Low Back Pain, RecurrentNCT05350254
Implementation of the MAINTAIN Instrument for Patients With Dysfunctional Spinal Pain
A study testing Chiropractic maintenance care and Standard chiropractic care in people with Low Back Pain, Recurrent and Neck Pain, run by Canadian Memorial Chiropractic College at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Recurrent, Neck Pain, Back Pain
- What is being tested?
- Chiropractic maintenance care and Standard chiropractic care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Canadian Memorial Chiropractic College
Toronto, Ontario, M2H 3
Martha Funabashi, PhD, 647 805 2024, mfunabashi@cmcc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain, Recurrent, Neck Pain, Back Pain
- Being tested
- Chiropractic maintenance care, Standard chiropractic care
- Medical subject headings
- Low Back Pain, Neck Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic maintenance careOther
Manual Therapy, individual exercises and lifestyle advice
Standard chiropractic careOther
Standard care based on clinician's judgement
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Standard chiropractic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with activity-limiting pain
Number of days with activity-limiting pain
Measured: 12-months
Secondary outcomes (3)
Number of missed working days
Number of missed working days due to pain
Measured: 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
Measured: 12-months
Pain intensity
11-point visual analogue scale, where 0 = no pain and 100 = worst imaginable pain
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start20 Nov 2023
- Primary completionFeb 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- Parker University, Karolinska Institutet, McMaster University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350254
- Sponsor's protocol ID
- 222006
- Status last verified
- Dec 2023
- First submitted
- 22 Apr 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Funabashi M, Ives G, Pohlman KA, Hogg-Johnson S, Townsend M, Macedo L, Lee J, Eklund A. C-prior-implementation of the MAINTAIN instrument for patients with spinal pain: study protocol for a randomized clinical trial. Trials. 2026 Feb 10;27(1):208. doi: 10.1186/s13063-026-09509-6.
PubMed 41664083
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-prior: Implementation of the MAINTAIN Instrument for Patients With Dysfunctional Spinal Pain - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05350254
- Acronym / sponsor ID
- 222006
- Conditions
- Low Back Pain, Recurrent, Neck Pain, Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Collaborators
- Parker University, Karolinska Institutet, McMaster University
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratified Maintenance Care | Experimental | Other: Chiropractic maintenance careAll 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). |
| Standard Chiropractic Care | Active comparator | Other: Standard chiropractic careAll 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic maintenance careManual Therapy, individual exercises and lifestyle advice | Other | Stratified Maintenance Care |
| Standard chiropractic careStandard care based on clinician's judgement | Other | Standard Chiropractic Care |
Primary outcome
Number of days with activity-limiting pain
Time frame: 12-months
Number of days with activity-limiting pain
3 secondary outcomes
Number of missed working days
Time frame: 12-months
Loss of work productivity
Time frame: 12-months
Pain intensity
Time frame: 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Derived from this study: PubMed 41664083Funabashi M, Ives G, Pohlman KA, Hogg-Johnson S, Townsend M, Macedo L, Lee J, Eklund A. C-prior-implementation of the MAINTAIN instrument for patients with spinal pain: study protocol for a randomized clinical trial. Trials. 2026 Feb 10;27(1):208. doi: 10.1186/s13063-026-09509-6.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic maintenance care and Standard chiropractic care in people with Low Back Pain, Recurrent and Neck Pain, run by Canadian Memorial Chiropractic College at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martha Funabashi, PhD (647 805 2024, mfunabashi@cmcc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days with activity-limiting pain (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.