Enhanced Physical Therapy for Chronic Lower Back Pain

(SCEPTER Trial)

Recruiting at16 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Enhanced Physical Therapy for Chronic Lower Back Pain?

Research shows that physical therapy can improve function and reduce pain in patients with chronic lower back pain, especially when the therapy is supervised and tailored to the individual's needs. ^{1 2 3 4 5}

Is enhanced physical therapy for chronic lower back pain safe for humans?

The research on physical therapy, including supervised exercise and conventional methods, generally indicates it is safe for managing chronic low back pain, with no significant safety concerns reported in the studies. ^{4 6 7 8 9}

How is the treatment Pain EASE different from other treatments for chronic lower back pain?

Pain EASE may incorporate higher intensity exercise and cognitive behavioral therapy (CBT) as part of its approach, which could lead to better improvements in pain, quality of life, and function compared to traditional lower-intensity exercise or physical therapy alone. ^{4 10 11 12 13}

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

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

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

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).

Participant Groups

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+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Significant Clinical Improvement Was Predicted in a Cohort of Patients With Low Back Pain Early in the Care Process. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Ability of early response to predict discharge outcomes with physical therapy for chronic low back pain. [2006]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Low Back Pain Chronicity on Patient Outcomes Treated in Outpatient Physical Therapy: A Retrospective Observational Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Responsiveness of the numeric pain rating scale in patients with low back pain. [2022]

7. United States 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. [2023]

8. Germany 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. [2023]

9. Japan pubmed.ncbi.nlm.nih.gov

The effects of kinesio taping on potential in chronic low back pain patients anticipatory postural control and cerebral cortex. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of therapeutic exercise versus manual therapy on athletes with chronic low back pain. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Exercise Intensity Matters in Chronic Nonspecific Low Back Pain Rehabilitation. [2020]

12. United States 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. [2020]

13. Turkey 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. [2022]