| 1 |
NCT02610335 |
Recruiting |
Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration |
|
- Other: Control group (C)
- Other: Test group
|
Interventional |
Not Applicable |
- University Hospital, Bordeaux
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- maximal walking distance
- evaluation of the lumbar pain
- evaluation of the radicular pain
- (and 5 more...)
|
300 |
All |
50 Years and older (Adult, Senior) |
NCT02610335 |
CHUBX 2012/36 |
CLEMOB |
January 2016 |
October 2017 |
July 2018 |
November 20, 2015 |
May 17, 2017 |
|
- University Hospital of Bordeaux - Hospital Pellegrin
Bordeaux, France
|
| 2 |
NCT02007083 |
Recruiting |
The NORDSTEN Studies/ The Spinal Stenosis Study |
|
- Procedure: Bilateral laminotomy (BL)
- Procedure: Unilateral laminotomy with crossover (UL)
- Procedure: Spinous Process Osteotomy (SPO)
|
Interventional |
Not Applicable |
- Haukeland University Hospital
- Møre and Romsdal Hospital Trust.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Oswestry Disability Index
- Zurich claudification Scale, Numeric Rating Scale for leg pain, Numeric Rating Scale for back pain, EQ-5D, and self evaluated effect of surgery.
|
465 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02007083 |
2011/2034 |
NORDSTEN/SST |
November 2013 |
October 2025 |
December 2025 |
December 10, 2013 |
November 1, 2017 |
|
- Haukeland University Hospital
Bergen, Hagevik, Norway
|
| 3 |
NCT03368638 |
Recruiting |
Physical Therapy Treatments, Including Neural Mobilization and Hip/Back Stretches for People Between 50-89 With Lumbar Spinal Stenosis and Leg Pain Provoked by Walking |
|
- Other: Physical therapy intervention
|
Interventional |
Not Applicable |
- Texas Tech University Health Sciences Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Swiss Spinal Stenosis Questionnaire
- Change in Numeric Pain Rating Scale
- Change in Total Ambulation Time
- Change in Time to First Symptoms
|
30 |
All |
50 Years to 89 Years (Adult, Senior) |
NCT03368638 |
A17-4019 |
|
January 1, 2018 |
December 2019 |
December 2020 |
December 11, 2017 |
March 12, 2018 |
|
- Texas Tech University Health Sciences Center
Amarillo, Texas, United States
|
| 4 |
NCT02644746 |
Recruiting |
Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis |
- Degenerative Lumbar Spinal Stenosis
|
- Device: acupuncture
- Device: placebo needle
|
Interventional |
Not Applicable |
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The change of Modified Roland-Morris Disability Questionnaire (RMDQ) from baseline.
- The change of Number Rating Scale (NRS) from baseline.
- The change of Self-paced Walking test (SPWT) from baseline to week 8.
- (and 2 more...)
|
80 |
All |
50 Years to 80 Years (Adult, Senior) |
NCT02644746 |
2015EC114 |
|
March 2016 |
September 2017 |
December 2017 |
January 1, 2016 |
December 6, 2016 |
|
- Guang'anmen Hospital, China Academy of Chinese Medical Science
Beijing, Beijing, China
|
| 5 |
NCT03365401 |
Not yet recruiting |
Efficiency of Surgical Treatment for Lumbar Spinal Stenosis |
|
- Procedure: decompression surgery
- Procedure: nonsurgical treatment
|
Interventional |
Not Applicable |
- Peking University People's Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- change of symptoms
- change of pain relief
|
150 |
All |
50 Years to 80 Years (Adult, Senior) |
NCT03365401 |
LSS011 |
|
February 1, 2018 |
February 1, 2020 |
February 1, 2020 |
December 7, 2017 |
December 7, 2017 |
|
|
| 6 |
NCT03194607 |
Recruiting |
Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis |
|
- Other: Functional walk tests
- Other: 3D analysis of locomotion and posture
- Other: questionnaires
|
Observational |
|
- Centre Hospitalier Universitaire Dijon
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Compare the free walking speed in patients (6-minute walk test), before and after surgery
|
55 |
All |
18 Years and older (Adult, Senior) |
NCT03194607 |
GRELAT 2016 |
SPEED |
September 20, 2016 |
May 2019 |
December 2019 |
June 21, 2017 |
June 21, 2017 |
|
- Chu Dijon Bourgogne
Dijon, France
|
| 7 |
NCT03167736 |
Recruiting |
Dry Needling and Spinal Manipulation vs. Conventional PT for Lumbar Spinal Stenosis |
|
- Other: electric dry needling, manipulation
- Other: conventional physical therapy
|
Interventional |
Not Applicable |
- Alabama Physical Therapy & Acupuncture
- Universidad Rey Juan Carlos
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in low back pain (NPRS) (Rating Score)
- Change in Oswestry Disability Index
- Change in Roland Morris Disability Index
- (and 2 more...)
