Clinical trial NCT05350254: Implementation of the MAINTAIN Instrument for Patients With Dysfunctional Spinal Pain
Official title: C-prior: Implementation of the MAINTAIN Instrument for Patients With Dysfunctional Spinal Pain - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Recurrent
Neck Pain
Back Pain
Lead sponsor: Canadian Memorial Chiropractic College
Sponsor class: OTHER
Collaborators: name: Parker University
name: Karolinska Institutet
name: McMaster University
First posted: 2022-04-28
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients with spinal pain (neck, mid-back, and/or low back) of recurrent (not the first episode) and significant (more than 30 days in the past 12 months) character
* 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:

* Pregnancy
* 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)

Primary outcomes:
measure: Number of days with activity-limiting pain
timeFrame: 12-months
Secondary outcomes:
measure: Number of missed working days
timeFrame: 12-months
measure: Loss of work productivity
timeFrame: 12-months
measure: Pain intensity
timeFrame: 12-months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Canadian Memorial Chiropractic College
state: Ontario
Study officials:
References: