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To demonstrate the analgesic effectiveness of 2 modalities of PEMF treatment compared to sham treatment in patients with persistent pain following lumbar surgery when treatment is administered twice daily over a 60 day period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham of Provant | Other | Sham of Provant |
|
| Active Treatment | Other | Active Provant Treatment |
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| Active Treatment with alternative settings | Other | Active Provant Treatment with alternative settings |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Pain Scores | Numerical Pain Rating Scale (NPRS) was used to score pain at Baseline and at End of Treatment. The Percent change (difference) from Baseline to End of Treatment was calculated. The NPRS is an 11-point scale ranging from scores of 0 (no pain) to 10 (worst pain imaginable). | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOC-Research | Birmingham | Alabama | 35209 | United States | ||
| Hope Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham of Provant | Sham of Provant Provant |
| FG001 | Active Treatment | Active Provant Treatment Provant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Phoenix |
| Arizona |
| 85018 |
| United States |
| Injury Care Research | Boise | Idaho | 83713 | United States |
| Rockford Orthopedic | Rockford | Illinois | 61114 | United States |
| Hope Research_Las Vegas | Las Vegas | Nevada | 89106 | United States |
| Tarheel Clinical Research | Raliegh | North Carolina | 27612 | United States |
| Upstate Clinical | Spartanburg | South Carolina | 29303 | United States |
| Danville Orthopedic | Danville | Virginia | 24541 | United States |
| FG002 |
| Active Treatment With Alternative Settings |
Active Provant Treatment with alternative settings Provant |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham of Provant | Sham of Provant Provant |
| BG001 | Active Treatment | Active Provant Treatment Provant |
| BG002 | Active Treatment With Alternative Settings | Active Provant Treatment with alternative settings Provant |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| PainDETECT Questionnaire | PainDETECT Questionniare (PD-q): a self-reported assessment designed to identify the presence of a neuropathic pain component in subjects with back pain. This was completed by the subject and scored by the research personnel at the Enrollment Visit. Subjects assessment current pain, strongest pain, average pain, areas of pain, course of pain and symptoms (such as burning, tingling, numbness and sensitivity). The scale ranged from 0 to 38 defined as follows: score 0-12 = neuropathic pain component unlikely; 13-18 = result is ambiguous; 19-38 = neuropathic pain component is likely. | Mean | Full Range | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Pain Scores | Numerical Pain Rating Scale (NPRS) was used to score pain at Baseline and at End of Treatment. The Percent change (difference) from Baseline to End of Treatment was calculated. The NPRS is an 11-point scale ranging from scores of 0 (no pain) to 10 (worst pain imaginable). | Per protocol population results displayed. This results in a discrepancy in the number of participants provided above. Baseline characteristics include the entire intent to treat population. | Posted | Mean | Standard Deviation | Percent Difference | 60 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham of Provant | Sham of Provant Provant | 0 | 14 | 5 | 14 | ||
| EG001 | Active Treatment | Active Provant Treatment Provant | 0 | 13 | 6 | 13 | ||
| EG002 | Active Treatment With Alternative Settings | Active Provant Treatment with alternative settings Provant | 0 | 14 | 3 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders |
| |||
| Gastric ulcer | Gastrointestinal disorders |
| |||
| Irritable bowel syndrome | Gastrointestinal disorders |
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| Fatigue | General disorders |
| |||
| Bronchitis | Infections and infestations |
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| Clostridium difficile infection | Infections and infestations |
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| Influenza | Infections and infestations |
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| Nasopharyngitis | Infections and infestations |
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| Urinary tract infection | Infections and infestations |
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| Fall | Injury, poisoning and procedural complications |
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| Back Pain | Musculoskeletal and connective tissue disorders |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders |
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| Pain in extremity | Musculoskeletal and connective tissue disorders |
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| Headache | Nervous system disorders |
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| Hypoaesthesia | Nervous system disorders |
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| Paraesthesia | Nervous system disorders |
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| Rash | Skin and subcutaneous tissue disorders |
| |||
| Skin irritation | Skin and subcutaneous tissue disorders |
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Publication Rights. Independent analysis and/or publication of data generated is not permitted without the prior written consent of sponsor. Such consent may be contingent on sponsor review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Vander Ploeg | Regenesis Biomedical Inc. | 602-428-7041 | Heather.VanderPloeg@regenesisbio.com |
| Male |
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