|
110 |
All |
50 Years and older (Adult, Senior) |
NCT03167736 |
AAMT0011 |
|
March 15, 2017 |
March 15, 2019 |
March 15, 2019 |
May 30, 2017 |
May 30, 2017 |
|
- Benchmark PT - Canton
Canton, Georgia, United States
|
| 8 |
NCT02258672 |
Recruiting |
Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis |
|
- Other: Prehabilitation program
|
Interventional |
Not Applicable |
- Université du Québec à Trois-Rivières
- Fonds pour la recherche clinique et le maintien des compétences cliniques (UQTR)
- Fonds de soutien au démarrage de projets en collaboration (CSSSTR)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from Baseline in disability
- Change from Baseline in pain intensity
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02258672 |
UQTR-CSSSTR 2014 |
|
October 2014 |
September 2016 |
December 2016 |
October 7, 2014 |
May 27, 2016 |
|
- Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, Canada
|
| 9 |
NCT03337178 |
Not yet recruiting |
Fitbit Pilot Study in Post-operative Lumbar Degenerative Spinal Stenosis Patients |
- Lumbar Degenerative Spinal Stenosis
|
- Behavioral: Blinded Fitbit
- Behavioral: Fitbit
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Care Provider)
- Primary Purpose: Other
|
- Self-Paced Walking Test
- Patient Recruitment
- Self-paced walking test
- (and 4 more...)
|
60 |
All |
60 Years and older (Adult, Senior) |
NCT03337178 |
109351 |
|
November 2017 |
July 2019 |
July 2020 |
November 8, 2017 |
November 14, 2017 |
|
- London Health Sciences Centre
London, Ontario, Canada
|
| 10 |
NCT03388983 |
Not yet recruiting |
Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis Surgery |
- Lumbar Spinal Stenosis
- Prehabilitation
|
- Other: 6-week prehabilitation
|
Interventional |
Not Applicable |
- The Hong Kong Polytechnic University
- Université du Québec à Trois-Rivières
- The University of Hong Kong
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Chinese/English Version Oswestry Disability Index (ODI)
- Pain medication
- Duration of hospital stay
- (and 6 more...)
|
120 |
All |
50 Years and older (Adult, Senior) |
NCT03388983 |
HSEARS20171204001 |
|
January 2, 2018 |
December 31, 2021 |
December 31, 2021 |
January 3, 2018 |
January 3, 2018 |
|
|
| 11 |
NCT01921530 |
Recruiting |
Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis |
- Degenerative Spondylolisthesis
- Spinal Stenosis
|
- Procedure: Interbody Fusion
- Procedure: Posterolateral Fusion
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Oswestry Disability Index
|
178 |
All |
50 Years and older (Adult, Senior) |
NCT01921530 |
103386 |
|
December 2013 |
December 2017 |
December 2019 |
August 13, 2013 |
March 8, 2017 |
|
- London Health Sciences Centre
London, Ontario, Canada
|
| 12 |
NCT03115983 |
Recruiting |
LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis |
- Degenerative Spondylolisthesis
- Lumbar Spinal Stenosis
|
- Device: LimiFlex
- Device: Fusion Instrumentation
- Procedure: Decompression
- Procedure: Fusion
|
Interventional |
Not Applicable |
- Empirical Spine, Inc.
