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

NCT06632535 | Recruiting

• 1 other identifier: 2024P002528
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Musculoskeletal Pain

Keywords

chiropractic; group medical visit; shared medical visit; older adults; spine pain

Outcome Measures

Primary Outcomes (4)

• Recruitment

  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.

  Prior to intervention initiation

• Retention

  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%.

  Monitored weekly throughout 8-week intervention period

• Adherence

  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%.

  Monitored weekly throughout 8-week intervention period

• Satisfaction with interventions

  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%.

  Measured at 8-week study visit

Secondary Outcomes (10)

• 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

Study Arms (1)

Combined chiropractic care and group medical visits

EXPERIMENTAL

Participants will attend 8 weekly chiropractic visits (40-minutes for initial visit, 20-minutes for remaining 7). Participants will simultaneously enroll in 8 weekly 90-minute virtual group medical visits.

Other: Chiropractic care; Other: Group medical visits

Interventions

Chiropractic care OTHER

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.

Combined chiropractic care and group medical visits

Group medical visits OTHER

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.

Combined chiropractic care and group medical visits

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

MassGeneralBrigham

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Central Study Contacts

Wren M Burton, DC, MPH

CONTACT

617-732-9456; wmburton@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)