500 Participants NeededMy employer runs this trial

Algorithm-Informed Treatment for Chronic Lower Back Pain

(ADAPT Trial)

BB
SS
Overseen BySana Shaikh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

AH

Afton Hassett, PsyD

Principal Investigator

University of Michigan

DC

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

Individuals must have a pain interference score of ≥60 on PROMIS Pain Interference, 1 standard deviation above the population mean
I am willing and able to receive at least three of the four study treatments.
I can stand on my own for at least 10 minutes.
See 1 more

Exclusion Criteria

Active uncontrolled drug or alcohol addiction
I have a scheduled back surgery, had back surgery in the last year, or had multiple back surgeries.
Visual or hearing difficulties that would preclude participation
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo various interventions such as Physical Therapy & Exercise, Duloxetine, Acupressure, and PRISM-CBT over 8 weeks

8 weeks
10 visits (in-person) for Physical Therapy & Exercise, daily self-administered for Duloxetine and Acupressure, weekly telehealth for PRISM-CBT

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

Extension

Participants may continue, switch, or add treatments based on algorithm and randomization

Variable

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

Group I: Physical Therapy & Exercise then add PRISM-CBTExperimental Treatment2 Interventions
Group II: Physical Therapy & Exercise then add DuloxetineExperimental Treatment3 Interventions
Group III: Physical Therapy & Exercise then add AcupressureExperimental Treatment2 Interventions
Group IV: Physical Therapy & Exercise followed by PRISM-CBTExperimental Treatment2 Interventions
Group V: Physical Therapy & Exercise followed by DuloxetineExperimental Treatment3 Interventions
Group VI: Physical Therapy & Exercise followed by AcupressureExperimental Treatment2 Interventions
Group VII: Physical Therapy & Exercise and continueExperimental Treatment2 Interventions
Group VIII: PRISM-CBT then add Physical Therapy & ExerciseExperimental Treatment3 Interventions
Group IX: PRISM-CBT then add DuloxetineExperimental Treatment3 Interventions
Group X: PRISM-CBT then add AcupressureExperimental Treatment3 Interventions
Group XI: PRISM-CBT followed by Physical Therapy & ExerciseExperimental Treatment3 Interventions
Group XII: PRISM-CBT followed by DuloxetineExperimental Treatment3 Interventions
Group XIII: PRISM-CBT followed by AcupressureExperimental Treatment3 Interventions
Group XIV: PRISM-CBT and continueExperimental Treatment2 Interventions
Group XV: Duloxetine then add Physical Therapy & ExerciseExperimental Treatment3 Interventions
Group XVI: Duloxetine then add PRISM-CBTExperimental Treatment3 Interventions
Group XVII: Duloxetine then add AcupressureExperimental Treatment3 Interventions
Group XVIII: Duloxetine followed by Physical Therapy & ExerciseExperimental Treatment2 Interventions
Group XIX: Duloxetine followed by PRISM-CBTExperimental Treatment3 Interventions
Group XX: Duloxetine followed by AcupressureExperimental Treatment2 Interventions
Group XXI: Duloxetine and ContinueExperimental Treatment2 Interventions
Group XXII: Acupressure then continueExperimental Treatment2 Interventions
Group XXIII: Acupressure then add Physical Therapy & ExerciseExperimental Treatment3 Interventions
Group XXIV: Acupressure then add PRISM-CBTExperimental Treatment3 Interventions
Group XXV: Acupressure then add DuloxetineExperimental Treatment3 Interventions
Group XXVI: Acupressure followed by Physical Therapy & ExerciseExperimental Treatment3 Interventions
Group XXVII: Acupressure followed by PRISM-CBTExperimental Treatment3 Interventions
Group XXVIII: Acupressure followed by DuloxetineExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

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 ...

Mindfulness 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 ...

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 ...