Cervical Distraction Minimal Intervention Development: Translating From Basic to Clinical Studies
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Neck Pain
- 发起方
- Palmer College of Chiropractic
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Range of Traction Forces
- 状态
- 已完成
- 最后更新
- 8年前
概览
简要总结
The purpose of the Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial is to examine the patient-centered clinical and biomechanical outcomes, doctor treatment delivery, and believability characteristics of a commonly used chiropractic procedure for the treatment of neck- or neck-related arm pain or disability.
详细描述
The purpose of the Manual Cervical Distraction (MCD): Measuring Chiropractic Delivery for Neck Pain Clinical Trial is to examine the patient-centered clinical and biomechanical outcomes, and believability characteristics of a manually-localized cervical distraction procedure for the treatment of neck- or neck-related arm pain or disability. One challenging issue in the study of manual therapies, including spinal manipulation (SM), is the development of sham and/or minimal intervention procedures suitable for use with control groups in clinical trials. With SM, active treatment requires substantial physical contact between a study clinician and the study participant, either directly or through a mechanical intermediary. Consequently, it is difficult to introduce differences in manual therapy procedures that distinguish sham and/or minimal interventions from the active treatment, but are not immediately obvious to the study participant. Another challenging issue is training clinicians to deliver a standardized SM treatment within specified force ranges. The muscles surrounding the neck could alter the forces transmitted to the cervical spine, and could alter the treatment effectiveness. The purpose of this pilot randomized controlled trial is to examine the patient-centered clinical, biomechanical, and believability outcome characteristics of a manually-localized cervical distraction procedure for the treatment of neck or neck-related arm pain or disability. We also will evaluate the ability of the doctor of chiropractic to deliver the MCD treatment within specified force ranges. An exploratory aim of this study is to evaluate EMG measurement during MCD delivery.
研究者
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Range of Traction Forces
时间窗: Day 1, 4, 8, 11, 14 (Each Study Visit)
We will evaluate the clinician's ability to deliver three randomly assigned manual interventions to the cervical spine within specified traction force ranges (\<20 Newtons \[N\], 20-50N, \>50N). The primary outcome of this study is to determine the accuracy and consistency of traction force delivery ranges both between clinicians and within individual clinicians. Traction force ranges (C5 contact level and Occiput contact level) will be measured at each study visit (visits 1, 2, 3, 4, 5) for 2 weeks and averaged to calculate final outcome.
次要结局
- Neck Disability Index (NDI)(Change from Baseline to Day 1 (Study Visit 1) and Day 14 (Study Visit 5))
- Neck Pain Visual Analogue Scale (VAS)(Change from Baseline, Day 1, 4, 8, 11, 14 (Pre- and Post-Study Visits 1, 2, 3, 4, 5))
- Patient Reported Outcomes Measurement Information System (PROMIS-43)(Change from Baseline to Day 14 (Study Visit 5))
- Cervical Range of Motion (cROM).(Change from Day 1 (Study Visit 1) to Day 14 (Study Visit 5))
- Procedure Believability Questionnaire(Baseline (BL), Day 1 (Study Visit 1/T1), Day 14 (Study Visit 5/T5))
- Credibility and Expectancy Questionnaire (CEQ)(Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5))