Contact information
Type
Scientific
Primary contact
Dr MA Ke
ORCID ID
Contact details
Department of Anaesthesiology and Pain Centre
Shanghai Sixth Peoples Hospital
Shanghai JiaoTong University
600 Yi-Shan Road
Shanghai
200233
China
marke72@163.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
We hypothesise:
1. That peripheral subcutaneous neuromodulation has analgesic efficacy in chronic refractory Postherpetic Neuralgia (PHN) patients
2. This simple neuromodulation can improve the quality of life and reduce the oral drugs dosage of patients
Ethics approval
Ethics approval received from the Ethics Committee of Shanghai Sixth People's Hospital, Shanghai Jiaotong University on the 15th August 2007.
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Postherpetic Neuralgia (PHN)
Intervention
Arm 1: peripheral subcutaneous neuromodulation
Arm 2: sham peripheral subcutaneous neuromodulation
Arm 3: naive control group
Treatment will continue for three weeks (two time per week), follow-up will continue for 6 months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Analgesic efficacy (Visual Analogue Scale [VAS]) and Quality Of Life (QOL) from 3 days to 1 month after neuromodulation.
Secondary outcome measures
1. QOL
2. 36-item Short Form health survey (SF-36)
3. Oral analgesic drugs dose
4. Three skin fiber (C-, Aâ and Aä) functional measurement
All measured from 1 month to 6 months after neuromodulation.
Overall trial start date
01/09/2007
Overall trial end date
01/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients were between 60 and 90 years old
2. Patients must have pain present for more than 6 months after the healing of shingles skin rash
3. Patients at screening must have a score of greater than or equal to 40 mm on the pain visual analogue scale
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Patients withdrawn from the study
2. Patients can't take self-assessment of the pain due to PHN
Recruitment start date
01/09/2007
Recruitment end date
01/10/2008
Locations
Countries of recruitment
China
Trial participating centre
Department of Anaesthesiology and Pain Centre
Shanghai
200233
China
Sponsor information
Organisation
Shanghai Sixth Peoples Hospital (China)
Sponsor details
c/o Dr MA Ke
Department of Anaesthesiology and Pain Centre
Shanghai JiaoTong University
600 Yi-Shan Road
Shanghai
200233
China
+86 (0)21 64369181 8648
macoo74@hotmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Shanghai Sixth People's Hospital (China) - clinical research fund
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