Supported Biopsychosocial Self-Management (SBSM) for Intervertebral Disc Displacement

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Minnesota, Minneapolis, MN
Intervertebral Disc Displacement+5 More
Supported Biopsychosocial Self-Management (SBSM) - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a self-management intervention is more effective than medical care for chronic low back pain.

See full description

Eligible Conditions

  • Intervertebral Disc Displacement
  • Sciatica
  • Pain, Chronic
  • Back Related Leg Pain
  • Low Back Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Intervertebral Disc Displacement

Study Objectives

This trial is evaluating whether Supported Biopsychosocial Self-Management (SBSM) will improve 16 primary outcomes, 8 secondary outcomes, and 4 other outcomes in patients with Intervertebral Disc Displacement. Measurement will happen over the course of Through study treatment, an average of 3 months.

Month 3 assessment
Percentage of enrollees completing the month 3 assessment
Month 6 assessment
Percentage of enrollees completing the month 6 assessment
Month 6
Percentage of weekly pain severity and frequency assessments completed
Month 6
Average time to enrollment from initial screening
Number of participants enrolled per month
Number of particpants screened per month
Participant views and perspectives on research participation
Percentage of enrolled participants who are female
Percentage of enrolled participants who are minorities
Percentage of participants declining participation
Percentage of participants excluded by eligibility criterion
Percentage of participants screened per month by recruitment method
Percentage of participants screened who are female by recruitment method
Percentage of participants screened who are minorities by recruitment method
Percentage of screened participants who are female
Percentage of screened participants who are minorities
Month 3
Enrollee views of intervention
Percentage of enrollees attending required sessions
Percentage of enrollees in medical care group reporting taking medications as prescribed
Percentage of enrollees in supported biopsychosocial self-management group reporting participation in home practice
Percentage of enrollees not receiving any treatment
Percentage of enrollees receiving prohibited treatments
Percentage of enrollees satisfied with treatment
Percentage of enrollees withdrawing from treatment
Percentage of provider visits where all required intervention activities were delivered
Percentage of required intervention activities not performed by provider
Provider beliefs regarding back-related leg pain
Provider views of intervention

Trial Safety

Safety Progress

1 of 3

Other trials for Intervertebral Disc Displacement

Trial Design

2 Treatment Groups

Medical Care
1 of 2
Supported Biopsychosocial Self-Management (SBSM)
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Supported Biopsychosocial Self-Management (SBSM) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Supported Biopsychosocial Self-Management (SBSM)
Behavioral
Supported Biopsychosocial Self-Management (SBSM)
Medical Care
Drug
Medical Care

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 6 assessment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly month 6 assessment for reporting.

Closest Location

University of Minnesota - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Back-related leg pain (BRLP) consistent with the Quebec Task Force (QTF) classifications 2-4 (radiating pain into proximal or distal extremity with or without neurological signs).
18 years of age or older.
Back-related leg pain severity of 3 or higher at all screening assessments (0 to 10 scale)
Episode duration of 12 weeks or more
Ability to read English fluently

Patient Q&A Section

What causes low back pain?

"There are many medical conditions that cause low back pain: back pain may be due to musculoskeletal (soft tissue) disorders, neurological disorders, or diseases of the skeleton. Common musculoskeletal conditions related to back pain include [degenerative disc disease](https://www.withpower.com/clinical-trials/degenerative-disc-disease), spinal stenosis, and osteoporosis. Neurological conditions related to low back pain include radiculopathy, neuralgia, myeloproliferative, and infectious disorders (e.g., Lyme disease, sciatica). Rarer diseases of the spine can cause back pain, including Paget disease of bone, metastatic carcinoma, and spinal tumor. Conditions of the spine can, in many cases, not be adequately explained by the preceding conditions." - Anonymous Online Contributor

Unverified Answer

What is low back pain?

"LBP refers to pain between the back and the tailbone, when standing, or lying down. There can be many causes of LBP, but there tends to be a self-perpetuating cycle of the disorder as the cause can only be changed." - Anonymous Online Contributor

Unverified Answer

How many people get low back pain a year in the United States?

"Between the years 2000-2009, there was 1.6 million new cases of low back pain. This would translate into an annual incidence of 12.6 per 10,000 population for those aged 40-64 years. The age distribution can be attributed to older age in the population and, thus, the lower number of new cases between the years 2000-2009. As a result, the probability of low back pain within an individual will, in fact, increase steadily with ageing, while the probability of low back pain within a population will remain comparatively constant; in other words, age is not a risk factor for low back pain." - Anonymous Online Contributor

Unverified Answer

Can low back pain be cured?

"A reduction in the number of days of low back pain can not be considered as a result of a cure of the underlying LBP condition, due to a change in the average LBP intensity." - Anonymous Online Contributor

Unverified Answer

What are common treatments for low back pain?

"A few of the most common treatments are effective for chronic low [back pain](https://www.withpower.com/clinical-trials/back-pain). These include low-dose NSAIDs such as aspirin or naproxen. Acetaminophen or other NSAIDs are a viable alternative, especially when used before going to bed. A combination of NSAIDS and opioids is effective for managing chronic pain. Other common treatments are chiropractic treatments, exercise, and spinal manipulation. Steroid injections may be effective for certain patients, but evidence is weak for their use. No treatment is effective for all cases of back pain. More research is needed to determine which treatments provide short-term pain relief and which do not." - Anonymous Online Contributor

Unverified Answer

What are the signs of low back pain?

"The majority of individuals presenting to primary care clinics with signs of low back pain have other potential causes, and are unlikely to have a life-threatening condition at admission." - Anonymous Online Contributor

Unverified Answer

Does supported biopsychosocial self-management (sbsm) improve quality of life for those with low back pain?

"A number of studies are in existence to support the view that CIMT can be successful in reducing disability and pain associated with specific physical conditions, such as chronic musculoskeletal pain and CFS/ME. Supported biopsychosocial self-management (sbsm) approaches are believed to be similar in efficacy in reducing disability and pain associated with chronic musculoskeletal pain, however, the mechanism of action or mechanism of action has yet to be fully understood. In the specific case of CFS/ME, the clinical significance of self-management approaches is also clear, since those who self-manage have been shown to have a significantly lower chance of being disabled at work." - Anonymous Online Contributor

Unverified Answer

What is the latest research for low back pain?

"In the absence of evidence to the contrary, we are assuming that the following therapies have similar analgesic effects on chronic low-back pain: transcutaneous electrical nerve stimulation, spinal cord stimulation, and behavioral therapies." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of supported biopsychosocial self-management (sbsm)?

"SBSM patients will most probably complain of insomnia and emotional distress or discomfort, and may also complain of decreased appetite, depression, insomnia, fatigue, back discomfort, and constipation. Other side effects may be more common in certain patient populations or with certain treatment modalities, such as changes in medication." - Anonymous Online Contributor

Unverified Answer

How serious can low back pain be?

"A substantial proportion of all LBP cases has severe duration. At least half of the patients received some type of treatment. Even though the proportion of LBP cases that can be treated is high, many had not been assessed, and the proportion of patients receiving long-term treatment is less than 15%. There is a need for more effective assessment in primary care before long-term treatment." - Anonymous Online Contributor

Unverified Answer

Does low back pain run in families?

"There are several potential risk factors associated with low back pain and low back pain behavior. This paper examines the link between low back pain behavior and shared family environment factors, and identifies a number of potential familial effects." - Anonymous Online Contributor

Unverified Answer

Is supported biopsychosocial self-management (sbsm) typically used in combination with any other treatments?

"The majority of participants in the CB-CBT and PT-CBT groups completed a sbsm program in addition to their regular therapy. However, in the CB-PBT group, only half completed a sbsm program in addition to usual care (see 'Description of self-management intervention')." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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