- Morley Research Consortium
- Biomedical Statistical Consulting
- Medical Metrics, Inc
|
Industry / Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Composite Clinical Success
- Oswestry Disability Index (ODI)
- Neurological Status
- (and 14 more...)
|
295 |
All |
25 Years to 80 Years (Adult, Senior) |
NCT03115983 |
LSS17001 |
|
July 17, 2017 |
December 2020 |
December 2023 |
April 14, 2017 |
January 18, 2018 |
|
- Stanford University Medical Center
Stanford, California, United States - Boulder Neurological & Spine Associates
Boulder, Colorado, United States - Emory University
Atlanta, Georgia, United States - (and 5 more...)
|
| 13 |
NCT02555280 |
Recruiting |
Post-Approval 'Real Conditions of Use' Study |
|
- Device: coflex® Interlaminar Technology
- Procedure: Decompression
|
Interventional |
Not Applicable |
- Paradigm Spine
- Musculoskeletal Clinical Regulatory Advisers
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- 5-Year Composite Clinical Success (CCS) - Superiority
- 2-Year Composite Clinical Success (CCS) - Non-Inferiority
- 2-Year Composite Clinical Success (CCS) - Superiority
- (and 18 more...)
|
345 |
All |
40 Years and older (Adult, Senior) |
NCT02555280 |
PAS003 |
PAS003 |
September 2016 |
July 2019 |
June 2022 |
September 21, 2015 |
April 4, 2017 |
|
- Center for Neurosciences
Tucson, Arizona, United States - Northshore University Health System
Evanston, Illinois, United States - Spine Institute of Louisiana
Shreveport, Louisiana, United States - Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
| 14 |
NCT02529943 |
Recruiting |
Changes in Motor Latency During Spinal Decompression: Relationship to Outcomes |
|
- Procedure: Surgical Decompression
|
Observational |
|
- University of Saskatchewan
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Motor Evoked Potential Latency
- 10 m Timed Walking speed
- Quality of Life measured in SF-36
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT02529943 |
Norton15_05 |
|
May 2016 |
October 2017 |
February 1, 2018 |
August 20, 2015 |
June 22, 2017 |
|
- Royal University Hospital
Saskatoon, Saskatchewan, Canada
|
| 15 |
NCT03118206 |
Recruiting |
Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis |
- Lumbar Spinal Stenosis
- Spinal Manipulation
- Physical Therapy
- Surgery
|
- Device: lumbar traction
- Procedure: spinal manipulation
- Procedure: surgery
|
Interventional |
Not Applicable |
- Shin Kong Wu Ho-Su Memorial Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- VAS pain score
- Modified OswestryDisability Questionnaire (MODQ)
- Swiss Spinal Stenosis Questionnaire
- (and 2 more...)
|
60 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT03118206 |
20160804R |
|
January 2017 |
December 2019 |
December 2020 |
April 18, 2017 |
April 24, 2018 |
|
- ShinKongHospital
Taipei, Taiwan
|
| 16 |
NCT03048955 |
Recruiting |
Assessing Superion Clinical Endpoints vs. Decompression |
- Spinal Stenosis, Lumbar Region With Neurogenic Claudication
|
- Device: Superion® IDS
- Procedure: Direct decompression Surgery
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Composite Endpoint (Primary)
- Zurich Claudication Questionnaire (ZCQ)
- No re-operations, revisions, removals, or supplemental fixation at the index level(s)
- Epidural steroid injections for the treated level(s)
|
358 |
All |
45 Years and older (Adult, Senior) |
NCT03048955 |
15-VISS-01 |
ASCEND |
February 8, 2017 |
July 31, 2022 |
July 31, 2025 |
February 9, 2017 |
June 7, 2017 |
|
- Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States - Coastal Pain Spinal Diagnostics
Carlsbad, California, United States - Lake Nona Medical Arts
Celebration, Florida, United States - (and 2 more...)
|
| 17 |
NCT02457468 |
Recruiting |
The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology |
|
|
Observational |
|
- Predicted, Reported and Observed Outcomes Foundation
- SPIRITT Research
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery
- Patient has not undergone any reoperations, removals, revisions, or supplemental fixations;
- Patient has not had any major device related complications
- (and 5 more...)
|
500 |
All |
Child, Adult, Senior |
NCT02457468 |
SR-2015-01 |
|
June 2015 |
June 2023 |
June 2023 |
May 29, 2015 |
February 28, 2018 |
|
- Center for Neurology and Spine
Phoenix, Arizona, United States - Arizona Brain and Spine
Scottsdale, Arizona, United States - Northwest NeuroSpecialists
Tucson, Arizona, United States - (and 23 more...)
|
| 18 |
NCT02464553 |
Recruiting |
EuroPainClinics® Study I (Prospective Trial) |
|
- Other: periradicular therapy (PRT)
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Pain as assessed by the Visual analogue scale
- Pain progress as assessed by global pain scale
- Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
- (and 2 more...)
