跳至主要内容
临床试验/NCT07617051
NCT07617051已完成不适用

The Effectiveness of Passive Physiological Intervertebral Movements in Patients With Cervicogenic Headache: A Randomized Clinical Trial

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年5月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1

研究概览

简要总结

Cervicogenic headache is a type of headache that originates from problems in the neck, particularly the upper cervical spine. It may cause headache pain, neck pain, reduced neck movement, disability, emotional distress, and reduced quality of life. Physiotherapy management commonly includes therapeutic exercise and manual therapy techniques.

This randomized clinical trial examined whether adding Passive Physiological Intervertebral Movements to a structured therapeutic exercise program was more effective than therapeutic exercise alone in patients with cervicogenic headache. Participants diagnosed with cervicogenic headache were randomly assigned to one of two groups. The intervention group received Passive Physiological Intervertebral Movements targeting the upper cervical joints, in addition to therapeutic exercises. The control group received the same therapeutic exercise program without Passive Physiological Intervertebral Movements.

Both groups received eight supervised treatment sessions over four weeks, with each session lasting approximately 15 to 20 minutes. The exercise program included cervical flexion exercises, scapular retraction, stretching exercises, and active neck mobility exercises. Participants were also encouraged to perform the exercises at home.

The study was conducted between May 2022 and August 2025 at the outpatient physiotherapy departments of Jordan University of Science and Technology and King Abdullah University Hospital. Outcomes were assessed at baseline, immediately after the four-week intervention, and at three-month follow-up. The outcomes included headache pain intensity, headache frequency, neck pain intensity, neck disability, depression, anxiety, stress, and quality of life. These were measured using validated tools, including the Numeric Pain Rating Scale, Neck Disability Index, Depression Anxiety Stress Scale-21, and Short Form-12 quality of life questionnaire.

The study aimed to determine whether adding Passive Physiological Intervertebral Movements to exercise provides additional benefits for patients with cervicogenic headache compared with exercise alone. The trial included 64 participants.

详细描述

This study was designed as a parallel-group randomized clinical trial to evaluate the added effect of Passive Physiological Intervertebral Movements when combined with therapeutic exercise for individuals with cervicogenic headache. The trial compared a combined manual therapy and exercise approach with the same exercise program delivered without Passive Physiological Intervertebral Movements.

Participants were screened using a standardized clinical diagnostic process for cervicogenic headache. The diagnostic process included clinical history, physical examination, assessment of upper cervical dysfunction, and exclusion of headache presentations more consistent with primary headache disorders or other cervical conditions not suitable for mobilization. Screening and baseline assessment procedures were performed using standardized methods to support consistency across participants.

After eligibility confirmation and baseline assessment, participants were randomly allocated to one of two treatment groups. Randomization was performed using a computer-generated random sequence. Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes prepared before recruitment. Group assignment was managed by an independent researcher who was not involved in treatment delivery or outcome assessment.

The experimental intervention consisted of Passive Physiological Intervertebral Movements applied to the upper cervical region in addition to a structured therapeutic exercise program. The manual therapy component was individualized according to the participant's clinical presentation and focused on restoring mobility of the upper cervical segments, particularly the atlanto-occipital, atlantoaxial, and C2-C3 regions. Manual therapy was delivered by a qualified physiotherapist with experience in spinal mobilization.

The comparator intervention consisted of the same structured therapeutic exercise program without Passive Physiological Intervertebral Movements. The exercise program included deep cervical flexor activation, scapular control exercises, cervical stretching, and active cervical mobility exercises. Exercise delivery was standardized through training of the treating students/therapists and use of a consistent intervention protocol. Participants were also encouraged to continue the prescribed exercises at home.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Were diagnosed with cervicogenic headache using a standardized clinical diagnostic protocol based on history and physical examination.
  • Had a positive Cervical Flexion-Rotation Test, defined as reduced cervical rotation by ≥10° on the symptomatic side compared with the asymptomatic side, or total rotation <32°.
  • Had referred pain originating from the cervical spine, confirmed by mechanical provocation such as manual palpation or pressure over the C1-C3 zygapophysial joints reproducing typical headache symptoms.
  • Had pain behavior consistent with cervicogenic headache, such as symptoms worsened by sustained neck posture or specific neck movements.
  • Had other primary headache disorders excluded based on clinical history and symptom characteristics.

排除标准

  • Diagnosed with disc herniation and stenosis of the spinal canal.
  • Clinically diagnosed as a case of cervical radiculopathy or myelopathy.
  • Subjects with conditions or diseases that are contraindicated for mobilization treatment: rheumatoid arthritis, ankylosing spondylitis, spondylolistheses, cervical fractures, osteoporosis, osteomyelitis, malignancy, and pregnancy
  • Have received manual therapy or exercise by a physical therapist in the last six months.
  • Patients diagnosed with cognitive dysfunction, psychological disorder, or communication/cognitive deficits.

研究者

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

Saddam Kanaan

Associate Professor

Jordan University of Science and Technology

研究点 (1)

Loading locations...

相似试验