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临床试验/NCT07838545
NCT07838545招募中不适用

Comparative Effects of Post Isometric Relaxation and Reciprocal Inhibition in Individuals With Cervicogenic Headache.

Foundation University Islamabad1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
46
试验地点
1
主要终点
Head Pain

研究概览

简要总结

This study aims to compare the effects of Post Isometric Relaxation (PIR) and Reciprocal Inhibition (RI) in individuals with cervicogenic headache, a secondary headache originating from dysfunction of the cervical spine, particularly the upper cervical segments. Cervicogenic headache is characterized by unilateral head and neck pain, restricted cervical mobility, muscle tightness, and functional limitations that negatively affect daily activities and quality of life. The study will employ a randomized controlled trial involving 46 participants aged 18-45 years who meet the inclusion criteria. Participants will be randomly allocated into two groups: Group A will receive Post Isometric Relaxation, while Group B will receive Reciprocal Inhibition. Both groups will also receive a standard physiotherapy protocol consisting of hot packs, cervical isometric exercises, and C1-C2 Sustained Natural Apophyseal Glides (SNAGs), administered three times per week for four weeks. Pain intensity, functional disability, and cervical range of motion will be assessed before and after the intervention using the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), and goniometric measurements, respectively. By comparing these two muscle energy techniques, the study seeks to determine which intervention is more effective in reducing pain, improving cervical mobility, and enhancing functional outcomes, thereby providing evidence to support clinical decision-making and optimize physiotherapy management for individuals with cervicogenic headache.

详细描述

"Comparative Effects of Post Isometric Relaxation and Reciprocal Inhibition in Individuals with Cervicogenic Headache," is designed to compare the effectiveness of two muscle energy techniques-Post Isometric Relaxation (PIR) and Reciprocal Inhibition (RI)-in reducing pain, improving cervical range of motion, and decreasing functional disability among individuals with cervicogenic headache (CGH). Cervicogenic headache is defined as a secondary headache caused by disorders of the cervical spine or its associated bony, disc, or soft tissue structures. It typically presents as unilateral pain that begins in the neck or occipital region and radiates toward the front of the head. Patients often experience restricted neck movement, cervical stiffness, muscle tightness, and occasionally ipsilateral shoulder or arm discomfort. These symptoms may significantly interfere with daily activities, work performance, and overall quality of life. The condition is commonly associated with dysfunction of the upper cervical spine, particularly the C1-C2 segment, where altered joint mobility and muscle imbalance contribute to the development and persistence of symptoms. The synopsis highlights that cervicogenic headache is a common musculoskeletal disorder with a considerable health burden worldwide. It is frequently triggered or aggravated by sustained neck postures, repetitive cervical movements, or prolonged physical activity. Diagnosis requires a detailed subjective and physical examination, with particular emphasis on assessing upper cervical mobility. The Cervical Flexion-Rotation Test (CFRT) is identified as a reliable and valid clinical test for confirming cervicogenic headache because it specifically evaluates C1-C2 rotation, which is often limited in affected individuals. Patients with CGH also commonly exhibit tightness in muscles such as the upper trapezius, levator scapulae, sternocleidomastoid, scalene, suboccipital muscles, and pectoral muscles, making manual therapy an important component of rehabilitation. The study focuses on two commonly used muscle energy techniques. Post Isometric Relaxation (PIR) is based on the principle that following an isometric muscle contraction, muscle tone decreases temporarily, allowing the therapist to gently stretch the muscle into a new range of motion. During the technique, the therapist applies resistance while the patient performs a gentle isometric contraction for a specified duration, after which the muscle is passively stretched. This process aims to reduce muscle tightness, improve flexibility, restore normal muscle length, and increase cervical mobility. Reciprocal Inhibition (RI), in contrast, relies on the physiological inhibition of a tight muscle through isometric contraction of its antagonist. When the antagonist contracts, the agonist muscle experiences reduced muscle tone, allowing a more effective passive stretch. Both techniques are intended to relieve pain, restore normal muscle function, and improve joint mobility in patients with cervicogenic headache. The rationale for this research is based on evidence from previous studies demonstrating the effectiveness of manual therapy and muscle energy techniques in treating neck pain and cervicogenic headache. Earlier research has shown that PIR, hold-relax techniques, SNAGs, and other manual therapy interventions significantly reduce pain, improve cervical range of motion, and decrease disability. However, limited evidence directly compares PIR and RI in individuals with cervicogenic headache. Therefore, this study seeks to determine which of these two techniques provides superior clinical outcomes and may guide physiotherapists in selecting the most effective treatment approach. The research will be conducted as a randomized controlled trial (RCT) over one year at the Foundation University College of Physical Therapy. A total of 46 participants, aged 18-45 years, diagnosed with cervicogenic headache according to the International Classification of Headache criteria, will be recruited using non-probability purposive sampling. Eligible participants must have unilateral neck pain associated with headache for more than three months, headache provoked by neck movement or sustained postures, restricted upper cervical mobility, and a positive Cervical Flexion-Rotation Test with a restriction greater than 10 degrees. Individuals with recent cervical trauma, cervical surgery, neoplasms, inherited spinal deformities, cognitive impairment, or other chronic pain syndromes will be excluded to ensure a more homogeneous study population. Participants will be randomly allocated into two equal groups using sealed opaque envelopes. Group A will receive Post Isometric Relaxation, while Group B will receive Reciprocal Inhibition. Both groups will receive the same standard physiotherapy protocol consisting of a 10-minute hot pack, cervical isometric exercises (10 repetitions with a 5-second hold), and C1-C2 Sustained Natural Apophyseal Glides (SNAGs) (10 repetitions with a 5-second hold). Treatment sessions will be conducted three times per week for four weeks, resulting in a total of twelve treatment sessions. PIR and RI techniques will be applied to muscles commonly involved in cervicogenic headache, including the upper trapezius, levator scapulae, suboccipital muscles, and sternocleidomastoid, using standardized positioning, therapist resistance, isometric contractions, and gentle stretching procedures. The effectiveness of the interventions will be assessed using validated outcome measures. Pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS), functional disability will be measured using the Neck Disability Index (NDI), and cervical range of motion will be assessed with a goniometer. Baseline measurements will be recorded before treatment begins, and the same assessments will be repeated after completion of the twelfth treatment session. These outcome measures will allow comparison of changes in pain severity, neck function, and cervical mobility between the two intervention groups. The study emphasizes that identifying the more effective muscle energy technique could improve evidence-based physiotherapy management of cervicogenic headache. The findings may help clinicians make informed treatment decisions by determining whether Post Isometric Relaxation or Reciprocal Inhibition provides greater improvements in pain reduction, cervical mobility, and functional ability. Ultimately, the study aims to enhance patient outcomes, improve quality of life, reduce disability associated with cervicogenic headache, and contribute to the growing body of evidence supporting manual therapy interventions in musculoskeletal physiotherapy. Additionally, the research follows ethical principles by obtaining informed consent from all participants, ensuring confidentiality, allowing voluntary withdrawal from the study at any stage, and maintaining equal treatment without discrimination throughout the research process.

