An interventional study of WaveWriter and Conventional Medical Managament in Chronic Pain, sponsored by Boston Scientific Corporation. Completed at 23 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.
2,928 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's enrollment of 241 is above the median of 60 across 2,160 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
To receive Spinal Cord Stimulation programming
Device: WaveWriter
To receive conventional medical management
Other: Conventional Medical Managament
To receive Spinal Cord Stimulation programming
To receive conventional medical management
Responder Rate
Proportion of subjects with 50% or greater reduction in overall pain relief
Time frame: 3 months post-activation
Change in Disability (Oswestry Disability Index)
Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.
Time frame: 3-Months post activation
241 subjects provided informed consent.
| Milestone | Spinal Cord Stimulation | Conventional Medical Management | Non-randomized Subjects |
|---|---|---|---|
| Started | 79 | 68 | 94 |
| Completed | 57 | 64 | 0 |
| Not completed | 22 | 4 | 94 |
| Withdrew: Screen failure/ | 1 | 1 | 85 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 |
| Withdrew: Adverse event | 2 | 0 | 1 |
| Withdrew: Physician decision | 2 | 0 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 | 6 |
| Withdrew: Will not move forward with permanent implant | 6 | 0 | 0 |
| Withdrew: Various reasons (moved, no longer meets criteria, visit not done etc.) | 7 | 1 | 1 |
Proportion of subjects with 50% or greater reduction in overall pain relief
| Participants | Spinal Cord Stimulation | Conventional Medical Management |
|---|---|---|
| Responder Rate | 51 | 5 |
Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.
| score on a scale | Spinal Cord Stimulation | Conventional Medical Management |
|---|---|---|
| Change in Disability (Oswestry Disability Index) | -27.5 ± 15.9 | -7.2 ± 9.9 |
Collected over Randomized subjects through 3-Months post-Activation, an average of 6 months.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Randomized to SCS | 0/79 (0%) | 8/79 (10.1%) | 9/79 (11.4%) |
| Randomized to CMM | 1/68 (1.5%) | 1/68 (1.5%) | 4/68 (5.9%) |
| Event | Randomized to SCS | Randomized to CMM |
|---|---|---|
| Urinary Tract InfectionInfections and infestations | 0/79 | 1/68 |
| Hiatus herniaGastrointestinal disorders | 1/79 | 0/68 |
| Oesophageal food impactionGastrointestinal disorders | 1/79 | 0/68 |
| Atrial fibrillationCardiac disorders | 1/79 | 0/68 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/79 | 0/68 |
| Renal MassRenal and urinary disorders | 1/79 | 0/68 |
| Alcohol Use DisorderPsychiatric disorders | 1/79 | 0/68 |
| CholecystitisHepatobiliary disorders | 1/79 | 0/68 |
| CholelithiasisHepatobiliary disorders | 1/79 | 0/68 |
| Event | Randomized to SCS | Randomized to CMM |
|---|---|---|
| FallInjury, poisoning and procedural complications | 3/79 | 4/68 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 3/79 | 0/68 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 3/79 | 0/68 |
All Randomized subjects
| Age, Continuous(years) | Randomized to Spinal Cord Stimulation (SCS) Treatment Activated | Randomized to Conventional Medical Management (CMM) Treatment Activated | Total |
|---|---|---|---|
| Mean | 57.3 ± 12.10 | 61.0 ± 11.9 | 59.0 ± 12.1 |
| Sex: Female, Male(Participants) | Randomized to Spinal Cord Stimulation (SCS) Treatment Activated | Randomized to Conventional Medical Management (CMM) Treatment Activated | Total |
|---|---|---|---|
| Female | 55 | 43 | 98 |
| Male | 24 | 25 | 49 |
| Race/Ethnicity, Customized(Participants) | Randomized to Spinal Cord Stimulation (SCS) Treatment Activated | Randomized to Conventional Medical Management (CMM) Treatment Activated | Total |
|---|---|---|---|
| Race and Ethnicity : American Indian or Alaska native | 0 | 1 | 1 |
| Race and Ethnicity : Black, of African heritage | 6 | 3 | 9 |
| Race and Ethnicity : Caucasian | 72 | 62 | 134 |
| Race and Ethnicity : Not disclosed | 1 | 0 | 1 |
| Race and Ethnicity : Hispanic or Latino | 0 | 3 | 3 |
| Region of Enrollment(participants) | Randomized to Spinal Cord Stimulation (SCS) Treatment Activated | Randomized to Conventional Medical Management (CMM) Treatment Activated | Total |
|---|---|---|---|
| United States | 79 | 68 | 147 |
| Duration of Low Back Pain(years) | Randomized to Spinal Cord Stimulation (SCS) Treatment Activated | Randomized to Conventional Medical Management (CMM) Treatment Activated | Total |
|---|---|---|---|
| Mean | 11.5 ± 10.4 | 12.9 ± 11.5 | 12.2 ± 10.9 |
| Average low back pain (VRS)(units on a scale) | Randomized to Spinal Cord Stimulation (SCS) Treatment Activated | Randomized to Conventional Medical Management (CMM) Treatment Activated | Total |
|---|---|---|---|
| Mean | 7.5 ± 1.0 | 7.6 ± 0.9 | 7.6 ± 0.9 |
| Average overall pain (VRS)(units on a scale) | Randomized to Spinal Cord Stimulation (SCS) Treatment Activated | Randomized to Conventional Medical Management (CMM) Treatment Activated | Total |
|---|---|---|---|
| Mean | 7.5 ± 0.9 | 7.5 ± 1.0 | 7.5 ± 0.9 |
| Oswestry Disability Index (ODI) Summary Score(units on a scale) | Randomized to Spinal Cord Stimulation (SCS) Treatment Activated | Randomized to Conventional Medical Management (CMM) Treatment Activated | Total |
|---|---|---|---|
| Mean | 54.4 ± 8.5 | 54.4 ± 9.4 | 54.4 ± 8.9 |
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