity. Frequent Episodic tension type headache increases the risk of developing chronic tension type headache due to analgesic overuse. instrumental assisted soft tissue mobilization, a physical therapy technique, promotes fascia realignment and reduces strain on the clinician's hands.

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 (Participant)

入排标准

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

入选标准

  • •Participants of both gender will be between the ages of 18 and
  • •Episodic tension type headache criteria, according to the International Headache Society's Headache Classification Committee., have at least two of the following characteristics.
  • •Recurrent episodes of headache on less than 15 days per month for at least 3 months
  • •Headache that last for from around 30 min till seven days.
  • •At least 2 of the following features are found in a headache:
  • •A location that is on two sides.
  • •Tightening/pressing quality (non-pulsating).
  • •Intensity is mild to moderate.
  • •Both of the following: Not worsened by routine physical activity, there is no nausea or vomiting.
  • •Only have one photophobia/ phonophobia
  • •Patients have active trigger points in suboccipital muscle and upper trapezius muscle
  • •The presence of myofascial trigger points was determined by therapist using the diagnostic criteria described by Simons .,(1999) ,The major criteria of active myofascial trigger points were: Regional neck pain, Pain or altered sensation in the expected distribution of referred pain from a myofascial trigger point, Taut band palpable in an accessible muscle.

排除标准

  • •Patients who have had a history of cancer
  • •Patients who have had cervical and cranial surgery
  • •Patients with severe psychological disorders (major Depression)
  • •Patients with uncontrolled hypertension
  • •Dysfunctions in the tempo-mandibular joint
  • •Headaches associated with high fever, stiff neck, or rash, problems of vision or profound dizziness
  • •Female who are pregnant or lactating

研究组 & 干预措施

conventional program

Active Comparator

Twenty patients will receive conventional physical therapy including Hot pack and exercise therapy program (ROM exercise, stretching exercise, isometric strengthening exercise for cervical muscles

干预措施: conventional physical therapy program (Other)

suboccipital release

Experimental

Twenty patients will receive suboccipital release plus the Same conventional physical therapy program.

干预措施: Suboccipital release (Other)

suboccipital release

Experimental

Twenty patients will receive suboccipital release plus the Same conventional physical therapy program.

干预措施: conventional physical therapy program (Other)

instrumental assisted soft tissue mobilization

Experimental

Twenty patients will receive instrumental assisted soft tissue mobilization plus the Sam conventional physical therapy program.

干预措施: Instrument Assisted soft tissue mobilization (Other)

instrumental assisted soft tissue mobilization

Experimental

Twenty patients will receive instrumental assisted soft tissue mobilization plus the Sam conventional physical therapy program.

干预措施: conventional physical therapy program (Other)

结局指标

主要结局

assessment of pain intensity using numeric pain rating scale

时间窗: at baseline and after 4 weeks

Assessment of pain intensity using Numerical pain Rating Scale An 1l-point numeric scale with 0 representing one pain extreme(e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable)

次要结局

  • Assessment of pressure pain threshold using pressure algometer(at baseline and after 4 weeks)
  • Assessment of the impact of headache using the Headache Impact Test questionnaire(at baseline and after 4 weeks)
  • Assessment of Frequency of headache(at baseline and after 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nada Gamal Saad

principal investigator

Cairo University

研究点 (1)

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