Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001038583
Ethics application status
Approved
Date submitted
25/05/2015
Date registered
7/10/2015
Date last updated
16/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study investigating movement, pain and activity in failed back surgery patients undergoing spinal cord stimulation.
Scientific title
An Investigator initiated prospective partially blinded study assessing movement, pain and activity in participants undergoing neuro-modulation trials and implantation for failed back surgery syndrome.
Secondary ID [1] 286770 0
Nil
Universal Trial Number (UTN)
U1111-1170-3600
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Failed Back Surgery Syndrome 295146 0
Lower back pain 295332 0
Leg pain 295333 0
Condition category
Condition code
Musculoskeletal 295388 295388 0 0
Other muscular and skeletal disorders
Neurological 295600 295600 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Undertake a preliminary investigation of pain, movement and activity in subjects undergoing SCS trial and implantation that will provide useful insights for the development of a larger randomised controlled study. ViMove wearable sensors will be worn by all subjects on their lower back.
Spinal cord stimulation delivers mild electrical impulses to the spinal cord that interrupt pain signals to the brain, replacing them with a tingling sensation. The stimulation to the spinal cord is delivered from the device through insulated wires called leads, which are placed adjacent to the spinal cord. Using a handheld device that works like a remote control, the stimulator can be adjusted to specific areas and levels of pain, depending on activities and pain levels during the day. SCS trial is when the leads are temporarily placed via needles to test the effectiveness of the device. This is an outpatient procedure, where the implant is tested for approximately one week at home in normal surroundings. SCS implantation involves surgery where a small incision in the back is needed to allow the leads to be placed underneath the skin, and another small incision is needed for the stimulator to be implanted permanently under the skin, usually in the buttocks or abdominal area.
ViMove are wearable sensors that measure movement and muscle activity. It is easily worn on the lower back through attaching with adhesives and can be worn throughout the day to objectively record and report to the clinician on a patient's movement and function. It will be worn in clinic for a short assessment and then for the rest of the day before SCS trial, during SCS trial and for those that go onto implantation will again be measured at 3 specific time points (4, 12 & 26 weeks) post the implantation to clearly track how SCS impacts on movement and function.
Intervention code [1] 291928 0
Treatment: Devices
Comparator / control treatment
No control arm; small pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295128 0
1. Collection of movement and lumbar extensor muscle activity data in subjects undergoing permanent SCS implantation using data recorded by ViMove
Timepoint [1] 295128 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Primary outcome [2] 295129 0
2. Correlation between pain and movement in subjects undergoing trial and permanent SCS using :
a) A change in range of motion in any one plane of movement compared to pre-intervention range of motion.
b) Maximum Pain during Movement Score (1-10 as recorded during the in clinic ViMove assessment) for flexion, extension, right and left lateral flexion and pelvic tilt.
Timepoint [2] 295129 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Secondary outcome [1] 314822 0
The Numerical Pain Rating scale is a 3-item Likert scale assessing pain severity on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). This is computed as the average of three items; current pain levels, least pain levels, and worst pain levels. The numerical pain rating scale is among the most common metrics in utilized to measure pain severity in the research literature.
Timepoint [1] 314822 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Secondary outcome [2] 317741 0
Short Form Health Survey 12

An abbreviated version of the SF 36 that has been validated. This questionnaire asks 12 questions about an individual’s physical and mental health, with items ranging from binary ‘yes/no’ responses to 3 or 6 point rating scales. One of the outcomes it estimates is a patients overall mental health
Timepoint [2] 317741 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Secondary outcome [3] 317742 0
The Oswestry Disability Index

A 10 item questionnaire assessing disability caused by lower-back pain where each item ranges from 0 (no disability) to 5 (high disability). This produces a single estimate of disability ranging from 0% (absence of disability) to 100% (total incapacitation)
Timepoint [3] 317742 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Secondary outcome [4] 317743 0
Pain Self-Efficacy Questionnaire

A 10 item questionnaire where patients rate their confidence to perform certain basic activities despite their pain from 0 (not at all confident) to 6 (completely confident). Examples include social activities and household chores. This produces a single estimate of self-efficacy
Timepoint [4] 317743 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Secondary outcome [5] 317744 0
A secondary outcome produced by the ViMove device is Activity levels

Timepoint [5] 317744 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Secondary outcome [6] 317745 0
Diary of medication usage
Timepoint [6] 317745 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Secondary outcome [7] 317967 0
The Brief Pain Inventory

A 7-item Likert scale assessing pain levels on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). One of the two outcomes it provides is an estimate of pain interference - how much pain interferes with day to day tasks
Timepoint [7] 317967 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Secondary outcome [8] 317968 0
Short Form Health Survey 12

An abbreviated version of the SF 36 that has been validated. This questionnaire asks 12 questions about an individual’s physical and mental health, with items ranging from binary ‘yes/no’ responses to 3 or 6 point rating scales. One of the two outcomes it provides is an estimate of physical health.
Timepoint [8] 317968 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Secondary outcome [9] 317969 0
A secondary outcome produced by the ViMove device is Sitting data
Timepoint [9] 317969 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant
Secondary outcome [10] 317970 0
A secondary outcome produced by the ViMove device is Walking data (timed walk test wearing ViMove)
Timepoint [10] 317970 0
Measurements will be taken at:
* Baseline
* 5-6 days post the insertion of the trial SCS leads
For group that go onto receive permanent SCS measurements will also be taken at:
* 4 weeks post implant,
* 12 weeks post implant,
* and 26 weeks post implant

Eligibility
Key inclusion criteria
1. Males and Females aged over 18
2. FBSS, defined as persistent or re-current low back and leg pain of at least 6 months duration, following at least one decompression and/or fusion procedure
3. Deemed as clinically appropriate for a trial of spinal cord stimulation for the treatment of FBSS
4. Minimum average pain level measured on a numerical rating scale of at least 3
5. Activity limitation as recorded by the Oswestry disability index of > 20%
6. Pain that changes with position or movement
7. Ability to understand and willingness to sign an informed consent statement in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lower back surgery within previous six months.
2. The subject is being currently treated or has been treated with SCS, subcutaneous or peripheral nerve stimulation, intrathecal drug delivery system, or is awaiting further lumbar surgery.
3. Is pregnant or planning to become pregnant during the course of the study;
4. Subjects with a severe hearing impairment or inability to follow verbal instructions.
5. Evidence of non-mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder or persistent non-fluctuating pain.
6. Implanted electrical medical device that would conflict with either the spinal cord stimulator implant or the measurement technology
7. Significant medical or psychological abnormalities/conditions, a history of substance abuse or recent history of a medical-surgical intervention that in the opinion of the investigator would interfere either with the ability to complete the study or the assessments.
8. Known allergy skin reaction to tapes and plasters.
9. Subject who is currently enrolled in an investigational drug or device study
10. Inability to operate the SCS equipment, comply with study requirements or complete questionnaires in English independently.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will come from a number of sources. Primarily, they will be patients with chronic lower back pain who have been referred to Precision Brain Spine and Pain Centre, and determined to be suitable candidates for SCS by Dr. Richard Sullivan. If a patient is suitable, they will be invited to take part in this study by Dr. Tom Perkins (a Research Fellow at Precision Brain Spine and Pain Centre), and receive an abridged summary of the project. If they are interested, they will receive a detailed version of the protocol, and a consent form. Following their formal consent, their trial appointments will be arranged. In this study, their will be no control group or sham treatment. All patients involved in this study will take part in SCS, where their own baseline condition serves as the point of comparison.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In this study, all participants who consent to take part in this research will undergo spinal stimulation. As there is no sham or control condition, randomization will not be required.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is an open label pilot study to gather information to be used in a follow-up randomized study, and these measures are yet to be completed on a group of subjects with FBSS. Therefore the variability between subjects is not able to be determined at this point. Estimates at this time would suggest that a sample of 23 participants would allow a correlation of 0.5 to be detected with 95% confidence level and power of 80%. Up to 50 subjects are predicted to be enrolled to result in 23 subjects to have the permanent implant.
Correlation analysis will be completed to determine the relationship between variables. A paired t test analysis will be completed on pre- and post data with a repeated measures ANOVA completed on data collected over multiple time points. All findings will be deemed significant with a p value of <0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2015
Actual
6/08/2015
Date of last participant enrolment
Anticipated
31/01/2017
Actual
Date of last data collection
Anticipated
1/08/2017
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9703 0
3101 - Kew

