Enhanced Physical Therapy for Chronic Lower Back Pain

(SCEPTER Trial)

Recruiting at 17 trial locations

Overseen By Charles Penza, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Uncontrolled hypertension, Recent myocardial infarction, Severe psychiatric illness, others

Compensation: Varies

Number of Visits: Unknown

2529 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best treatment for chronic lower back pain in veterans, focusing on non-surgical and non-drug options. In the first phase, participants will try either regular care, an online pain management program, or enhanced physical therapy with personalized exercises. If the initial treatment proves insufficient, participants may choose to try yoga, spinal manipulation therapy (such as chiropractic care), or cognitive behavioral therapy (talk therapy to change pain-related thoughts). Veterans who have experienced back pain almost daily for at least six months and find it significantly disrupts their daily activities may be well-suited for this trial. As an unphased trial, it offers veterans the chance to explore innovative, non-invasive treatments that could improve their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on non-drug treatments for chronic lower back pain.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this study for managing chronic lower back pain are generally safe and well-tolerated.

For the Pain EASE program, which combines online pain self-management with personalized exercises, previous studies have shown that this method often reduces pain without causing serious side effects.

Yoga is considered safe for people with chronic back pain. One study found that a 12-week yoga program was not only effective but also safe and practical for participants, with few risks involved.

Spinal Manipulation Therapy (SMT) has also been studied for safety. While mild to moderate effects like temporary discomfort can occur, serious side effects are rare. Research supports its use for easing lower back pain.

Cognitive Behavioral Therapy (CBT) is another safe treatment. Studies have shown it helps manage chronic pain and improve quality of life, with minimal negative effects.

Overall, these treatments have been studied and are considered safe for managing chronic lower back pain. However, discussing any concerns with a healthcare provider before starting a new treatment is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for chronic lower back pain, which often rely on medication or generic physical therapy, the Enhanced Physical Therapy approach is unique because it combines an internet-based pain self-management program with personalized exercises guided by a physical therapist. This tailored approach allows for a more individualized treatment plan, potentially leading to better pain management and improved mobility. Researchers are excited about this method because it empowers patients to actively participate in their recovery, leveraging technology to enhance traditional therapy. Additionally, the inclusion of yoga and spinal manipulation therapy offers a holistic approach, focusing on both mental and physical well-being, which is a departure from the standard reliance on pharmaceuticals alone.

What evidence suggests that this trial's treatments could be effective for chronic lower back pain?

Research has shown that enhanced physical therapy, which includes self-managed pain control and specific exercises, can help with chronic low back pain (cLBP). In this trial, participants may receive enhanced physical therapy, yoga, spinal manipulation therapy (SMT), or cognitive behavioral therapy (CBT) as separate treatment options. Studies have found that treatments like CBT and mindfulness effectively reduce pain and improve mobility. Yoga has also lessened pain, increased flexibility, and reduced the need for medication in people with cLBP. SMT provides benefits similar to other recommended treatments for cLBP, offering pain relief and improved movement. CBT has reduced pain and disability more effectively than standard care. Each of these treatments shows promise for managing chronic low back pain. ^{3 5 6 7 8}

Who Is on the Research Team?

David J Clark, PhD MD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Matthew J. Bair, MD MS

Principal Investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Stable access to the internet at home, work, or other location (e.g. mobile phone), and an email address

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

Exclusion Criteria

Currently enrolled in any other interventional study unless exempted by CSP

You have a serious problem with alcohol or drug abuse.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Step 1 Treatment

Participants receive either continued care and active monitoring (CCAM), internet-based pain self-management (Pain EASE), or an enhanced physical therapy intervention combining Pain EASE with tailored exercise and physical activity.

3 months

Step 2 Treatment

Participants who do not achieve significant pain reduction in Step 1 or desire additional treatment are randomized to yoga, spinal manipulation therapy (SMT), or cognitive behavioral therapy (CBT).

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment to assess the durability of treatment effects.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy (CBT)
• Pain EASE
• Spinal Manipulation Therapy (SMT)
• Tailored exercise
• Yoga

Trial Overview 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).

How Is the Trial Designed?

Group I: Enhanced Physical Therapy Active Control 2 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: Yoga Active Control 1 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 Control 1 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 program Active Control 1 Intervention

Internet-based treatment (Step 1 Treatment)

Group V: Cognitive Behavioral Therapy (CBT) Active Control 1 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 Group 1 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)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a cohort study of patients with low back pain undergoing physical therapy, a 2-point change on the Numerical Pain Rating Scale (NPRS) was found to indicate a clinically meaningful improvement, surpassing measurement error.

