A Pragmatically Applied Cervical and Thoracic Non-thrust Mobilizations Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change from baseline on the Neck Disability Index (NDI)
研究概览
简要总结
The purpose of this clinical trial is to compare the use of thrust manipulation to non-thrust mobilizations for mechanical neck pain when they are applied to both the cervical and thoracic spine. Both of these techniques have been compared in previous trials but a pragmatic approach will be employed as well as controlling for clinical equipoise.
详细描述
A total sample size of 136 subjects with mechanical neck pain will be recruited to participant in this trial from multiple clinic and university sites around the country. Each subject will be evaluated by a licensed physical therapist that specializes in orthopedic manual therapy (OMT). Each treating therapist will be blinded be the data collection and each data collection therapist will be blinded to the treatment allocation. Subjects data will be collected at the initial visit, second visit, and at discharge. The maximum number of weeks that a subject may be enrolled is 8 weeks (2 months). At that point, they are discharged from the study. The treating therapist will allocate the subject through the already completed randomization procedures. Once the subject is randomized, the treating therapist will perform the OMT based on their clinical reasoning and in a manner they feel would benefit the patient the most. In addition to the OMT, each subject will receive a home exercise program, advice, encouragement, and education. A number of outcome variables will be collected regarded pain and disability as well as one physical performance measure.
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 (Investigator, Outcomes Assessor)
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
- •Chief complaint of neck pain. (Non-specific neck pain with a primary location between the superior nuchal line and the first thoracic spinous process)
- •A minimum Neck Disability Index (NDI) score ≥ 20%
排除标准
- •Contraindications to OMT including; malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use.
- •Nerve root compression diagnosed as having at least 2 of the following:
- •Upper extremity muscle weakness within a specific cervical/thoracic myotome
- •Diminished deep tendon reflexes of the biceps brachii, brachioradialis, or triceps muscle.
- •Diminished sensation to light touch or pinprick in a specific upper extremity dermatome.
- •History of neck or thoracic spine surgery
- •Neck pain of <2 on the NPRS
- •Currently receiving other forms of conservative care and unwilling to stop for the duration of their participation in the study.
- •Any pending litigation related to their neck pain
- •Therapist is unable to elicit the chief complaint with passive accessory intervertebral movements (PAIVM).
研究组 & 干预措施
Thrust Manipulation
Subjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines.
干预措施: Home Exercise Program (Other)
Thrust Manipulation
Subjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines.
干预措施: Patient advice, encouragement, and education (Other)
Thrust Manipulation
Subjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines.
干预措施: Thrust Manipulation (Other)
Non-thrust Mobilizations
Subjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines
干预措施: Home Exercise Program (Other)
Non-thrust Mobilizations
Subjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines
干预措施: Patient advice, encouragement, and education (Other)
Non-thrust Mobilizations
Subjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines
干预措施: Non-thrust Mobilizations (Other)
结局指标
主要结局
Change from baseline on the Neck Disability Index (NDI)
时间窗: 3 days and 8 weeks
The NDI is a self-report measure of perceived disability and it is comprised of ten questions using an ordinal scale from 0 to 5 for a maximum of 50 points. The score is doubled to achieve a % score. The higher an individual scores on the NDI, the greater their perceived level of disability.
次要结局
- Change from baseline on The Patient Specific Functional Scale (PSFS)(3 days and 8 weeks)
- Change from baseline on The Numerical Pain Rating Scale (NPRS)(3 days and 8 weeks)
- Change from baseline on The Global Rating Of Change Scale (GROC)(3 days and 8 weeks)
- Change from baseline on the Deep Cervical Flexion Endurance (DCF)(3 days and 8 weeks)
研究者
David W. Griswold
Assistant Professor of Physical Therapy
Youngstown State University