Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache: a Multi-center Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Change in Headache Intensity (NPRS) (Rating Score)
研究概览
简要总结
The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation and dry needling. Physical therapists commonly use all of these techniques to treat cervicogenic headaches. This study is attempting to find out if one treatment strategy is more effective than the other.
详细描述
Patients with cervicogenic headaches will be randomized to receive 1-2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) Dry Needling and HVLA thrust manipulation group, or the (2) Exercise and non-thrust mobilization group
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
- 否
入选标准
- •Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
- •Headache frequency of at least one per week for a minimum of 3 months
- •Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50
排除标准
- •Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
- •Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc.
- •History of whiplash injury within the last 6 weeks
- •Diagnosis of cervical stenosis
- •Bilateral upper extremity symptoms
- •Evidence of CNS involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes).
- •Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following:
- •Muscle weakness involving a major muscle group of the upper extremity.
- •Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
- •Diminished or absent sensation to pinprick in any UE dermatome.
- •Prior surgery to neck of thoracic spine
- •Involvement in litigation or worker's compensation regarding their neck pain and/or headaches
- •PT or chiropractic care treatment for neck pain or headaches in the 3 months prior to baseline exam.
- •Any condition that might contraindicate spinal manipulative therapy.
研究组 & 干预措施
Dry Needling,Thrust Manipulation
干预措施: Dry Needling,Thrust Manipulation (Other)
Exercise,Non-thrust Mobilization
干预措施: Exercise,Non-thrust Mobilization (Other)
结局指标
主要结局
Change in Headache Intensity (NPRS) (Rating Score)
时间窗: Baseline, 1 week, 4 weeks, 3 months
Rating Score. Baseline score must exceed 2/10 to be included in the study.
Change in Headache Frequency (Number of headaches in the last week)
时间窗: Baseline, 1 week, 4 weeks, 3 months
Number of headaches in the last week
Change in Disability (NDI 0-50 points)
时间窗: Baseline, 1 week, 4 weeks, 3 months
10 Questions each worth 0-5 points with maximum score of 50 points possible. Baseline score must exceed 10/50 to be included in study.
次要结局
- Change in Global Rating of Change Score(1 week, 4 weeks, 3 months)
- Change in Headache Duration (Total hours of headaches in the last week)(Baseline, 1 week, 4 weeks, 3 months)
- Change in Medication Intake (Frequency of medication intake in last week)(Baseline, 3 months)
研究者
James Dunning, DPT, MSc, FAAOMPT
DPT MSc FAAOMPT
Alabama Physical Therapy & Acupuncture