Effects of Chiropractic Care on Pro- and Anti-inflammatory Cytokine Levels in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Serum inflammatory cytokine levels
研究概览
简要总结
Multiple sclerosis (MS) is an inflammatory autoimmune disease associated with an imbalance between pro- and anti-inflammatory markers (cytokines) resulting in a demyelinating and neurodegenerative disease. There is early evidence that spinal manipulation (chiropractic care) is better than control in influencing immune (cytokine) activity in asymptomatic participants, but few studies have been completed in participants with chronic inflammatory conditions, such as MS. The purpose of this project is to examine the immediate (after a single thoracic spinal manipulation treatment) and summative impact (after 8 thoracic spinal manipulation treatments occurring over 4 weeks) on pro-inflammatory (interleukin (IL) IL-1ß, IL-2, IL-6, Tumor necrosis factor-alpha) and anti-inflammatory (IL-4, IL-10) plasma cytokines 20 minutes and 2 hours after thoracic spinal manipulation in participants diagnosed with neuroinflammatory relapsing-remitting MS (RR-MS). Spinal manipulation treatment will be limited to the thoracic spine. Secondary outcomes will include determining the impact of 8 thoracic spinal manipulations on fatigue, cognitive processing speed, pain, depression, sleep, and motor function through questionnaires and performance of various in assessments such as the timed 25 foot walk test.
详细描述
Study Design. The investigators plan to conduct a pilot parallel-group randomized controlled trial with appropriate SM and Sham SM treatment groups. Randomization will occur with the sequence being completed prior to enrolling the first participant and with concealed allocation by a member of the team not involved with the outcomes or treatments. The investigators designed the Sham SM treatments to ensure all participants have similar amounts of physical contact and clinician interaction (i.e. contextual environment for placebo-related improvement). The primary and secondary outcomes of the study will be assessed and processed by blinded assessors who are not part of the intervention delivery to reduce any potential bias in collected outcomes.
SM Delivery. Diversified (i.e. crossed bilateral hypothenar contact) chiropractic technique will be administered at levels of identified spinal joint restriction/dysfunction (derived from thoracic spine x-rays, static and motion palpation, and confirmed or provoked localized tenderness in paraspinal soft tissues). Participants in the SM and Sham SM group will be scheduled for 8 office visits (2x/wk) over a period of 4 weeks.
The Sham-SM will be delivered by setting the expansion control knob on an Activator II (Activator Methods®, Phoenix AZ) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician (no actual instrument contact with study participant). At a setting of zero, no excursion of the Activator II stylus occurs, despite the device delivering an audible clicking sound, with no biomechanical force being imparted to the participant.
Primary Outcome Variable. To examine the immediate (1x) and summative impact of SM (8x/4wk) on pro-inflammatory and anti-inflammatory plasma cytokine levels at 20 minutes and 2 hours post-SM (after the first and 8th treatment) and compared to baseline measures.
Secondary Outcome Variables. To examine the summative and secondary impact of 8 chiropractic treatments over 4 weeks on RR-MS-related fatigue (Fatigue Severity Scale, Modified Fatigue Impact Scale), cognitive processing speed (Symbol Digit Modalities Test), pain (short-form McGill Pain Questionnaire), depression (Hospital Anxiety Depression Scale), subjective sleep (Insomnia Severity Index) and upper/lower body motor function (Nine-Hole Peg Test, Timed 25 foot Walk Test). These secondary outcomes will be measured before onset of treatment (baseline) and upon completion of 8 spinal manipulation treatments over the period of 4 weeks) (2 visits per week).
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 (Participant, Outcomes Assessor)
盲法说明
The chiropractic clinician will not be blinded in order to deliver the assigned treatment (spinal manipulation or Sham spinal manipulation) but all other assessors and study personnel will be blinded to the group assignment.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 55 years
- •Physician-confirmed diagnosis of MS within the last 5 years
- •Expanded Disability Status Scale (EDSS) score below 4 based on Neurostatus-certified examination
- •Relapse free in the last 30 days
- •No known cardiovascular, pulmonary, or metabolic disease
- •Currently on stable FDA-approved disease modifying therapy (eg, interferon beta-1a or beta-1b, natalizumab etc.)