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT02464553 |
74/EK/15 |
EPCSI |
May 2015 |
May 2018 |
May 2018 |
June 8, 2015 |
April 23, 2018 |
|
- Algesiology ambulance
Praha, Czech Republic, Czechia - Czech republic
Praha, Czechia
|
| 19 |
NCT02459392 |
Recruiting |
EuroPainClinics® Study II (Prospective Trial) |
|
- Other: Epiduroscopy
- Drug: Hyaluronic Acid
- Drug: DepoMedrol
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Pain as assessed by the Visual analogue scale
- Pain progress as assessed by global pain scale
- Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
- Pain localization as assessed by note of radiating dermatome as neurologic examination
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT02459392 |
75/EK/15 |
EPCSII |
May 2015 |
November 2019 |
November 2019 |
June 2, 2015 |
April 23, 2018 |
|
- Czech republic
Praha, Czechia
|
| 20 |
NCT03072927 |
Recruiting |
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study |
|
|
Observational |
|
|
Industry |
- Observational Model: Other
- Time Perspective: Other
|
- Rate of surgical, minimally invasive intervention.
- Rate of participants with harms associated with the index procedure
|
4000 |
All |
66 Years and older (Senior) |
NCT03072927 |
MILD Medicare Claims |
|
March 10, 2017 |
December 2020 |
December 2020 |
March 7, 2017 |
April 23, 2018 |
|
- Outpatient Surgery Center of Jonesboro
Jonesboro, Arkansas, United States - VA Medical Center - Little Rock
Little Rock, Arkansas, United States - Pacific Ambulatory Surgery Center
Alhambra, California, United States - (and 154 more...)
|
| 21 |
NCT01455805 |
Recruiting |
Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis |
- Lumbar Spinal Stenosis
- Spondylolisthesis
- Degenerative Disc Disease
|
- Device: Minuteman Fusion Implant
- Procedure: surgical decompression
|
Interventional |
Phase 4 |
- Spinal Simplicity LLC
- The Leeds Teaching Hospitals NHS Trust
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline of clinical efficacy up to 60 months post procedure
- measures of quality of life
- Adverse events related to device and procedure
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT01455805 |
SS2011UK |
|
June 2012 |
December 2016 |
December 2020 |
October 20, 2011 |
April 14, 2016 |
|
- The Ipswich Hospital NHS Trust
Ipswich, Suffolk, United Kingdom - Pallium Research Group, Pain Management Dept Seacroft Hospital
Leeds, West Yorkshire, United Kingdom - The Dudley Group NHS Foundation Trust, Russell Hall Hospital
Birmingham, United Kingdom
|
| 22 |
NCT03495661 |
Not yet recruiting
New |
Decompression vs Physical Training for the Treatment of Lumbar Spinal Stenosis |
- Spinal Stenosis
- Spinal Stenosis Lumbar
- Degeneration Lumbar Spine
- (and 3 more...)
|
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Oswestry Disability Index (ODI)
- Motor Amplitude (ENG)
- Denervation Activity (EMG)
- (and 11 more...)
|
120 |
All |
50 Years to 85 Years (Adult, Senior) |
NCT03495661 |
u1 |
UppSten |
April 30, 2018 |
December 2021 |
December 2021 |
April 12, 2018 |
April 19, 2018 |
|
|
| 23 |
NCT02215551 |
Recruiting |
Predictors of Decompressive Laminectomy Outcomes |
|
|
Observational |
|
- VA Office of Research and Development
|
U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Brigham Spinal Stenosis Questionnaire
|
350 |
All |
50 Years to 90 Years (Adult, Senior) |
NCT02215551 |
O0798-R |
|
October 1, 2014 |
July 1, 2018 |
December 31, 2018 |
August 13, 2014 |
January 18, 2018 |
|
- VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States - Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States - VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States - (and 4 more...)
|
| 24 |
NCT02348645 |
Recruiting |
Decompression vs. Fusion for Stable Degenerative Spondylolisthesis |
- Spinal Stenosis
- Spondylolisthesis
|
- Procedure: Spinal fusion
- Procedure: Spinal decompression
|
Interventional |
Not Applicable |
- University Health Network, Toronto
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of patients recruited
- Number of eligible patients
- Reasons for refusal to consent
- (and 13 more...)
