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Challenges to recruit qualified participants
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The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SQS plus OMM | Experimental | subcutaneous nerve stimulation plus optimized medical management |
|
| OMM | Active Comparator | optimized medical management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subcutaneous nerve stimulation | Device | subcutaneous nerve stimulation plus optimized medical management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Treatment on Reduction of Back Pain Intensity | Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Back Pain Intensity | Average change in back pain intensity from baseline to the 6 and 9-month follow-up visits. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. A reduction in average pain score is indicated by a negative number. | 6 and 9 months |
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Inclusion Criteria:
Provides written Patient Informed Consent/Patient Information Sheet prior to study-related activities being conducted
≥ 18 years of age at time of informed consent
Willing and available to attend visits as scheduled and to comply with the study protocol
Willing and able to undergo assessments as part of the evaluation for eligibility and endpoints
Willing and able to use the external neurostimulator, recharging equipment (if applicable), and patient programmer per the schedule required by the protocol
Diagnosed with FBSS (i.e.):
Back pain is considered intractable and has been adequately treated (failed an appropriate trial of at least 3 different classes of back pain treatments (pharmaceutical and/or non-pharmaceutical))
Is an appropriate implant candidate for the SQS system
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Eldabe, MD | The James Cook Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Pain Clinic | Broadmeadow | 2292 | Australia | |||
| Greenslopes Private Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23799929 | Derived | Eldabe S, Kern M, Peul W, Green C, Winterfeldt K, Taylor RS. Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial. Trials. 2013 Jun 25;14:189. doi: 10.1186/1745-6215-14-189. |
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Patients were considered enrolled in the study upon signing an Informed Consent Form. Enrolled subjects then completed additional assessments and were provided a diary to record ther back and leg pain intensity. Upon completion of the at-home diary, eligibility was reassessed based on pain scores. Eligible subjects were then randomized.
The first subject enrolled in the study on January 11, 2013. The last subject was enrolled on January 15, 2016 and all subject visits were stopped as of the study termination date of February 12, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | SQS+OMM | Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM) |
| FG001 | OMM Alone | Optimized Medical Management alone (OMM) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Optimized Medical Management | Other | Optimized medical management |
|
| Back Pain Responder Rate (≥50%) at 6 Months | Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 6-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. | 6 months |
| Back Pain Responder Rate (≥30%) at 9 Months | Percentage of participants who responded to the treatment, where response was defined as ≥ 30% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. | 9 months |
| Greenslopes |
| 4120 |
| Australia |
| Royal North Shore Hospital | St Leonards | 2065 | Australia |
| Krankenhaus der Elisabethinen | Graz | 8020 | Austria |
| Krankenhaus der Landes Kärnten | Klagenfurt | 9020 | Austria |
| Krankenhaus der Barmherzigen Brüder | Vienna | 1021 | Austria |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| AZ Sint Jan | Bruges | 8000 | Belgium |
| INDC Jolimont | La Louvière | 7100 | Belgium |
| Pijnkliniek Stedelijk Ziekenhuis | Roeselare | 8800 | Belgium |
| Clinique Mutualiste de la porte de l'Orient | Lorient | 56100 | France |
| Hospices civils de LYON | Lyon | 69003 | France |
| Clinique Brétéché | Nantes | 44046 | France |
| Fondation Rothschild | Paris | 75019 | France |
| Hopital Purpan | Toulouse | 31059 | France |
| Universitätsklinikum Köln | Cologne | 50937 | Germany |
| Märkische Kliniken GmbH / Marienhospital Letmathe | Iserlohn-Letmathe | 58642 | Germany |
| Universitätsklinikum Jena | Jena | 07743 | Germany |
| Tel Aviv Medical Center | Tel Aviv | 61999 | Israel |
| Rijnland Ziekenhuis | Alphen aan den Rijn | 2402 | Netherlands |
| Albert Schweitzer Ziekenhuis | Dordrecht | 3300 | Netherlands |
| Amphia Ziekenhuis | Oosterhout-Breda | 3079 | Netherlands |
| Maasstad Ziekenhuis | Rotterdam | 3079 | Netherlands |
| Hospital Universitario del Rio Hortega | Valladolid | 47012 | Spain |
| Hopital de Morges | Morges | 1110 | Switzerland |
| The James Cook Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SQS+OMM | Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM) |
| BG001 | OMM Alone | Optimized Medical Management alone (OMM) |
| BG002 | 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 age at time of enrollment (in years) | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Percentage of males and females | Count of Participants | Participants |
| |||||||||||||||
| Pain intensity at baseline | Pain intensity was measured by a 100 mm visual analog scale (VAS), with 0 representing no pain and 100 representing the worst pain imaginable. | Mean | Standard Deviation | 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 | Effectiveness of Treatment on Reduction of Back Pain Intensity | Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. | The Intent-to-Treat patient set (ITT) consists of all subjects as they were randomized into the study. The As Treated consists of all patients of the ITT patient set, but excludes those with major protocol deviations; they are analysed according to last treatment received before the actual assessment, without replacement of missing data. | Posted | Number | 95% Confidence Interval | Percentage of responders | 9 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change in Back Pain Intensity | Average change in back pain intensity from baseline to the 6 and 9-month follow-up visits. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. A reduction in average pain score is indicated by a negative number. | The Intent-to-Treat patient set (ITT) consists of all subjects as they were randomized into the study. The As Treated consists of all patients of the ITT patient set, but excludes those with major protocol deviations; they are analysed according to last treatment received before the actual assessment, without replacement of missing data. | Posted | Mean | Standard Deviation | units on a scale | 6 and 9 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Back Pain Responder Rate (≥50%) at 6 Months | Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 6-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. | The Intent-to-Treat patient set (ITT) consists of all subjects as they were randomized into the study. The As Treated consists of all patients of the ITT patient set, but excludes those with major protocol deviations; they are analysed according to last treatment received before the actual assessment, without replacement of missing data. | Posted | Number | 95% Confidence Interval | Percentage of responders | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Back Pain Responder Rate (≥30%) at 9 Months | Percentage of participants who responded to the treatment, where response was defined as ≥ 30% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. | The Intent-to-Treat patient set (ITT) consists of all subjects as they were randomized into the study. The As Treated consists of all patients of the ITT patient set, but excludes those with major protocol deviations; they are analysed according to last treatment received before the actual assessment, without replacement of missing data | Posted | Number | 95% Confidence Interval | Percentage of responders | 9 months |
|
|
Adverse events were collected from randomization through the study end (up to 36 months follow-up).
All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
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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 | SQS+OMM | Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM) | 19 | 55 | 18 | 55 | ||
| EG001 | OMM Alone | Optimized Medical Management alone (OMM) | 9 | 60 | 17 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Device stimulation issue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Implant site paraesthesia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Therapeutic product ineffective | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| C-reactive protein abnormal | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Muscle contractions involuntary | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Drug detoxification | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
| |
| Haemorrhoid operation | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oral lichen planus | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Device stimulation issue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Therapeutic product ineffective | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Breast infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Splinter | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood pressure difference of extremities | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Drop attacks | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thoracic outlet syndrome | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rash follicular | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
The Study Publication Committee manages and oversees publications generated from the study. The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication related to patentable and copyrightable material and can extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Study Manager | Medtronic | medtronicneurotrials@medtronic.com |
| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Leg pain |
|
| As treated |
|
|
|
|
|
|
|
|