dorsaVi Back Pain and Movement Registry

NCT03001037 | Suspended DMC

• 1 other identifier: 051626(27149)
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 3

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.

Conditions

Low Back Pain

Keywords

Functional Outcome Measures; Wearable Sensors; ViMove; Low Back Pain; Range of Movement; Muscle Activity

Outcome Measures

Primary Outcomes (1)

• Change in Range of Movement from baseline

  Maximal range of low back movement in sagittal and coronal planes

  Baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (9)

• Change in Muscle Activity from baseline

  Baseline, 3 months, 6 months, and 12 months

• Change in Pain from baseline

  Baseline, 3 months, 6 months, and 12 months

• Change in Keele StarT Back Tool scores from baseline

  Baseline, 3 months, 6 months, and 12 months

• Change in Fear Avoidance Beliefs Questionnaire responses from baseline

  Baseline, 3 months, 6 months, and 12 months

• Change in Low Back Pain Classifier score from baseline

  Baseline, 3 months, 6 months, and 12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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 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

Sponsors & Collaborators

• dorsaVi Ltd: lead
• International Spine, Pain and Performance Center: collaborator

Study Sites (3)

The George Washington University

Washington DC, Maryland, 20006, United States

Location

International Spine, Pain and Performance Center

Washington DC, Maryland, 20037, United States

Location

Synergy Manual Physical Therapy LLC

Arlington, Virginia, 22209, United States

Location

Related Publications (1)

• Desai MJ, Jonely H, Blackburn M, Wanasinghage S, Sheikh S, Taylor RS. The Back Pain and Movement (B-PAM) registry; a study protocol. BMC Musculoskelet Disord. 2019 May 24;20(1):249. doi: 10.1186/s12891-019-2625-x.

  PMID: 31122221 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Mehul J Desai, MD

  International Spine, Pain and Performance Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 22, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

US (3)