|
130 |
All |
50 Years and older (Adult, Senior) |
NCT02348645 |
13-6927-B |
|
October 2014 |
September 2017 |
December 2017 |
January 28, 2015 |
October 31, 2016 |
|
- Foothills Medical Centre
Calgary, Alberta, Canada - Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada - University of British Columbia Hospital
Vancouver, British Columbia, Canada - (and 10 more...)
|
| 25 |
NCT03388307 |
Not yet recruiting |
Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis |
|
- Procedure: unilateral laminotomy
- Procedure: decompressive laminectomy
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- back pain
- neurogenic claudication pain
|
30 |
All |
40 Years to 60 Years (Adult) |
NCT03388307 |
29109242502338 |
|
January 15, 2018 |
November 1, 2018 |
November 15, 2018 |
January 2, 2018 |
January 3, 2018 |
|
|
| 26 |
NCT03381677 |
Recruiting |
Pedicle Osteotomy for Stenosis Trial |
- Lumbar Spinal Stenosis
- Spondylolisthesis, Grade 1
- Neurogenic Claudication
|
- Device: Pedicle Lengthening Osteotomy with Altum® Device
- Device: Control
|
Interventional |
Not Applicable |
- Innovative Surgical Designs
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Zurich Claudication Questionnaire (ZCQ)
- No reoperations
- Adjacent level surgery
- (and 11 more...)
|
344 |
All |
40 Years to 80 Years (Adult, Senior) |
NCT03381677 |
A-2016-01 |
POST |
October 26, 2017 |
October 26, 2022 |
October 26, 2024 |
December 22, 2017 |
April 6, 2018 |
|
- University of Maryland
Baltimore, Maryland, United States - Beaumont Hospital
Royal Oak, Michigan, United States - Rothman Institute
Bryn Mawr, Pennsylvania, United States
|
| 27 |
NCT02975011 |
Recruiting |
Effectiveness and Safety of Korean Medicine for Lumbar Stenosis Patients With Sciatica |
|
- Drug: Herbal medicine
- Procedure: Chuna manipulation
- Procedure: Bee venom pharmacopuncture
- (and 5 more...)
|
Observational |
|
- Jaseng Medical Foundation
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Change in Numeric rating scale (NRS) of low back pain
- Change in Numeric rating scale (NRS) of radiating leg pain
- Numeric rating scale (NRS) of low back pain
- (and 7 more...)
|
120 |
All |
19 Years to 75 Years (Adult, Senior) |
NCT02975011 |
JS-CT-2016-03 |
|
March 4, 2017 |
September 2018 |
September 2018 |
November 29, 2016 |
April 5, 2018 |
|
- Jaseng Medical Foundation
Seoul, Korea, Republic of
|
| 28 |
NCT03240042 |
Recruiting |
Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery |
- Cervical Spinal Stenosis
- Cuff
|
- Procedure: nasotracheal intubation
- Procedure: orotracheal intubation
|
Interventional |
Not Applicable |
- Taipei Veterans General Hospital, Taiwan
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Care Provider, Outcomes Assessor)
- Primary Purpose: Prevention
|
- cuff pressure
- sore throat
- dysphonia
- dysphagia
|
200 |
All |
20 Years to 90 Years (Adult, Senior) |
NCT03240042 |
2017-07-013C |
|
October 17, 2017 |
August 31, 2020 |
August 31, 2020 |
August 4, 2017 |
October 18, 2017 |
|
- Taipei Veterans General Hospital
Taipei, Taiwan - Taipei Veterans General Hospital
Taipei, Taiwan
|
| 29 |
NCT03012776 |
Recruiting |
A Pivotal Study of the Premia Spine TOPS™ System |
- Lumbar Spinal Stenosis
- Degenerative Spondylolisthesis
|
- Device: Total Posterior Spine System (TOPS)
- Procedure: Transforaminal Lumbar Interbody Fusion (TLIF)
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Improvement in Oswestry Disability Index (ODI)
- Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator
- No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator
- (and 6 more...)
|
266 |
All |
35 Years to 80 Years (Adult, Senior) |
NCT03012776 |
CL-2830 - US IDE |
|
January 2017 |
September 2020 |
September 2023 |
January 6, 2017 |
March 19, 2018 |
|
- Cedars Sinai
Los Angeles, California, United States - Eisenhower Desert Orthopedic Center
Palm Desert, California, United States - Scripps
San Diego, California, United States - (and 24 more...)
