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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23340530
Publication citations
-
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.