Implementation of the MAINTAIN Instrument for Patients With Dysfunctional Spinal Pain

NCT05350254 | Unknown

• 1 other identifier: 222006
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Recurrent; Neck Pain; Back Pain

Outcome Measures

Primary Outcomes (1)

• Number of days with activity-limiting pain

  Number of days with activity-limiting pain

  12-months

Secondary Outcomes (3)

• Number of missed working days

  12-months

• Loss of work productivity

  12-months

• Pain intensity

  12-months

Study Arms (2)

Stratified Maintenance Care

EXPERIMENTAL

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

Standard Chiropractic Care

ACTIVE COMPARATOR

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

Interventions

Chiropractic maintenance care OTHER

Manual Therapy, individual exercises and lifestyle advice

Stratified Maintenance Care

Standard chiropractic care OTHER

Standard care based on clinician's judgement

Standard Chiropractic Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Canadian Memorial Chiropractic College: lead
• Parker University: collaborator
• Karolinska Institutet: collaborator
• McMaster University: collaborator

Study Sites (1)

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3, Canada

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Neck Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Martha Funabashi, PhD

CONTACT

647 805 2024; mfunabashi@cmcc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: November 20, 2023
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)