Clinical trial NCT02436434: The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis
Official title: The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Keywords: Pulsed radiofrequency, osteoarthritis
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue. In contrast with conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many studies have shown its benefits in pain relief for certain kinds of chronic pain conditions. For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF is difficult and complicated because the supplying nerve of joint is complex or small. Hence, some authors perform intra-articular PRF on the chronic painful joint for example, knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and shoulder joint and the excellent long-term effects are reported.

The purpose of this study is to investigate the effect of intra-articular PRF in osteoarthritis.

Detailed description: Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue. In contrast with conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many studies have shown its benefits in pain relief for certain kinds of chronic pain conditions. For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF is difficult and complicated because the supplying nerve of joint is complex or small. Hence, some authors perform intra-articular PRF on the chronic painful joint for example, knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and shoulder joint and the excellent long-term effects are reported.

However, the definite effect of intra-articular PRF for osteoarthritis from current published studies are insufficiently proved because of small patient numbers and lack of placebo-controlled design. The purpose of this study is to investigate the effect of intra-articular PRF in osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* Age between 30-75 year-old
* Clear consciousness
* No receive steroid injection, hyaluronic acid, platelet rich plasma in past 6 months
* The pain (VAS) more than 4
* Symptom duration at least 6 months

Exclusion Criteria:

* Cancer
* Joint contracture
* Coagulopathy
* Pregnancy
* Status of Pacemaker
* Inflammation status
* Operative history of treated joint

Primary outcomes:
measure: Change from baseline of pain on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Secondary outcomes:
measure: Change from baseline in severity of symptoms and functional status on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
measure: Change from baseline of range of motion on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
timeFrame: Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
measure: Change from baseline of strength on 4th, 8th,12th and 16th weeks after treatment.
timeFrame: Pre-treatment 4th, 8th,12th and 16th weeks after treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
state: Neihu District
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center,
state: Neihu District
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
name: Yung-Tsan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.
citation: Rahimzadeh P, Imani F, Faiz SH, Entezary SR, Nasiri AA, Ziaeefard M. Investigation the efficacy of intra-articular prolotherapy with erythropoietin and dextrose and intra-articular pulsed radiofrequency on pain level reduction and range of motion improvement in primary osteoarthritis of knee. J Res Med Sci. 2014 Aug;19(8):696-702.
citation: Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. Epub 2013 Aug 14.
citation: Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.