The clinical study of effect of pregabalin to functional Magnetic Resonance Imaging (fMRI) and Iowa Gambling task (IGT) in postherpetic neuralgia patients

ISRCTN	ISRCTN55574777
DOI	https://doi.org/10.1186/ISRCTN55574777
Secondary identifying numbers	N/A

Submission date: 02/10/2011
Registration date: 28/10/2011
Last edited: 06/12/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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 patients 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

Contact information

Prof MA Ke
Scientific

Department of Anesthesiology
Xinhua Hospital
Shanghai Jiaotong University School of Medicine
1665 Kongjiang Road
Shanghai
200092
China

Email	macoo72@gmail.com

Study information

Study design	Prospective double blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
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
Study objectives	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(s)	Xinhua Hospital affiliated to Shanghai Jiaotong Universty School of Medicine, 17 of March 2011, ref: 2011-003
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Pregabalin
Primary outcome measure	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 study start date	01/12/2011
Completion date	30/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40 patients
Key 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
Key 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
Date of first enrolment	01/12/2011
Date of final enrolment	30/12/2012

Locations

Countries of recruitment

China

Study participating centre

Department of Anesthesiology

Shanghai
200092
China

Sponsor information

Xinhua Hospital (China)
Hospital/treatment centre

Department of Anesthesiology
Shanghai Jiaotong University School of Medicine
1665 Kongjiang Road
Shanghai
200092
China

Email	Marke72@163.com
"ROR"	https://ror.org/04dzvks42

Funders

Funder type

Government

Shanghai Education Committee (China) ref: 11YZ56

No information available

Results and Publications

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