|
| 30 |
NCT03011866 |
Not yet recruiting |
Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries |
- Spinal Stenosis
- Intervertebral Disc Displacement
|
- Drug: Wound topically irrigated with 500mg TXA
- Drug: 1mg/kg/hr TXA intravenous infusion till the last suture
|
Interventional |
Not Applicable |
- Peking Union Medical College Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Perioperative Total blood loss (TBL)
- Visible intraoperative blood loss
- Visible postoperative blood loss within 24hrs
- (and 17 more...)
|
176 |
All |
50 Years and older (Adult, Senior) |
NCT03011866 |
PUMCH-000391 |
TARGETS |
February 2017 |
December 2018 |
|
January 5, 2017 |
January 5, 2017 |
|
|
| 31 |
NCT02875431 |
Recruiting |
Multicentric Registry for the Detection of C5 Palsy After Anterior Cervical Discectomy and Fusion |
- Degenerative Cervical Spinal Stenosis
- Cervical Disc Herniation
- Suspected Cervical Spine Instability
|
- Procedure: Patients undergo ACDF or cervical vertebral body replacement
|
Observational |
|
- Technische Universität München
- Medical University Innsbruck
- Charite University, Berlin, Germany
- (and 9 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
1087 |
All |
Child, Adult, Senior |
NCT02875431 |
C5 registry |
C5registry |
August 2016 |
August 2017 |
November 2017 |
August 23, 2016 |
August 23, 2016 |
|
- Department of Neurosurgery
Munich, Bavaria, Germany
|
| 32 |
NCT03434223 |
Recruiting |
Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM) |
- Spondylolisthesis
- Spinal Stenosis
- Degenerative Disease
|
- Device: Implanet Jazz System
|
Observational |
|
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Number of patients who have undergone lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System
|
100 |
All |
60 Years to 99 Years (Adult, Senior) |
NCT03434223 |
2016H0350 |
|
December 29, 2016 |
December 1, 2021 |
December 1, 2021 |
February 15, 2018 |
February 15, 2018 |
|
- The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
|
| 33 |
NCT03105167 |
Not yet recruiting |
Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation |
- Spinal Stenosis Lumbar
- Lumbar Disc Herniation
- Intervertebral Disc Degeneration
|
- Procedure: cortical bone trajectory screws
- Procedure: pedicle screws
|
Interventional |
Not Applicable |
- Second Affiliated Hospital of Wenzhou Medical University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Visual analogue scale(VAS)
- Oswestry Disability Index (ODI)
- Symptomatic adjacent-segment disease (SASD)
- Japanese Orthopedic Association (JOA)
|
108 |
All |
18 Years and older (Adult, Senior) |
NCT03105167 |
SAHoWMU-CR2017-08-106 |
|
November 20, 2017 |
December 13, 2020 |
December 13, 2021 |
April 7, 2017 |
September 11, 2017 |
|
|
| 34 |
NCT03088306 |
Recruiting |
Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients |
- Lumbar Spinal Stenosis
- Lumbar Spinal Instability
- Lumbar Spine Degeneration
|
- Drug: Standard analgesia use [Oxygen]
- Drug: Standard analgesia use [Hydromorphone]
- Drug: Standard analgesia use [Volatile Anesthesia]
- (and 5 more...)
|
Interventional |
Early Phase 1 |
- Johns Hopkins University
- North American Spine Society
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of participants undergoing lumbar spine surgery with complete follow-up
- Patient controlled analgesia (PCA) pump use
- Opioid medication use
- (and 9 more...)
