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Trial registered on ANZCTR


Registration number
ACTRN12611000747921
Ethics application status
Approved
Date submitted
8/06/2011
Date registered
18/07/2011
Date last updated
12/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical pressure on sciatic nerve for pain relief
Scientific title
Three-minute physical pressure on sciatic nerve for short-term dental pain relief
Secondary ID [1] 262398 0
Nil.
Universal Trial Number (UTN)
U1111-1122-0205
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients at pain with dental diseases. 268044 0
Condition category
Condition code
Anaesthesiology 268182 268182 0 0
Pain management
Oral and Gastrointestinal 268228 268228 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical pressure on the sciatic nerve by squatting down, without any other kinds of intervention before or at the same time. The study is conducted immediately before the the dental procudure.
The duration of the pressure is 3 minutes.
Patients were randomized to receive placebo or treatment intervention.
Each patient is allowed to join the study for one time.
Intervention code [1] 266787 0
Treatment: Other
Comparator / control treatment
For the control treatment, patients are required to sit on the soft chair, with arm holding around the fold legs.
Control group
Placebo

Outcomes
Primary outcome [1] 266927 0
Pain as measured by VAS scores and assessed statistically.
Timepoint [1] 266927 0
One minute before the intervention (squatting down or sitting on soft chair), 1 min and 15 min after the intervention.
Secondary outcome [1] 276638 0
Nil.
Timepoint [1] 276638 0
Nil.

Eligibility
Key inclusion criteria
Mental stable;
Education high than middle school;
patients with pain caused by acute pulpitis, gingivitis and periodontitis.
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Without any other medicine before intevention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment outside Australia
Country [1] 3620 0
China
State/province [1] 3620 0
Guangdong Province

Funding & Sponsors
Funding source category [1] 267221 0
Hospital
Name [1] 267221 0
Nanfang Hospital
Country [1] 267221 0
China
Primary sponsor type
Hospital
Name
Nanfang Hospital
Address
1838# North Guangzhou Ave, Guangzhou, Guangdong Province, 510515
Country
China
Secondary sponsor category [1] 266287 0
None
Name [1] 266287 0
Nil
Address [1] 266287 0
Nil.
Country [1] 266287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269214 0
Ethic Committee of Nanfang Hospital, Southern Medical University
Ethics committee address [1] 269214 0
Ethics committee country [1] 269214 0
China
Date submitted for ethics approval [1] 269214 0
18/05/2011
Approval date [1] 269214 0
26/05/2011
Ethics approval number [1] 269214 0
2011-42

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32718 0
Address 32718 0
Country 32718 0
Phone 32718 0
Fax 32718 0
Email 32718 0
Contact person for public queries
Name 15965 0
Jiman He
Address 15965 0
1838# North Guangzhou Ave, Guangzhou, Guangdong Province, 510515
Country 15965 0
China
Phone 15965 0
86-20-62786221
Fax 15965 0
(+86)-20-87280770
Email 15965 0
jimanhe@smu.edu.cn
Contact person for scientific queries
Name 6893 0
Jiman He
Address 6893 0
1838# North Guangzhou Ave, Guangzhou, Guangdong Province, 510515
Country 6893 0
China
Phone 6893 0
(+86)-20062786221
Fax 6893 0
(+86)-20-87280770
Email 6893 0
jimanhe@smu.edu.cn

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA Self–Administered Method2014https://doi.org/10.1111/pme.12338
N.B. These documents automatically identified may not have been verified by the study sponsor.