Condition category
Nervous System Diseases
Date applied
11/01/2018
Date assigned
24/01/2018
Last edited
22/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Postherpetic neuralgia is lasting nerve pain in an area previously affected by shingles. It seriously affects the patient's sleep, mood and quality of life. After treatment there are still some patients who suffer from neuropathic pain and it is still a difficult clinical problem. Diazepam is a long-acting drug used in insomnia and sedation. Animal studies have shown that an injection of diazepam can treat neuropathic pain. The aim of this study is to assess the effects of diazepam on postherpetic neuralgia, anxiety, depression and quality of life, and its safety and side effects.

Who can participate?
Patients aged 18 to 80 with postherpetic neuralgia

What does the study involve?
Participants are randomly allocated to two groups. Those in group 1 are given diazepam injections for 3 days. Those in group 2 are given saline (salt water) injections instead. The pain experienced after treatment is assessed for each patient every day for the next 3 months.

What are the possible benefits and risks of participating?
The participants could have better pain relief. The main possible risks are the side effects of diazepam.

Where is the study run from?
Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine) (China)

When is the study starting and how long is it expected to run for?
February 2018 to July 2019

Who is funding the study?
Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine) (China)

Who is the main contact?
Prof. Ke Ma

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ke Ma

ORCID ID

Contact details

No 1665
Kongjiang Road
Yangpu District
Shanghai
200092
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XINHUA2018-02

Study information

Scientific title

Clinical trial of effects of intramuscular diazepam in chronic postherpetic neuralgia

Acronym

Study hypothesis

1. Intramuscular diazepam is effective and safe when administered for chronic postherpetic neuralgia patients.
2. Treatment of Intramuscular diazepam can improve the quality of life of chronic postherpetic neuralgia patients.

Ethics approval

Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiaotong University School of Medicine, 26/12/2017, ref: XHEC-C-2017-105

Study design

Single-center double-blinded randomized controlled clinical study

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 the contact details to request a patient information sheet

Condition

Neuralgia

Intervention

78 participants are randomly allocated to two groups. Those in group 1 (n=39) are given diazepam 10mg intramuscularly for 3 days. Those in group 2 (n=39) are given saline instead. The basic treatment is oral administration of Gabapentin 0.3g t.i.d. The pain experienced after treatment is assessed for each patient every day for the next 3 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Diazepam

Primary outcome measure

1. Pain, measured using the visual analogue score (VAS) during the treatment and at 7 days, 14 days, 21 days, 28 days, 2 months and 3 months post-treatment.
2. The frequency and intensity of the pain outbreak during the treatment and at 7 days, 14 days, 21 days, 28 days, 2 months and 3 months post-treatment
3. The dosage of Gabapentin per day during the treatment

Secondary outcome measures

1. Intensity of anxiety, measured using the PHQ-9 evaluation scale during the treatment and at 7 days, 14 days, 21 days, 28 days, 2 months and 3 months after treatment
2. Intensity of depression, measured by the GAD-7 anxiety screening scale during the treatment and at 7 days, 14 days, 21 days, 28 days, 2 months and 3 months after treatment
3. Quality of life, measured by the quality of life score (QOL) during the treatment and at 7 days, 14 days, 21 days, 28 days, 2 months and 3 months after treatment

Overall trial start date

01/02/2018

Overall trial end date

31/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Subjects voluntarily signed the informed consent
2. Patients suffering from chronic postherpetic neuralgia aged from 18 to 80 regardless of gender
3. Moderate to severe pain, VAS> 4 points or more, or burst pain> 3 times/day
4. Patients can follow the drug dose and follow-up plan
5. Patients can describe the symptoms, no serious infection, respiratory insufficiency and has the ability to cooperate
6. Non-allergic persons
7. No drug abuse or drug addiction
8. Non-lactating, non-pregnant women, subjects who did not have a pregnancy plan within 1 month after the test
9. Patients did not participate in a drug test within 3 months before this test (including the test drug)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

78

Participant exclusion criteria

1. Researchers think that there is any reason participant should be excluded
2. In poor situation, severe systemic infection or respiratory dysfunction and uncooperative
3. Suffering from severe respiratory system, cardiovascular system diseases, liver and kidney dysfunction, cancer
4. Patients who are allergic to diazepam or other benzodiazepines
5. Patient who has or a history of drug abuse
6. Breastfeeding, gestational women or subjects who do not have a pregnancy plan within 1 month after the test
7. Patients who participated in a drug trial within 3 months before this trial
8. Patients does not meet the inclusion criteria

Recruitment start date

01/02/2018

Recruitment end date

31/01/2019

Locations

Countries of recruitment

China

Trial participating centre

Pain Management Department, Xinhua Hospital affiliated to Shanghai Jiaotong University, School of Medicine
Shanghai
200092
China

Trial participating centre

Pain Management Centre, Xinhua Hospital affiliated with Shanghai Jiaotong University school of medicine
No 1665 Kongjiang Road, Yangpu District
Shanghai
200092
China

Sponsor information

Organisation

Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine)

Sponsor details

No 1665
Kongjiang Road
Yangpu District
Shanghai
SH 21
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The clinical trial will be finished in July 2019, and the paper will be finished and submitted to an appropriate journal in December 2019.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/03/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes