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临床试验/CTRI/2024/11/076143
CTRI/2024/11/076143尚未招募1 期

Comparing the efficacy of Eye Cervical Re-Education Program (ECRP) with Conventional Therapy in Cervicogenic Headache patients: A Comparative study

Radhika Sinha1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年11月10日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
Cervical Joint Position Error - Active movement angle reproduction test in which the difference between the reference point position and the position produced by the subject is called Joint Position Error.

研究概览

简要总结

IntroductionCervicogenic headache (CGH) is a condition characterized by unilateral pain originating from the neck, often triggered by head and neck movements. The condition is frequently misdiagnosed as migraines or tension-type headaches due to overlapping symptoms. Reduced neck flexibility and proprioceptive deficits are common in CGH, which can further affect cervical sensorimotor control. Proprioception impairment may lead to dysfunctional motor patterns, increasing the risk of injury and chronic pain. The Eye-Cervical Re-education Program (ECRP), a proprioceptive training program, has been used in managing neck pain, but its effectiveness in treating CGH is not well established. This study aims to evaluate the efficacy of ECRP compared to conventional physiotherapy for reducing pain, improving range of motion (ROM), and enhancing quality of life in CGH patients.

Need of the StudyCervicogenic headache is a prevalent condition in physiotherapy clinics, with most treatments focusing on flexibility and strengthening. However, research indicates that proprioception deficits are significant contributors to CGH. Despite this, proprioceptive training, particularly through programs like ECRP, has been poorly evaluated for its effectiveness in treating CGH. Given its potential in addressing maladaptive changes in cervical structures, this study seeks to determine whether ECRP can provide superior outcomes compared to conventional physiotherapy interventions in CGH patients.

MethodologyStudy Design: This is an experimental study with a pre-post control design. Study Population: Cervicogenic headache patients aged 20-50 years. Sample Size: 42 participants, divided into two groups of 21 each, calculated using G power software. Groups:

Group A: ECRP group (Hot pack, Interferential Therapy (IFT), ECRP training).

Group B: Conventional group (Hot pack, IFT, conventional exercises).

Randomization: Chit method.

Study Setting: Outpatient Department (OPD) of Amar Jyoti Institute of Physiotherapy.

Inclusion Criteria1. Diagnosed CGH patients based on International Classification of Headache Disorders (ICHD-3) criteria.2. Age range 20-50 years, both genders.3. English-speaking patients.Exclusion Criteria1. Patients with primary headaches (e.g., migraines).2. Presence of red flags (e.g., tumors, fractures, RA, or high blood pressure).3. History of recent surgery, congenital disorders, or psychological conditions.Outcome MeasuresPhysical Function:

  1. Verbal Rating Scale (VRS): Measures pain intensity from 0-4 based on descriptive adjectives.

2. Cervical Spine ROM: Measured using a digital inclinometer for cervical flexion, extension, and rotation.

3. Cervical Joint Position Error (JPE): Measures proprioceptive accuracy during head movement using an inclinometer.

Quality of Life:

Headache Disability Inventory (HDI): A 25-item scale assessing the functional and emotional impacts of headaches on daily life.

ProcedureAfter ethical approval from the Amar Jyoti Institute Review Board, patients will be screened and randomized into two groups. Both groups will receive standard treatment, including a hot pack and IFT, but Group A will undergo ECRP, while Group B will follow conventional exercises. Pre- and post-assessments of pain, ROM, cervical proprioception, and quality of life will be conducted. Data will be collected and analyzed using SPSS 27.0.

InterventionsGroup A (ECRP Group):

1. Hot pack and IFT (15 minutes each).

  1. ECRP includes 10 proprioceptive exercises targeting cervical-eye coordination, such as head repositioning and gaze stability exercises.

Group B (Conventional Training Group):

1. Hot pack and IFT (15 minutes each).

  1. Conventional exercises focus on craniocervical flexion, flexion-extension, and neck strengthening exercises, targeting overall neck flexibility and strength.

Data AnalysisData will be entered into Microsoft Excel and analyzed using SPSS software (version 27.0). Descriptive statistics will be used to assess demographics, and comparative analyses will evaluate the effectiveness of both interventions in reducing pain and improving function and quality of life.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • A. Diagnosed Cervicogenic headache patients as per Internation Headache Society under International Criteria for Headache Disorders.
  • B. Patients who can understand and read spoken English.

排除标准

  • Patients with other primary headaches (Migraine, Tension-type Headache).
  • Patients exhibiting any red flags (i.e., tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc.).
  • A diagnosis of cervical spinal stenosis.
  • Patients having a known history of musculoskeletal soft tissue injury or surgery in the last 6 months.
  • History of congenital musculoskeletal/neurological disorders such as epiphyseal plate disturbance, and multiple sclerosis.
  • History of any psychological disorders such as seizures, or schizophrenia.

结局指标

主要结局

Cervical Joint Position Error - Active movement angle reproduction test in which the difference between the reference point position and the position produced by the subject is called Joint Position Error.

时间窗: Baseline values will be taken before the start of the treatment, and post-treatment values will be taken after the completion of the treatment, that is, after a period of four weeks, after the patient has taken 12 sessions of the treatment.

2. Cervical Range of Motion

时间窗: Baseline values will be taken before the start of the treatment, and post-treatment values will be taken after the completion of the treatment, that is, after a period of four weeks, after the patient has taken 12 sessions of the treatment.

3. Verbal rating Scale

时间窗: Baseline values will be taken before the start of the treatment, and post-treatment values will be taken after the completion of the treatment, that is, after a period of four weeks, after the patient has taken 12 sessions of the treatment.

4. Headache Disability Index

时间窗: Baseline values will be taken before the start of the treatment, and post-treatment values will be taken after the completion of the treatment, that is, after a period of four weeks, after the patient has taken 12 sessions of the treatment.

次要结局

  • Cervical Range of Motion - Flexion, extension, left and right rotations, left and right lateral flexion(Baseline values will be taken before the start of the treatment, and post-treatment values will be taken after the completion of the treatment, that is, after a period of four weeks, after the patient has taken 12 sessions of the treatment.)

研究者

发起方
Radhika Sinha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Radhika Sinha

Amar Jyoti Institute of Physiotherapy

研究点 (1)

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