C-prior-implementation of the MAINTAIN instrument for patients with spinal pain: study protocol for a randomized clinical trial.

backgroundSpinal pain is a highly prevalent condition affecting a large part of the population. Chiropractic maintenance care (MC) is a management strategy intended to prevent spinal pain recurrent episodes and deterioration by treating patients at pre-planned intervals. A previous study showed that patients identified as a dysfunctional subgroup by the West Haven-Yale Multidimensional Pain Inventory (MPI) and receiving MC had fewer days with bothersome LBP. This suggests MC may have superior effectiveness in this subgroup of patients. The MPI, however, is not practical for daily clinical practice, prompting the development of the MAINTAIN instrument. This study aims to (1) assess the effectiveness and cost-effectiveness of stratified MC using the MAINTAIN instrument, and (2) assess the fidelity and procedure compliance of implementing the MAINTAIN instrument.

methodsThis pragmatic randomized clinical trial will recruit 225 consecutive patients (18-65 years old) with significant (> 30 days in the past 12 months) recurrent spinal pain presenting to chiropractic clinics. After the initial 3 weeks (6 visits) of chiropractic care, patients will be randomized to receive either Stratified MC or Standard Chiropractic Care. Stratified MC: patients will complete the MAINTAIN instrument and be stratified to MC or symptom-guided care (clinicians' judgment). Patients in the Standard Chiropractic Care arm will receive standard treatment based on the chiropractor's judgment. The primary outcome is the total number of days with activity-limiting pain measured at 12 months. Secondary outcomes include the number of missed working days and loss of work productivity due to pain, pain intensity, disability, health-related quality of life, perceived improvement, and implementation of MAINTAIN instrument outcomes. An intention-to-treat protocol and generalized estimating equations (GEE) linear regression models will be used for analysis. DISCUSSION: This study investigates the impact of using a clinical instrument to identify patients with recurrent spinal pain to target those who benefit most from a chiropractic MC approach. Strict inclusion criteria should ensure a suitable target group, and frequently collected repeated measures should provide accurate outcome assessment. The study is pragmatic and includes standard clinical procedures facilitating the generalizability and transferability of the results into clinical practice.

trial registrationClinicalTrials.gov NCT05350254. Prospectively registered on April 22, 2022, last modified on December 08, 2023. The first patient was randomized into the study on December 21, 2023.