Condition category
Nervous System Diseases
Date applied
20/10/2007
Date assigned
30/10/2007
Last edited
30/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr MA Ke

ORCID ID

Contact details

Department of Anaesthesiology and Pain Centre
Shanghai Sixth People’s 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 People’s 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

Publication citations

Additional files

Editorial Notes