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

NCT04543396 | Completed

• 1 other identifier: 20-007281
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Keywords

Tonal; low back pain; nonspecific; physical therapy; chiropractic; resistance training

Outcome Measures

Primary Outcomes (4)

• Patient Pain

  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.

  1 year

• PROMIS Subjective Health Assessment score

  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.

  2 years

• Kinesiophobia

  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.

  2 years

• Isometric Lumbar Strength

  Maximum lumbar flexion/extension strength as determined with a Humac dynamometer isometric lumbar attachment.

  1 year

Secondary Outcomes (3)

• Frequency of Back Pain Recurrence

  2 years

• Functional Strength

  1 year

• Lumbar Endurance

  1 year

Study Arms (4)

Physical Thearpy + Resistance Training

EXPERIMENTAL

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

Physical Thearpy

NO 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.

Chiropractic Care + Resistance Training

EXPERIMENTAL

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

Chiropractic Care

NO 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.

Interventions

Resistance exercise OTHER

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.

Also known as: Tonal

Chiropractic Care + Resistance Training; Physical Thearpy + Resistance Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Resistance Training; Timbre Perception

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Auditory Perception; Vestibulocochlear Physiological Phenomena; Physiological Phenomena

Study Officials

• Aaron Krych, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will be blinded to subject intervention group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 10, 2020
• Study Start: November 1, 2020
• Primary Completion: June 10, 2024
• Study Completion: June 17, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)