Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001204932
Ethics application status
Approved
Date submitted
22/11/2011
Date registered
23/11/2011
Date last updated
15/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of acupressure in decreasing pain and anxiety in injured athletes
Scientific title
The effectiveness of acupressure in decreasing pain and anxiety in athletes presenting with acute musculoskeletal injuries: A prospective randomised controlled trial
Secondary ID [1] 273435 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal sports injury 279218 0
Pain 279219 0
Anxiety 279220 0
Condition category
Condition code
Alternative and Complementary Medicine 279425 279425 0 0
Other alternative and complementary medicine
Injuries and Accidents 279426 279426 0 0
Other injuries and accidents
Anaesthesiology 279427 279427 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1. “True acupressure” – will receive 3 min of acupressure treatment on predefined acu-point (LI 4-Hegu) for general anaesthesia. This point have been traditionally used to treat pain and anxiety. Group 2. “sham acupressure” – will receive 3 min of pressure on sham point (on the palm, proximal to the second MCP joint at the head of the second metacarpal bone). Group 3. “no-treatment group” – no pressure on any points. The intervention group (1) will recieve the intervention only on one occasion and within 72 hours of the initial injury occurence.
Intervention code [1] 283765 0
Treatment: Other
Comparator / control treatment
Group 2. “sham acupressure” – will receive 3 min of pressure on sham point (on the palm, proximal to the second MCP joint at the head of the second metacarpal bone). Group 3. “no-treatment group” –no pressure on any points.
Control group
Placebo

Outcomes
Primary outcome [1] 285994 0
>20 mm decrease in pain on 100mm Visual Analogue Scale (VAS)
Timepoint [1] 285994 0
Pre-intervention and post-intervention
Primary outcome [2] 285995 0
>20 mm decrease in anxiety on 100mm Visual Analogue Scale (VAS)
Timepoint [2] 285995 0
Pre-intervention and post-intervention
Secondary outcome [1] 294917 0
Overall satisfaction of treatment on Likert scale
Timepoint [1] 294917 0
post-intervention

Eligibility
Key inclusion criteria
People presenting to Otago Sports Injury Clinic with minor and moderate acute sports injuries requiring analgesia.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Insufficient knowledge of the English language, inability to give informed consent, overt neurological or psychiatric disorders or self-reported, pregnancy, recent pharmacological pain relief for the presenting injury, major (severe) injuries, wounds over acupressure application point, any type of drug abuse

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)
Sports participants/athletes attending the Otago Sports Injury Clinic will be approached by clinic staff during enrolment at the clinic.
Sequentially numbered opaque envelopes will be used. These are generated before patient recruitment begins. As there are 3 study groups (true acupressure, sham acupressure, no-treatment group), there are 3 possibilities of the modality application diagram which will be placed into the sequentially numbered opaque envelopes based on the outcome of the random number table. True acupressure group diagram shows acupressure points used for pain and anxiety. Sham acupressure diagram shows points unrelated to pain or anxiety. Rest group diagram shows no points. Once informed consent and pre-treatment questionnaire is obtained, the envelope will be opened and researcher will carry out the modality based on diagram.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generator with blocking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2012
Actual
28/04/2012
Date of last participant enrolment
Anticipated
Actual
17/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
138
Accrual to date
Final
Recruitment outside Australia
Country [1] 3970 0
New Zealand
State/province [1] 3970 0

Funding & Sponsors
Funding source category [1] 284241 0
Self funded/Unfunded
Name [1] 284241 0
Country [1] 284241 0
Primary sponsor type
Individual
Name
Dr Anthony Schneiders
Address
School of Physiotherapy
University of Otago
325 Great King Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 269197 0
None
Name [1] 269197 0
Address [1] 269197 0
Country [1] 269197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286206 0
Lower South Regional Ethics Committee, New Zealand
Ethics committee address [1] 286206 0
c/- Ministry of Health
1-3 The Terrace
Level 1
Wellington 6011
Ethics committee country [1] 286206 0
New Zealand
Date submitted for ethics approval [1] 286206 0
28/11/2011
Approval date [1] 286206 0
19/01/2012
Ethics approval number [1] 286206 0
LRS/11/12/054

Summary
Brief summary
Acupressure is a technique which is derived from Traditional Chinese Medicine. It is a non-invasive and easy technique to perform which consists of a pressure of a finger or thumb on specific points on the body. It is a common technique used to manage symptoms such as pain, anxiety, nausea and sickness.
The purpose of this research project is to determine the effectiveness of acupressure as pain relief for sports injuries. The aim of the proposed study is to compare the effects of acupressure with placebo (sham) and no treatment on the pain and anxiety of patients with a sports injury. Participants will fill in a questionnaire that collects basic (age, gender), and data about pain and anxiety. Participants will then be randomized to one of three treatment groups (true acupressure, sham or non-treatment group). After treatment patients will be asked to re-evaluate their pain and anxiety scales.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33424 0
Address 33424 0
Country 33424 0
Phone 33424 0
Fax 33424 0
Email 33424 0
Contact person for public queries
Name 16671 0
Dr Anthony G. Schneiders
Address 16671 0
School of Physiotherapy
University of Otago
325 Great King Street
Dunedin 9016
Country 16671 0
New Zealand
Phone 16671 0
+64 03 479 5426
Fax 16671 0
+64 03 479 8414
Email 16671 0
[email protected]
Contact person for scientific queries
Name 7599 0
Dr Anthony G. Schneiders
Address 7599 0
School of Physiotherapy
University of Otago
325 Great King Street
Dunedin 9016
Country 7599 0
New Zealand
Phone 7599 0
+64 03 479 5426
Fax 7599 0
+64 03 479 8414
Email 7599 0
[email protected]

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
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