Cervical Distraction Minimal Intervention Development: Translating From Basic to Clinical Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Range of Traction Forces
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years (inclusive).
- •Mechanical neck pain or neck-related upper extremity pain lasting at least 4 weeks duration.
- •Mechanical neck pain or neck-related upper extremity pain classified as Quebec Task Force (QTF) 2-
- •Naïve to flexion-distraction manual therapy procedures to cervical area.
- •Average neck pain in the past 24 hours rated between 3 and 7 on a 0-10 Pain Numerical Rating Scale (NRS) at Phone Screen and Baseline 1 Interview.
- •Signed Informed Consent Document.
排除标准
- •Doctor of chiropractic or current or former chiropractic student.
- •Average neck pain in past 24 hours rated 0-2 or 8-10 on a 0-10 Pain NRS at Phone Screen and Baseline 1 Interview.
- •Neck pain from other than somatic tissues as determined by history and clinical examination.
- •Surgery to cervical-thoracic area within the past 6 months.
- •Recent fracture in the cervico-thoracic spine or ribs within the past 8 weeks.
- •Injections for pain in neck, shoulders, arms or hands in the past 4 weeks.
- •Neck pain classified as QTF 1, 5-
- •Unwillingness to postpone use of all types of manual treatment for neck pain, except those provided in the study for the duration of the study.
- •Inability or unwillingness to comply with study protocols.
- •Bone or joint pathologies representing a contraindication to study procedures.
- •Any single or multisegmental fusion (surgical or congenital) of the 1st through the 7th cervical vertebrae.
- •Other safety concerns as determined by the clinical evaluation/opinion at case review.
- •Unable to tolerate study procedures.
- •Uncontrolled hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
- •Simultaneous clinical management for a health condition that compromises ability to deliver study treatment or assess health status.
- •Inability to read or verbally comprehend English.
- •Drug or alcohol abuse or dependence, suspected or confirmed through self-report questionnaires and clinical interview.
- •Depression rated as ≥ 29 on the Beck Depression Inventory.
- •Cognitive or memory impairment identified during eligibility exam.
- •Pregnancy, under either of the following 2 circumstances: 1) Participant safety, if participant is unable to tolerate or undergo study procedures; or 2) Fetus safety, if x-rays are required for diagnosis.
- •Weight greater than 300 lbs (table weight limit).
- •Referral for evaluation, diagnosis, or management of other health conditions, or additional diagnostics required for neck pain diagnosis.
- •Retention of legal advice or seeking a health-related insurance claim.
- •Household member previously enrolled in MCD Clinical Trial.
- •Compliance concerns identified during baseline eligibility process.
研究组 & 干预措施
Manual Cervical Distraction High Force
Manual Cervical Distraction forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
干预措施: Manual Cervical Distraction (Procedure)
Manual Cervical Distraction Medium Force
Manual Cervical Distraction forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
干预措施: Manual Cervical Distraction (Procedure)
Manual Cervical Distraction Low Force
Manual Cervical Distraction forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
干预措施: Manual Cervical Distraction (Procedure)
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))