Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585033
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Placebo Effect in Spinal Cord Electrical Stimulation for Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Spinal Cord Stimulation for the Treatment of Therapy-Resistant Neuropathic Pain After Lumbar Spinal Surgery - a Randomized Double-Blind Sham-Controlled Cross-over Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PISCES
Brief Summary:
Objective To evaluate if spinal cord stimulation SCS performs better than placebo no stimulation in the long term to reduce persistent neuropathic leg pain refractory to medication and other conservative treatments in patients who have undergone lumbar spinal surgery
Study design Multicenter double blind randomized sham-controlled trial
After a positive SCS test trial participants 18-70 years will be implanted with a non-rechargeable SCS system providing active subthreshold stimulation and followed for 12 months in a blinded cross-over design The primary outcome measure is the difference in change in leg pain intensity scores using the Numeric Rating Scale NRS between a 3-month period with optimized subthreshold stimulation and a 3-month period with no stimulation as compared to baseline Quality of life physical functioning sleep quality return to work and reduction in medication use will also be investigated
Background Up to 20 of patients who have undergone lumbar spinal surgery experience persistent backleg pain leading to long-term reduction in functionality and quality of life SCS is an established and safe minimally invasive treatment for these patients when no further surgery is indicated and conservative therapies have been found to be ineffective Placebo-controlled studies comparing active and sham stimulation were lacking until recently as traditional SCS relied on the patient feeling the stimulation paresthesia Technological progress with development of paresthesia-free stimulation forms now allows for the execution of placebo-controlled studies A recent trial showing no significant difference in long-term effectiveness between active SCS and sham suffers from significant methodological shortcomings This necessitates further sham-controlled studies to determine the effectiveness of SCS
Study design Multicenter double blind randomized sham-controlled trial
After a positive SCS test trial participants 18-70 years will be implanted with a non-rechargeable SCS system providing active subthreshold stimulation and followed for 12 months in a blinded cross-over design The primary outcome measure is the difference in change in leg pain intensity scores using the Numeric Rating Scale NRS between a 3-month period with optimized subthreshold stimulation and a 3-month period with no stimulation as compared to baseline Quality of life physical functioning sleep quality return to work and reduction in medication use will also be investigated
Background Up to 20 of patients who have undergone lumbar spinal surgery experience persistent backleg pain leading to long-term reduction in functionality and quality of life SCS is an established and safe minimally invasive treatment for these patients when no further surgery is indicated and conservative therapies have been found to be ineffective Placebo-controlled studies comparing active and sham stimulation were lacking until recently as traditional SCS relied on the patient feeling the stimulation paresthesia Technological progress with development of paresthesia-free stimulation forms now allows for the execution of placebo-controlled studies A recent trial showing no significant difference in long-term effectiveness between active SCS and sham suffers from significant methodological shortcomings This necessitates further sham-controlled studies to determine the effectiveness of SCS
Detailed Description:
1 INTRODUCTION AND RATIONALE
SCS is an established and safe minimally invasive treatment for patients with therapy-resistant chronic neuropathic pain The treatment is based on the development of the gate-control theory presented in the mid-1960s as a way to dampen pain impulses at the spinal cord level SCS treatment involves the insertion of electrodes in the epidural space delivering weak electrical stimulation to the dorsal columns of the spinal cord to block pain impulses traveling to the brain In patients experiencing sufficient pain relief usually pain reduction over 50 during a test trial period an implantable pulse generator IPG is placed under the skin and connected to the electrodes Patients with chronic neuropathic pain may experience pain relief with SCS when other more invasive surgical and conservative treatments have been attempted and appeared to be ineffective
The most common condition treated with SCS is enduring neuropathic back andor leg pain after lumbar spinal surgeries such as lumbar discectomy Up to 20 of patients who have undergone lumbar spinal surgery for degenerative conditions exhibit new or persistent low backleg pain leading to impaired functionality and reduced quality of life This condition is entitled persistent spinal pain syndrome type 2 PSPS2 formerly known as failed back surgery syndrome Randomized controlled trials RCTs with SCS have shown long-term pain reduction of up to 70-80 in this patient group In these studies the effectiveness of SCS is based on either comparing different forms of stimulation or comparing SCS with reoperations and medication treatments However placebosham-controlled studies comparing active stimulation with inactive stimulation were lacking until recently since traditional SCS relied on the patient feeling the stimulation paresthesia making it impossible to conduct blinded studies where the patient does not know if the stimulation is on or off This has constituted a major disadvantage in terms of the strength of the scientific evidence for the effect of SCS treatment as it is known that the placebo effect is significant in surgical treatments
