Trial Review

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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] 284817 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic back pain +/- leg pain 292199 0
Condition category
Condition code
Neurological 292537 292537 0 0
Other neurological disorders
Anaesthesiology 292538 292538 0 0
Pain management
Musculoskeletal 292602 292602 0 0
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] 289610 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292404 0
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] 292404 0
- 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] 308874 0
Improvment in daily pain severity scores as determined by patient questionnaires: numeric pain rating scale, LANSS pain scale
Timepoint [1] 308874 0
Baseline questionnaires will be administered prior to IPG impant, followed by repeat assessements at months 1, 3, 6 and 12.
Secondary outcome [2] 308875 0
Improvement in level of daily activity as measure by the
- RestoreSENSOR data and
- Actigraph GT3X sensor data.
Timepoint [2] 308875 0
- 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] 308876 0
Improvment in quality of life as determined by patient questionnaires: DASS21, ODI and medication use
Timepoint [3] 308876 0
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?
No
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
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289431 0
Commercial sector/Industry
Name [1] 289431 0
Medtronic Corporation
Country [1] 289431 0
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] 288117 0
Individual
Name [1] 288117 0
Dr. Paul Verrills
Address [1] 288117 0
Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162
Country [1] 288117 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291188 0
Bellberry Ltd.
Ethics committee address [1] 291188 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 291188 0
Australia
Date submitted for ethics approval [1] 291188 0
08/08/2012
Approval date [1] 291188 0
11/10/2012
Ethics approval number [1] 291188 0
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 40622 0
Dr Bruce Mitchell
Address 40622 0
Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162
Country 40622 0
Australia
Phone 40622 0
+61 3 9595 6111
Fax 40622 0
Email 40622 0
[email protected]
Contact person for public queries
Name 40623 0
Dr Adele Barnard
Address 40623 0
Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162
Country 40623 0
Australia
Phone 40623 0
+61 3 9595 6111
Fax 40623 0
Email 40623 0
[email protected]
Contact person for scientific queries
Name 40624 0
Dr Adele Barnard
Address 40624 0
Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162
Country 40624 0
Australia
Phone 40624 0
+61 3 9595 6111
Fax 40624 0
Email 40624 0
[email protected]

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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