Group Medical Visits and Chiropractic Care for Older Adults With Chronic Spine Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
Chronic spine pain is one of the most common and conditions in adults over the age of 65. Treatments for pain that are non-pharmacologic (do not use over-the-counter or prescription drugs) are recognized as some of the most important to study. Chiropractic care has shown to be effective at reducing chronic pain, and growing research supports the use of group visit programs for the management of chronic pain. There is reason to believe that combining the two could enhance the benefit previously demonstrated by these treatments individually. There are no studies that have examined the combined delivery of chiropractic care and group visit programs for adults over the age of 65. The investigators plan assess the feasibility of treating adults over the age of 65 with chronic spine pain with chiropractic care and a group visit program. A battery of biopsychosocial outcomes will be collected to inform a more definitive trial.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65+ years of age
- •Chronic neck, thoracic, and/or low back pain at least 5 days a week for at least 3 consecutive months
- •Neck, thoracic, and/or low back pain averaged over past week of 3 or more on numerical rating scale ranging from 0 to 10, with 10 described as 'worst pain imaginable'
- •Oswestry Disability Index score of 10% or greater
- •Access to and ability to use a smartphone, tablet, or computer and broadband internet
- •Access to reliable mode of transportation for study visits and chiropractic treatments
- •Agreeable to participate in all study procedures
- •Fluent in English
排除标准
- •Currently, or having received chiropractic care in past 12 months (for any spine pain condition)
- •Any disability precluding safe exercise practice
- •Any prior spinal surgery within previous year
- •Persons currently involved in a disability/accident claim
- •Currently living in a nursing home and/or enrolled in hospice
- •Need for additional diagnostic imaging at the eligibility exam
- •Signs/symptoms of major systemic illness that may impair the participant's ability to effectively attend intervention sessions, or present risk factors to the care protocol: Participants with signs or symptoms suggesting the need for evaluation and/or management by other providers (e.g., Parkinson's disease, cancer, psychosis, substance use addiction)
- •Non-neuromusculoskeletal source: Participants with neck or back pain suspected or confirmed non-neuromusculoskeletal source (e.g., vasculitis, referred pain of cardiopulmonary origin, neoplasm, or infection)
- •Inflammatory arthritis: Participants suspected or confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis or other systemic inflammatory arthritis condition
- •Health conditions influencing compliance: Participants with health conditions that lead to difficulty complying with study protocol, such as renal dialysis, untreated psychiatric symptoms, or cognitive impairment
- •Vascular risk: Participants at increased risk for adverse cerebrovascular events are ineligible. Examples include a history of stroke, carotid artery dissection, or vertebral artery dissection, and those scheduled for endarterectomy procedures due to arterial stenosis. The presence of carotid artery bruit is exclusionary due to a presumed increased vascular risk and the likely need for referral and diagnostic testing
- •Neurological disorder: Participants exhibiting a clinical picture of serious or potentially serious neurological disorders are ineligible. Examples include:
- •Progressive neurologic deficit evidenced by signs/symptoms such as paralysis, progressive muscle weakness, poor coordination, loss of sensation, and loss of bladder or bowel function
- •Suspected or confirmed myelopathy or radiculopathy
- •Space occupying lesions, within or adjacent to the spinal canal, including tumors (benign or malignant)
- •Neurological deficit (loss of sensation, motor strength, and/or deep tendon reflexes) present for less than 12 months
- •Note: The presence of a cervical disc herniation/protrusion is not exclusionary without signs of neurological deficit.
- •Note: Stable neurological deficit (present for more than 12 months without change) is not exclusionary
- •Pathological hypermobility: Participants with suspected or confirmed diagnosis of a disorder known to cause spinal joint hypermobility including congenital conditions (Marfan Syndrome, Ehlers-Danlos Syndrome, and Osteogenesis imperfecta) and degenerative or traumatic instability are ineligible. Potential participants will be screened using Beighton criteria, health history, and (when available) diagnostic imaging review.
- •Contraindication: Participants with confirmed or suspected contraindication to care not otherwise described (e.g., cervical fracture) are ineligible. This criterion does not include factors representing relative contraindications to specific procedures such as the presence of osteoporosis, for which chiropractic care can be safely adapted.
- •Recent interventional pain management: defined as procedures such as corticosteroid injection, trigger point injection, and radiofrequency ablation to the cervical or lumbar region within the past 4 weeks and/or scheduled for interventional pain management procedures within the study timeframe.
- •Hearing or visual impairment affecting participation in a virtual program
结局指标
主要结局
Recruitment
时间窗: Prior to intervention initiation
Recruitment will be evaluated by tracking the recruitment source of participants, the number of participants enrolled per week overall, the reasons that screened individuals were not eligible, and the number of individuals deciding not to be screened, or if screened, why they are not interested in enrolling. Recruitment is estimated to be 10 total participants.
Retention
时间窗: Monitored weekly throughout 8-week intervention period
Retention will be quantified by the proportion of participants who complete all outcome assessments at the end of the intervention period. We will consider future testing of our interventions if the expected proportion of participants to have completed primary outcome assessments is least 70%.
Adherence
时间窗: Monitored weekly throughout 8-week intervention period
Adherence will be calculated as the proportion of participants who attend at least 6 of the 8 chiropractic care visits and 6 of the 8 of virtual group visits. We will consider future testing of our interventions if the expected proportion of participants judged to be adherent to the intervention is at least 70%.
Satisfaction with interventions
时间窗: Measured at 8-week study visit
Satisfaction will be calculated as the proportion of participants who report satisfaction with the program. We will consider future testing of our interventions if the expected proportion of participants who report satisfaction is at least 70%.
次要结局
- Pain intensity(Measured at baseline and 8-week study visit)
- Oswestry Disability Index(Measured at baseline and 8-week study visit)
- PROMIS-29(Measured at baseline and 8-week study visit)
- Self-efficacy(Measured at baseline and 8-week study visit)
- Locus of control(Measured at baseline and 8-week study visit)
- Pain catastrophizing(Measured at baseline and 8-week study visit)
- Fear of Movement(Measured at baseline and 8-week study visit)
- Social Support(Measured at baseline and 8-week study visit)
- Short Physical Performance Battery (SPPB)(Measured at baseline and 8-week study visit)
- Qualitative interviews(Measured at baseline and 8-week study visit)
研究者
Peter M. Wayne, Ph.D.
Associate Professor of Medicine
Brigham and Women's Hospital