New SCS treatments for pain in which the patient does no longer experience paresthesia have been developed in recent years which allows the execution of sham-controlled studies A recently published study showed no significant difference between SCS and sham stimulation in long-term pain relief and improving physical functioning in patients with PSPS2 raising doubts about the effectiveness and use of the treatment which is costly due to high material costs However this single study has significant methodological shortcomings This necessitates further sham-controlled studies to ascertain whether SCS is an adequate treatment for chronic pain The aim of the current study is to compare the long-term effect of paresthesia-free SCS with a sham treatment no stimulation in reducing neuropathic pain in patients with PSPS2 It is hypothesized that SCS treatment will be superior compared to treatment with sham stimulation
2 OBJECTIVES
Primary Objective To compare active subthreshold SCS with sham stimulation in reducing neuropathic leg pain
Secondary Objectives To compare subthreshold SCS with sham stimulation on
1 quality of life
2 physical functioning
3 sleep quality
4 medication use
5 return to work
3 STUDY DESIGN
This is an international multicenter double-blind randomized sham-controlled study Patients evaluated as candidates for SCS will after a positive test trial be implanted with the non-rechargeable Boston Alpha Prime system Boston Sci Marlborough MA USA providing active subthreshold stimulation forms that the patient does not feel ie paresthesia-free and are proven to be effective in reducing chronic neuropathic pain According to standard clinical practice research participants are implanted with electrodes during an initial surgery which are inserted into the epidural space posterior to the spinal cord dorsal columns with the aim of obtaining the best possible coverage of the painful area Subsequently patients undergo a trial phase of 2 weeks with an external IPG to determine if treatment with a subthreshold stimulation provides adequate pain relief over 50 pain reduction If no adequate pain relief is experienced during the trial phase the electrodes are removed and the patient is excluded from further study participation In patients responding with adequate pain relief a permanent IPG is placed under the skin and connected to the electrodes Patients will then be randomized into either the active subthreshold stimulation or sham stimulation group After randomization patients will undergo a four-week period where stimulation settings will be optimized and patients can recover from their surgery
After the optimization period patients will receive either subthreshold or sham stimulation in accordance with the randomization The subthreshold stimulation form that will be used will be based on patient response in terms of optimal pain reduction during the 2-week trial and the 4-week optimization period Patients can use any of the subthreshold stimulation forms or combinations that are available within the Alpha Prime system After 3 months patients will switch to the other stimulation group according to a crossover design where they will receive the other stimulation form until the 6-month follow-up Subsequently patients will receive the stimulation form they found most effective for an additional 6 months until the end of the study Both the physician who implanted the system and the patient will be unaware of the stimulation type received a double-blind design during the entire study period Patients will be aware they will receive two different stimulation forms while being unaware of the fact that one of the stimulation forms is sham stimulation Activationdeactivation and programming of the stimulation will be performed by a research nurse who is the only person in the study aware of which group the patient belongs to Subjects enrolled will be asked to complete several questionnaires prior to their procedure and at routine follow up visits at 3 6 and 12 months After study termination at the 12-month follow-up blinding will be lifted and patients can receive any stimulation form available within the Boston Alpha Prime system
SCS is an established and safe minimally invasive treatment for patients with therapy-resistant chronic neuropathic pain The treatment is based on the development of the gate-control theory presented in the mid-1960s as a way to dampen pain impulses at the spinal cord level SCS treatment involves the insertion of electrodes in the epidural space delivering weak electrical stimulation to the dorsal columns of the spinal cord to block pain impulses traveling to the brain In patients experiencing sufficient pain relief usually pain reduction over 50 during a test trial period an implantable pulse generator IPG is placed under the skin and connected to the electrodes Patients with chronic neuropathic pain may experience pain relief with SCS when other more invasive surgical and conservative treatments have been attempted and appeared to be ineffective
