Condition category
Musculoskeletal Diseases
Date applied
12/06/2003
Date assigned
04/07/2003
Last edited
23/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Krishna Kumar

ORCID ID

Contact details

Department of Neurosurgery
Regina General Hospital
1440 - 14th Avenue
Regina
Saskatchewan
S4P 0W5
Canada
+1 306 781 61 16
krishna.kumar@rqhealth.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

Acronym

PROCESS

Study hypothesis

Patients will be randomised to receive either spinal cord stimulation (SCS) or conventional medical management (CMM) for a period of 24 months (1:1 randomisation). Patients receiving SCS will first undergo trial stimulation. In case of less than 80% paraesthesia coverage and/or less than 50% pain relief in the legs following trial stimulation the patients will not undergo the implantation of the Synergy™ stimulator, but will still be followed-up according to the intention to treat principle. At the 6 months visit, a review of the effectiveness of treatment will take place based on leg pain relief. Patients will be classified as successful (i.e. ? 50% pain relief in the legs) or non-successful (i.e. less than 50% pain relief in the legs). Moreover, the treatment of the patient will be reviewed and patients not successful may switch to the other treatment for the remainder of the study duration (18 months) if deemed necessary by the physician and the patient.
The assumption is that the proportion of patients successfully treated will be 42.5% in the SCS arm and 14.5% in the CMM arm.Patients will be randomised to receive either spinal cord stimulation (SCS) or conventional medical management (CMM) for a period of 24 months (1:1 randomisation). Patients receiving SCS will first undergo trial stimulation. In case of less than 80% paraesthesia coverage and/or less than 50% pain relief in the legs following trial stimulation the patients will not undergo the implantation of the Synergy(tm) stimulator, but will still be followed-up according to the intention to treat principle. At the 6 months visit, a review of the effectiveness of treatment will take place based on leg pain relief. Patients will be classified as successful (i.e. >50% pain relief in the legs) or non-successful (i.e. less than 50% pain relief in the legs). Moreover, the treatment of the patient will be reviewed and patients not successful may switch to the other treatment for remainder of the study duration (18 months) if deemed necessary by the physician and the patient.
The assumption is that the proportion of patients successfully treated will be 42.5% in the SCS arm and 14.5% in the CMM arm, with a power of 80% and an alpha <0.05.
The primary aim of the study is to evaluate the clinical effectiveness of spinal cord stimulation using the Synergy(tm) System on leg pain in patients with failed back surgery syndrome of a predominantly neuropathic nature compared to CMM.
The secondary aim of the study is to evaluate the cost effectiveness of spinal cord stimulation using the Synergy(tm) System on pain in patients with failed back surgery syndrome of a predominantly neuropathic nature compared to CMM.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Failed Back Surgery Syndrome (FBSS), chronic neurophatic pain

Intervention

Treatment A:
Spinal cord stimulation using the Synergy™ Neuromodulation System (Medtronic) including trial stimulation. Patients may receive conventional treatment such as pain medication, physical therapy and/or other therapies on the basis of need and at the discretion of the investigator, but not spinal surgery or intrathecal drug delivery systems

Treatment B:
Conventional medical management, to include physical and psychological therapy/rehabilitation and drug treatment, but not spinal surgery or intrathecal drug delivery systems. The particular package of conventional therapy (drug and non-drug), will be determined by the investigator on the basis of the needs of each patient.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Percentage of patients reporting >50% pain relief in the legs

Secondary outcome measures

Pain relief, health-related quality of life (SF-36 and EQ-5D), functional capacity (Oswestry), patient satisfaction, time away from work, adverse events

Overall trial start date

09/04/2003

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male/female between 18 and 65 years
Protocol Amended 07/10/03 - Patients aged 65 and older are also included
2. Bilateral or unilateral chronic neuropathic pain predominantly in the leg(s)(>50%)
3. Pain radiating in dermatomo segments L4 and/or L5 and/or S1 for at least 6 months following at least one anatomically successful surgery for a herniated disc
4. Pain intensity assessed by visual analogue scales (VAS) >5 (50%)
5. Willing to provide informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Predominantly back pain (>50%)
2. Presence of any other clinically significant or disabling chronic pain condition
3. Expected inability of patients to receive or properly operate the spinal cord stimulation system
4. History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
5. Active malignancy
6. Current use of medicines affecting coagulation which cannot be temporarily stopped
7. Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
8. Life expectancy of less than 1 year
9. Existing or planned pregnancy

Recruitment start date

09/04/2003

Recruitment end date

30/06/2005

Locations

Countries of recruitment

Canada

Trial participating centre

Department of Neurosurgery
Regina, Saskatchewan
S4P 0W5
Canada

Sponsor information

Organisation

Medtronic Europe sarl

Sponsor details

Route du Molliau
31
Tolochenaz
CH-1131
Switzerland
+41-21-802 73 29
carine.van.den.abeele@medtronic.com

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Medtronic Europe Sàrl (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17845835
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19281499

Publication citations

  1. Results

    Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB, Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome., Pain, 2007, 132, 1-2, 179-188, doi: 10.1016/j.pain.2007.07.028.

  2. Results

    Thomson S, Jacques L, Demographic characteristics of patients with severe neuropathic pain secondary to failed back surgery syndrome., Pain Pract, 9, 3, 206-215, doi: 10.1111/j.1533-2500.2009.00276.x.

Additional files

Editorial Notes