Utilization of Tonal Exercise System to Improve Short- and Long-term Low Back Pain (LBP) Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Patient Pain
研究概览
简要总结
This study will assess the effect of incorporating a tonal exercise device into clinical and chiropractic care for lower back pain.
详细描述
All accrued subjects will be assigned study ID numbers to de-identify subject data and keep research team members blinded to group assignments. The CRC will maintain a master keyfile of subject Group randomization that will be revealed to the research team after between-group statistical analyses have been performed.
For all subjects: The active study period for this investigation will be 8 weeks in duration. Passive monitoring will then continue for 12 months after the initial 8 week period. All subjects will continue to receive standard of care treatments from their preferred clinical practitioner (physical therapist, chiropractor, none). All subjects will complete three progress assessments over the duration of the 8-week intervention period. These progress assessments will occur at baseline, week 4, and week 8 and will include the following elements:
- Clinical Questionnaires - Clinical questionnaires will be digitally completed by each participant. There will be four (4) clinical questionnaires (Visual Analog Pain Scale, Tampa Scale for Kinesiophobia, PROMIS Physical Function, and PROMIS Pain Interference).
PROMIS Physical Function Questionnaire: Developed by the NIH, this question bank is used to assess patient function. Patients rate each question on a nominal scale from 1-5 related to their ability to complete activities of daily living and exercise. We will use the version 2.0 question bank.
PROMIS Pain Interference: Developed by the NIH, this question band is used to assess the degree to which pain interferes with quality of life and how much pain restricts the patient from activities of daily living and exercise. We will use the version 1.1 question bank.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Investigator will be blinded to subject intervention group assignments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not able to attend Mayo Clinic Rochester for treatment
- •Women who are pregnant
研究组 & 干预措施
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.
干预措施: Resistance exercise (Other)
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.
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.
干预措施: Resistance exercise (Other)
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.
结局指标
主要结局
Patient Pain
时间窗: 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.
PROMIS Subjective Health Assessment score
时间窗: 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.
Isometric Lumbar Strength
时间窗: 1 year
Maximum lumbar flexion/extension strength as determined with a Humac dynamometer isometric lumbar attachment.
Kinesiophobia
时间窗: 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.
次要结局
- Functional Strength(1 year)
- Lumbar Endurance(1 year)
- Frequency of Back Pain Recurrence(2 years)