Condition category
Mental and Behavioural Disorders
Date applied
08/10/2011
Date assigned
27/10/2011
Last edited
14/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Post-herpetic neuralgia (PHN) is a condition in which a feeling of pain arises as a consequence of the herpes zoster (HZ) virus infection and it damages the corresponding neurological system. Unfortunately, existing treatments often do not work against PHN. Traditional Chinese acupuncture offers some advantages: it is simple to perform, has little systemic effect and few side effects. There is no published evidence on the effects of acupuncture on the central nervous system and this study is about the therapeutic effects of acupuncture on PHN patients.

Who can participate?
Patients admitted to the Department of Acupuncture, Massage and Traumatology of Shanghai Sixth People's Hospital (China) and diagnosed with post-herpetic neuralgia diagnoses.

What does the study involve?
Participants are randomly allocated to one of two groups: Group A (acupuncture group) receives acupuncture (Ashi point) for 3 weeks; Group B (sham acupuncture group, also called the control group) receives acupuncture (non-Ashi point) for 3 weeks. Patients and investigators do not know which treatment they receive (this is called blinding). Follow up continues for 14 days after treatment.
Oxycodone 5-30mg/day or more orally to be used as 'rescue medication' (to relieve symptoms immediately) for pain control.

What are the possible benefits and risks of participating?
There are no known risks to participants. All participants, including controls, will receive all the tests which may improve their treatment of PHN.

Where is the study run from?
The study takes place at Department of Acupuncture Massage and Traumatology at the Shanghai Sixth People's Hospital (China).

When is the study starting and how long is it expected to run for?
The study will start recruiting participants between December 2011 and July 2012. Follow-up examinations will continue until October 2012.

Who is funding the study?
Chinese Traditional Medical and Drug Administration Bureau (China)

Who is the main contact?
Dr Mi Yiqun
miyiqun@126.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mi Yiqun

ORCID ID

Contact details

Department of Acupuncture
Massage and Traumatology
Shanghai Sixth People's Hospital
Shanghai JiaoTong University
600 Yishan Road
Shanghai
200233
China
-
miyiqun@126.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A clinical study of the effect of acupuncture on fMRI and IGT in postherpetic neuralgia patients: a prospective, double-blind, randomised controlled trial

Acronym

Study hypothesis

1. That functional magnetic resonance imaging (fMRI) signal and Iowa Gambling Task (IGT) were different among postherpetic neuralgia (PHN) patients and control patients.
2. The acupuncture can affect the signal of fMRI, the outcome of the IGT, quality of life and reduce the dosage required of oral pain-related drugs in PHN patients

Ethics approval

Shanghai Sixth Peoples Hospital, Shanghai JiaoTong University, 16 March 2011, ref: 2011-19

Study design

Prospective, double blind, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Postherpetic neuralgia

Intervention

PHN patients were randomized to receive acupuncture (Ashi point), or sham acupuncture for 3 weeks

Rescue medication - Oxycodone 5-30mg/day orally (or more) was used as rescue medication for pain controlled at more than 3 on the VAS and the frequency of acute pain flare-ups more than 3 times per day.

Intervention type

Drug

Phase

Not Applicable

Drug names

Oxycodone

Primary outcome measures

1. fMRI signal change, IGT results at baseline and 14 days after treatment
2. Visual Analogue Scale (VAS), measured at baseline and 1, 2, 3,7 and 14 days after treatment
3. Pain flare-ups per day during days 3, 7, 14 after treatment

Secondary outcome measures

1. SF-36 at baseline, 14 days after treatment
2. Dosage of rescue drug (Oxycodone) consumed per day at 3, 7, and 14 days after treatment
3. Presence, frequency and duration of adverse effects at 7 and 14 days after treatment

Overall trial start date

01/12/2011

Overall trial end date

01/10/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age greater than 60 years
2. Weighs over 40kg
3. History of pain is longer than 3 months
4. Pain on Visual Analogue Scale (VAS) >3 (0-10 VAS scale), with acute pain flares that occurred more than 3 times per day
5. Refractory to formal treatment such as antiepileptic medicine, antidepressants, opioids, physical treatments and epidural block
6. No history of severe liver and renal diseases
7. PHN patents whose pain area was at T1-12 level
8. Male and female participants

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

38 patients

Participant exclusion criteria

1. 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 drug
6. Malignancy

Recruitment start date

01/12/2011

Recruitment end date

30/07/2012

Locations

Countries of recruitment

China

Trial participating centre

Department of Acupuncture, Massage and Traumatology
Shanghai
200233
China

Sponsor information

Organisation

Shanghai Sixth People's Hospital (China)

Sponsor details

600 Yi-Shan Road
Shanghai
200233
China

Sponsor type

Hospital/treatment centre

Website

http://www.6thhosp.com/eng/

Funders

Funder type

Government

Funder name

Chinese Traditional Medical and Drug Administration Bureau ref: 2009ZL23

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