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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: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12616001196437
Date of registration: 30/08/2016
Prospective Registration: Yes
Primary sponsor: Christoph Schnelle
Public title: A Randomised Controlled Trial of Esoteric Connective Tissue Therapy on Chronic Low Back Pain
Scientific title: A Randomised Controlled Trial of Esoteric Connective Tissue Therapy on Chronic Low Back Pain
Date of first enrolment: 01/03/2018
Target sample size: 100
Recruitment status: Not yet recruiting
URL:  https://anzctr.org.au/ACTRN12616001196437.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
Australia Viet Nam
Contacts
Name: Mr Christoph Schnelle   
Address:  School of Public Health University of Queensland Herston Road Herston QLD 4006 Australia
Telephone: +61415888884
Email: christoph.schnelle@uqconnect.edu.au
Affiliation: 
Name: Mr Christoph Schnelle   
Address:  School of Public Health University of Queensland Herston Road Herston QLD 4006 Australia
Telephone: +61415888884
Email: christoph.schnelle@uqconnect.edu.au
Affiliation: 
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Chronic Low Back Pain;
Chronic Low Back Pain
Alternative and Complementary Medicine - Other alternative and complementary medicine
Musculoskeletal - Other muscular and skeletal disorders
Intervention(s)
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.

Primary Outcome(s)
Pain levels as measured by the Visual Analogue Pain Scale
[12 months after the last session.]
Pain functionality as measured by the the Quebec Back Pain Disability Scale.
[12 months after the last session.]
SF-36 questionnaire scores.
[12 months after the last session.]
Secondary Outcome(s)
Correlation between change in pain level and initial pain intensity, assessed by visual analogue scale.[12 months after the last session.]
Secondary ID(s)
None
Source(s) of Monetary Support
No funding
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
University of Queensland appointed for full ethical approvals: Bellberry Pty Ltd
Results
Results available:
Date Posted:
Date Completed:
URL:
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