Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616001196437 |
Date of registration:
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30/08/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomised Controlled Trial of Esoteric Connective Tissue Therapy on Chronic Low Back Pain
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Scientific title:
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A Randomised Controlled Trial of Esoteric Connective Tissue Therapy on Chronic Low Back Pain |
Date of first enrolment:
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01/03/2018 |
Target sample size:
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100 |
Recruitment status: |
Not yet recruiting |
URL:
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https://anzctr.org.au/ACTRN12616001196437.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Viet Nam
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Contacts
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Name:
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Mr Christoph Schnelle
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Address:
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School of Public Health
University of Queensland
Herston Road
Herston QLD 4006
Australia |
Telephone:
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+61415888884 |
Email:
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christoph.schnelle@uqconnect.edu.au |
Affiliation:
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Name:
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Mr Christoph Schnelle
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Address:
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School of Public Health
University of Queensland
Herston Road
Herston QLD 4006
Australia |
Telephone:
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+61415888884 |
Email:
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christoph.schnelle@uqconnect.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: * Aged over 18, able to speak, read and write Vietnamese.
* Suffering from chronic low back pain which according to the NIH taskforce’s definition is pain for at least half the days in the past six months.
* At evaluation time suffering from low back pain at a minimum 40 out of 100 on the Visual Analogue Pain Scale.
* Physically able to undertake the standard physiotherapy treatment given by the hospitals
Able to fill in the SF-36 questionnaire and the Quebec Pain Functionality questionnaire with the writing done by themselves or the hospital staff.
Exclusion criteria: * Being pregnant
* If the patient is not sure whether she is pregnant.
* Clinically Diagnosed Schizophrenia, Bipolar conditions and or states including Mania and Delirium, Psychosis or showing any signs of Psychosis, Borderline Disorder or Major Depressive Disorder
* Diagnosed or suspected neoplasm
* Severe joint degeneration causing pain of a mechanical nature in the spine, hip or knees
* Past surgery to the spine
* Osteoporotic fracture or infection.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Chronic Low Back Pain; Chronic Low Back Pain
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Alternative and Complementary Medicine - Other alternative and complementary medicine
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Musculoskeletal - Other muscular and skeletal disorders
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Intervention(s)
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Esoteric Connective Tissue Therapy (ECTT) Materials: Participant Information and Consent Form Procedures: Esoteric Connective Tissue Therapy The treatment consists of small circular motions, primarily with a diameter of 2–3.5cm to the legs, arms and head, with the motions to the head being even smaller. Further actions involve techniques for gently holding the hip, knee, ankle, back and spine, allowing the body to adjust (align). Who: Two ECTT Practitioners with eight years' experience each. One per patient. Mode of delivery: Face to face, client lies on massage table Number of times: Four 40 minute sessions, once per week for four weeks Location: Hospital Personalisation: No personalisation Adherence: Each session is recorded by the nursing staff.
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Primary Outcome(s)
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Pain levels as measured by the Visual Analogue Pain Scale [12 months after the last session.]
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Pain functionality as measured by the the Quebec Back Pain Disability Scale. [12 months after the last session.]
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SF-36 questionnaire scores. [12 months after the last session.]
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Secondary Outcome(s)
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Correlation between change in pain level and initial pain intensity, assessed by visual analogue scale.[12 months after the last session.]
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Source(s) of Monetary Support
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No funding
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Ethics review
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Status: Approved
Approval date:
Contact:
University of Queensland appointed for full ethical approvals: Bellberry Pty Ltd
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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