What side effects are associated with this type of intervention?

Common treatments for chronic lower back pain, such as pain self-management education combined with tailored exercise and physical activity, generally have minimal side effects. However, patients may experience muscle soreness, fatigue, or temporary increases in pain as they adjust to new physical activities. Oral anti-inflammatory or analgesic medications can cause gastrointestinal issues, liver or kidney damage, and increased risk of cardiovascular events. Cognitive behavioral therapy (CBT) is generally safe but may cause temporary emotional discomfort as patients confront pain-related thoughts and behaviors. Overall, these treatments are considered safer compared to surgical options or long-term opioid use, which carry higher risks of complications and addiction.

What other types of research exist?

Promising novel alternatives to Enhanced Physical Therapy for CLBP patients include: 1) Telerehabilitation-Based McKenzie Therapy (TBMT), which has shown comparable effects to clinic-based therapy. 2) Cognitive Behavioral Therapy (CBT), which can be delivered online and has been effective in managing chronic pain. 3) Pedometer-driven walking programs, which have demonstrated feasibility and effectiveness in increasing physical activity and reducing pain. 4) Acceptance and Commitment Therapy (ACT) delivered online, which has shown efficacy in chronic pain management. 5) Mind-Body Therapies, such as mindfulness and meditation, which have been effective in reducing pain and improving quality of life.

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Enhanced Physical Therapy for Chronic Lower Back Pain (SCEPTER Trial)

Q: What prior FDA approvals exist?

The FDA has approved various treatments for chronic lower back pain, including pharmacologic options like NSAIDs and acetaminophen, and non-pharmacologic treatments such as physical therapy and exercise programs. Enhanced Physical Therapy, which combines pain self-management education with tailored exercise and physical activity, aligns with these non-pharmacologic approaches. While specific FDA approvals for combined therapies like Enhanced Physical Therapy are not detailed, the components—exercise and pain management education—are well-supported in clinical practice for managing chronic lower back pain.

N/A

Recruiting

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low back pain present for at least 6 months

Low back pain present for at least 6 months, present most days or everyday, and interferes the most with activities

Must not have

Refusal to provide written consent

Undergoing evaluation for back surgery or planned back surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3,6, 9, and 12 months post-treatment

Summary

This trial aims to find the best non-drug treatments for chronic low back pain in U.S. Veterans. It compares regular care, online programs, and physical therapy first. If needed, patients can then try yoga, spinal adjustments, or mental health therapy to manage their pain.

Who is the study for?

This trial is for US Veterans over 18 with chronic lower back pain lasting at least 6 months, who can attend in-person sessions and have internet access. It's not for those currently in another study, with certain acute illnesses or recent heart issues, pregnant women, or those recently treated with CBT, SMT, or Yoga.

What is being tested?

The study tests non-surgical treatments for chronic low back pain. Step one compares continued care to an internet-based self-management program and enhanced physical therapy. Those needing further treatment proceed to step two: yoga, spinal manipulation therapy (SMT), or cognitive behavioral therapy (CBT).

What are the potential side effects?

Potential side effects may include discomfort from exercise-related activities and temporary soreness from therapies like SMT. Psychological distress could arise from CBT discussions about personal issues related to pain management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had low back pain for at least 6 months.

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I have had low back pain almost every day for the last 6 months, affecting my daily activities.

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My pain affects my enjoyment and activity level significantly.

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I can go to the clinic for my treatments.

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My pain affects my enjoyment and activity level significantly.

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I experience low back pain almost every day.

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I can go to the clinic for my treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing to provide written consent.

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I am being evaluated for or planning to have back surgery.

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I do not have any severe illnesses that would stop me from receiving the study treatments.

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I do not have any nerve problems from spine disease that stop me from joining the study.

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I do not have severe cognitive, hearing, or visual impairments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3,6, 9, and 12 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3,6, 9, and 12 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3,6, 9, and 12 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Brief Pain Inventory (BPI) Interference scale

EuroQol Quality of Life Scale (EQ-5D-5L)

Follow-up Treatments and Medications

+12 more

Trial Design

6Treatment groups

Active Control

Placebo Group

Group I: Enhanced Physical TherapyActive Control2 Interventions

Intervention that combines the internet-based pain self-management program with tailored exercise and physical activity guided by a physical therapist (Step 1 treatment)

Group II: YogaActive Control1 Intervention

The Yoga for Veterans with cLBP program consists of up to 10 weekly, 60-minute instructor-led sessions along with 15-20 minutes of yoga practiced at home each non-session day. The initial session is 75 minutes (15 minutes longer than the other sessions). The yoga program can be considered classical hatha yoga with influences from Iyengar and Viniyoga yoga. These styles emphasize modifications and adaptations including the use of props such as straps and blocks to minimize the risk of injury and make the poses accessible to people with health problems and limitations (Iyengar, 1979). The instructor leads participants through a series of 23 yoga poses (32 total variations) at a slow-moderate pace (Step 2 Treatment).

Group III: Spinal Manipulation Therapy (SMT)Active Control1 Intervention

After examination by a qualified Doctor of Chiropractic (DC), a SMT intervention consisting of up to 10 sessions over 3 months will be designed focusing on spinal manipulation and/or mobilization of the lower thoracic, lumbar and/or sacroiliac joints. Adjunctive use of myofascial and/or stretching techniques are allowed as they are commonly used along with SMT, and can be considered a standard accompaniment to SMT (Step 2 Treatment).

Group IV: Internet-based pain self-management programActive Control1 Intervention

Internet-based treatment (Step 1 Treatment)

Group V: Cognitive Behavioral Therapy (CBT)Active Control1 Intervention

Participants randomized to CBT in Step 2 will receive treatment with a trained therapist using the VA's CBT-chronic pain (CBT-CP) protocol involving one planning session and 9 treatment sessions (10 total) over 3 months (Step 2 Treatment).

Group VI: Continued Care and Active Monitoring (CCAM)Placebo Group1 Intervention

CCAM will not be standardized keeping in line with the pragmatic nature of this trial. CCAM may be variable across sites and for individual participants reflecting de facto clinical practice for cLBP. Clinical practice may involve pharmacological and non-pharmacological treatments for cLBP. Current analgesics (including opioids, acetaminophen, NSAIDs, topical analgesics (capsaicin), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, skeletal muscle relaxants, and alpha-2-delta ligands (gabapentin-like drugs)) and non-pharmacological treatments may be continued by participants. CCAM participants will be encouraged to discuss pain problems with their treating physician, but not begin new treatments if possible. Patients will specifically be discouraged from starting CBT, chiropractic, or yoga. Other than this, there will be no attempt by study personnel to influence pain management (Step 1 Treatment)

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Enhanced Physical Therapy for Chronic Lower Back Pain (CLBP) combines pain self-management education with tailored exercise and physical activity to address both the physical and psychological aspects of pain. This approach helps patients understand their pain, develop coping strategies, and improve their physical function through targeted exercises. Cognitive Behavioral Therapy (CBT) focuses on changing pain-related thoughts and behaviors, reducing distress, and improving pain management. Yoga and Spinal Manipulation Therapy (SMT) enhance flexibility, strength, and neuromuscular function, contributing to pain relief and functional improvement. These treatments are crucial for CLBP patients as they offer holistic, non-pharmacological options that can lead to sustainable pain management and improved quality of life.

Evaluation of patients' needs to design and assess a patient education program in cancer pain.Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.A multicenter real-world review of 10 kHz SCS outcomes for treatment of chronic trunk and/or limb pain.