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Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial (SAPHENERO)

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Saphenous Nerve
Genicular nerves
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Pulsed Radiofrequency Treatment, Ultrasonography, Interventional

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Will be included patients older than 18 years, who have moderate to strong chronic pain in knee on most of the days days for at least 3 months, with osteoarthritis of the knee documented by graded radiologically at 3 to 4 in Kellgren-Lawrence rating, refractory to medical treatment (physical therapy, oral analgesics, intra-articular injections of hyaluronic acid or corticosteroids).

Exclusion Criteria:

  • The exclusion criteria are: acute knee pain, prior surgery on the knee, another connective tissue disease affecting the knee, psychiatric or neurological disorders, intra-articular injection of hyaluronic acid or corticosteroid for less than 3 months, pain related to nerve sciatic, use of anticoagulants and pacemaker.

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Genicular nerves

Saphenous Nerve

Arm Description

Neurotomy by radiofrequency of genicular nerves knee guided by fluoroscopy

Neurotomy of saphenous nerve by radiofrequency on the distal third of the thigh, guided by ultrasound

Outcomes

Primary Outcome Measures

Pain scores
Number verbal scale

Secondary Outcome Measures

Opioids consumption
Morphine oral equivalent dose needed
Side effects
Nausea, vomiting, sedation
Functional capacity
WOMAC score

Full Information

First Posted
July 5, 2016
Last Updated
July 7, 2016
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02826850
Brief Title
Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial
Acronym
SAPHENERO
Official Title
Comparative Study of Neurotomy by Radiofrequency of Genicular Nerves, Guided by Fluoroscopy, and Neurotomy by Radiofrequency of Saphenous Nerve, Guided by Ultrasound, for the Treatment of Chronic Knee Pain in Patients With Osteoarthritis .
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project is one of four components of a thematic project that aims to evaluate the use of ultrasound in regional and infiltration blocks, called "Use of ultrasound in regional blocks and infiltration for the treatment of acute and chronic pain". It aims to evaluate quantitatively and qualitatively the knee pain control in patients with osteoarthritis after neurotomy by saphenous nerve radiofrequency guided by ultrasound , compared to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy . Differences between total consumption of analgesics, side effects of medications , impact on quality of life and functional capacity in patients undergoing saphenous nerve neurotomy by radiofrequency guided by ultrasound compared to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy, will also be evaluated.
Detailed Description
BACKGROUND: Osteoarthritis of the knees is currently a major public health problem, with patients suffering from pain and functional limitation. Depending on the severity of the impairment, the definitive treatment is surgical, but the old ages often associated and morbidities present in these patients some times limit such conduct. More effective treatments for pain control are necessary. OBJECTIVES: To evaluate quantitative and qualitative pain control in patients with osteoarthritis in knees after neurotomy of saphenous nerve by radiofrequency guided by ultrasound, compared to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy. METHODS: This was a prospective, randomized clinical study and blind to the evaluators. Will include 20 patients with knee osteoarthritis grade III or IV, refractory to medical treatment. A group will be submitted to neurotomy by radiofrequency of genicular nerves guided by fluoroscopy and the other group will receive neurotomy by radiofrequency of saphenous nerve, guided by ultrasound. They will be assessed in pain intensity at rest and movement, functionality, satisfaction and adverse effects related to treatment. Patients will be evaluated 15 days, 1 month, 3, 6 and 12 months after the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, Pulsed Radiofrequency Treatment, Ultrasonography, Interventional

