Chronic PainGOLDENNCT06632535
Group Medical Visits and Chiropractic Care for Older Adults With Chronic Spine Pain
A study testing Chiropractic care and Group medical visits in people with Chronic Pain and Musculoskeletal Pain, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain
- What is being tested?
- Chiropractic care and Group medical visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 5 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MassGeneralBrigham
Boston, Massachusetts, 02215
About this study
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
- Being tested
- Chiropractic care, Group medical visits
- Keywords
- chiropractic, group medical visit, shared medical visit, older adults, spine pain
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic careOther
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.
Group medical visitsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chiropractic care; Other: Group medical visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 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%.
Measured: 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: Measured at 8-week study visit
Secondary outcomes (10)
Pain intensity
Pain intensity will be measured using a 11-point numerical rating scale (NRS) with 0 indicating "no pain at all" and 10 indicating "worst pain imaginable".
Measured: Measured at baseline and 8-week study visit
Oswestry Disability Index
Pain-related disability will be measured using the Oswestry Disability Index (ODI). These 10-item questionnaires determine how participants see their pain affecting their daily activities. The maximum score is 100%. Scores of <8% indicate no disability; 10% to 28% indicate mild disability, 30% to 48% moderate disability, and 50% to 68% severe disability. Scores >70% indicate a complete perceived disability.
Measured: Measured at baseline and 8-week study visit
PROMIS-29
PROMIS 29 is a system of validated, highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. In addition to pain intensity and pain interference, this set of measures includes physical function, fatigue, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.Raw scores are extracted and converted to T-scores on all subscales. Items are scored from 1 to 5, with a higher score indicating a higher degree of the construct being measured. The T-score metric used for data analysis uses a mean of 50 and a standard deviation of 10 in the U.S. population.
Measured: Measured at baseline and 8-week study visit
Self-efficacy
Self-efficacy will be measured using the General Self-Efficacy Scale (GSES). The GSES measures a participant's confidence in their ability to respond to environmental demands and challenges. The scale consists of 10 items with a 4-point Likert response scale ranging from 1 ("not at all true") to 4 ("exactly true"). Higher summed scores indicate greater self-efficacy to complete tasks.
Measured: Measured at baseline and 8-week study visit
Locus of control
Locus of control will be measured using the Internal-External Locus of Control short Scale-4 (IE-4). The IE-4 measures two dimensions of the locus of control (internal and external) with two items each. Each statement consists of a 5-point Likert scale with responses ranging from 1 ("doesn't apply at all") to 5 ("applies completely"). Higher scores in the first two items indicate an internal locus of control, while higher scores in the second two items indicate an external locus of control.
Measured: Measured at baseline and 8-week study visit
Pain catastrophizing
Pain Catastrophizing Scale used to assess catastrophic thinking associated with pain. This instrument consists of 13 items that measure rumination, magnification, and helplessness related to pain and has adequate to excellent internal consistency, with higher scores representing more of the item tested.
Measured: Measured at baseline and 8-week study visit
Fear of Movement
Fear of Movement will be measured using the Tampa Scale for Kinesiophobia. This instrument consists of 17 items that measure pain-related fear and has been validated in chronic low back pain and fibromyalgia patients. Higher scores represent more fear of movement.
Measured: Measured at baseline and 8-week study visit
Social Support
Social Support will be measured with the Multidimensional Scale of Perceived Social Support (MSPSS) which measures an individual's perception of support from family, friends, and a significant other. It consists of 12 items with lower scores indicating low perceived support, and higher scores indicating higher perceived support.
Measured: Measured at baseline and 8-week study visit
Short Physical Performance Battery (SPPB)
The SPPB measures lower extremity physical performance status including balance, gait speed, and chair stands and has been linked to mortality and disability. Gait speed, contained in the SPPB, will be assessed using the ZenoTM Walkway, developed by ProtoKinetics (https://www.protokinetics.com). The portable 2' X 20' gait walkway and associated hardware system can be easily assembled for use in a clinical setting (e.g., hallway), and comes with laptop computer with sophisticated, but user-friendly software (PKMAS). Gait data is collected by simply having the patient walk across an electronic gait mat. A series of gait parameters automatically calculated by ZENOTM will be captured including walking speed and stride time variability.
Measured: Measured at baseline and 8-week study visit
Qualitative interviews
Qualitative interviews will be employed to further probe participants' perceptions of the combined interventions focusing on a) understanding facilitators and barriers to participation, and b) patient-centered experiences that might inform outcome measures to use in a future trial.
Measured: Measured at baseline and 8-week study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Jul 2025
- Primary completion5 Oct 2026 (estimated)
- Study completion5 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter M. Wayne, Ph.D., Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632535
- Sponsor's protocol ID
- 2024P002528
- Acronym
- GOLDEN
- Status last verified
- Nov 2025
- First submitted
- 7 Oct 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Medical Visits and Chiropractic Care for Older Adults With Chronic Spine Pain
- ClinicalTrials.gov ID
- NCT06632535
- Acronym / sponsor ID
- GOLDEN / 2024P002528
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Keywords
- chiropractic, group medical visit, shared medical visit, older adults, spine pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 5 Oct 2026 (estimated)
- Study completion
- 5 Oct 2026 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined chiropractic care and group medical visits | Experimental | Other: Chiropractic care, Other: Group medical visitsParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic careChiropractic 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. | Other | Combined chiropractic care and group medical visits |
| Group medical visitsParticipants 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. | Other | Combined chiropractic care and group medical visits |
Primary outcome
Recruitment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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%.
10 secondary outcomes
Pain intensity
Time frame: Measured at baseline and 8-week study visit
Oswestry Disability Index
Time frame: Measured at baseline and 8-week study visit
PROMIS-29
Time frame: Measured at baseline and 8-week study visit
Self-efficacy
Time frame: Measured at baseline and 8-week study visit
Locus of control
Time frame: Measured at baseline and 8-week study visit
Pain catastrophizing
Time frame: Measured at baseline and 8-week study visit
Fear of Movement
Time frame: Measured at baseline and 8-week study visit
Social Support
Time frame: Measured at baseline and 8-week study visit
Short Physical Performance Battery (SPPB)
Time frame: Measured at baseline and 8-week study visit
Qualitative interviews
Time frame: Measured at baseline and 8-week study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic care and Group medical visits in people with Chronic Pain and Musculoskeletal Pain, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wren M Burton, DC, MPH (617-732-9456, wmburton@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Prior to intervention initiation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.