Group Medical Visits and Chiropractic Care for Older Adults With Chronic Spine Pain

Обзор

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.

Вмешательства

• Другое Chiropractic care
  Chiropractic treatment will involve a personalized treatment plan within the context of a general care protocol administered by a chiropractor at the Osher Clinical Center for Integrative Health. The treatment plan will be customized to the patient's clinical needs following the current evidence and clinical practice guidelines.
• Другое Group medical visits
  Participants will simultaneously enroll in virtual group medical visits with group discussion, practice based learning, and curricular themes pertaining to chronic pain management, healthy aging, and pillars of lifestyle medicine.

Первичные конечные точки

• Recruitment [Срок оценки: Prior to intervention initiation]
• Retention [Срок оценки: Monitored weekly throughout 8-week intervention period]
• Adherence [Срок оценки: Monitored weekly throughout 8-week intervention period]
• Satisfaction with interventions [Срок оценки: Measured at 8-week study visit]

Вторичные конечные точки (10)

• Pain intensity [Срок оценки: Measured at baseline and 8-week study visit]
• Oswestry Disability Index [Срок оценки: Measured at baseline and 8-week study visit]
• PROMIS-29 [Срок оценки: Measured at baseline and 8-week study visit]
• Self-efficacy [Срок оценки: Measured at baseline and 8-week study visit]
• Locus of control [Срок оценки: Measured at baseline and 8-week study visit]
• Pain catastrophizing [Срок оценки: Measured at baseline and 8-week study visit]
• Fear of Movement [Срок оценки: Measured at baseline and 8-week study visit]
• Social Support [Срок оценки: Measured at baseline and 8-week study visit]
• Short Physical Performance Battery (SPPB) [Срок оценки: Measured at baseline and 8-week study visit]
• Qualitative interviews [Срок оценки: Measured at baseline and 8-week study visit]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• MassGeneralBrigham — Boston

Идентификаторы

NCT: NCT06632535 · 2024P002528

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