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Enhanced Physical Therapy for Chronic Lower Back Pain (SCEPTER Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3,6, 9, and 12 months post-treatment
Awards & highlights
SCEPTER Trial Summary
This trial is testing whether an enhanced physical therapy intervention, combining pain self-management education with a tailored exercise program, can reduce pain interference more than internet-based pain self-management or usual care in Veterans with chronic low back 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.Check my eligibility
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).See study design
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.
SCEPTER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
My pain affects my enjoyment and activity level significantly.
Select...
I can go to the clinic for my treatments.
Select...
My pain affects my enjoyment and activity level significantly.
Select...
I experience low back pain almost every day.
Select...
I can go to the clinic for my treatments.
SCEPTER Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Brief Pain Inventory (BPI) Interference scale
EuroQol Quality of Life Scale (EQ-5D-5L)
Follow-up Treatments and Medications
+12 moreSCEPTER 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)
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,302,755 Total Patients Enrolled
David J Clark, PhD MDStudy ChairVA Palo Alto Health Care System, Palo Alto, CA
Matthew J. Bair, MD MSStudy ChairRichard L. Roudebush VA Medical Center, Indianapolis, IN
4 Previous Clinical Trials
1,154 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious problem with alcohol or drug abuse.I have had low back pain for at least 6 months.I have recently been involved in Cognitive Behavioral Therapy, Spinal manipulation, or Yoga.I have had low back pain almost every day for the last 6 months, affecting my daily activities.I am willing to provide written consent.My most severe pain is in my lower back.My most severe pain affects my daily activities the most.I am being evaluated for or planning to have back surgery.My pain affects my enjoyment and activity level significantly.I do not have any severe illnesses that would stop me from receiving the study treatments.My condition has been present for at least 6 months.I do not have any nerve problems from spine disease that stop me from joining the study.You have a serious mental illness, like hallucinations, thoughts of harming yourself, or needing to stay in the hospital for mental health reasons in the last 6 months.I am a veteran, 18 or older, of any sex and ethnicity.I can go to the clinic for my treatments.My pain affects my enjoyment and activity level significantly.My symptoms are present most days or every day.You are able to understand and are willing to sign the study informed consent form.I experience low back pain almost every day.You have stable access to the internet at home, work, or other location (e.g.I do not have severe cognitive, hearing, or visual impairments.I am a veteran aged 18 or older.You anticipate continuing care at the enrolling VA for the period of the study.I have low back pain.I can go to the clinic for my treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Physical Therapy
- Group 2: Continued Care and Active Monitoring (CCAM)
- Group 3: Yoga
- Group 4: Spinal Manipulation Therapy (SMT)
- Group 5: Internet-based pain self-management program
- Group 6: Cognitive Behavioral Therapy (CBT)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Lower Back Pain Patient Testimony for trial: Trial Name: NCT04142177 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many distinct locations is this medical trial taking place?
"This clinical trial is currently being conducted in 21 distinct sites, including Salisbury W.G. (Bill) Hefner VA Medical Center located in Salisbury, VA Portland Health Care System situated in Portland, OR and Richard L. Roudebush VA Medical Center found within Indianapolis in., as well as many other locations around the US."
Answered by AI
Can you confirm if enrollment is open for this clinical trial?
"The clinical trial is still open for applications, as evidenced by the information available on clinicaltrials.gov which was last updated in July of 2022 following its initial posting date in June."
Answered by AI
What is the current intake capacity for participants in this clinical experiment?
"This randomized controlled trial requires 2,529 subjects that meet the pre-defined eligibility criteria. Potential participants can register at Salisbury W.G. (Bill) Hefner VA Medical Center in North carolina or VA Portland Health Care System in Oregon."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Nevada
Arizona
Other
How old are they?
65+
What site did they apply to?
VA Palo Alto Health Care System, Palo Alto, CA
Phoenix VA Health Care System, Phoenix, AZ
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
2
What questions have other patients asked about this trial?
How long and often does process take? Is there any compensation for this study?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
Nothing has alleviated my pain. Haven’t done any drugs for my pain yet. i want to get rid of my chronic back pain.
PatientReceived 1 prior treatment
I have tried everything and nothing has helped. I have had two back surgeries and still have chronic back pain.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA: < 24 hours
Average response time
- < 1 Day
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