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dorsaVi Back Pain and Movement Registry (BPAM)

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ClinicalTrials.gov Identifier: NCT03001037
Recruitment Status : Suspended (Pending internal study review and potential protocol modification)
First Posted : December 22, 2016
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
International Spine, Pain and Performance Center
Information provided by (Responsible Party):
dorsaVi Ltd

Brief Summary:
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.

Condition or disease
Low Back Pain

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: dorsaVi Back Pain and Movement Registry
Study Start Date : October 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort
Group A - Low Back Pain

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

Observational study, no intervention

Group B - Without Low Back Pain
  • 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

Observational study, no intervention




Primary Outcome Measures :
  1. Change in Range of Movement from baseline [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Maximal range of low back movement in sagittal and coronal planes


Secondary Outcome Measures :
  1. Change in Muscle Activity from baseline [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Surface EMG measurement of erector spinae muscle activity at L3 vertebra level

  2. Change in Pain from baseline [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Pain Score out of 100 as measured on VAS scale

  3. Change in Keele StarT Back Tool scores from baseline [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Screening test for Classification of severity of low back pain

  4. Change in Fear Avoidance Beliefs Questionnaire responses from baseline [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Measurement of fear and avoidance of physical activity and work related to low back pain

  5. Change in Low Back Pain Classifier score from baseline [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Questionnaire to classify low back pain into movement sub-categories based on movement related painful activities.

  6. Change in EuroQol-5D scores from baseline [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Quality of life measurement tool

  7. Change in Oswestry Disability Index scores from baseline [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Measurement of disability related to low back pain

  8. ViMove 40m Fast Paced Walk [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Time taken to complete test

  9. Vimove 30 sec Sit to Stand Test [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Count of repetitions of movement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Group A:

• Subject present with a predominant complaint of Low Back Pain, with a minimum daily average VAS ≥ 30/100

Group B:

• Subject is without current low back pain

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT03001037


Locations
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United States, Maryland
The George Washington University
Washington DC, Maryland, United States, 20006
International Spine, Pain and Performance Center
Washington DC, Maryland, United States, 20037
United States, Virginia
Synergy Manual Physical Therapy LLC
Arlington, Virginia, United States, 22209
Sponsors and Collaborators
dorsaVi Ltd
International Spine, Pain and Performance Center
Investigators
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Principal Investigator: Mehul J Desai, MD International Spine, Pain and Performance Center

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: dorsaVi Ltd
ClinicalTrials.gov Identifier: NCT03001037     History of Changes
Other Study ID Numbers: 051626(27149)
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by dorsaVi Ltd:
Functional Outcome Measures
Wearable Sensors
ViMove
Low Back Pain
Range of Movement
Muscle Activity

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms