The clinical study of intercostal nerve pulsed radiofrequency in postherpetic neuralgia

ISRCTN	ISRCTN25588650
DOI	https://doi.org/10.1186/ISRCTN25588650
Protocol serial number	N/A
Sponsor	Xinhua Hospital (China)
Funder	Shanghai Education Funding Committee (China)

Submission date: 10/06/2010
Registration date: 21/06/2010
Last edited: 26/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr MA Ke
Scientific

Department of Anesthesiology
Xinhua Hospital
Shanghai Jiaotong University School of Medicine
1665 Kongjiang Road
Shanghai
200092
China

Email	macoo74@hotmail.com

Study information

Primary study design	Interventional
Study design	Prospective double blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The clinical study of intercostal nerve pulsed radiofrequency in postherpetic neuralgia: A randomised controlled trial.
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	28/05/2011

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	96
Key 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
Key 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
Date of first enrolment	22/02/2008
Date of final enrolment	28/05/2011

Locations

Countries of recruitment

China

Study participating centre

Department of Anesthesiology

Shanghai
200092
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes