In-Person (or Remote) Intervention for Low Back Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Florida, Gainesville, FL
Low Back Pain+2 More
In-Person (or Remote) Intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

EMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward

See full description

Eligible Conditions

  • Low Back Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether In-Person (or Remote) Intervention will improve 7 primary outcomes and 4 secondary outcomes in patients with Low Back Pain. Measurement will happen over the course of Baseline to Week 1.

Baseline
Treatment Credibility
Baseline to 8 Months
Participant Retention
Pleasant Activity Engagement
Recruitment Rate
Baseline to 8 months
Global Treatment Engagement
Session-level Engagement (NOTE: this is a pilot study and there is not a true . There are several descriptive outcomes that will inform our decision to proceed to a traditional, fully powered clinical trial).
Baseline to Week 1
Enrollment Rate
Month 8
Body Weight
Meaningful Activity Participation
Pain Impact
Month 8
Participant Satisfaction

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

In-Person (or Remote) Intervention Visits
1 of 1
Experimental Treatment

This trial requires 48 total participants across 1 different treatment group

This trial involves a single treatment. In-Person (or Remote) Intervention 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.

In-Person (or Remote) Intervention Visits
Behavioral
Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Due to COVID-19, intervention sessions may be delivered online through PHI Zoom. Group sessions will be delivered every-other week and phone calls will occur every-other week (during weeks with no group). Sessions will be administered by a study interventionist with bachelors- or masters-level training and certification in health education or a related field (e.g., Certified Health Education Specialist), and materials will be developed to be appropriate for delivery by this level of training, given the potential for greater availability of these types of health professionals.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4 months, 8 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 4 months, 8 months for reporting.

Closest Location

University of Florida - Gainesville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
45-80 years of age
Have a BMI≥25kg/m2
Endorse pain in the lower back region (i.e., space between the lower posterior margin of the rib cage and the horizontal gluteal fold), knees, or hips
Pain must occur on at least 50% of the days in the previous six months
Pain must be rated, at minimum, of moderate intensity (rating of 3 on a numeric rating scale ranging from 0-10)
Pain impact must be rated as moderate to severe
Study physician, Shawn McGargill, MD, reviews medical record and declares patient medically appropriate for exercise protocol

Patient Q&A Section

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

"Approximately 11 million adults seek medical treatment for back pain each year. The data suggest that back pain is more prevalent in the United States than in a number of developed countries. The findings from this study also show that the need for care for back pain may be higher in the United States than in other developed countries." - Anonymous Online Contributor

Unverified Answer

What are common treatments for back pain?

"Pain management is a common treatment for [back pain](https://www.withpower.com/clinical-trials/back-pain) and is often difficult to relieve. One of the most common treatments for back pain is a fusion or rod placement. The placement of a fusion rod or screw usually results in little pain relief, but it does ease the mobility of a spine that has been damaged by trauma, tumor, or disease. Stretching and adjusting exercises such as the McKenzie brace or slant seat exercises have been proven to be highly effective for treating chronic back pain. Exercises such as shoulder shrugs, calf raisers, and lunges and abdominal exercises that strengthen the glutes, lower back and core are also part of the back pain management program." - Anonymous Online Contributor

Unverified Answer

What causes back pain?

"The cause of back pain is complex. Many predisposing and precipitating factors, including genetic and psychological characteristics, environmental events such as work load, physical injuries, and lifestyle, are associated with back pain. In many patients, the cause of back pain can only be determined when other confounding factors are controlled for." - Anonymous Online Contributor

Unverified Answer

Can back pain be cured?

"Pain is caused by a complex interplay between the brain and the extremities, including extrinsic and intrinsic factors. Pain management involves pain-management that is multidisciplinary. Current guidelines are ambiguous, indicating that only 50 to 70% of patients with back pain can be cured with existing treatments." - Anonymous Online Contributor

Unverified Answer

What are the signs of back pain?

"Pain may be present in the back, upper back, or hips or shoulders. It may feel like an old injury but present a little differently during the day or night. Pain or stiffness in the back is also known as sciatica. It may be caused by a degenerated disc, spinal fusion or infection. Spinal stenosis is a very common condition at the root of [back pain](https://www.withpower.com/clinical-trials/back-pain). It is a condition where there is a tightness or restriction at the base of part of the spine." - Anonymous Online Contributor

Unverified Answer

What is back pain?

"The prevalence of [back pain](https://www.withpower.com/clinical-trials/back-pain) in US adults is low, but pain worsens the quality of life of many people, and its burden is increasing. Future research is needed to understand and ameliorate the risk factors and processes contributing to the etiology, trajectory and presentation of back pain; its persistence and risk of being chronic. There are also urgent questions about the best quality care for individuals with back pain and ways to reduce their use of health resources." - Anonymous Online Contributor

Unverified Answer

What is the latest research for back pain?

"The current literature is extremely interesting, but often too broad to be applied to clinical practice, given the nature of the scientific research. For example, more research is needed to elucidate what kind of treatment is most effective in relieving the patient’s pain. However, recent advances in the treatment of back pain will likely come to the clinic soon, and for this reason, we advise our patients to continue checking back pain literature updates." - Anonymous Online Contributor

Unverified Answer

How serious can back pain be?

"In most cases, [back pain](https://www.withpower.com/clinical-trials/back-pain) is reasonably manageable. The main treatment objectives are to reduce pain and to maintain muscle tone. Although some people have severe back pain that is refractory to treatment and prevents them from doing everyday activities, spinal surgery with or without fusion will not solve their chronic back pain. Findings from a recent study strongly indicate that back pain can be a normal symptom, in patients with normal spines, who have undergone successful fusion surgery." - Anonymous Online Contributor

Unverified Answer

How does in-person (or remote) intervention work?

"Results indicate that one-time, in-person interventions are not necessarily superior to no intervention. Remote interventions can be effective by changing the patient's attitude or changing the patient's interaction style with caregivers (i.e. the patient's ability to listen and reciprocate care-giving attentions)." - Anonymous Online Contributor

Unverified Answer

Does back pain run in families?

"Back pain is not linked to family history of back pain, suggesting that genetic susceptibility to back pain is a complex trait, possibly the result of the summation of a number of susceptibility factors." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of in-person (or remote) intervention?

"In this pilot study, the prevalence and intensity of the most frequently reported side effects were in accordance with those previously reported for other online psychological interventions. Future studies, however, are needed to examine whether specific measures or technologies in these interventions could reduce their prevalence." - Anonymous Online Contributor

Unverified Answer

Has in-person (or remote) intervention proven to be more effective than a placebo?

"A study evaluating the effectiveness of individualized, motivational, face-to-face telephone counseling delivered by a specialist in a primary care setting may detect statistically and clinically significant improvements similar to those found in published systematic reviews. A comparison of the results of the study with that of a well-established and accepted intervention and treatment in medicine, of the management of depression, is necessary to establish a meaningful standard of comparison." - 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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