Chiropractic and Exercise Management of Spinal Dysfunction in Seniors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patient-rated neck and back disability
研究概览
简要总结
This study will compare the effectiveness of chiropractic and exercise treatment in the short- and long-term, when managing chronic neck and back disability in seniors over the age of 65 years.
详细描述
Interventions that temper declining functional status due to aging are critical to the vitality and longevity of the elderly. Conservative, non-drug treatments that address disability and pain may significantly reduce the societal burden associated with spinal dysfunction in this population. Chiropractic and exercise are two such promising therapies, and have yet to be compared in the context of short- versus long-term management.
Unanticipated recruitment challenges and repeated reductions to the award negatively impacted our ability to implement the study as proposed. After careful deliberation among the study's Steering Committee, and approval by the IRB and funding agency, the study has been modified to a 2-treatment comparison (formerly 3 treatments).
As such, the primary aim of this study is to compare the effectiveness of 3 versus 9 months of chiropractic care and exercise in 200 seniors with chronic spinal dysfunction. The primary outcomes are patient-rated neck and back disability.
Additionally, initial inclusion criteria regarding disability ratings have been relaxed to allow more individuals with global spine-related disability to qualify. Specifically, participants now must have:
- a minimum of 10% disability in both neck and back regions (at least 5/50 on Neck Disability Index (NDI) and Oswestry Disability Index(ODI)) at baseline 1 evaluation, and
- a combined disability (NDI+ODI) score of at least 25/100 at baseline 1 evaluation.
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)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years of age and older
- •independent ambulation and community dwelling
- •stable medication plan
- •neck-related disability (minimal score of 10% on Neck Disability Index)
- •back-related disability (minimal score of 10% on Oswestry Disability Index)
- •minimum combined disability score (above) of 25% at first baseline screening
- •at least 12 week duration of neck and back related disability
排除标准
- •moderate or severe cognitive impairment
- •untreated clinical depression
- •surgical spinal fusion or multiple incidents of spinal surgery
- •contraindications to spinal manipulation or exercise
- •ongoing, non-pharmacological treatment for a spinal condition
研究组 & 干预措施
9 months of chiropractic care and exercise
chiropractic, exercise
干预措施: chiropractic (Other)
9 months of chiropractic care and exercise
chiropractic, exercise
干预措施: exercise (Behavioral)
3 months of chiropractic care and exercise
chiropractic, exercise
干预措施: chiropractic (Other)
3 months of chiropractic care and exercise
chiropractic, exercise
干预措施: exercise (Behavioral)
结局指标
主要结局
Patient-rated neck and back disability
时间窗: 9 months
次要结局
- Pain(9 and 18 months)
- Satisfaction(9 and 18 months)
- Improvement(9 and 18 months)
- General health(9 and 18 months)
- Medication use(9 and 18 months)
研究者
Michele Maiers
Faculty
Northwestern Health Sciences University