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Trial registered on ANZCTR


Registration number
ACTRN12608000038392
Ethics application status
Approved
Date submitted
20/01/2008
Date registered
23/01/2008
Date last updated
2/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute Pressure for discomfort Relief
Scientific title
Acute pressure for the short-term relief of nonpainful discomfort from various pathologies: A randomized, placebo controlled trial
Secondary ID [1] 252196 0
New secondary ID. Please modify.
Secondary ID [2] 262205 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-painful discomfort 2751 0
Condition category
Condition code
Other 2878 2878 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acute pressure on legs with 11-25 kg each hand for 2 minutes
Intervention code [1] 2412 0
Other interventions
Comparator / control treatment
Acute pressure on different area of legs with 11-25kg each hand or with less amount of pressure (2-5kg each hand).
Control group
Placebo

Outcomes
Primary outcome [1] 3762 0
The relief of the discomfort.
Timepoint [1] 3762 0
Ten minute intervals throughout the 30 minutes.
Secondary outcome [1] 6355 0
incidence of any discomfort
Timepoint [1] 6355 0
Ten minuteclu intervals throughout the 30 minutes.

Eligibility
Key inclusion criteria
Any patient who was feeling non-painful discomfort caused by various pathologies.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any less than 18 or greater than 70 years old, emotional instability, or administration of another drug within 12 hours of the test.

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)
Patients are sequentially recruited by participating physicians during clinic visits. After giving the written consent, patients are randomly assigned to the placebo group or the active treatment group by sealed opaque envelopes. Instructions and explanations are provided equally to all patients. Patients are advised that they may discontinue participation in the study at any time without penalty, and that their healthcare treatment would not otherwise be affected. The participating doctor(s) or assistants teach the patients how to evaluate discomfort using a visual analogue scale (VAS), where the scored from “0” for no discomfort, to “10” for most discomfort. The three stages of the test were then described to each patient: baseline rating, 2 min of hand pressure while lying down, and post-pressure rating at the specified times.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization of patients using the method of Random Permuted Blocks with allocation ratio one to one. The random number designations are placed in sealed opaque envelopes. Each patient blindly drew one from the envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 719 0
China
State/province [1] 719 0
Anhui, 230001
Country [2] 720 0
United States of America
State/province [2] 720 0
Ohio, 42003
Country [3] 721 0
Germany
State/province [3] 721 0
Marburg, 35043
Country [4] 722 0
United States of America
State/province [4] 722 0
Boston, MA 02111

Funding & Sponsors
Funding source category [1] 2984 0
Self funded/Unfunded
Name [1] 2984 0
None.
Address [1] 2984 0
Country [1] 2984 0
Primary sponsor type
Individual
Name
Jiman He
Address
Biomedicine(TC), CAS, Beijing, 100080
Country
China
Secondary sponsor category [1] 2693 0
Hospital
Name [1] 2693 0
Bin Wu
Address [1] 2693 0
Anhui Province Hospital, Hefei, 230001
Country [1] 2693 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4938 0
Anhui Province Hospital, Anhui Medical University
Ethics committee address [1] 4938 0
Anhui Province Hospital, Hefei, 230001
Ethics committee country [1] 4938 0
China
Date submitted for ethics approval [1] 4938 0
Approval date [1] 4938 0
05/12/2007
Ethics approval number [1] 4938 0

Summary
Brief summary
To determine whether the method will or will not significantly relieve clinical non-painful discomfort. The study hypothesis is that a acute manual stimulation correctly applied to the right areas of skin could relief non-painful discomfort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28272 0
Address 28272 0
Country 28272 0
Phone 28272 0
Fax 28272 0
Email 28272 0
Contact person for public queries
Name 11429 0
Bin Wu
Address 11429 0
Anhui Province Hospital, Hefei, 230001
Country 11429 0
China
Phone 11429 0
(+86)13905518347
Fax 11429 0
Email 11429 0
wubin@ahmu.edu.cn
Contact person for scientific queries
Name 2357 0
Diane Chin.
Address 2357 0
Stanford, California.
Country 2357 0
United States of America
Phone 2357 0
001-784-3323
Fax 2357 0
001-784-4123
Email 2357 0
diane.chin@stanford.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary