A prospective, randomised, controlled, multicentre study to evaluate the effectiveness and cost-effectiveness of spinal cord stimulation using the Synergy™ System in reducing pain in patients with failed back surgery syndrome compared to conventional medical management (PROCESS study)
| ISRCTN | ISRCTN77527324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77527324 |
| Secondary identifying numbers | NA |
- Submission date
- 12/06/2003
- Registration date
- 04/07/2003
- Last edited
- 23/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Krishna Kumar
Scientific
Scientific
Department of Neurosurgery
Regina General Hospital
1440 - 14th Avenue
Regina, Saskatchewan
S4P 0W5
Canada
| Phone | +1 306 781 61 16 |
|---|---|
| krishna.kumar@rqhealth.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | PROCESS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 09/04/2003 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/04/2003 |
| Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
Department of Neurosurgery
Regina, Saskatchewan
S4P 0W5
Canada
S4P 0W5
Canada
Sponsor information
Medtronic Europe sarl
Not defined
Not defined
Route du Molliau, 31
Tolochenaz
CH-1131
Switzerland
| Phone | +41-21-802 73 29 |
|---|---|
| carine.van.den.abeele@medtronic.com | |
"ROR" |
https://ror.org/00grd1h17 |
Funders
Funder type
Industry
Medtronic Europe Sàrl (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2007 | Yes | No | |
| Results article | results | 01/05/2009 | Yes | No |
