Recruiting

Chiropractic Maintenance Care

Sponsor:

Canadian Memorial Chiropractic College

Code:

NCT05350254

Conditions

Low Back Pain, Recurrent

Neck Pain

Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Chiropractic maintenance care

Standard chiropractic care

Study Details

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

Study ID

NCT05350254

Start date

Nov 20, 2023

Status verified date

Dec, 2023

Completion date

Jul, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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).

Interventions

Chiropractic maintenance care

Manual Therapy, individual exercises and lifestyle advice

Standard chiropractic care

Standard care based on clinician's judgement

Primary outcome measure

  • Number of days with activity-limiting pain [ Time Frame: 12-months ]

Central Contacts and Locations

Central contacts

Martha Funabashi, PhD

647 805 2024mfunabashi@cmcc.ca

Locations

Canadian Memorial Chiropractic College

Recruiting

Toronto, Ontario, Canada, M2H 3

Contacts

Martha Funabashi, PhD

647 805 2024mfunabashi@cmcc.ca

More Information

Sponsor

Canadian Memorial Chiropractic College

Last update posted

Dec 14, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Memorial Chiropractic College on 2023-12-14.