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Back Exosuit for Lower Back Pain

N/A

Recruiting

Led By Lou N. Awad, PhD,DPT

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported LBP with bending or lifting

Age 18-70

Must not have

Must not have had LBP lasting less than 2 weeks

Diagnosed or self-reported neurological disorders effecting motor control (stroke, Parkinson's disease, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how a device worn during physical therapy can help reduce Low Back Pain and improve movement. Results will help decide if larger trials should be done.

Who is the study for?

This trial is for individuals aged 18-70 with lower back pain (LBP) that worsens with bending or lifting. Participants must be able to walk unaided, provide consent, and communicate with healthcare providers. They should not be pregnant, have had recent back surgery, experience pain extending below the buttock, suffer from neurological disorders affecting movement control like stroke or Parkinson's disease, use a pacemaker or similar devices, currently undergo cancer treatment, or have skin conditions aggravated by wearing an exosuit.

What is being tested?

The study tests a wearable soft robotic 'exosuit' designed to alleviate LBP during physical therapy sessions. It aims to see if this high-tech garment can reduce pain and disability and improve patients' ability to train and move. The results will help plan a larger trial on the effectiveness of this innovative approach in treating LBP.

What are the potential side effects?

Since this is a non-drug intervention focusing on a wearable device for physical support during therapy sessions for back pain relief, specific side effects are not listed but may include discomfort while wearing the device or potential skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience lower back pain when I bend or lift.

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I am between 18 and 70 years old.

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I can walk on my own without needing help from devices.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lower back pain has lasted for more than 2 weeks.

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I have a neurological disorder affecting my movement.

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I do not have pain that spreads down my leg from my lower back.

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I am currently receiving treatment for cancer.

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I can attend all visits and a phone follow-up after a month.

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I have not had surgery for my current lower back pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (time 0), all follow-up visits (up to 8 weeks of treatment) and post-discharge follow-up (up to 13 months from time 0) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Biomechanical Suit Effect measured by Trunk range of motion

Change in Biomechanical Suit Effect measured by Trunk velocity

Change in Biomechanical Suit Effect measured by trunk coordination

+9 more

Secondary study objectives

Change in Pain measured by Numerical rating scale of pain (worst in last 24 hours)

Change in Patient-reported Disability score measured by the modified Oswestry Disability Questionnaire (MDQ)

Other study objectives

Change in Patient-reported anxiety symptoms: Generalized anxiety disorder 2-item scale (GAD-2)

Change in Patient-reported physical function: Patient specific functional scale (PSFS)

Change in Physical Function: 5x sit to stand

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Exosuit Augmented Physical TherapyExperimental Treatment1 Intervention

participants will attend an in person screening, initial visit (1), 10 (2-11) sessions of physical therapy and a discharge visit (12). Participants will undergo a comprehensive biomechanical analysis on visits 1, 3, 6, 9 and 12, completing an extensive battery of surveys at visits 1, discharge, and 1-month post-discharge. Treatment will incorporate evidence-based physical therapy care based on clinical presentation to include manual therapy, therapeutic exercise, and functional therapeutic activities. A portion of each session will include exosuit use.

0 / 9Eligibility criteria met