## Protocol Section
### Identification Module
**NCT ID:** NCT01572779

**Brief Title:** A Study to Investigate the Effect of a New Postural Bio-feedback Device on Low Back Pain

**Official Title:** A Multicentre, Cluster Randomised, Placebo-controlled, Open-label Pilot Study of Back Strain Monitor (BSM) With Feedback Compared With the BSM Without Feedback in Subjects With Moderate Lower Back Pain.

#### Organization Study ID Info
**ID:** ProA-BSM-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Pro-Active Medical Pty Ltd
### Status Module
#### Completion Date
**Date:** 2013-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-03-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-03-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-06

**Type:** ACTUAL

#### Start Date
**Date:** 2009-11

**Status Verified Date:** 2015-03

#### Study First Post Date
**Date:** 2012-04-06
**Type:** ESTIMATED
**Study First Submit Date:** 2011-06-07
**Study First Submit QC Date:** 2012-04-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Department of Business and Innovation, Victoria, Australia

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pro-Active Medical Pty Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** A postural bio-feedback device worn by subjects for 4-10 hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group. The device records movement and muscle activity data relating to the lower back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration and aims to prompt the subject to alter their posture or position in line with recommendations given by the treating practitioner. Four small sensors are adhered to the lower back and send data wirelessly to a data logger carried in the pocket by the subject (the size of a small mobile phone).

### Conditions Module

**Conditions:**

- Low Back Pain

**Keywords:**

- dorsavi

- vimove

- biofeedback

- objective movement data

- back pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 112

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** BSM device with bio-feedback

**Intervention Names:**

- Device: BSM device with bio-feedback

**Label:** Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The BSM device without feed-back

**Intervention Names:**

- Device: BSM device with no bio-feedback

**Label:** Control

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** A postural bio-feedback device worn by subjects for 4-10hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group. The device records movement and muscle activity data relating to the lower back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration and aims to prompt the subject to alter their posture or position in line with recommendations given by the treating practitioner. Four small sensors are adhered to the lower back and send data wirelessly to a data logger carried in the pocket by the subject (the size of a small mobile phone).

**Name:** BSM device with bio-feedback

**Other Names:**

- ViMove

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** The BSM device is worn as a placebo with no bio-feedback given to the subject. The subjects in the control group wear the device for 4-10 hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group.

**Name:** BSM device with no bio-feedback

**Other Names:**

- ViMove with no Feedback

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Functional Outcome measure

**Measure:** Roland Morris Disability Questionaire (RMDQ-23)

**Time Frame:** over 12 months

**Description:** Functional Outcome Measure

**Measure:** Patient Specific Functional Scale (PSFS)

**Time Frame:** over 12 months

**Description:** Pain Scale

**Measure:** Quadruple Visual Analogue Scale (QVAS)

**Time Frame:** over 12 months

#### Secondary Outcomes

**Description:** Functional Outcome Measure

**Measure:** The change over time from baseline in the range of movement, recorded by the device. Measured in degrees of movement in the three anatomical planes.

**Time Frame:** over 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Subject provides informed consent
2. Age between 18 and 65 years of age
3. At least moderate intensity low back pain (LBP) and/or back related leg pain, as defined by a QVAS score \> 3 (Carragee, Spine 2000).
4. Initial QVAS score of \> 3 out of 10
5. Subjects must be assessed by the practitioner as Sub Acute (3 to 12 weeks post onset of low back pain (LBP) or Chronic (\> 12 weeks post onset of low back pain (LBP).

Exclusion Criteria:

1. Lower back surgery within previous twelve (12) months.
2. Females who are pregnant.
3. Subjects with a severe hearing impairment.
4. Evidence of non mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder.
5. Preceding chronic neurological changes (Sub Acute group only).
6. Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator)
7. Nerve block, spinal injection or anesthetic procedure for the treatment of lower back pain within 12 months of the study.
8. Significant medical abnormalities or conditions that in the opinion of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy.
9. Recent history of a significant medical-surgical intervention that in the judgment of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy.
10. Known allergic skin reaction to tapes and plasters.
11. Subject who is currently enrolled in an investigational drug or device study.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Caulfield

**Country:** Australia

**Facility:** Metro Spinal Clinic

**State:** Victoria

**Zip:** 3162

**Location 2:**

**City:** Footscray

**Country:** Australia

**Facility:** Stanlake Specialist Centre

**State:** Victoria

**Zip:** 3011

**Location 3:**

**City:** Geelong

**Country:** Australia

**Facility:** Myers Street Family Medical

**State:** Victoria

**Zip:** 3220

**Location 4:**

**City:** Hampton

**Country:** Australia

**Facility:** Peak Musculoskeletal

**State:** Victoria

**Zip:** 3188

**Location 5:**

**City:** Heidelberg

**Country:** Australia

**Facility:** Austin Hopsital

**State:** Victoria

**Zip:** 3084

**Location 6:**

**City:** Melbourne

**Country:** Australia

**Facility:** Olympic Park Sports Medicine Centre

**State:** Victoria

**Zip:** 3003

**Location 7:**

**City:** Richmond

**Country:** Australia

**Facility:** Epworth Hospital Richmond

**State:** Victoria

**Zip:** 3121

**Location 8:**

**City:** Ringwood

**Country:** Australia

**Facility:** Bounce Health Group

**State:** Victoria

**Zip:** 3084

**Location 9:**

**City:** Werribee

**Country:** Australia

**Facility:** The Clinic Werribee

**State:** Victoria

**Zip:** 3030

#### Overall Officials

**Official 1:**

**Affiliation:** Stanlake Specialist Centre

**Name:** Steven Jensen, MB BS FAFMM

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Myers Street Family Medical

**Name:** Adrian Jury, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** The Clinic Werribee

**Name:** Joe Garra, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Stanlake Specialist Centre

**Name:** Peter Braun, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Austin Hospital Pysiotherapy Outpatients

**Name:** Robert Laird

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Kent P, Laird R, Haines T. The effect of changing movement and posture using motion-sensor biofeedback, versus guidelines-based care, on the clinical outcomes of people with sub-acute or chronic low back pain-a multicentre, cluster-randomised, placebo-controlled, pilot trial. BMC Musculoskelet Disord. 2015 May 29;16:131. doi: 10.1186/s12891-015-0591-5.

**PMID:** 26022102

#### See Also Links

**Label:** device description

**URL:** http://www.dorsavi.com/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: HIGH

- As Found: Back Pain

- ID: M19433

- Name: Low Back Pain

- Relevance: HIGH

- As Found: Low Back Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001416

- Term: Back Pain

- ID: D000017116

- Term: Low Back Pain

### Misc Info Module

- Version Holder: 2024-05-24
