Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05350254 |
Other study ID # |
222006 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 20, 2023 |
Est. completion date |
July 2025 |
Study information
Verified date |
December 2023 |
Source |
Canadian Memorial Chiropractic College |
Contact |
Martha Funabashi, PhD |
Phone |
647 805 2024 |
Email |
mfunabashi[@]cmcc.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Previous studies showed that some back pain patients (with specific characteristics) present
less days with pain when treated with chiropractic maintenance care. A clinical instrument
(called MAINTAIN instrument) was developed to identify those patients who would benefit from
chiropractic maintenance care. This study will investigate the impact of using the MAINTAIN
instrument in clinical practice. This study will help to improve clinical care of patients
with back and neck pain by providing them with more individualized care.
Description:
Rationale: Non-specific Low Back Pain (LBP) is one of the largest societal economic burdens
with a 80-85% lifetime prevalence worldwide, often characterized by recurrent episodes.
Chiropractic maintenance care (MC) is a management strategy aimed at preventing LBP episodes
and deterioration by treating patients at pre-planned intervals, regardless of symptoms. It
consists of manual therapy, individual exercises and lifestyle advice, and patients are
selected based on their previous history of pain and the effectiveness of the initial care
plan. A pragmatic randomized clinical trial showed that patients receiving MC had 12.8 fewer
days with bothersome LBP compared to a control group. More specifically, patients in the
Dysfunctional sub-group, categorized by the West Haven-Yale Multidimensional Pain Inventory
(MPI) instrument, reported fewer days with pain when receiving MC, suggesting MC's superior
effectiveness in this subgroup of patients. The MPI instrument, however, is not suited for
daily clinical practice use, prompting the development of the more practical MAINTAIN
instrument. It captures 5 dimensions of the pain experience yielding 3 categories of
patients: not a candidate for MC, good candidate for MC (sensitivity: 95.8%; specificity:
64.3%) and very good candidate for MC (sensitivity: 81.1%; specificity: 79.2%). Despite these
encouraging preliminary results, the usability and impact of using the MAINTAIN instrument in
clinical practice remains unknown and a thorough investigation on its implementation is
fundamental.
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.