Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 278 subjects were recruited between January 2013 and August 2015 from 28 sites in Canada, Colombia, Europe, and US.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 60 subjects didn't meet the inclusion and/or exclusion criteria and discontinued from the study before randomization.

Reporting Groups

	Description
SCS + OMM	Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
OMM Alone	Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.

Participant Flow for 2 periods

Period 1:   Period I: Randomization to 6 Months

	SCS + OMM	OMM Alone
STARTED	110	108
COMPLETED	97	107
NOT COMPLETED	13	1
Withdrawal by Subject	6	0
Physician Decision	4	0
Adverse Event	1	1
Lost to Follow-up	2	0

Period 2:   Period II: 6-24M Long-term Follow-up

	SCS + OMM	OMM Alone
STARTED	97	107
COMPLETED	48	52
NOT COMPLETED	49	55
Physician Decision	3	12
Withdrawal by Subject	8	10
Lost to Follow-up	3	3
Death	1	1
Adverse Event	0	3
Active subjects at the time of posting	34	26

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
SCS + OMM	Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
OMM Alone	Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
Total	Total of all reporting groups

Baseline Measures

	SCS + OMM	OMM Alone	Total
Overall Participants Analyzed  [Units: Participants]	110	108	218
Age  [Units: Years] Mean (Standard Deviation)	52.8  (12.5)	55.1  (10.2)	53.9  (11.5)
Sex: Female, Male  [Units: Participants] Count of Participants
Female	68  61.8%	64  59.3%	132  60.6%
Male	42  38.2%	44  40.7%	86  39.4%
Region of Enrollment  [Units: Participants] Count of Participants
Belgium	25	24	49
Canada	4	4	8
Colombia	6	4	10
France	12	13	25
Germany	2	2	4
Netherlands	6	6	12
Spain	5	6	11
United Kingdom	18	17	35
United States	32	32	64

1.  Primary:

Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups   [ Time Frame: 6 months post randomization ]

2.  Secondary:

Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups   [ Time Frame: 6 months post randomization ]

3.  Secondary:

Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups   [ Time Frame: 6 months post randomization ]

4.  Secondary:

Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups   [ Time Frame: 6 months post randomization ]

5.  Secondary:

Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups   [ Time Frame: 6 months post randomization ]

6.  Other Pre-specified:

Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups   [ Time Frame: 6 months post randomization ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.