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Trial registered on ANZCTR


Registration number
ACTRN12611000837921
Ethics application status
Approved
Date submitted
30/07/2011
Date registered
9/08/2011
Date last updated
9/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute pressure relieves sciatica caused by chronic pressure
Scientific title
Acute pressure on sciatic nerve results in immediate short-term relief of sciatica caused by chronic pressure
Secondary ID [1] 262747 0
Nil.
Universal Trial Number (UTN)
U1111-1123-3058
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with sciatic pain. 270457 0
Condition category
Condition code
Anaesthesiology 270609 270609 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three-minutes pressure with the dorsal proximal phalangeal surface of the fists was applied simmultaneously to the sciatic nerves on the center of back legs. The pressure is 15-20 kg per hand.
Patients were randomized to receive placebo or treatment intervention group. Each patient is allowed to join once the study, and receive once the 3-minutes' pressure.
Intervention code [1] 267092 0
Treatment: Other
Comparator / control treatment
Three-minutes pressure with the dorsal proximal phalangeal surface of the fists was applied simmultaneously to the sciatic nerves on the center of back legs. The pressure is 0-1 kg per hand for 3 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 269342 0
Pain as measured by VAS scores and assessed statistically.
Timepoint [1] 269342 0
One minute before the intervention, 1 min and 15 min after the intervention.
Secondary outcome [1] 279415 0
Nil.
Timepoint [1] 279415 0
Nil.

Eligibility
Key inclusion criteria
Mental stable;
Education above the middle school.
sciatic pain caused by chronic pressure, such as tumors, abnormal bone formation, etc.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients mental unstable;
Education lower than the middle school;
Patents had pain drugs within 10 hours before intervention.

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)
The patients have never been exposure to this analgesic method before, then are unware of the difference between placebo and treatment.
All the introduction and procedures are same to the patients from both treatment and placebo group, except the different level pressure, which blind to patients, but not to physicians.
Each patient draws from an envelop a number which shows the allocation group the subject would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 3761 0
China
State/province [1] 3761 0
Guangdong

Funding & Sponsors
Funding source category [1] 267563 0
Hospital
Name [1] 267563 0
Nanfang Hospital
Country [1] 267563 0
China
Primary sponsor type
Hospital
Name
Nanfang Hospital
Address
Nanfang Hospital,
Southern Medical University,
1838# North Guangzhou Ave, Guangzhou, Guangdong Province, 510515
Country
China
Secondary sponsor category [1] 266604 0
None
Name [1] 266604 0
Address [1] 266604 0
Country [1] 266604 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269525 0
Ethic Committee of Nanfang Hospital, Southern Medical University
Ethics committee address [1] 269525 0
Ethics committee country [1] 269525 0
China
Date submitted for ethics approval [1] 269525 0
06/07/2011
Approval date [1] 269525 0
28/07/2011
Ethics approval number [1] 269525 0
2011-67

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

Contacts
Principal investigator
Name 32957 0
Address 32957 0
Country 32957 0
Phone 32957 0
Fax 32957 0
Email 32957 0
Contact person for public queries
Name 16204 0
Jiman He
Address 16204 0
1838# North Guangzhou Ave, Guangzhou, Guangdong Province, 510515
Country 16204 0
China
Phone 16204 0
(+086)-20-62786221
Fax 16204 0
(+086)-20-87280770
Email 16204 0
jiman_he@brown.edu
Contact person for scientific queries
Name 7132 0
Jiman He
Address 7132 0
1838# North Guangzhou Ave, Guangzhou, Guangdong Province, 510515
Country 7132 0
China
Phone 7132 0
(+086)-20-62786221
Fax 7132 0
(+086)-20-87280770
Email 7132 0
jiman_he@brown.edu

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
No additional documents have been identified.