Condition category
Nervous System Diseases
Date applied
02/10/2011
Date assigned
28/10/2011
Last edited
06/12/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Postherpetic neuralgia (PHN) is a nerve pain that occurs at the site of a previous attack of a condition called shingles. Neuralgia is a term that describes nerve pain. Postherpetic neuralgia is nerve pain which continues 3-6 months after the shingles rash has healed. PHN can have a severe impact on a patient’s quality of life. The health care costs related to persistent PHN puts a heavy economic burden and stress on families and societies. Unfortunately, PHN is often does not respond very well to the existing treatments.
The aim of this study is observe the effect of pregabalin in PHN patents. Treatment of PHN with pregabalin is safe and effective in relieving pain and sleep interference. However, to date no known studies investigating the effect of pregabalin on the central nerve system measured using functional Magnetic Resonance Imaging.

Who can participate?
Patients diagnosed with postherpetic neuralgia, aged over 60 years and weighing over 40kg.

What does the study involve?
Participants were randomly allocated to one of two 2 groups:
Pregabalin group), which received pregabalin twice a day for 14 days.
Placebo group, which received a placebo (dummy drug) twice a day for 14 days.
Oxycodone was used as rescue medication for pain if required.

What are the possible benefits and risks of participating?
All participants received treatments which may improve the symptoms of PHN.
There were no known risks associated with participating in this trial.

Where is the study run from?
Pain Management Center, Xinhua Hospital

When is the study starting and how long is it expected to run for?
Participants were enrolled the study between December 2011 and November 2012 and follow-up examinations will continued until December 2012.

Who is funding the study?
Shanghai Education Committee, China ref: 11YZ56

Who is the main contact?
Prof M A Ke,
macoo72@163.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof MA Ke

ORCID ID

Contact details

Department of Anesthesiology
Xinhua Hospital
Shanghai Jiaotong University School of Medicine
1665 Kongjiang Road
Shanghai
200092
China
macoo72@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The clinical study of effect of pregabalin to functional Magnetic Resonance Imaging (fMRI) and Iowa Gambling task (IGT) in postherpetic neuralgia patients: a prospective, double blind, randomised controlled trial

Acronym

Study hypothesis

1. That fMRI signal and IGT were different among postherpetic neuralgia (PHN) patients and control patients.
2. The drug (pregabalin) can affect signal of fMRI, the outcome of IGT, quality of life and reduce the oral pain-related drugs dosage of PHN patients

Ethics approval

Xinhua Hospital affiliated to Shanghai Jiaotong Universty School of Medicine, 17 of March 2011, ref: 2011-003

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 pregabalin 150mg twice a day (Bid) or placebo for 2 weeks.

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

Intervention type

Drug

Phase

Not Applicable

Drug names

Pregabalin

Primary outcome measures

1. fMRI signal change, IGT results at baseline, days 14 after treatment
2. Visual Analogue Scale (VAS), measured at baseline, days1, 2, 3,7,14 after treatment
3. Flare pain per day during days 3, 7, 14 after treatment

Secondary outcome measures

1. SF-36 at baseline, days 14 after treatment
2. Dosage of rescue drug (Oxycodone) consumed per day at days3, 7, and 14 after treatment
3. Presence, frequency and duration of adverse effects at 7, 14 days

Overall trial start date

01/12/2011

Overall trial end date

30/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age greater than 60 years and over 40kg of body weight
2. Pain history is longer than 3 months
3. Pain on Visual Analogue Scale (VAS) >3 (0-10 VAS scale), the frequency of acute pain flares occurred more than 3 times per day
4. Refractory to formal treatment such as antiepileptic medicine, antidepressants, opioids and physical treatments and epidural block
5. No history of severe liver and renal diseases

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 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, qulaity of life [QOL] and SF-36)
4. Coagulation disturbances
5. Allergies to drug
6. Malignancy

Recruitment start date

01/12/2011

Recruitment end date

30/12/2012

Locations

Countries of recruitment

China

Trial participating centre

Department of Anesthesiology
Shanghai
200092
China

Sponsor information

Organisation

Xinhua Hospital (China)

Sponsor details

Department of Anesthesiology
Shanghai Jiaotong University School of Medicine
1665 Kongjiang Road
Shanghai
200092
China
Marke72@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Shanghai Education Committee (China) ref: 11YZ56

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