Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation

Chronic Pain Clinical Trial

Official title:

Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation: A Prospective Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02546336
• Other study ID #: HIP RFD
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Ultrasound-Guided Cooled Radiofrequency Hip Denervation
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.

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Akatov OV, Dreval ON. Percutaneous radiofrequency destruction of the obturator nerve for treatment of pain caused by coxarthrosis. Stereotact Funct Neurosurg. 1997;69(1-4 Pt 2):278-80. — View 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. — View Citation

Chaiban G, Paradis T, Atallah J. Use of ultrasound and fluoroscopy guidance in percutaneous radiofrequency lesioning of the sensory branches of the femoral and obturator nerves. Pain Pract. 2014 Apr;14(4):343-5. doi: 10.1111/papr.12069. Epub 2013 May 9. — View Citation

Fukui S, Nosaka S. Successful relief of hip joint pain by percutaneous radiofrequency nerve thermocoagulation in a patient with contraindications for hip arthroplasty. J Anesth. 2001;15(3):173-5. — View Citation

Gupta G, Radhakrishna M, Etheridge P, Besemann M, Finlayson RJ. Radiofrequency denervation of the hip joint for pain management: case report and literature review. US Army Med Dep J. 2014 Apr-Jun:41-51. — View Citation

Hoeber S, Aly AR, Ashworth N, Rajasekaran S. Ultrasound-guided hip joint injections are more accurate than landmark-guided injections: a systematic review and meta-analysis. Br J Sports Med. 2016 Apr;50(7):392-6. doi: 10.1136/bjsports-2014-094570. Epub 2015 Jun 10. Review. — View Citation

Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Nelson AE, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of hip symptoms and radiographic and symptomatic hip osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2009 Apr;36(4):809-15. doi: 10.3899/jrheum.080677. Epub 2009 Mar 13. — View 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. — View Citation

Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176. — View Citation

Malik A, Simopolous T, Elkersh M, Aner M, Bajwa ZH. Percutaneous radiofrequency lesioning of sensory branches of the obturator and femoral nerves for the treatment of non-operable hip pain. Pain Physician. 2003 Oct;6(4):499-502. — View Citation

MULDER JD. Denervation of the hip joint in osteoarthritis. J Bone Joint Surg Br. 1948 Aug;30B(3):446-8. — View Citation

Rivera F, Mariconda C, Annaratone G. Percutaneous radiofrequency denervation in patients with contraindications for total hip arthroplasty. Orthopedics. 2012 Mar 7;35(3):e302-5. doi: 10.3928/01477447-20120222-19. — View Citation

Vincent HK, Heywood K, Connelly J, Hurley RW. Obesity and weight loss in the treatment and prevention of osteoarthritis. PM R. 2012 May;4(5 Suppl):S59-67. doi: 10.1016/j.pmrj.2012.01.005. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months

External Links

•   Hip and Knee Replacements in Canada: Canadian Joint Replacement Registry 2013 Annual Reports