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The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02436434
Enrollment
0
Registered
2015-05-06
Start date
2015-05-31
Completion date
2016-11-30
Last updated
2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Pulsed radiofrequency, osteoarthritis

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.

Interventions

DEVICEpulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)

Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint

Sponsors

Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline of pain on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

Secondary

MeasureTime frameDescription
Change from baseline in severity of symptoms and functional status on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.Use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Change from baseline of range of motion on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.Use the goniometer to measure the ROM before treatment and multiple time frame after treatment.
Change from baseline of strength on 4th, 8th,12th and 16th weeks after treatment.Pre-treatment 4th, 8th,12th and 16th weeks after treatment.Use the isokinetic machine to measure the ROM before treatment and multiple time frame after treatment.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026