Comparing the Use of Cervical-Cranial Dry Needling With Orthopedic Manual Therapy to the Cervical Spine for Cervicogenic Headache: A Multi-center RCT With 1-Year Follow Up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in NPRS headache intensity
研究概览
简要总结
Dry needling is a therapeutic modality used to treat a number of neuromusculoskeletal conditions. Practice trends suggest it is becoming widely used by Physical Therapists to help patients manage symptoms associated with CGH, however, there is limited scientific evidence demonstrating meaningful impact for dry needling for CGH. Manual therapy (thrust and non-thrust mobilizations) to the cervical spine are well researched and have an established treatment effect for managing symptoms related to CGH. The purpose of this study is to compare outcomes (1 week, 1 month, 3 months, 12 months) for patients with CGH treated with cervical-cranial dry needling or pragmatically applied orthopedic manual therapy to the cervical spine. In addition to either the cervical-cranial dry needling or manual therapy to the cervical spine, patients will also receive patient education, thoracic manipulation, and exercise.
详细描述
The use of dry needling is becoming widely used by Physical Therapists in the United States for a number of neuromusculoskeletal conditions including cervicogenic headache (CGH). Dry needling is performed by taking a mono-filament needle and inserting it into symptomatic soft tissue. In this trial, the dry needling will be performed segmentally in the neck and along the patient's headache distribution pattern. Orthopedic manual therapy (OMT) may include both thrust and non-thrust techniques applied to a targeted spinal level and has a well-established treatment effect for patients with CGH. In this trial, the OMT will be applied pragmatically to the cervical spine at the most symptomatic level of the headache. Other interventions used in this trial will include patient education, thoracic manipulation and exercise.
Patients will be randomized to receive either dry needling or OMT 2x/week for 2 weeks and then 1-2x/week for 2 weeks totaling 6-8 visits over the course of 1 month. The 1 week and 1 month outcomes collected will be reported on separately from the 3 and 12 months.
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 (Care Provider, Outcomes Assessor)
盲法说明
The outcome assessor will be blinded the treatment group. The clinician providing treatment will be blinded to outcomes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Meets the IHS criteria for CGH
- •Headache frequency of at least 1 per week over a period greater than 3 months.
- •Demonstrates segmental dysfunction with passive mobility testing.
排除标准
- •Patients whose headache experience is primarily of migraine origin. Tension-type headache, headache pain <2, contraindications to the interventions (malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use), headache presentation suggesting cervical arterial insufficiency, severe metal allergy, needle phobia, history of neck or thoracic spine surgery, Non-English speaking patients, therapist is unable to elicit the headache with passive accessory intervertebral movements (PAIVM), or pending litigation for neck pain and/or headache.
结局指标
主要结局
Change in NPRS headache intensity
时间窗: Baseline, 1 week, 1 month, 3 months, 12 months.
Average and most intense in the last week will be recorded using a 0 (no headache) to 10 (most intense)
次要结局
- Change in current NPRS neck or headache intensity(Baseline and Immediately post intervention)
- Change in Medication intake(Baseline, 1 week, 1 month, 3 months, 12 months)
- Leeds Assessment of Neuropathic Signs and Symptoms (LANSS)(Baseline)
- Change in disability using Neck Disability Index(Baseline 1 week, 1 month, 3 months, 12 months)
- Change in disability using Headache Disability Index (HDI)(Baseline, 1 week, 1 month, 3 months, 12 months)
- Patient Satisfaction(1 month)
- SANE Percent Recovery(1 month)
- Health care utilization(3 and 12 months)