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MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain

Primary Purpose

Chronic Low Back Pain, Facet Joint Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

MRgFUS ablation

Radiofrequency ablation

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Focused ultrasound Ablation, Radiofrequency Ablation, Facet joint syndrome, Chronic low back pain

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women age 20 to 79 years old
Suffering from lumbar vertebral facet joint syndrome.
Lower back pain at least six months (NRS≥4).
Conventional treatment of pain includes NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic therapy.
Imaging of the spine have facet osteoarthritis.
Referred pain is no more below the knee.
At least once when local anesthesia or diagnostic medial nerve branch injection, pain reduction> 75% (0.5ml of 2% lidocaine).

Exclusion Criteria:

Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain.
Patients with motor deficit or any other indication for surgical intervention.
Patients with MRgFUS or RF treatment for LBP within the last 6 months.
Patients with previous low back surgery.
Patients who are pregnant.
Patients with existing malignancy.
Patients with allergies to relevant contrast, anesthetics, sedation drugs.
Patients with contraindications for MRI.
Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction less than 40 days prior to protocol enrolment
- Patients with Severe Congestive Heart Failure, NYHA class 4.
- Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
- Patients with pacemaker
Patients with severe cerebrovascular disease (CVA within last 6 months)
Patients with severe hypertension (diastolic BP > 100 on medication)
Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
Patients unable to communicate with the investigator and staff.
Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment.
When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).

Sites / Locations

Taipei medical university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MRgFUS facet treatment

Radiofrequency ablation facet treatment

Arm Description

MRgFUS ablation for facet joint pain once at Lumbar spine

Radiofrequency ablation for facet joint pain once at Lumbar spine

Outcomes

Primary Outcome Measures

Pain score change: Numerical Rating Scale (NRS)

Efficacy

Secondary Outcome Measures

Pain score change: Numerical Rating Scale (NRS)

Efficacy

Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL)

Efficacy

Functional scales change: Oswestry Disability Questionnaire (ODQ)

Efficacy

Functional scales change: Core Outcome Measurement Index (COMI)

Efficacy

Functional scales change: EQ5D Quality of Life questionnaires

Efficacy

Amount of analgesic consumption

Efficacy

Adverse event

Safety

Full Information

NCT ID

NCT03168802

First Posted

April 10, 2017

Last Updated

March 9, 2020

Sponsor

Taipei Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03168802

Brief Title

MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain

Official Title

Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 24, 2018 (Actual)

Primary Completion Date

January 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taipei Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This is a prospective, randomized, two-arm, phase II study. The purpose of this study is: To evaluate and compare the efficacy and safety of magnetic resonance-guided focused ultrasound (MRgFUS) and radiofrequency ablation (RFA) for treatment of facet-joint osteoarthritis low back pain. Determining the effect of the MRgFUS System and RFA for improving functional disabilities and in reducing pain resulting from facet-joint osteoarthritis low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics/opiate, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), general health status (as measured by the EQ5D), physical exam, X-ray and MRI studies from baseline up to 12-Months post- MRgFUS and radiofrequency treatment. Evaluate incidence and severity of adverse events associated with the MRgFUS system and RFA used for the treatment of pain resulting from facet-joint osteoarthritis low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain, Facet Joint Syndrome

Keywords

Focused ultrasound Ablation, Radiofrequency Ablation, Facet joint syndrome, Chronic low back pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

50 patients in each arm.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MRgFUS facet treatment

Arm Type

Experimental

Arm Description

MRgFUS ablation for facet joint pain once at Lumbar spine

Arm Title

Radiofrequency ablation facet treatment

Arm Type

Active Comparator

Arm Description

Radiofrequency ablation for facet joint pain once at Lumbar spine

Intervention Type

Procedure

Intervention Name(s)

MRgFUS ablation

Intervention Description

Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome.

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency ablation

Intervention Description

Radiofrequency ablation therapy under C-arm navigation for facet joint syndrome.

