Condition category
Nervous System Diseases
Date applied
10/06/2010
Date assigned
21/06/2010
Last edited
26/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr MA Ke

ORCID ID

Contact details

Department of Anesthesiology
Xinhua Hospital
Shanghai Jiaotong University School of Medicine
1665 Kongjiang Road
Shanghai
200092
China
macoo74@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The clinical study of intercostal nerve pulsed radiofrequency in postherpetic neuralgia: A randomised controlled trial.

Acronym

Study hypothesis

1. That pulsed radiofrequency of intercostals nerve was effective and safe in chronic refractory postherpetic neuralgia (PHN) patients
2. This pulsed radiofrequency can improve the quality of life and reduce the oral pain-related drugs dosage of PHN patients

Ethics approval

1. The ethics committee of Xinhua Hospital (affiliated to Shanghai Jiaotong Universty School of Medicine) approved on the 16th of March 2010 (ref: 2010-002)
2. The ethics committee of Shanghai Sixth People's Hospital approved on the 28th of October 2009 (ref: 2009-96)

Study design

Prospective double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Postherpetic neuraglia (PHN)

Intervention

Patients were randomised to receive one of the following treatments, once a week for 3 weeks:
1. Pulsed radiofrequency (42 degree, 120 second) of the intercostal nerve (Thoracic 1 to T12 level)
2. Sham procedure, apparatus was left in test mode without the appropriate power output

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Visual Analogue Scale (VAS) score, measured at baseline, days 3, 7, 14, 30 and 60, 6 months and 1 year
2. Flare pain per day during days 3, 7, 14, 30, 60 and at 6 months
3. Neurometer CPT/C (Neurotron, Inc) to measure three fiber function
4. SF-36 at baseline, 2 months, 6 months and 1 year following-up

Secondary outcome measures

1. Need to PRF again or other invasive operation at 2 day, 6 month or 1 year following-up
2. Dosage of rescue drug consumed per week at the end of treatment and after 4 weeks follow-up - including Tramadol and/or acetaminophen - and the dosage of combined drug, anti-depressive drug (amitriptyline)
3. Presence, frequency and duration of adverse effects at 7, 14, 30, and 60 days

Overall trial start date

22/02/2008

Overall trial end date

28/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age greater than 60 years
2. PHN history is longer than 3 months
3. Pain on Visual Analogue Scale (VAS) >3 (0-10 VAS scale)
4. PHN affected nerve sectors were thoracic nerves from T1 to T12 level
5. Refractory to formal treatment such as antiepileptic medicine, antidepressants, opioids and physical treatments and epidural block

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

96

Participant exclusion criteria

1. Exclusion criteria included withdraws from the study
2. Poor effect, intolerant to the study
3. Uncooperative and unable to finish the self evaluation (VAS, QOL and SF-36)
4. Coagulation disturbances
5. Allergies to local anaesthetic
6. Malignancy

Recruitment start date

22/02/2008

Recruitment end date

28/05/2011

Locations

Countries of recruitment

China

Trial participating centre

Department of Anesthesiology
Shanghai
200092
China

Sponsor information

Organisation

Xinhua Hospital (China)

Sponsor details

Department of Anesthesiology
Shanghai Jiaotong University School of Medicine
1665 Kongjiang Road
Shanghai
200092
China
marke72@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Shanghai Education Funding Committee (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23340530

Publication citations

  1. Results

    Ke M, Yinghui F, Yi J, Xeuhua H, Xiaoming L, Zhijun C, Chao H, Yingwei W, Efficacy of pulsed radiofrequency in the treatment of thoracic postherpetic neuralgia from the angulus costae: a randomized, double-blinded, controlled trial., Pain Physician, 2013, 16, 1, 15-25.

Additional files

Editorial Notes