Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation

NCT02546336 | Withdrawn

• 1 other identifier: HIP RFD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis; Chronic Pain

Keywords

Ultrasound Guidance; Cooled Radiofrequency; Hip Denervation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Short Form (12) Health Survey (SF-12)

  12 months

• EQ-5D

  12 months

Study Arms (1)

Ultrasound-Guided Hip Denervation

EXPERIMENTAL

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.

Device: Ultrasound-Guided Cooled Radiofrequency Hip Denervation

Interventions

Ultrasound-Guided Cooled Radiofrequency Hip Denervation DEVICE

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.

Ultrasound-Guided Hip Denervation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (13)

• 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.

  PMID: 18163497 BACKGROUND

• 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.

  PMID: 19286855 BACKGROUND

• 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.

  PMID: 22632704 BACKGROUND

• 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.

  PMID: 22632703 BACKGROUND

• MULDER JD. Denervation of the hip joint in osteoarthritis. J Bone Joint Surg Br. 1948 Aug;30B(3):446-8. No abstract available.

  PMID: 18877978 BACKGROUND

• 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. doi: 10.1159/000099888.

  PMID: 9711767 BACKGROUND

• 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.

  PMID: 22385437 BACKGROUND

• 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.

  PMID: 11707799 BACKGROUND

• 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.

  PMID: 16871303 BACKGROUND

• 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. doi: 10.1007/s005400170023. No abstract available.

  PMID: 14566519 BACKGROUND

• 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.

  PMID: 26062955 BACKGROUND

• 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.

  PMID: 24706242 BACKGROUND

• 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.

  PMID: 23656575 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Chronic Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Gofeld, MD, FIPP

  Women's College Hospital/ Saint Michael's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: September 10, 2015
• Study Start: February 1, 2019
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

CA (1)