Implementation of the MAINTAIN Instrument for Patients With Dysfunctional Spinal Pain
NCT ID: NCT05350254
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2023-11-20
2025-07-31
Brief Summary
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Detailed Description
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Purpose: The overall goal of this multicenter randomized clinical trial is to investigate the process and outcomes of implementing the MAINTAIN instrument in clinical practice. The specific aims are to: 1) assess the effectiveness and cost-effectiveness of stratified MC using the MAINTAIN instrument compared to standard chiropractic care; and 2) assess the fidelity and procedure compliance of implementing the MAINTAIN instrument.
Analysis Plan: An intention to treat protocol will be used and estimates will be reported with arithmetic means and 95% confidence intervals. Analysis of the primary outcome (number of days with activity limiting pain) will be conducted as it was in Eklund et al. (2018, 2019). The total number of days with activity limiting pain will be modelled using Generalized Estimating Equations (GEE) linear regression, using appropriate correlation structure and robust variance estimator. Terms for study arm, time and study arm by time interaction will be included. A term for MC candidate (Yes or No) will be added to this model to further investigate the stratification and its relationship to outcomes. The RE-AIM framework will be used to assess the impact and implementation of the MAINTAIN instrument.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stratified Maintenance Care
All participating patients will receive pragmatic chiropractic care for the initial 3 weeks (6 visits) and home exercise recommendations.
Participants in the Stratified Maintenance Care group will be classified based on the MAINTAIN instrument into: not a candidate, good candidate, and very good candidate for maintenance care:
* Participants showing a good response to the initial care and classified as not a candidate or a good candidate for maintenance care will be given home exercise recommendations. Return for further manual treatment will be recommended if they have a relapse or exacerbation of symptoms (symptom-guided care).
* Participants classified as having a good response to the initial care and very good candidates for maintenance care, will have visits with tapering manual treatments and home exercise recommendations. They will then be recommended maintenance care with pre-planned visits at 4-12 week intervals (aiming at increasing the interval as soon as possible).
Chiropractic maintenance care
Manual Therapy, individual exercises and lifestyle advice
Standard Chiropractic Care
All participating patients will receive pragmatic chiropractic care for the initial 3 weeks (6 visits) and home exercise recommendations.
In the Standard chiropractic care group, participating patients will receive a standard (pragmatic) chiropractic care in which treatment will be provided based on the clinician's judgement and home exercise recommendations. This may or may not include maintenance care depending on the clinicians' standard operating procedures. All treatments provided will be recorded. Return for further treatment will be recommended if they have a relapse or exacerbation of symptoms (symptom-based).
Standard chiropractic care
Standard care based on clinician's judgement
Interventions
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Chiropractic maintenance care
Manual Therapy, individual exercises and lifestyle advice
Standard chiropractic care
Standard care based on clinician's judgement
Eligibility Criteria
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Inclusion Criteria
* No pain episode in the past 3 months
* Access to a mobile phone and email.
* Ability to send and receive SMS (text messages).
Exclusion Criteria
* Serious pathology (e.g., acute trauma, cancer, infection, cauda equina, osteoporosis, vertebral fractures)
* Contraindications to manual therapy
* Specific spinal conditions (e.g., radiculopathy, spinal stenosis)
18 Years
65 Years
ALL
No
Sponsors
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Parker University
OTHER
Karolinska Institutet
OTHER
McMaster University
OTHER
Canadian Memorial Chiropractic College
OTHER
Responsible Party
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Locations
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Canadian Memorial Chiropractic College
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Martha Funabashi, PhD
Role: primary
Other Identifiers
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222006
Identifier Type: -
Identifier Source: org_study_id