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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02436434
Other study ID # TriServiceGH
Secondary ID
Status Withdrawn
Phase N/A
First received May 1, 2015
Last updated November 30, 2016
Start date May 2015
Est. completion date November 2016

Study information

Verified date November 2016
Source Tri-Service General Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital Taipei Neihu District
Taiwan Tri-Service General Hospital, National Defense Medical Center, Taipei Neihu District

Sponsors (1)

Lead Sponsor Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Karaman H, Tüfek A, Kavak GÖ, 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline of pain on1st, 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. Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment. Yes
Secondary Change from baseline in severity of symptoms and functional status on1st, 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. Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment. Yes
Secondary Change from baseline of range of motion on1st, 2th, 4th, 8th,12th and 16th weeks after treatment. Use the goniometer to measure the ROM before treatment and multiple time frame after treatment. Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment. Yes
Secondary Change from baseline of strength on 4th, 8th,12th and 16th weeks after treatment. Use the isokinetic machine to measure the ROM before treatment and multiple time frame after treatment. Pre-treatment 4th, 8th,12th and 16th weeks after treatment. Yes
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