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)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients are diagnosed according to ICH criteria.
  • •Age 18-45 years.
  • •Both Genders (Male and Female).
  • •Headache > 3 months.
  • •Unilateral neck pain and associated headache.
  • •Headache is precipitated by neck movements or sustained positions.
  • •Restricted upper cervical segmental mobility.
  • •Positive cervical flexion rotation test, restriction greater than 10°.

排除标准

  • •History of head and neck trauma.
  • •Neoplasm.
  • •Cognitive disability.
  • •Inherited disorders such as scoliosis and torticollis.
  • •Other chronic pain syndrome (i.e.: fibromyalgia, systematic inflammatory disease).
  • •History of recent surgery of cervical spine.

研究组 & 干预措施

Group A Post Isometric Relaxation

Experimental

干预措施: Post Isometric Relaxation (Procedure)

Group B Reciprocal Inhibition

Experimental

干预措施: Reciprocal Inhibition (Procedure)

结局指标

主要结局

Head Pain

时间窗: Baseline and after 4 weeks of intervention

Pain intensity will be assessed using the Numeric Pain Rating Scale(NPRS).The NPRS is an 11-point self reported scale ranging from 0 to 10,where 0 indicates no pain and 10 reprents the worst pain.

Cervical Range of Motion

时间窗: Baseline and after 4 weeks of treatment

Cervical range of motion (ROM) will be assessed as an outcome measure using a goniometer. The assessment will be performed before the intervention and after completion of the treatment protocol to determine changes in cervical mobility. The cervical movements assessed will include flexion, extension, right and left lateral flexion, and right and left rotation. The participant will be positioned appropriately, and the goniometer will be aligned according to the anatomical landmarks for each movement. The available cervical ROM will be measured in degrees and recorded on the data collection form. Goniometry has demonstrated good reliability for assessing cervical ROM, with reported intraclass correlation coefficients (ICC) ranging from 0.79 to 0.98.

Neck Disability

时间窗: Baseline and after 4 weeks of treatment

Neck disability will be assessed as an outcome measure using the Neck Disability Index (NDI). The NDI is a valid and reliable self-report questionnaire designed to evaluate the level of disability associated with neck pain and its effects on daily activities. It consists of 10 items covering pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 to 5, with higher scores indicating greater disability. The total score ranges from 0 to 50 and is used to determine the severity of functional disability. A score of 0-4 indicates no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, and 35 or more complete disability.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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