Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000439549
Ethics application status
Approved
Date submitted
6/10/2006
Date registered
12/10/2006
Date last updated
12/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of a means to relieve pain for short term periods
Scientific title
A Manual Stimulation for Short-term Relief of Pain: A Randomized Controlled Trial in Patients with Pain seen in the Emergency Room, Renal, Dental and Oncology Clinics
Secondary ID [1] 309 0
No.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain from diverse pathologies seen in the Emergency room, Renal, Dental and Oncology Clinics 1411 0
Condition category
Condition code
Other 1506 1506 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were randomly assigned to an active stimulation group, or a placebo stimulation group. Mild, non-invasive, and not injurious manual stimulation was applied to an area of the limbs' surface (the skin), while patients lay on a clinic bed.Thereafter, the patients arose to rate pain level by means of a Visual Analogue Scale (VAS).
To determine if the pain relief was durable, rating times varied from immediate to 60 minutes in various protocols. Patients in the Emergency Room test gave their evaluation, as soon as possible after the stimulation. The 10-min test protocol asked patients to determine pain relief at 0, 5 and 10 minutes, and the 60-min test protocol, at ten minutes intervals up to sixty minutes.
Intervention code [1] 1390 0
Treatment: Other
Comparator / control treatment
For the placebo stimulation, the manual stimulus was applied on the oppsite surface of the limbs, while patients lay on a clinic bed. Thereafter, the patients arose to rate pain level by means of a Visual Analogue Scale (VAS).
Control group
Placebo

Outcomes
Primary outcome [1] 2084 0
Significant reduction of Visual Analogue Scale scores for the active stimulation relative to the placebo stimulation
Timepoint [1] 2084 0
At time points up to 60 minutes (0, 5, 10, 20, 30, 40, 50, and 60 minutes).
Secondary outcome [1] 3599 0
No secondary outcomes were evaluated.
Timepoint [1] 3599 0

Eligibility
Key inclusion criteria
Pain from their respective pathologies when recruited for the tests.
Minimum age
15 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Emotional instability, questionable metal status, younger than 15 years old, and, receipt of another analgesic 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)
The allocation of patients was performed in each test center under the direction of the primary investigator using the method of Random Permuted Blocks for numberical designation to a placebo or treatment group. The random number designations were placed in envelopes. Following study enrollment by clinic staff, each patient blindly drew one. Then, the doctor or his assistant applied the treatment ascribed to the number the patient drew. The patients were blinded to the intervention's atribute as placebo or therapy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization with allocation ratio one to one in varied block sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients were blind to the intervention as active treatment or placebo.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 404 0
United States of America
State/province [1] 404 0

Funding & Sponsors
Funding source category [1] 1643 0
Other
Name [1] 1643 0
Taibaihe Organ
Country [1] 1643 0
China
Primary sponsor type
Other
Name
Taibaihe Organ, Wuwei, China
Address
Country
China
Secondary sponsor category [1] 1451 0
None
Name [1] 1451 0
none
Address [1] 1451 0
Country [1] 1451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3088 0
Anhui Province Hospital
Ethics committee address [1] 3088 0
Anhui Province Hospital, Hefei, 230001
Ethics committee country [1] 3088 0
China
Date submitted for ethics approval [1] 3088 0
Approval date [1] 3088 0
02/06/2005
Ethics approval number [1] 3088 0
Ethics committee name [2] 3089 0
Tongling People Hospital
Ethics committee address [2] 3089 0
Tongling People Hospital, Tongling, 244000
Ethics committee country [2] 3089 0
China
Date submitted for ethics approval [2] 3089 0
Approval date [2] 3089 0
11/04/2005
Ethics approval number [2] 3089 0
Ethics committee name [3] 3090 0
Tongling Count Hospital
Ethics committee address [3] 3090 0
Tongling Count Hospital, Tongling Count, 244100
Ethics committee country [3] 3090 0
China
Date submitted for ethics approval [3] 3090 0
Approval date [3] 3090 0
18/10/2005
Ethics approval number [3] 3090 0
Ethics committee name [4] 3091 0
Chuzou Zhongxiyi Hospital
Ethics committee address [4] 3091 0
Chuzou Zhongxiyi Hospital, Chuzou, 239000
Ethics committee country [4] 3091 0
China
Date submitted for ethics approval [4] 3091 0
Approval date [4] 3091 0
28/05/2005
Ethics approval number [4] 3091 0
Ethics committee name [5] 3092 0
Maanshan People Hospital
Ethics committee address [5] 3092 0
Maanshan People Hospital, Maanshan, 243000
Ethics committee country [5] 3092 0
China
Date submitted for ethics approval [5] 3092 0
Approval date [5] 3092 0
20/05/2005
Ethics approval number [5] 3092 0

Summary
Brief summary
To determine whether the manipulation will or will not significantly relieve clinical pain, and the durability of that relief. The study hypothesis was that a brief manual stimulation correctly applied to specific areas of skin (based on Traditional Chinese Medicine) could relief pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27617 0
Address 27617 0
Country 27617 0
Phone 27617 0
Fax 27617 0
Email 27617 0
Contact person for public queries
Name 10579 0
Jiman He
Address 10579 0
55 Claverick St, Rhode Island Hospital, Brown University, Providence, RI 02903 USA &
Biomedicine (CT) Chinese Academy of Sciences, Beijing, 100080
Country 10579 0
China
Phone 10579 0
+1 401 345 6284
Fax 10579 0
+1 401 444 7479
Email 10579 0
[email protected]
Contact person for scientific queries
Name 1507 0
Jiman He
Address 1507 0
55 Claverick St, Rhode Island Hospital, Brown University, Providence, RI 02903 &
Biomedicine (CT) Chinese Academy of Sciences, Beijing, 100080
Country 1507 0
United States of America
Phone 1507 0
+1 401 345 6284
Fax 1507 0
+1 401 444 7479
Email 1507 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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