|
50 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT03088306 |
IRB00113816 |
IPaRO |
July 1, 2017 |
May 31, 2018 |
July 31, 2018 |
March 23, 2017 |
April 9, 2018 |
|
- Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
|
| 35 |
NCT02411799 |
Recruiting |
Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz SystemTMd |
- Spondylolisthesis
- Spinal Stenosis
- Proximal Joint Kyphosis (PJK)
|
|
Observational |
|
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Number of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02411799 |
2014H0433 |
|
April 2015 |
April 2020 |
April 2025 |
April 8, 2015 |
February 12, 2018 |
|
- The Ohio State University
Columbus, Ohio, United States
|
| 36 |
NCT03047044 |
Recruiting |
The Comparison of Postoperative Pain After Lumbar Fusion Surgery in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment |
- Back Pain
- Fusion of Spine, Lumbar Region
- Spinal Stenosis
|
- Other: Optimizing basal infusion (B.I)
- Other: Conventional PCA mode
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Other
|
- the pain numeric rating scale
|
68 |
All |
20 Years to 70 Years (Adult, Senior) |
NCT03047044 |
4-2016-1079 |
|
March 2, 2017 |
January 15, 2020 |
January 30, 2020 |
February 8, 2017 |
April 4, 2018 |
|
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of
|
| 37 |
NCT01934868 |
Recruiting |
Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg |
- Sciatica
- Spinal Stenosis of Lumbar Region
- Degeneration of Lumbar or Lumbosacral Intervertebral Disc
|
- Drug: prolotherapy solution of 20% dextrose
- Drug: Epidural Steroid Injection
|
Interventional |
Early Phase 1 |
- Hadassah Medical Organization
- Reuth Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Numerical Rating Scale
- Oswestry Back Disability Questionnaire Score
|
160 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT01934868 |
0309-13-HMO-CTIL |
|
November 2013 |
December 2018 |
December 2019 |
September 4, 2013 |
February 28, 2018 |
|
- Pain Unit, Hadassah Medical Center
Jerusalem, Israel
|
| 38 |
NCT02700451 |
Recruiting |
Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes |
- Lumbar Osteoarthritis
- Spondylosis
- Lumbar Disc Disease
- Spinal Stenosis
|
- Drug: Ketorolac
- Drug: Acetaminophen
- Drug: Placebo
|
Interventional |
Not Applicable |
- Hospital for Special Surgery, New York
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Perioperative Opioid use
- Opioid Use at 4-6 weeks
- Opioid Use at 3 months
- (and 14 more...)
|
300 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02700451 |
2014-333 |
|
March 2016 |
August 2019 |
August 2021 |
March 7, 2016 |
April 5, 2018 |
|
- Hospital for Special Surgery
New York, New York, United States
|
| 39 |
NCT03480893 |
Not yet recruiting
New |
Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication |
|
- Procedure: small size interarcuair decompression
- Procedure: Laminectomy
|
Interventional |
Not Applicable |
- Erasmus Medical Center
- Park MC
- Maasstad Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change on the Modified Roland-Morris Disability Questionnaire
- Change on the Numeric Rating Scale for leg pain
- Change on the Numeric Rating Scale for back pain
- (and 12 more...)
|
236 |
All |
40 Years and older (Adult, Senior) |
NCT03480893 |
MRace 108226 |
Size |
April 1, 2018 |
April 1, 2020 |
April 1, 2024 |
March 29, 2018 |
March 29, 2018 |
|
- Erasmus MC
Rotterdam, Zuid-Holland, Netherlands
|
| 40 |
NCT03064802 |
Recruiting |
Burst Biologics Spinal Fusion Registry |
- Degenerative Disc Disease
- Spinal Stenosis
- Spondylitis
- (and 2 more...)
|
- Device: BioBurst Fluid, Burst Allograft
|
Observational |
|
- Burst Biologics
- Smart-Surgical Inc. dba Burst Biologics
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
- Fusion Rate (%) . Number of patients fused/all patients operated (%)
- Visual Analog Scale (VAS)
- Change from Baseline in Oswestry Disability Index (ODI)
- (and 2 more...)
|
450 |
All |
18 Years and older (Adult, Senior) |
NCT03064802 |
SP001 |
|
March 24, 2017 |
December 31, 2019 |
June 2020 |
February 27, 2017 |
February 14, 2018 |
|
- Orlando Neurosurgery
Winter Garden, Florida, United States - Polaris Spine and Neurosurgery Center
Atlanta, Georgia, United States - Carrollton Orthopaedic Clinic
Carrollton, Georgia, United States - (and 2 more...)
|
| 41 |
NCT02931279 |
Recruiting |
PASS OCT® Post-market Clinical Follow-up |
- Intervertebral Disc Disease
- Spondylolisthesis
- Spinal Stenosis
- (and 2 more...)
|
- Device: PASS OCT® Spinal System
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Adverse events
- Fusion
- Disability
- (and 2 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02931279 |
1701 |
|
September 2016 |
September 2019 |
December 2020 |
October 13, 2016 |
March 21, 2018 |
|
- Hopital la Timone
Marseille, France
|
| 42 |
NCT03321357 |
Recruiting |
Retest-reliability and At-home-assessment Feasibility of the 5R-STS |
- Degenerative Disc Disease
- Spondylolisthesis
- Spondylosis
- (and 4 more...)
