Algorithm-Informed Treatment for Chronic Lower Back Pain
(ADAPT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find the best treatment for individuals with chronic lower back pain. Researchers use an algorithm to predict the most effective treatment based on personal factors like symptoms and lifestyle. Participants may receive treatments such as Cognitive-Behavioral Therapy for Pain (PRISM-CBT), Duloxetine (a type of medication), mHealth Acupressure Self-Management, and Physical Therapy (PT) and Exercise. It is ideal for those who have experienced back pain for at least six months and struggle with pain on most days. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could personalize pain management strategies.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments in this trial are generally safe.
Cognitive-Behavioral Therapy for Pain (PRISM-CBT) is considered safe. Studies indicate it helps manage chronic pain without major side effects, reducing pain and improving quality of life.
Duloxetine, a medication already approved by the FDA for other uses, significantly reduces back pain and is usually well-tolerated. Most patients do not experience serious side effects.
mHealth Acupressure Self-Management has shown positive results with few side effects. Some users might experience minor issues like bruising, but these are rare.
Physical Therapy and Exercise are also safe options, providing significant pain relief. Some people might feel sore after exercise, but this is usually temporary and not harmful.
Overall, existing studies consider these treatments safe and well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a combination of treatments for chronic lower back pain that might offer more comprehensive relief than existing options. Traditional treatments often include medications like NSAIDs or opioids, physical therapy, or cognitive-behavioral therapy. However, this trial investigates the use of an algorithm-informed approach that combines Cognitive-Behavioral Therapy for Pain (PRISM-CBT), Duloxetine, mHealth Acupressure Self-Management, and Physical Therapy (PT) and Exercise in various sequences. These combinations aim to address pain from multiple angles - physiological, psychological, and behavioral - potentially offering a more personalized and effective treatment strategy. By exploring how these therapies interact and complement each other, researchers hope to discover new insights that could lead to improved pain management strategies.
What evidence suggests that this trial's treatments could be effective for chronic lower back pain?
Research has shown that Cognitive-Behavioral Therapy for Pain (PRISM-CBT), one of the treatments in this trial, can reduce pain and improve function in individuals with chronic lower back pain. Studies have found significant improvements in pain management with this therapy. Duloxetine, another treatment option in this trial, has significantly reduced pain in people with chronic low back pain, with many patients experiencing more relief than those taking a placebo. mHealth Acupressure, also under study in this trial, is a self-care technique that shows promise as a non-drug option for managing chronic pain by pressing specific points on the body to ease discomfort. Lastly, Physical Therapy and Exercise, another treatment arm in this trial, have provided modest improvements in physical function, effectively managing chronic pain through regular activity. Each of these treatments has evidence supporting their ability to help manage chronic lower back pain.13567
Who Is on the Research Team?
Afton Hassett, PsyD
Principal Investigator
University of Michigan
Daniel Clauw, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for adults with chronic lower back pain. Participants should not have serious health issues that would prevent them from joining, and must be able to take part in physical therapy, medication, or self-management activities.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo various interventions such as Physical Therapy & Exercise, Duloxetine, Acupressure, and PRISM-CBT over 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue, switch, or add treatments based on algorithm and randomization
What Are the Treatments Tested in This Trial?
Interventions
- Algorithmically informed randomization
- Cognitive-Behavioral Therapy for Pain (PRISM-CBT)
- Duloxetine
- mHealth Acupressure Self-Management
- Physical Therapy (PT) and Exercise
Trial Overview
The study tests if an algorithm can help match people with the most effective treatment for their back pain. Treatments include physical therapy and exercise, acupressure using a mobile app, duloxetine (a medication), and cognitive-behavioral therapy.
How Is the Trial Designed?
28
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Citations
Evidence informed management of chronic low back pain with ...
To date, the literature indicates that CBT is an effective component in the overall treatment of CLBP. As noted earlier, the biopsychosocial approach to chronic ...
Mindfulness vs Cognitive Behavioral Therapy for Chronic ...
Conclusions and Relevance In this large trial, CLBP-related symptoms improved, while opioid dosage decreased in both MBT and CBT groups at 6 and ...
3.
news-medical.net
news-medical.net/news/20250410/Mindfulness-and-cognitive-behavioral-therapies-offer-lasting-relief-for-chronic-low-back-pain.aspxMindfulness and cognitive behavioral therapies offer ...
Researchers compare the long-term effectiveness of mindfulness and CBT among adults with opioid-treated chronic low back pain.
Evaluation of Cognitive Behavioral Therapy on Improving ...
We found low-quality evidence that there was a better effect of CBT on reducing pain compared with other therapies. The effect was statistically ...
5.
2minutemedicine.com
2minutemedicine.com/physical-therapy-yields-modest-improvements-in-chronic-low-back-pain/Physical therapy yields modest improvements in chronic ...
At 10 weeks, PT was associated with a modest improvement in physical function compared with CBT, although there were no statistically or ...
CBT Approach to Chronic Low Back Pain
Results showed cognitive therapy to be as effective as imipramine, an antidepressant. ... Comparison of group progressive-relaxation training and cognitive- ...
Effect of 8 weeks of cognitive behavioral therapy versus 8 ...
The results of the current study support the involvement of cognitive therapy in the management of chronic pain as it guides the patient to be ...
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