Implementation of the MAINTAIN Instrument for Patients With Dysfunctional Spinal Pain

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05350254
• Other study ID #: 222006
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Recurrent
• Neck Pain

Intervention

Other:
• Chiropractic maintenance care
Manual Therapy, individual exercises and lifestyle advice
• Standard chiropractic care
Standard care based on clinician's judgement

Locations

Country	Name	City	State
Canada	Canadian Memorial Chiropractic College	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Canadian Memorial Chiropractic College	Karolinska Institutet, McMaster University, Parker University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days with activity-limiting pain	Number of days with activity-limiting pain	12-months
Secondary	Number of missed working days	Number of missed working days due to pain	12-months
Secondary	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
Secondary	Pain intensity	11-point visual analogue scale, where 0 = no pain and 100 = worst imaginable pain	12-months