Implementation of the MAINTAIN Instrument for Patients With Dysfunctional Spinal Pain

C-prior: Implementation of the MAINTAIN Instrument for Patients With Dysfunctional Spinal Pain - a Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Back Pain; Neck Pain; Low Back Pain, Recurrent
• Intervention / Treatment: Other: Chiropractic maintenance care; Other: Standard chiropractic 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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martha Funabashi, PhD; Phone Number: 647 805 2024; Email: mfunabashi@cmcc.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2H 3
      • Recruiting
      • Canadian Memorial Chiropractic College
      • Contact: Martha Funabashi, PhD; Phone Number: 647 805 2024; Email: mfunabashi@cmcc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Chiropractic maintenance care; Manual Therapy, individual exercises and lifestyle advice
Active Comparator: 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).	Other: Standard chiropractic care; Standard care based on clinician's judgement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days with activity-limiting pain	Number of days with activity-limiting pain	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of missed working days	Number of missed working days due to pain	12-months
Loss of work productivity	11-point numeric rating scale, where 0 = did not affect my work and 10 = completely prevented me from working	12-months
Pain intensity	11-point visual analogue scale, where 0 = no pain and 100 = worst imaginable pain	12-months

Collaborators and Investigators

• Sponsor: Canadian Memorial Chiropractic College
• Collaborators: Karolinska Institutet; McMaster University; Parker University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Neck Pain
• Other Study ID Numbers: 222006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study will be part of an international project where multiple coordinated trials will collect data on different aspects of maintenance care. While this specific project is independent and focuses on Canadian population, a core set of outcomes collected in each study will be merged with data from the other trials internationally for secondary analyses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No