The most common condition treated with SCS is enduring neuropathic back andor leg pain after lumbar spinal surgeries such as lumbar discectomy Up to 20 of patients who have undergone lumbar spinal surgery for degenerative conditions exhibit new or persistent low backleg pain leading to impaired functionality and reduced quality of life This condition is entitled persistent spinal pain syndrome type 2 PSPS2 formerly known as failed back surgery syndrome Randomized controlled trials RCTs with SCS have shown long-term pain reduction of up to 70-80 in this patient group In these studies the effectiveness of SCS is based on either comparing different forms of stimulation or comparing SCS with reoperations and medication treatments However placebosham-controlled studies comparing active stimulation with inactive stimulation were lacking until recently since traditional SCS relied on the patient feeling the stimulation paresthesia making it impossible to conduct blinded studies where the patient does not know if the stimulation is on or off This has constituted a major disadvantage in terms of the strength of the scientific evidence for the effect of SCS treatment as it is known that the placebo effect is significant in surgical treatments
New SCS treatments for pain in which the patient does no longer experience paresthesia have been developed in recent years which allows the execution of sham-controlled studies A recently published study showed no significant difference between SCS and sham stimulation in long-term pain relief and improving physical functioning in patients with PSPS2 raising doubts about the effectiveness and use of the treatment which is costly due to high material costs However this single study has significant methodological shortcomings This necessitates further sham-controlled studies to ascertain whether SCS is an adequate treatment for chronic pain The aim of the current study is to compare the long-term effect of paresthesia-free SCS with a sham treatment no stimulation in reducing neuropathic pain in patients with PSPS2 It is hypothesized that SCS treatment will be superior compared to treatment with sham stimulation
2 OBJECTIVES
Primary Objective To compare active subthreshold SCS with sham stimulation in reducing neuropathic leg pain
Secondary Objectives To compare subthreshold SCS with sham stimulation on
1 quality of life
2 physical functioning
3 sleep quality
4 medication use
5 return to work
3 STUDY DESIGN
This is an international multicenter double-blind randomized sham-controlled study Patients evaluated as candidates for SCS will after a positive test trial be implanted with the non-rechargeable Boston Alpha Prime system Boston Sci Marlborough MA USA providing active subthreshold stimulation forms that the patient does not feel ie paresthesia-free and are proven to be effective in reducing chronic neuropathic pain According to standard clinical practice research participants are implanted with electrodes during an initial surgery which are inserted into the epidural space posterior to the spinal cord dorsal columns with the aim of obtaining the best possible coverage of the painful area Subsequently patients undergo a trial phase of 2 weeks with an external IPG to determine if treatment with a subthreshold stimulation provides adequate pain relief over 50 pain reduction If no adequate pain relief is experienced during the trial phase the electrodes are removed and the patient is excluded from further study participation In patients responding with adequate pain relief a permanent IPG is placed under the skin and connected to the electrodes Patients will then be randomized into either the active subthreshold stimulation or sham stimulation group After randomization patients will undergo a four-week period where stimulation settings will be optimized and patients can recover from their surgery
After the optimization period patients will receive either subthreshold or sham stimulation in accordance with the randomization The subthreshold stimulation form that will be used will be based on patient response in terms of optimal pain reduction during the 2-week trial and the 4-week optimization period Patients can use any of the subthreshold stimulation forms or combinations that are available within the Alpha Prime system After 3 months patients will switch to the other stimulation group according to a crossover design where they will receive the other stimulation form until the 6-month follow-up Subsequently patients will receive the stimulation form they found most effective for an additional 6 months until the end of the study Both the physician who implanted the system and the patient will be unaware of the stimulation type received a double-blind design during the entire study period Patients will be aware they will receive two different stimulation forms while being unaware of the fact that one of the stimulation forms is sham stimulation Activationdeactivation and programming of the stimulation will be performed by a research nurse who is the only person in the study aware of which group the patient belongs to Subjects enrolled will be asked to complete several questionnaires prior to their procedure and at routine follow up visits at 3 6 and 12 months After study termination at the 12-month follow-up blinding will be lifted and patients can receive any stimulation form available within the Boston Alpha Prime system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None