The study demonstrated that most patients experienced significant pain reduction after 1 and 4 weeks of rehabilitation, with responsiveness metrics showing strong reliability in assessing pain changes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsiveness of the numeric pain rating scale in patients with low back pain. Childs, JD., Piva, SR., Fritz, JM.[2022]

Kinesio tape significantly improved anticipatory postural control in chronic low back pain patients, particularly enhancing the function of the transversus abdominis muscle compared to standard physical therapy.

Both kinesio tape and conventional therapy reduced pain levels and disability, but the experimental group using kinesio tape showed greater improvements in the Oswestry Disability Index, indicating a more effective intervention for managing chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of kinesio taping on potential in chronic low back pain patients anticipatory postural control and cerebral cortex. Bae, SH., Lee, JH., Oh, KA., et al.[2022]

Manual therapy, particularly joint mobilization of the lumbar spine, can significantly reduce pain and enhance functioning in individuals with chronic low back pain (CLBP).

Therapeutic exercises not only help alleviate pain but can also lead to lasting improvements in functioning, with some patients experiencing benefits for up to a year after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of therapeutic exercise versus manual therapy on athletes with chronic low back pain. Dvorak, H., Kujat, C., Brumitt, J.[2019]

Adding cognitive behavioral treatment (CBT) to routine physical therapy (PT) can improve pain, disability, quality of life, and functional capacity in patients with chronic low back pain, according to a systematic review of 10 randomized controlled trials.

However, the review found no consistent evidence that CBT enhances depression outcomes compared to PT alone, with one high-quality study even showing PT to be more effective than CBT+PT for reducing depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Cognitive Behavioral Therapy on Pain, Quality of Life, and Depression in Patients Receiving Physical Therapy for Chronic Low Back Pain: A Systematic Review. Hajihasani, A., Rouhani, M., Salavati, M., et al.[2020]

In a study of 64 participants with chronic low back pain, those who underwent supervised physical therapy showed statistically significant improvements in pain and disability immediately after treatment compared to those who performed exercises unsupervised at home.

However, by the six-month follow-up, there were no significant differences between the two groups in pain, functionality, fear of movement, or quality of life, suggesting that while supervised therapy may offer short-term benefits, these do not translate into long-term advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of efficacy of a supervised versus non-supervised physical therapy exercise program on the pain, functionality and quality of life of patients with non-specific chronic low-back pain: a randomized controlled trial. Matarán-Peñarrocha, GA., Lara Palomo, IC., Antequera Soler, E., et al.[2022]

Patients with low back pain (LBP) who had symptoms for more than 6 months showed significantly less functional improvement after physical therapy compared to those with symptoms lasting less than 1 month, indicating that longer symptom duration may hinder recovery.

The study found that age, symptom duration, and specific types of exercises (mobilization/manipulation, strengthening, and flexibility) significantly influenced functional improvement, explaining over 55% of the variance in recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in disability following physical therapy intervention for patients with low back pain: dependence on symptom duration. Badke, MB., Boissonnault, WG.[2015]

Physical therapy (PT) significantly improved pain severity and functional status in patients with chronic non-specific low back pain (NSLBP), as evidenced by decreased Visual Analog Scale (VAS) scores and improved Oswestry Disability Index (ODI) scores after treatment.

The study, involving 100 patients, showed that PT also enhanced spinal alignment and mobility, with significant improvements in sagittal spinal alignment and spinal mobility measures only observed in the PT group after 10 treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Physical Therapy on Pain, Functional Status, Sagittal Spinal Alignment, and Spinal Mobility in Chronic Non-specific Low Back Pain. Filiz, MB., Firat, SC.[2022]

In a study of 6,523 patients with low back pain, 42.7% achieved a 30% improvement in disability by the third physical therapy visit, and this increased to 49% by the sixth visit, indicating that many patients benefit from early intervention.

