A Study to Utilize a Tonal Exercise System to Improve Low Back Pain (LBP) Treatment Outcomes
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-007281
- Minneapolis, Minnesota: 20-007281
NCT ID: NCT04543396
About this study
This study will assess the effect of incorporating a tonal exercise device into clinical and chiropractic care for lower back pain.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
For Groups 1-4
- Patients seeking clinical treatment for non-specific LBP through sports medicine, PM&R, or orthopedic physical therapy (PT) or through chiropractic care at Mayo Clinic.
- Subjects between 18-65 years old.
For Group 5
- Subjects between 18-65 years old.
- Self-reported non-specific LBP from the Tonal customer base.
- Specific to Group 5 subjects, participants recruited from the Tonal customer base will be matched (as near as possible) to existing clinical subjects recruited for Groups 1-4.
Exclusion Criteria:
- Acute and traumatic LBP onset (identifiable by singular event such as a car accident). Specific to Group 5, Tonal customers will be excluded if they indicate that they are seeking external physical therapy or chiropractic care to treat their LBP.
- Pregnant females. Pregnancy will be verbally assessed in female participants. In Groups 1-4, this will be addressed during consent. In Group 5 this will be addressed during the question screening. Female subjects will be asked to inform the study team if they become pregnant during the study period. If a subject becomes pregnant, they will be excluded from participation in any future study activities as pregnancy is a known confounding factor to lower back pain.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Aaron Krych, M.D. |
Closed for enrollment |
|
Minneapolis, Minn.
Mayo Clinic principal investigator Aaron Krych, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available