This research project is designed to address the question of what type of treatment works best for which type of patient with chronic low back pain, and what sequence of treatments is most beneficial for patients who do not respond to the first treatment attempted. The treatments we are examining are physical therapy and cognitive behavioral therapy, each of which we have combined with principles of motivational interviewing to enhance patient engagement within these treatments. We are also studying mindfulness as a treatment for back pain, which is a promising strategy for at least some patients. We are examining the value of different treatments and treatment sequences using patient-centered outcomes including pain and disability levels, as well as additional dimensions of quality of life (e.g., mood and sleep) and the need for more health care or long-term use of opioids to manage back pain.
Nearly everyone experiences back pain at some point, and it is one of the most common reasons for a visit to a healthcare provider. From our conversations with several patients and other stakeholders, we know that an episode of low back pain can be extremely disabling and painful. Patients are often frustrated by the inability to find a treatment that works well for them. Several treatments provide some benefit to patients with chronic back pain, but it is difficult to know which patient may respond best to which treatment, or what combination of treatments may be helpful in assisting patients to achieve the outcomes they desire.
This study will be a randomized trial comparing the effectiveness of a first-line treatment of either physical therapy or cognitive behavioral therapy. For patients who do not respond successfully to their first treatment, we will perform a second randomization and assign patients to either switch to the other treatment or begin mindfulness. We plan to enroll 500 patients and assess outcomes at baseline, six weeks, three months, six months, and one year. Patient partners have been involved in designing the research questions and study design in this project. Patients will continue to provide input throughout the project along with our other stakeholder partners: healthcare providers, administrators, and insurance providers. A patient member is part of the investigator team, one patient from each healthcare system will participate in bi-annual stakeholder advisory committee meetings, and we will conduct quarterly meetings with our patient advisory panel at each site. The results of this project will provide important information on the best ways to tailor treatment to individual patients with chronic low back pain.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.