The initial and third visit disability scores were strong predictors of improvement, with excellent diagnostic accuracy (area under the curve values of 0.84 and 0.85) for forecasting significant clinical progress by the sixth visit, highlighting the importance of routine outcome assessments in physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant Clinical Improvement Was Predicted in a Cohort of Patients With Low Back Pain Early in the Care Process. Brennan, GP., Snow, G., Minick, KI., et al.[2023]

In a study of 11,941 patients with low back pain (LBP) receiving physical therapy, those with acute symptoms (0-14 days) showed the greatest improvement in functional status, with an average score change of 29.32, compared to 15.92 for chronic symptoms (>90 days).

The findings suggest that patients with chronic LBP may not benefit as much from physical therapy as those with acute or subacute symptoms, indicating that earlier intervention could lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low Back Pain Chronicity on Patient Outcomes Treated in Outpatient Physical Therapy: A Retrospective Observational Study. Walston, Z., McLester, C., McLester, J.[2020]

Early physical therapy (PT) for acute low back pain significantly reduces short-term pain and disability compared to non-PT care, with a moderate effect size based on a meta-analysis of 7 studies involving various participants.

However, early PT does not show significant advantages over delayed PT in terms of pain or disability outcomes, indicating that while early intervention is beneficial compared to no therapy, the timing of PT may not greatly impact long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical therapy timing on patient-reported outcomes for individuals with acute low back pain: A systematic review with meta analysis of randomized controlled trials. McDevitt, AW., Cooper, CG., Friedrich, JM., et al.[2023]

In a study of 60 male adults with chronic low back pain, Kinesio taping combined with conventional physical therapy significantly reduced pain and disability after 2 and 6 weeks compared to conventional therapy alone.

The experimental group also showed improved lumbar flexion range of motion, indicating that Kinesio taping may enhance the effectiveness of standard physical therapy treatments for chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of Kinesio taping and conventional physical therapy in the management of chronic low back pain: a randomized clinical trial. Pakkir Mohamed, SH., Al Amer, HS., Nambi, G.[2023]

A 12-week high-intensity exercise therapy (HIT) program for chronic nonspecific low back pain (CNSLBP) resulted in significantly greater improvements in disability and exercise capacity compared to a moderate-intensity program, with 38 participants showing marked benefits in pain reduction and functional ability.

HIT was found to be feasible and well-tolerated, demonstrating a 64% reduction in disability and a 14% increase in exercise capacity, indicating that higher intensity training can enhance treatment outcomes for individuals with CNSLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Intensity Matters in Chronic Nonspecific Low Back Pain Rehabilitation. Verbrugghe, J., Agten, A., Stevens, S., et al.[2020]

In a study of chronic low back pain patients undergoing physical therapy, early changes in pain severity after the second, third, and fourth visits were significantly correlated with pain reduction at discharge, indicating that initial responses can be a good predictor of treatment success.

The study found that these early responses could accurately predict discharge outcomes in 80.4% of cases, suggesting that monitoring pain changes early in therapy can help guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ability of early response to predict discharge outcomes with physical therapy for chronic low back pain. Tong, HC., Geisser, ME., Ignaczak, AP.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12153248/

Effects of cognitive behavioral therapy combined with physical ... The combination of CBT intervention and a basic physical therapy program results in better pain reduction in patients with CLBP than in those ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832235

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... Results of the study suggest that both treatments have potential utility in treating adults with refractory CLBP and improving pain, function, and quality-of- ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0325122

The effect of cognitive behavioural therapy on pain and ... Results showed that CBT is more effective in reducing pain and disability compared to waiting list/usual care (WL/UC). CBT in conjunction with other active ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35345623/

Evaluation of Cognitive Behavioral Therapy on Improving ... Conclusion: CBT is beneficial in patients with CLBP for improving pain, disability, fear avoidance, and self-efficacy in CLBP patients. Further ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2023/11100/efficacy_of_cognitive_behavioral_therapy_for.3.aspx

Efficacy of cognitive behavioral therapy for reducing pain... CBT can improve patients' social participation and pain susceptibility to some extent, but it does not show advantages for managing negative emotions.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40193079/

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... In this large trial, CLBP-related symptoms improved, while opioid dosage decreased in both MBT and CBT groups at 6 and 12 months.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... Although evidence has suggested that both hypochondriasis and chronic low-back pain can be treated effectively with CBT [10, 11, 14], this has ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1526590018301421

Randomized Controlled Trial of Nurse-Delivered Cognitive ... This study evaluated a nurse-delivered, telehealth intervention of cognitive-behavioral therapy (CBT) versus supportive psychotherapy for chronic back pain.