- •Naïve to chiropractic care
- •No contraindications to spinal manipulation
- •Acceptance of informed consent.
排除标准
- •Uncontrolled hypertension (systolic pressure >160 mmHg, diastolic blood pressure >95 mmHg) Any past spinal surgery or recent history of bone fractures
- •Pregnancy in the last 12 months
- •Unable to understand English or follow simple instruction.
研究组 & 干预措施
Spinal Manipulation
The spinal manipulation (SM) group will receive manually delivered SM limited to the thoracic spine.
干预措施: Spinal Manipulation (Other)
Sham Spinal Manipulation
Sham-spinal manipulation will be delivered by setting the expansion control knob on an Activator II (Activator Methods®) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician. At a setting of zero, no excursion of the Activator II stylus occurs, despite the device delivering an audible clicking sound, with no biomechanical force being imparted.
干预措施: Sham Spinal Manipulation (Other)
结局指标
主要结局
Serum inflammatory cytokine levels
时间窗: Week 4 (after 8th treatment)
Determine changes in serum inflammatory cytokine levels from baseline
IL-6 Serum Inflammatory Cytokine Levels
时间窗: From baseline to after 8th treatment at 4 weeks
Determined mean changes in serum inflammatory cytokine levels from baseline for each group
IL-4 Serum Inflammatory Cytokine Levels
时间窗: From baseline to after 8th treatment at 4 weeks
Determine changes in serum inflammatory cytokine levels from baseline
IL-10 Serum Inflammatory Cytokine Levels
时间窗: From baseline to after 8th treatment at 4 weeks
Determine changes in serum inflammatory cytokine levels from baseline
IL-2 Serum Inflammatory Cytokine Levels
时间窗: From baseline to after 8th treatment at 4 weeks
Determine changes in serum inflammatory cytokine levels from baseline
TNFalpha Serum Inflammatory Cytokine
时间窗: baseline to after 8th treatment at 4 weeks
Determine changes in serum inflammatory cytokine levels from baseline
IL-B Serum Cytokine Levels
时间窗: baseline and 8th treatment after 4 weeks
Mean change in serum from baseline and after 8 treatments
次要结局
- Fatigue Severity Scale(Week 4 (after 8th treatment))
- Nine-Hole Peg Test(Week 4 (after 8th treatment))
- Cognitive Processing Speed(Week 4 (after 8th treatment))
- Timed 25 foot Walk Test(Week 4 (after 8th treatment))
- Modified Fatigue Impact Scale(Week 4 (after 8th treatment))
- Short-form McGill Pain Questionnaire(Week 4 (after 8th treatment))
- Hospital Anxiety Depression Scale(Week 4 (after 8th treatment))
- Insomnia Severity Index(Week 4 (after 8th treatment))
- Fatigue Severity Scale (FSS)(From Baseline to after 8th treatment at 4 weeks)
- Modified Fatigue Impact Scale(From baseline to after 8th treatment at 4 weeks)
- Cognitive Processing Speed(From Baseline to after 8th treatment at 4 weeks)
- Total Change in Pain Short-form McGill Pain Questionnaire(From Baseline to after 8th treatment at 4 weeks)
- Total Change in Hospital Anxiety Depression Scale(From Baseline to after 8th treatment at 4 weeks)
- Insomnia Severity Index(From Baseline to after 8th treatment at 4 weeks)
- Nine-Hole Peg Test(From Baseline to after 8th treatment at 4 weeks)
- Timed 25 Foot Walk Test(From Baseline to after 8th treatment at 4 weeks)
研究者
William R Reed DC, PhD
Associate Professor
University of Alabama at Birmingham