NCT04609709招募中不适用
Thrust Manipulation, Electric Dry Needling and Exercise Vs. Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS for Tension Type Headache Sufferers
Alabama Physical Therapy & Acupuncture2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年10月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in Headache Intensity (NPRS)
研究概览
简要总结
The purpose of this research is to compare two different approaches for treating patients with tension-type headaches: thrust Manipulation, electric dry Needling and exercise Vs. non-thrust mobilization, soft-tissue mobilization, exercise and TENS. Physical therapists commonly use all of these techniques to treat tension-type headaches. This study is attempting to find out if one treatment strategy is more effective than the other.
详细描述
Patient will tension-type headaches will be randomized to receive 2 sessions per week for 6 weeks (up to 8-12 sessions total) of either: 1. thrust Manipulation, electric dry Needling and exercise or 2. non-thrust mobilization, soft-tissue mobilization, exercise and TENS
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
- •Patient must be between 18 and 65 years old and report ALL YES under one of the Tension-type Headaches described below:
- •2.2 Frequent Episodic Tension-type Headaches: Frequent episodes of headache, typically bilateral, pressing or tightening in quality and of mild to moderate intensity, lasting minutes to days. The pain does not worsen with routine physical activity and is not associated with nausea, but photophobia or phonophobia may be present.
- •At least 10 episodes of headache occurring on 1- 14 days per month on average for >3 months (12 and <180 days per year)
- •Headache lasting from 30 minutes to 7 days
- •Patient has headaches that have at least two of the following four characteristics:
- •Bilateral location
- •Pressing or tightening (non-pulsating) quality
- •Mild or moderate intensity
- •Not aggravated by routine physical activity such as walking or climbing stairs
- •Both of the following are true:
- •No nausea or vomiting
- •No more than one of photophobia or phonophobia
- •2.2.1 Frequent Episodic Tension-type Headache associated with pericranial tenderness
- •Episodes fulfilling criteria for Frequent episodic tension-type headache (See 2.2 above)
- •Increased pericranial tenderness on manual palpation.
- •2.3 Chronic Tension-type Headaches: A disorder evolving from frequent episodic tension-type headache, with daily or very frequent episodes of headache, typically bilateral, pressing or tightening in quality and of mild to moderate intensity, lasting hours to days, or unremitting. The pain does not worsen with routine physical activity, but may be associated with mild nausea, photophobia or phonophobia.
- •Headache occurring on 15 days per month on average for >3 months (180 days per year)
- •Headache lasting hours to days, or unremitting
- •At least two of the following four characteristics
- •Bilateral location
- •Pressing or tightening (non-pulsating) quality
- •Mild or moderate intensity
- •Not aggravated by routine physical activity such as walking of climbing stairs
- •Both of the following:
- •No more than one of the photophobia, phonophonbia, or mild nausea
- •Neither moderate or severe nausea nor vomiting
- •2.3.1 Chronic Tension-type Headache associated with pericranial tenderness
- •Headache fulfilling criteria for 2.3 Chronic tension- type headache
- •Increased pericranial tenderness on manual palpation.
排除标准
- •Exclusion Criteria: Must all be NO to be eligible
- •Patient presents with other primary and/or secondary headache
- •Patient presents with Medication Overuse Headache defined as:
- •Headache occurring on 15 days per month in a patient with a pre-existing headache disorder
- •Regular overuse for >3 months of one of more drug that can be taken for acute and/or symptomatic treatment of headache
- •Not better accounted for by another headache diagnosis
- •History of head/neck trauma (to include whiplash)
- •History of Cervical Stenosis
- •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.
- •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
- •Diagnosis of fibromyalgia syndrome
- •Received anesthetic blocks or botulinum toxin within the previous 6 months
- •Received physical treatment in the neck and head the previous 6 months
- •Any condition that might contraindicate spinal manipulative therapy
结局指标
主要结局
Change in Headache Intensity (NPRS)
时间窗: Baseline, 4-weeks, 8-weeks, 12-weeks
Average Numeric Pain Rating Score. Higher score means greater pain
次要结局
- Change in Headache Disability Inventory(Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks)
- Change in Headache Frequency(Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks)
- Change in Medication Intake (Frequency of medication intake during last time period)(Baseline, 3-months)
- Change in GROC (Global Rating of Change score)(8 Weeks, 12 weeks)
- Change in Headache Duration(Baseline (4-Weeks After Initial Evaluation, but BEFORE the first treatment is given), 4-weeks, 8-weeks, 12-weeks)
研究者
James Dunning, DPT, MSc, FAAOMPT
DPT, MSc, FAAOMPT
Alabama Physical Therapy & Acupuncture
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Dry Needling, Manipulation and Stretching vs. Manual Therapy, Exercise and Ultrasound for Lateral EpicondylalgiaLateral EpicondylitisNCT03167710Alabama Physical Therapy & Acupuncture143
已完成
不适用
Dry Needling and Spinal Manipulation vs. Interocclusal Appliance (Splint), NSAIDs and Joint Mobs for Temporomandibular DysfunctionTemporomandibular Joint Dysfunction SyndromeNCT03409874Alabama Physical Therapy & Acupuncture120
已完成
不适用
Dry Needling and Manipulation vs. Mobilization, Exercise and Interferential Electrotherapy for Shoulder Impingement (Subacromial Pain Syndrome)Subacromial Pain SyndromeNCT03168477Alabama Physical Therapy & Acupuncture145
招募中
不适用
Electrical DN as an Adjunct to Eccentric Exercise, Stretching + MT for Achilles TendinopathyAchilles TendinopathyNCT03968614Alabama Physical Therapy & Acupuncture110
已完成
不适用
Dry Needling and Spinal Manipulation vs. Conventional PT for Lumbar Spinal StenosisLumbar Spinal StenosisNCT03167736Alabama Physical Therapy & Acupuncture128