The clinical study of intercostal nerve pulsed radiofrequency in postherpetic neuralgia
| ISRCTN | ISRCTN25588650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25588650 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Anesthesiology
Xinhua Hospital
Shanghai Jiaotong University School of Medicine
1665 Kongjiang Road
Shanghai
200092
China
| macoo74@hotmail.com |
Study information
| Study design | Prospective double blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 22/02/2008 |
| Completion date | 28/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
200092
China
Sponsor information
Xinhua Hospital (China)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesiology
Shanghai Jiaotong University School of Medicine
1665 Kongjiang Road
Shanghai
200092
China
| marke72@163.com | |
"ROR" |
https://ror.org/04dzvks42 |
Funders
Funder type
Government
Shanghai Education Funding Committee (China)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