|
- Diagnostic Test: five-repetition sit-to-stand test
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- 5R-STS
- EQ-5D-3L
- Oswestry Disability Index
- (and 3 more...)
|
75 |
All |
Child, Adult, Senior |
NCT03321357 |
5R-STS-2 |
5RSTS-2 |
December 8, 2017 |
January 31, 2018 |
February 16, 2018 |
October 25, 2017 |
December 11, 2017 |
|
- Bergman Clinics
Naarden, Netherlands
|
| 43 |
NCT03398915 |
Recruiting |
The European Robotic Spinal Instrumentation (EUROSPIN) Registry |
- Degenerative Disc Disease
- Spondylolisthesis
- Spinal Stenosis
- (and 4 more...)
|
- Procedure: Transpedicular Instrumentation
|
Observational |
|
- Marc Schröder
- Bergman Clinics
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Overall rate of screw revisions
- Intraoperative pedicle screw revisions
- Reoperations for pedicle screw malposition
- (and 11 more...)
|
500 |
All |
16 Years and older (Child, Adult, Senior) |
NCT03398915 |
EUROSPIN |
EUROSPIN |
February 20, 2018 |
January 1, 2021 |
January 1, 2023 |
January 16, 2018 |
March 6, 2018 |
|
- Medisch Spectrum Twente
Enschede, Netherlands - Bergman Clinics
Naarden, Netherlands - MC Haaglanden
the Hague, Netherlands - HUG Geneva
Geneva, Switzerland
|
| 44 |
NCT02873182 |
Not yet recruiting |
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study |
- Intervertebral Disc Degeneration
- Intervertebral Disc Displacement
- Spinal Curvatures
- (and 5 more...)
|
- Device: Autonomic nervous system monitoring
|
Interventional |
Not Applicable |
- Stanley Skinner
- Allina Health System
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions.
- Amplitude and frequency of changes in smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulations and recordings.
- The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.
|
20 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02873182 |
NSSS-1601 |
|
August 2016 |
August 2018 |
August 2018 |
August 19, 2016 |
August 19, 2016 |
|
|
| 45 |
NCT02444702 |
Recruiting |
Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders. |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- The change in Oswestry Disability Index (ODI) score which is equal to or greater than 50% has been used consistently in Physical Therapy literature as the definition of success following an intervention
- The Roland Morris Disability Questionnaire (RMQ)
- The Fear Avoidance Beliefs questionnaire (FABQ)
- (and 10 more...)
|
200 |
All |
40 Years to 80 Years (Adult, Senior) |
NCT02444702 |
0006-15-MMC |
|
June 15, 2015 |
May 2018 |
December 2018 |
May 14, 2015 |
March 22, 2018 |
|
- Assuta hospital
Tel Aviv, Israel
|
| 46 |
NCT02883569 |
Recruiting |
Comparative Effectiveness Study for Surgery vs. Non-Surgery in Patients With Low Back Pain |
|
- Procedure: open or endoscopic discectomy
- Procedure: epidural block
- Other: exercise
- (and 5 more...)
|
Interventional |
Not Applicable |
- Seoul National University Hospital
- Seoul National University Bundang Hospital
- Gangnam Severance Hospital
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Compare the change of pain score after treatment
- Appropriate conservative treatment period
- the change of pain score (Visual anlogue pain score) after time of treatment
- (and 3 more...)
|
1102 |
All |
18 Years and older (Adult, Senior) |
NCT02883569 |
LBP |
CES_SNS_LBP |
September 2016 |
December 2018 |
December 2021 |
August 30, 2016 |
February 6, 2018 |
|
- Seoul National University Hospital
Seoul, Korea, Republic of
|
| 47 |
NCT03077204 |
Recruiting |
BIO4 Clinical Case Study: Cervical Spine |
- Degenerative Disc Disease
- Trauma (Including Fractures)
- Spondylolisthesis
|
- Biological: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
- Device: Aviator Anterior Cervical Plating System
|
Interventional |
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Radiological assessment : Fusion Status
- Arthrodesis rates
- Revision rates (if any)
- (and 2 more...)
|
20 |
All |
19 Years and older (Adult, Senior) |
NCT03077204 |
CR-16-109 |
|
April 6, 2017 |
April 30, 2018 |
April 30, 2018 |
March 10, 2017 |
April 25, 2017 |
|
- Seton Spine and Scoliosis Center
Austin, Texas, United States
|
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