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Resistance Exercise for Lower Back Pain

N/A

Waitlist Available

Led By Aaron Krych, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Males and Females between ages 18 and 65

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test whether adding a tonal exercise device to standard clinical and chiropractic care can help improve lower back pain.

Who is the study for?

This trial is for men and women aged 18-65 who are experiencing non-specific lower back pain and seeking physical therapy or chiropractic care at Mayo Clinic Rochester. Pregnant women or those unable to attend treatment at this location cannot participate.Check my eligibility

What is being tested?

The study is testing the effectiveness of a tonal exercise system, which is a type of resistance exercise device, when used alongside clinical and chiropractic care in improving short and long term low back pain.See study design

What are the potential side effects?

While not explicitly stated, typical side effects of resistance exercises may include muscle soreness, fatigue, strain injuries if improperly performed, but these will vary by individual.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Isometric Lumbar Strength

Kinesiophobia

PROMIS Subjective Health Assessment score

+1 more

Secondary outcome measures

Frequency of Back Pain Recurrence

Functional Strength

Lumbar Endurance

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Physical Thearpy + Resistance TrainingExperimental Treatment1 Intervention

Subjects will receive standard of care treatments from their physical therapist. In addition, an investigative team member will customize a program of core-strengthening resistance exercises that will be prescribed to all intervention group subjects. Subjects will be expected to complete the protocol twice (2x) per week for an 8 week period. The protocol was approved by the Mayo Clinic IRB. Evaluations will be completed at baseline, week 4, and week 8 for all subject groups. Evaluations will consist of a strength assessment, standard clinical questionnaires about back health, a Sorenson's Back Endurance Test, and ultrasound images of back musculature. Longitudinal follow-ups will be completed quarterly for one year after the initial evaluation. These follow-ups will be performed remotely via phone and/or email and incorporate clinical questionnaires.

Group II: Chiropractic Care + Resistance TrainingExperimental Treatment1 Intervention

Subjects will receive standard of care treatments from their chiropractor. In addition, an investigative team member will customize a program of core-strengthening resistance exercises that will be prescribed to all intervention group subjects. Subjects will be expected to complete the protocol twice (2x) per week for an 8 week period. The protocol was approved by the Mayo Clinic IRB. Evaluations will be completed at baseline, week 4, and week 8 for all subject groups. Evaluations will consist of a strength assessment, standard clinical questionnaires about back health, a Sorenson's Back Endurance Test, and ultrasound images of back musculature. Longitudinal follow-ups will be completed quarterly for one year after the initial evaluation. These follow-ups will be performed remotely via phone and/or email and incorporate clinical questionnaires.

Group III: Chiropractic CareActive Control1 Intervention

Subjects will receive standard of care treatments from their chiropractor. Evaluations will be completed at baseline, week 4, and week 8 for all subject groups. Evaluations will consist of a strength assessment, standard clinical questionnaires about back health, a Sorenson's Back Endurance Test, and ultrasound images of back musculature. Longitudinal follow-ups will be completed quarterly for one year after the initial evaluation. These follow-ups will be performed remotely via phone and/or email and incorporate clinical questionnaires.

Group IV: Physical ThearpyActive Control1 Intervention

Subjects will receive standard of care treatments from their physical therapist. Evaluations will be completed at baseline, week 4, and week 8 for all subject groups. Evaluations will consist of a strength assessment, standard clinical questionnaires about back health, a Sorenson's Back Endurance Test, and ultrasound images of back musculature. Longitudinal follow-ups will be completed quarterly for one year after the initial evaluation. These follow-ups will be performed remotely via phone and/or email and incorporate clinical questionnaires.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,766,953 Total Patients Enrolled

Aaron Krych, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

165 Total Patients Enrolled

Nathaniel A Bates, PhDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any opportunities for participation in the experiment available at this time?

"According to the information on clinicaltrials.gov, this particular trial is not currently recruiting patients; it was first posted on November 1st 2020 and last updated on September 28th 2022. Even so, there are 336 other trials that participants may be eligible for right now."

Answered by AI

Who is most suitable to partake in this investigation?

"Eligibility for this trial requires individuals with low back pain and in the age bracket of 18 to 65. The study is hoping to recruit approximately 120 patients."

Answered by AI

Are individuals aged 20 and above eligible for enrollment in this trial?

"The population of patients eligible to enroll in this trial is restricted between 18 and 65 years old. A total of 11 trials are aimed at minors, while 266 studies target seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tonal Exercise System to Improve Short and Long Term Low Back Pain

Aaron Krych 2020. "Tonal Exercise System to Improve Short and Long Term Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04543396.

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