Funding & Sponsors
Funding source category [1] 291319 0
Commercial sector/Industry
Name [1] 291319 0
dorsaVi
Country [1] 291319 0
Australia
Primary sponsor type
Individual
Name
Dr Richard Sullivan
Address
Precision Brain Spine and Pain Centre
Lower Ground
115 Cotham Road
Kew
3101, VIC
Country
Australia
Secondary sponsor category [1] 290000 0
None
Name [1] 290000 0
Address [1] 290000 0
Country [1] 290000 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292884 0
Bellberry Limited
Ethics committee address [1] 292884 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 292884 0
Australia
Date submitted for ethics approval [1] 292884 0
01/04/2015
Approval date [1] 292884 0
01/06/2015
Ethics approval number [1] 292884 0
2015-03-137

Summary
Brief summary
Spinal cord stimulation (SCS) is a treatment option for cases of persistent pain, refractory to other forms of treatment. The first wave of studies produced generally favourable results, with reductions in pain ranging from 49% (Alo, Redko & Charnov, 2002), 55% (Villavicencio et al., 2000) to 74% (Dario et al., 2001). Since this time, a systematic review of 63 publications, predominantly comprised of case series, found that 58% of patients achieved clinically meaningful pain relief at two year follow up (Taylor et al., 2014). Taking this finding at face-value, it appears approximately 42% of chronic pain patients under-going SCS do not achieve significant pain relief. However, among this population, there is presently a scarcity of research to examine change to mobility and function. This is important, as it is plausible that the analgesic effects of SCS could be mitigated by patients increasing their mobility; a clinically important outcome in and of itself. To the author’s knowledge, objective measures of movement pre and post SCS have not been reported in the literature.
Thus, the key aim of the present clinical trial is to objectively assess change to motion and mobility in patients with persistent pain following SCS, and its relationship to change in pain levels. On this basis, the following hypotheses were generated:
1. Movement and pain will correlate in participants with FBSS undergoing SCS trial and implantation
2. Activity and the ODI index will correlate in participants with FBSS undergoing SCS trial and implantation.
Trial website
Trial related presentations / publications
Public notes
Ethics submission to Bellberry done 1/4/2015. Approval was granted on 1/6/2015 (Application ID: 2015-03-137)

Contacts
Principal investigator
Name 57482 0
Dr Richard Sullivan
Address 57482 0
Precision Brain, Spine and Pain Centre Lower Ground
115 Cotham Road Kew, Victoria, 3101
Country 57482 0
Australia
Phone 57482 0
+61 3 8862 0000
Fax 57482 0
Email 57482 0
[email protected]
Contact person for public queries
Name 57483 0
Dr Richard Sullivan
Address 57483 0
Precision Brain, Spine and Pain Centre Lower Ground
115 Cotham Road Kew, Victoria, 3101
Country 57483 0
Australia
Phone 57483 0
+61 3 8862 0000
Fax 57483 0
Email 57483 0
[email protected]
Contact person for scientific queries
Name 57484 0
Dr Richard Sullivan
Address 57484 0
Precision Brain, Spine and Pain Centre Lower Ground
115 Cotham Road Kew, Victoria, 3101
Country 57484 0
Australia
Phone 57484 0
+61 3 8862 0000
Fax 57484 0
Email 57484 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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