Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation
Primary Purpose
Hip Osteoarthritis, Chronic Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound-Guided Cooled Radiofrequency Hip Denervation
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Ultrasound Guidance, Cooled Radiofrequency, Hip Denervation
Eligibility Criteria
Inclusion Criteria:
- Primary degenerative osteoarthritis of hip joint
- Pain pre-intervention qualified as at least moderate with functional limitation moderate/severe.
- Radiological confirmation of hip osteoarthritis
- Failure of conservative therapy to control symptoms, defined as the persistence of at least moderate with functional limitation moderate/severe pain that has been refractory to prescribed medications, and other modalities, such as physical therapy and intraarticular injections. Intolerable side effects of medications and contraindications to specific methods will be also considered as a failure of the conservative therapy.
- Positive articular branches analgesic block, defined as >50% improvement in pain and function for at least 2 hours
Exclusion Criteria:
- Non-English speakers
- Daily dose of opioids more than 90 MEQ
- Body Mass Index (BMI) > 30
- Uncorrectable coagulopathy
- Local and systemic infection
- Inability to obtain ultrasound image of ventral acetabulum
- Documented prior Anaphylactic Reaction to Contrast Agent
- Pregnancy
Sites / Locations
- Women's College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound-Guided Hip Denervation
Arm Description
This is a pilot study. 15 Hip Osteoarthritis patients with chronic pain will be recruited in this pilot arm. These will undergo Ultrasound-Guided Cooled Radiofrequency Hip Denervation as intervention.
Outcomes
Primary Outcome Measures
Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) Score
A questionnaire designed to assess pain, stiffness, and physical function in patients with hip and/or knee osteoarthritis (OA)1
The WOMAC consists of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing Stiffness (2 items): after first waking and later in the day Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.
Secondary Outcome Measures
Short Form (12) Health Survey (SF-12)
A generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.
EQ-5D
EQ-5D is a standardised instrument for use as a measure of health outcome.It is applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is primarily designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.
Full Information
NCT ID
NCT02546336
First Posted
August 13, 2015
Last Updated
February 25, 2019
Sponsor
Women's College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02546336
Brief Title
Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation
Official Title
Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation: A Prospective Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Staff for the study is no longer available.
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hip osteoarthritis (HOA) is a common cause of pain and disability in aging population. Conservative treatment is based on lifestyle modifications, physical therapy, analgesic and anti-inflammatory medications and intra articular injections. This Prospective Pilot Study aims at investigating the efficacy of Ultrasound-Guided Cooled Radiofrequency Hip Denervation as a treatment offered to patients with HOA.
Detailed Description
Radiological prevalence of HOA is very high. Hip denervation (HD) is a known palliative procedure that was initially performed as an open surgery. The role of the obturator, femoral and sciatic nerves in hip joint innervation was discovered. Several small clinical and anatomical studies addressed feasibility and benefits of the radiofrequency hip denervation (RFHD). Ultrasound guidance may eliminate equivocality of previously published techniques and provide precise image guidance as it a is logical and anatomically sound approach when procedural targets include soft tissue, such as nerves, tendons and joint capsule. None of these structures can be localized under routine fluoroscopy. Ultrasound is a bedside imaging tool that has been accepted as safe and reliable. In two meta-analyses, the use of real-time two-dimensional ultrasound for the placement of CVCs substantially decreased mechanical complications and reduced the number of attempts at required cannulation and failed attempts at cannulation compared with the standard landmark placement. Pertinent to the proposed study, recent systematic review and meta-analysis of the accuracy of US-guided versus landmark-guided hip joint injections revealed that US-guided injections are significantly more accurate than those that are landmark-guided. The significance of this study lies in its potential to improve functional activity and pain control in patients with HOA. Also, it may eventually lead to a decrease in patients resorting to Total Hip Arthroplasty (THA) as an ultimate end solution for HOA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Chronic Pain
Keywords
Ultrasound Guidance, Cooled Radiofrequency, Hip Denervation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound-Guided Hip Denervation
Arm Type
Experimental
Arm Description
This is a pilot study. 15 Hip Osteoarthritis patients with chronic pain will be recruited in this pilot arm. These will undergo Ultrasound-Guided Cooled Radiofrequency Hip Denervation as intervention.
Intervention Type
Device
Intervention Name(s)
Ultrasound-Guided Cooled Radiofrequency Hip Denervation
Intervention Description
Light neuroleptic anesthesia and skin preparation will be performed. Under Ultrasound guidance, an active probe will be inserted. Sensory and motor stimulation will be administered. Anteroposterior fluoroscopy image will be recorded. Lesioning of articular branches of femoral and obturator nerves via radiofrequency will be performed after lidocaine injection. WOMAC, EQ-5D and SF-12 questionnaires will be used for measuring outcomes postoperatively.
Primary Outcome Measure Information:
Title
Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) Score
Description
A questionnaire designed to assess pain, stiffness, and physical function in patients with hip and/or knee osteoarthritis (OA)1
The WOMAC consists of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing Stiffness (2 items): after first waking and later in the day Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Short Form (12) Health Survey (SF-12)
Description
A generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.
Time Frame
12 months
Title
EQ-5D
Description
EQ-5D is a standardised instrument for use as a measure of health outcome.It is applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is primarily designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary degenerative osteoarthritis of hip joint
Pain pre-intervention qualified as at least moderate with functional limitation moderate/severe.
Radiological confirmation of hip osteoarthritis
Failure of conservative therapy to control symptoms, defined as the persistence of at least moderate with functional limitation moderate/severe pain that has been refractory to prescribed medications, and other modalities, such as physical therapy and intraarticular injections. Intolerable side effects of medications and contraindications to specific methods will be also considered as a failure of the conservative therapy.
Positive articular branches analgesic block, defined as >50% improvement in pain and function for at least 2 hours
Exclusion Criteria:
Non-English speakers
Daily dose of opioids more than 90 MEQ
Body Mass Index (BMI) > 30
Uncorrectable coagulopathy
Local and systemic infection
Inability to obtain ultrasound image of ventral acetabulum
Documented prior Anaphylactic Reaction to Contrast Agent
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gofeld, MD, FIPP
Organizational Affiliation
Women's College Hospital/ Saint Michael's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18163497
Citation
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Results Reference
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19286855
Citation
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Citation
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Results Reference
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PubMed Identifier
22632703
Citation
Brakke R, Singh J, Sullivan W. Physical therapy in persons with osteoarthritis. PM R. 2012 May;4(5 Suppl):S53-8. doi: 10.1016/j.pmrj.2012.02.017.
Results Reference
background
PubMed Identifier
18877978
Citation
MULDER JD. Denervation of the hip joint in osteoarthritis. J Bone Joint Surg Br. 1948 Aug;30B(3):446-8. No abstract available.
Results Reference
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PubMed Identifier
9711767
Citation
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Results Reference
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PubMed Identifier
22385437
Citation
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Results Reference
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PubMed Identifier
11707799
Citation
Kawaguchi M, Hashizume K, Iwata T, Furuya H. Percutaneous radiofrequency lesioning of sensory branches of the obturator and femoral nerves for the treatment of hip joint pain. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):576-81. doi: 10.1053/rapm.2001.26679.
Results Reference
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PubMed Identifier
16871303
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
background
Links:
URL
https://secure.cihi.ca/estore/productFamily.htm?pf=PFC2209&lang=en&media=0
Description
Hip and Knee Replacements in Canada: Canadian Joint Replacement Registry 2013 Annual Reports
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Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation
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