Primary Outcome Measure Information:

Title

Pain score change: Numerical Rating Scale (NRS)

Description

Efficacy

Time Frame

24-week post-treatment

Secondary Outcome Measure Information:

Title

Pain score change: Numerical Rating Scale (NRS)

Description

Efficacy

Time Frame

1-, 4-, 8-, 12-, 36-, 52-week post-treatment

Title

Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL)

Description

Efficacy

Time Frame

1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Title

Functional scales change: Oswestry Disability Questionnaire (ODQ)

Description

Efficacy

Time Frame

1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Title

Functional scales change: Core Outcome Measurement Index (COMI)

Description

Efficacy

Time Frame

1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Title

Functional scales change: EQ5D Quality of Life questionnaires

Description

Efficacy

Time Frame

1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Title

Amount of analgesic consumption

Description

Efficacy

Time Frame

1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Title

Adverse event

Description

Safety

Time Frame

1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Other Pre-specified Outcome Measures:

Title

Physical exams for back range of motion

Description

Efficacy

Time Frame

1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

Title

X-ray for spine facet change

Description

Efficacy

Time Frame

1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women age 20 to 79 years old Suffering from lumbar vertebral facet joint syndrome. Lower back pain at least six months (NRS≥4). Conventional treatment of pain includes NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic therapy. Imaging of the spine have facet osteoarthritis. Referred pain is no more below the knee. At least once when local anesthesia or diagnostic medial nerve branch injection, pain reduction> 75% (0.5ml of 2% lidocaine). Exclusion Criteria: Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain. Patients with motor deficit or any other indication for surgical intervention. Patients with MRgFUS or RF treatment for LBP within the last 6 months. Patients with previous low back surgery. Patients who are pregnant. Patients with existing malignancy. Patients with allergies to relevant contrast, anesthetics, sedation drugs. Patients with contraindications for MRI. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study. Patients with unstable cardiac status including: Unstable angina pectoris on medication Patients with documented myocardial infarction less than 40 days prior to protocol enrolment Patients with Severe Congestive Heart Failure, NYHA class 4. Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status Patients with pacemaker Patients with severe cerebrovascular disease (CVA within last 6 months) Patients with severe hypertension (diastolic BP > 100 on medication) Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. Patients unable to communicate with the investigator and staff. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.) Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment. When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meng-Huang Wu, MD

Phone

227372181

Ext

3740

maxwutmu@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yen Yun, PhD

Organizational Affiliation

Taipei Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Taipei medical university hospital

City

Taipei

State/Province

Please Select

ZIP/Postal Code

11031

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meng-Huang Wu, MD

Phone

227372181

Ext

3740

maxwutmu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22935902

Citation

Weeks EM, Platt MW, Gedroyc W. MRI-guided focused ultrasound (MRgFUS) to treat facet joint osteoarthritis low back pain--case series of an innovative new technique. Eur Radiol. 2012 Dec;22(12):2822-35. doi: 10.1007/s00330-012-2628-6. Epub 2012 Aug 31.

Results Reference

background

PubMed Identifier

27443328

Citation

Kaye EA, Monette S, Srimathveeravalli G, Maybody M, Solomon SB, Gulati A. MRI-guided focused ultrasound ablation of lumbar medial branch nerve: Feasibility and safety study in a swine model. Int J Hyperthermia. 2016 Nov;32(7):786-94. doi: 10.1080/02656736.2016.1197972. Epub 2016 Jul 21.

Results Reference

background

PubMed Identifier

27054038

Citation

Krug R, Do L, Rieke V, Wilson MW, Saeed M. Evaluation of MRI protocols for the assessment of lumbar facet joints after MR-guided focused ultrasound treatment. J Ther Ultrasound. 2016 Apr 6;4:14. doi: 10.1186/s40349-016-0057-8. eCollection 2016.

Results Reference

background

PubMed Identifier

26495910

Citation

Maas ET, Ostelo RW, Niemisto L, Jousimaa J, Hurri H, Malmivaara A, van Tulder MW. Radiofrequency denervation for chronic low back pain. Cochrane Database Syst Rev. 2015 Oct 23;2015(10):CD008572. doi: 10.1002/14651858.CD008572.pub2.

Results Reference

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MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain

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