Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Education and Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 18
- 主要终点
- Perceived Disability as measured by the Neck Disability Index
研究概览
简要总结
The annual incidence of neck pain has been reported to be 14.6%. Other studies outline a wide disparity in the lifetime incidence of neck pain ranging from 22% to 70%. Numerous treatment options exist for the management of neck pain however, there is limited evidence to support which interventions are most effective. Exercise based interventions are commonly used in the treatment of patients with neck pain however; it is not clear which patients are most likely to benefit from this type of treatment. The purpose of this project is to develop a clinical prediction rule (CPR) to identify which patients with neck pain have a greater probability of benefiting from a standardized program of education and exercise. Ninety (90) patients referred to physical therapy will undergo a standardized examination to assess potential predictor variables. Upon completion of the examination a standardized treatment program of education and exercise will be administered regardless of examination findings. Self report measures will be administered on the initial examination and on follow up visits at 2, 4, and 6 weeks. A questionnaire and outcome measures will be also mailed out 6 months after initiation of treatment to assess long-term change. Once the treatment plan is completed, patients will be classified as having either a successful or non-successful response. Subjects which rated their perceived recovery on the Global Rating of Chance (GROC) as "a very great deal better", "a great deal better", "quite a bit better", or "moderately better" (i.e., a score of +4 or greater) will be categorized as having a successful outcome. The primary endpoints to determine the outcome will be analyzed at 6 weeks and 6 months. The result of this study will assist physical therapists to identify sub-groups of patients likely to benefit from a program of education and exercise. The categorization of patients in groups based on beneficial treatments may help to provide improved outcomes.
详细描述
The sample size will consist of 90 subjects ages 18 or above with a primary complaint of neck pain. The subjects must be able to read and communicate in English in order to complete the required documentation. No specific conditions are to be included which would make this a protected population.
Patients will be recruited in one of two ways. First, flyers will be sent to local referrals announcing the study and request for subjects. Should a patient be interested in participating they will call the PI at the phone number listed on the flyer. The PI will inquire about patient location and coordinate a convenient location. Second, patients which present to a participating clinic with primary complaint of neck pain will be handed a flyer and asked by the front office if they would be interested to hear more about the study. If the patient expresses interest in participating they will meet with a clinician trained in the study to review inclusion and exclusion criterion. Should the patient meet all inclusion and have no exclusion criterion, the informed consent form will be reviewed with the patient by a trained clinician. Once the patient has agreed to participate and signed the informed consent they will be formally enrolled into the study.
All information obtained in this study is strictly confidential unless disclosure is required by law. Federal Privacy Regulations provide safeguards for privacy, security, and authorized access. Except when required by law, the patient will not be identified by name, social security number, address, telephone number, or any other direct personal identifier.
All records pertaining to the patient's involvement in this research study will be stored in a locked file cabinet. A case number will indicate the patient's identity on these records. This information will only be accessible to the investigators listed on the first page of this document and the research study staff.
Methods and Procedures This study will follow a standardized examination and treatment protocol. All interventions and techniques have been proven to be effective in this patient population. Once the patient is deemed eligible for the study the informed consent will be reviewed by an investigator. If the patient agrees to participate in the study they will sign the informed consent. The patient will complete self report measures which will take approximately 20 minutes. Self report measures to be completed include the neck disability index (NDI), fear avoidance beliefs questionnaire (FABQ), global rating of change (GROC), and numeric pain rating scale (NPRS). An investigator will then perform a standardized examination which will take approximately 1 hour. Examination findings will be recorded on the cervical examination form. The patient will then be given an opportunity to undergo a second examination by a blinded examiner for reliability purposes. This second examination is optional and must be performed within 48 hours and before treatment is initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Over the age of 18
- •Primary complaint of neck pain with or without unilateral UE symptoms
- •Neck Disability Index (NDI) of 10% or greater.
排除标准
- •Presence of medical "red flags' noted in the Neck Medical Screening Questionnaire. (i.e. tumor, fracture, etc.)
- •Evidence of central nervous system (CNS) involvement (i.e. 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, the presence of pathological reflexes such as Hoffman's or Babinski reflexes, etc.)
- •Spasmodic torticollis
- •Frequent migraine
- •Fibromyalgia
- •Prior Surgery to the neck or thoracic spine
- •Severe psychiatric illness
- •Inability to comply with treatment and follow-up schedule
- •Pending legal action regarding their neck pain
- •Insufficient English language skills to complete all questionnaires.
- •Latex allergies
结局指标
主要结局
Perceived Disability as measured by the Neck Disability Index
时间窗: 6 weeks
Perceived pain intensity as measure by the Numeric pain rating scale
时间窗: Baseline, 2 weeks, 4 weeks, 6 weeks, 6 months
Perceived fear avoidance beliefs as measure by the Fear Avoidance Belief Questionnaire
时间窗: 6 weeks
Perceived rating of change as measure by the Global Rating of Change
时间窗: 6 weeks
次要结局
- Perceived fear avoidance beliefs as measure by the Fear Avoidance Belief Questionnaire(baseline, 2 weeks, 4 weeks, 6 months)
- Perceived rating of change as measure by the Global Rating of Change(2 weeks, 4 weeks, 6 months)
- Disability as measured by the Neck Disability Index(baseline, 2 weeks, 4 weeks, 6 months)
- Perceived pain intensity as measure by the Numeric pain rating scale(baseline, 2 weeks, 4 weeks, 6 months)
研究者
William J. Hanney
Assistant Professor
University of Central Florida