dorsaVi Back Pain and Movement Registry
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Conditions studied: Low Back Pain
In brief
This study will compare patients with low back pain (LBP) to age and gender matched controls to determine if there are differences between the two groups related to: range of movement, secondary outcomes (level of disability, quality of life, evidence of depression, anxiety or stress), movement patterns and demographic characteristics. The first phase will include a baseline and 3 month follow-up assessment of the LBP patients and controls, including demographic characteristics, outcome measures, and a physical assessment. The second phase is an ongoing phase with continued interim assessments of LBP patients only, at 6 and 12 months.
Key facts
- Study ID
- NCT03001037
- Run by
- dorsaVi Ltd
- People needed
- 350
- Starts
- 2016-10-01
- Expected to finish
- 2020-04-01
- Last updated by the study team
- 2019-02-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Group A:
- Subject provides written authorization and/or consent per institution and geographical requirements
- Subjects in Group A with a predominant complaint of Low back pain, with a minimum daily average VAS ≥ 30/100
- Subjects in Group A are intended to be assessed with ViMove based on standard of care - Subject is willing to participate in follow ups at 3, 6, 12 months post initial assessment
- Group B:
- Subject is without current low back pain
- Subject does not have a history of low back pain lasting longer than 3 months in the past 12 months
- Subject is willing to follow up 3 months post initial assessment
You may not qualify if…
- Subject who is, or is expected to be inaccessible for follow-up
- Subject with exclusion criteria required by local law
- Subject in whom movement assessment is contraindicated.
- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
- Body mass index ≥ 35 - In Group B only, subjects who had a history of low back pain in the past 12 months which lasted > 3 months
Where it is running
- The George Washington University — Washington DC, Maryland, United States
- International Spine, Pain and Performance Center — Washington DC, Maryland, United States
- Synergy Manual Physical Therapy LLC — Arlington, Virginia, United States
Full record on ClinicalTrials.gov
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