ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000902695

Ethics application status

Approved

Date submitted

17/06/2014

Date registered

25/08/2014

Date last updated

25/08/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

A Prospective, Open-Label, Pilot Study to Assess the Effect of Spinal Cord Stimulation on Quality of Sleep and Activity Levels in patients with Chronic Low Back pain with or without Leg Pain

Scientific title

A Prospective, Open-Label, Pilot Study to Assess the Effect of Spinal Cord Stimulation on Quality of Sleep and Activity Levels in patients with Chronic Low Back pain with or without Leg Pain

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic back pain +/- leg pain

Condition category

Condition code

Neurological

Other neurological disorders

Anaesthesiology

Pain management

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Twelve month observation of sleep quality and activity levels in patients implanted with the Medtronic RestoreSENSOR implantable pulse generator (IPG) for management of chronic back pain +/- leg pain.

The Medtronic RestoreSENSOR IPG uses motion sensors to detect changes in posture and activity and then automatically adjusts the level of electrical stimulation needed for relief of chonic pain symptoms. The motion-sensing implant eliminates the need for constant manual real-time adjustments for positional changes, and stores the frequency of posture and activity changes.

The range of electrical stimulation is approximately 60-80hz. The duration of treatment is up to 12 months for observational data collection. Following this, the patient will resume standard of care, with duration of implant to be determined by the patient/physician.

The IPG/sensor is located internally in a position determined by the physician (eg. buttock, lateral flank/axillae). The duration of implant procedure is approximately 20-30mins. The entire procedure is conducted as per usuual standard of care.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The primary outcome measure will be improvement in quality of sleep as determined by:
- two formal overnight sleep studies
- questionnaires (Pittsburgh Sleep Quality Index; Epworth Sleepiness Scale) and
- data from an Actigraph GT3X external sensor device attached to the patients trunk and worn for 1 week at various timepoints throughout the study period.

Timepoint [1]

- sleep studies conducted at baseline (at least 1 week prior to IPG insertion) and at 6 months post IPG impant
- questionnaires conducted at baseline (at least 1 week prior to IPG insertion) and at 1, 3, 6 and 12 months post IPG implant
- Actigraph GT3X data will be collected for 1 week at baseline(at least 1 week prior to IPG insertion) and at 1, 3, 6 and 12 months post IPG implant

Secondary outcome [1]

Improvment in daily pain severity scores as determined by patient questionnaires: numeric pain rating scale, LANSS pain scale

Timepoint [1]

Baseline questionnaires will be administered prior to IPG impant, followed by repeat assessements at months 1, 3, 6 and 12.

Secondary outcome [2]

Improvement in level of daily activity as measure by the
- RestoreSENSOR data and
- Actigraph GT3X sensor data.

Timepoint [2]

- Data stored in the RestoreSENSOR IPG will be obtained from the week preceding months 1, 3, 6 and 12 follow up visits.

- A Baseline assessment will be made wearing the Actigraph sensor for one week prior to undergoing the IPG implant. Following this, the patient will wear the device for one week at months 1, 3, 6 and 12.

Secondary outcome [3]

Improvment in quality of life as determined by patient questionnaires: DASS21, ODI and medication use

Timepoint [3]

Baseline questionnaire will be administered prior to IPG implant, followed by repeat assessments at months 1, 3, 6 and 12.

Eligibility

Key inclusion criteria

1. 18 years of age or older
2. Have undergone a positive Spinal Cord Stimulator (SCS) trial and scheduled for an SCS implant with the Medtronic RestoreSENSOR implantable pulse generator (IPG)
3. Subject is ambulatory
4. Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
5. Undergoing treatment for low back pain or low back pain plus leg pain
6. Does not have or has not had a previous SCS implant
7. Willing and able to complete protocol requirements including:
a. Willing to wear a RestoreSENSOR device for 1 week during the baseline monitoring period
b. Willing and able to complete health questionnaires and pain scales as specified in the protocol
c. Willing and able to undergo a formal sleep examination
d. Willing and able to sign the study-specific Informed Consent form
8. Male or non-pregnant female
9. Patient is privately insured

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Have plans to enrol in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study
2. Cancer or any other malignant disease
3. Present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder
4. A pain-related surgery in the previous 12 weeks of enrolment, the intent to undergo surgery during the period of the study
5. Non-English speaking or an inability to complete questionnaires accurately.
6. Previously diagnosed with sleep apnoea or other sleep disorder that would affect the objective measure of sleep quality following treatment.

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

12/09/2013

Actual

12/09/2013

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Medtronic Corporation

Address [1]

710 Medtronic Parkway, Minneapolis, MN 55432-5604

Country [1]

United States of America

Primary sponsor type

Individual

Name

Dr. Bruce Mitchell

Address

Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr. Paul Verrills

Address [1]

Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Ltd.

Ethics committee address [1]

129 Glen Osmond Road Eastwood South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/08/2012

Approval date [1]

11/10/2012

Ethics approval number [1]

2012-07-954

Summary

Brief summary

Spinal cord stimulation (SCS) is a minimally invasive procedure used for the treatment of persistent, refractory and neuropathic pain. 

Conventional SCS systems require regular manual adjustments of the level of electrical stimulation after initial programming. These adjustments are necessary because the level of the spinal cord stimulation is dependent on the distance between the spinal cord and the implanted electrodes, which changes with patient’s daily activity (e.g., standing, lying down, seating, etc.). When a patient changes body position, the movement of the spinal cord relative to the implanted lead may result in uncomfortable or inconsistent stimulation. This may lead to suboptimal pain control and significantly reduce the effectiveness of the SCS therapy, which may impact heavily on patient’s quality of life. For instance, one of the most important daily activities – sleep, may be significantly affected by the inconsistent stimulation. This may compromise effective treatment and lead to increase in the levels of dissatisfaction and pain.

The RestoreSENSOR (Medtronic Inc, USA) is the first in its class implantable pulse generator for spinal cord stimulation that automatically changes stimulation settings in response to position changes and provides objective patient activity data. It achieves this thanks to the inbuilt acceleration sensor that enables continuous motion sensing. The Medtronic RestoreSENSOR neurostimulator also records and stores the frequency of patient’s posture and activity changes.  These objective data can be used by the clinician to understand whether the patient’s individual stimulation requirements are changing over time.

If the SCS therapy with RestoreSENSOR improves patients’ quality of sleep and activity levels in this study, this will demonstrate superior effectiveness of position-adaptive stimulation technology in providing pain relief and convenience to patients suffering from chronic pain.

Improvement in quality of sleep and daily activity levels will serve as an indicator of efficacy of the treatment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bruce Mitchell

Address

Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162

Country

Australia

Phone

+61 3 9595 6111

Fax

bmitchell@metrospinal.com.au

Contact person for public queries

Name

Adele Barnard

Address

Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162

Country

Australia

Phone

+61 3 9595 6111

Fax

abarnard@metrospinal.com.au

Contact person for scientific queries

Name

Adele Barnard

Address

Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162

Country

Australia

Phone

+61 3 9595 6111

Fax

abarnard@metrospinal.com.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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