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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04543396
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Nathaniel (Nate) A. Bates, Mayo Clinic

Brief Summary:
This study will assess the effect of incorporating a tonal exercise device into clinical and chiropractic care for lower back pain.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Resistance exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Four study groups will be assessed in parallel. Subjects will encompass patients who have sought physical therapy or chiropractic care for nonspecific lower back pain. Clinical care selection will be made by subject and clinical care team prior to study enrollment and will be made in the best interest of the subject. Intervention groups will consist of standard of care and an 8-week physical training supplement performed that will consist of concentric and eccentric resistance exercises as well as dynamic warm-up and cool-down periods. These interventions will be performed in addition to the standard regimen of clinical care.
Masking: Single (Investigator)
Masking Description: Investigator will be blinded to subject intervention group assignments.
Primary Purpose: Supportive Care
Official Title: Utilization of Tonal Exercise System to Improve Short- and Long-term Low Back Pain (LBP) Outcomes
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Thearpy + Resistance Training
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.
Other: Resistance exercise
A training program designed to enhance core strength, stability, and function will be performed on the Tonal device. Training sessions will occur twice weekly for eight weeks. Performance of this program will be supervised by a designated and clinically trained research team member who will not conduct the statistical analysis and subsequently not be blinded to Group assignment. The program will last approximately 20 minutes in length and incorporate the a series of progressive exercises.
Other Name: Tonal

No Intervention: Physical Thearpy
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.
Experimental: Chiropractic Care + Resistance Training
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.
Other: Resistance exercise
A training program designed to enhance core strength, stability, and function will be performed on the Tonal device. Training sessions will occur twice weekly for eight weeks. Performance of this program will be supervised by a designated and clinically trained research team member who will not conduct the statistical analysis and subsequently not be blinded to Group assignment. The program will last approximately 20 minutes in length and incorporate the a series of progressive exercises.
Other Name: Tonal

No Intervention: Chiropractic Care
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.



Primary Outcome Measures :
  1. Patient Pain [ Time Frame: 1 year ]
    Subjective assessment of patient pain scores as assessed by a 0-10 Visual Analog Scale, where 0 is no pain and 10 is the worst pain imaginable.

  2. PROMIS Subjective Health Assessment score [ Time Frame: 2 years ]
    Subjective assessment of patient health performed with the Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test. Scores range from 14.1-61.7 with higher scores representative of better functioning.

  3. Kinesiophobia [ Time Frame: 2 years ]
    Subjective assessment of patient fear of movement as assessed by the Tampa Scale of Kinesiophobia questionnaire. Scale is scored from 17-68 where higher scores indicate increased fear of movement.

  4. Isometric Lumbar Strength [ Time Frame: 1 year ]
    Maximum lumbar flexion/extension strength as determined with a Humac dynamometer isometric lumbar attachment.


Secondary Outcome Measures :
  1. Frequency of Back Pain Recurrence [ Time Frame: 2 years ]
    Number of recurrent visits and time between visits for low back pain that occur after completion of intervention period.

  2. Functional Strength [ Time Frame: 1 year ]
    Objective strength as assessed by Tonal artificial intelligence algorithm.

  3. Lumbar Endurance [ Time Frame: 1 year ]
    Time to lumbar muscle fatigue as determined by the Sorenson's Back Endurance Test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Subjects seeking treatment for nonspecific LBP will be recruited by their treating therapist, physiatrist, athletic trainer, or chiropractor then enrolled by a clinical research coordinator (CRC). The CRC will assign study IDs and randomize clinical patients into groups based on the each subject's selected treatment of choice. Care will be taken to match subject distribution between groups based on demographics (sex and age), activity level, and subjective pain scores. Lead investigators will remain blinded to group assignments. Subjects will have to complete 2 screening evaluations prior to participation in this study. The first screen will be that the treating physical therapist, physiatrist, athletic trainer, or chiropractor will approve the patient for participation. The second screen will consist of completing two basic activities on the Tonal at minimal weight without being restricted by pain. The two activities will be 10 repetitions on each arm of standing unilateral bicep curl and seated unilateral lateral pulldown. For both activities Tonal resistance will be set at 5 pounds, which is the minimum resistance for the device. This screen will affirm that the subject is capable of completing at least the minimum level of workout provided by the Tonal.

Inclusion Criteria:

  • Males and Females between ages 18 and 65
  • Seeking physical therapy (PT) or chiropractic care
  • Non-specific LBP
  • Treatment at Mayo Clinic Rchester

Exclusion Criteria:

  • Not able to attend Mayo Clinic Rochester for treatment
  • Women who are pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543396


Contacts
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Contact: Stephen O'Brien, BS 507-284-0806 obrien.stephen@mayo.edu
Contact: Nathaniel Bates, PhD 507-538-6953 bates.nathaniel@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Nathaniel A Bates, PhD Mayo Clinic
Additional Information:
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Responsible Party: Nathaniel (Nate) A. Bates, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04543396    
Other Study ID Numbers: 20-007281
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nathaniel (Nate) A. Bates, Mayo Clinic:
Tonal
low back pain
nonspecific
physical therapy
chiropractic
resistance training
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations