The clinical study of peripheral subcutaneous neuromodulation in postherpetic neuralgia treatment

ISRCTN	ISRCTN58767633
DOI	https://doi.org/10.1186/ISRCTN58767633
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr MA Ke
Scientific

Department of Anaesthesiology and Pain Centre
Shanghai Sixth Peoples Hospital
Shanghai JiaoTong University
600 Yi-Shan Road
Shanghai
200233
China

Email	marke72@163.com

Study design	Prospective randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	The clinical study of peripheral subcutaneous neuromodulation in postherpetic neuralgia treatment
Study objectives	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(s)	Ethics approval received from the Ethics Committee of Shanghai Sixth People's Hospital, Shanghai Jiaotong University on the 15th August 2007.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2007
Completion date	01/10/2008

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	120
Total final enrolment	102
Key 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
Key exclusion criteria	1. Patients withdrawn from the study 2. Patients can't take self-assessment of the pain due to PHN
Date of first enrolment	01/09/2007
Date of final enrolment	01/10/2008

Department of Anaesthesiology and Pain Centre

Shanghai
200233
China

Shanghai Sixth Peoples Hospital (China)
Hospital/treatment centre

c/o Dr MA Ke
Department of Anaesthesiology and Pain Centre
Shanghai JiaoTong University
600 Yi-Shan Road
Shanghai
200233
China

Hospital/treatment centre

Shanghai Sixth People's Hospital (China) - clinical research fund

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/12/2013	10/06/2021	Yes	No

10/06/2021: Publication reference and total final enrolment added.