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genicular nerves
Arm Type
Sham Comparator
Arm Description
Neurotomy by radiofrequency of genicular nerves knee guided by fluoroscopy
Arm Title
Saphenous Nerve
Arm Type
Active Comparator
Arm Description
Neurotomy of saphenous nerve by radiofrequency on the distal third of the thigh, guided by ultrasound
Intervention Type
Procedure
Intervention Name(s)
Saphenous Nerve
Intervention Description
Saphenous nerve neurotomy by radiofrequency, guided by ultrasound.
Intervention Type
Procedure
Intervention Name(s)
Genicular nerves
Intervention Description
Genicular nerves neurotomy by radiofrequency, guided by fluoroscopy
Primary Outcome Measure Information:
Title
Pain scores
Description
Number verbal scale
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Opioids consumption
Description
Morphine oral equivalent dose needed
Time Frame
90 days
Title
Side effects
Description
Nausea, vomiting, sedation
Time Frame
90 days
Title
Functional capacity
Description
WOMAC score
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Will be included patients older than 18 years, who have moderate to strong chronic pain in knee on most of the days days for at least 3 months, with osteoarthritis of the knee documented by graded radiologically at 3 to 4 in Kellgren-Lawrence rating, refractory to medical treatment (physical therapy, oral analgesics, intra-articular injections of hyaluronic acid or corticosteroids). Exclusion Criteria: The exclusion criteria are: acute knee pain, prior surgery on the knee, another connective tissue disease affecting the knee, psychiatric or neurological disorders, intra-articular injection of hyaluronic acid or corticosteroid for less than 3 months, pain related to nerve sciatic, use of anticoagulants and pacemaker.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hermann S Fernandes, M.D.
Phone
+55 84 988966348
Email
hermann.fernandes@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley A Santos, M.D.
Phone
+55 11 985733798
Email
shirleyandrade.s@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazem A Ashmawi, Ph.D
Organizational Affiliation
Head of the Pain Management Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joaquim E Vieira, Ph.D
Organizational Affiliation
Associated Professor of Anesthesiology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermann S Fernandes, M.D.
Phone
+55 84 988966348
Email
hermann.fernandes@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Shirley A Santos, M.D.
Phone
+55 11 985733798
Email
shirleyandrade.s@gmail.com
First Name & Middle Initial & Last Name & Degree
Hazem A Ashmawi, Ph.D
First Name & Middle Initial & Last Name & Degree
Joaquim E Vieira, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
17143985
Citation
Andrianakos AA, Kontelis LK, Karamitsos DG, Aslanidis SI, Georgountzos AI, Kaziolas GO, Pantelidou KV, Vafiadou EV, Dantis PC; ESORDIG Study Group. Prevalence of symptomatic knee, hand, and hip osteoarthritis in Greece. The ESORDIG study. J Rheumatol. 2006 Dec;33(12):2507-13.
Results Reference
background
PubMed Identifier
12759299
Citation
Mannoni A, Briganti MP, Di Bari M, Ferrucci L, Costanzo S, Serni U, Masotti G, Marchionni N. Epidemiological profile of symptomatic osteoarthritis in older adults: a population based study in Dicomano, Italy. Ann Rheum Dis. 2003 Jun;62(6):576-8. doi: 10.1136/ard.62.6.576.
Results Reference
background
PubMed Identifier
3632732
Citation
Felson DT, Naimark A, Anderson J, Kazis L, Castelli W, Meenan RF. The prevalence of knee osteoarthritis in the elderly. The Framingham Osteoarthritis Study. Arthritis Rheum. 1987 Aug;30(8):914-8. doi: 10.1002/art.1780300811.
Results Reference
background
PubMed Identifier
21463469
Citation
Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.
Results Reference
background
PubMed Identifier
21055873
Citation
Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
Results Reference
background
PubMed Identifier
21558611
Citation
Akbas M, Luleci N, Dere K, Luleci E, Ozdemir U, Toman H. Efficacy of pulsed radiofrequency treatment on the saphenous nerve in patients with chronic knee pain. J Back Musculoskelet Rehabil. 2011;24(2):77-82. doi: 10.3233/BMR-2011-0277.
Results Reference
background
PubMed Identifier
25785007
Citation
Jin SQ, Ding XB, Tong Y, Ren H, Chen ZX, Wang X, Li Q. Effect of saphenous nerve block for postoperative pain on knee surgery: a meta-analysis. Int J Clin Exp Med. 2015 Jan 15;8(1):368-76. eCollection 2015.
Results Reference
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Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisaAgrupador.jsf#
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisaAgrupador.jsf#

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Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial

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