Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000288921
Ethics application status
Approved
Date submitted
15/03/2011
Date registered
18/03/2011
Date last updated
21/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture for the treatment of Anorexia Nervosa: a pilot study
Scientific title
A pilot study to examine the role of acupuncture to restore weight, improve eating behaviours and reduce anxiety and depression in those with Anorexia Nervosa.
Secondary ID [1] 259782 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight restoration in sufferers of Anorexia Nervosa. 261364 0
Eating behaviours in sufferers of Anorexia Nervosa 261365 0
Anxiety in sufferers of Anorexia Nervosa 261366 0
Depression in sufferers of Anorexia Nervosa 261367 0
Condition category
Condition code
Alternative and Complementary Medicine 259524 259524 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study group 1: Traditional Acupuncture while receiving their usual care at the Hills Private Hospital. Usual care is the participant's individually tailored Hills treatment which involves a combination of medical, pharmacological and psychological therapy and rehabilitation.
Pragmatic acupuncture based on Traditional Chinese Medicine (TCM) diagnosis will be used. Two treatments a week will be administered for the first three weeks while they are an inpatient and then weekly for three weeks during their attendance as an outpatient. Acupuncture will be applied bilaterally. Duration of each treatment is 45 minutes. Acupuncture needles will be inserted to tissue level and stimulated manually to elicit the needling sensation de qi and stimulated once more during this treatment session. Needles will be retained for a minimum of 20 minutes. Single-use disposable stainless steel needles (0.25 x 40mm) will be used. All points will be located according to the WHO International Standard Acupuncture Point Locations that was agreed on at Tsukuba, Japan, November 2006.
Intervention code [1] 264216 0
Treatment: Other
Comparator / control treatment
Study group 2: The active control group will receive light massage (plus usual care) involving acupressure and light longitudinal massage therapy. The acupressure will be applied bilaterally. Longitudinal massage therapy will also be applied bilaterally. Trial procedures will be identical to the acupuncture group regarding duration, and interaction with the practitioner will be the same for the light massage control group.
Study group 3: Usual care only. Participants in this group will receive the usual care at the Hills Private Hospital only.
Control group
Active

Outcomes
Primary outcome [1] 262328 0
Weight restoration measured by body weight and BMI
Timepoint [1] 262328 0
Baseline, 6, 12 and 26 weeks.
Primary outcome [2] 262329 0
Eating behaviour as measured by the Eating Disorder Inventory-3 (EDI-3) and the Eating Disorder Examination Questionnaire (EDE-Q v 16).
Timepoint [2] 262329 0
Baseline, 6, 12 and 26 weeks.
Secondary outcome [1] 273550 0
Depression and anxiety as measured by the DAAS.
Timepoint [1] 273550 0
Baseline, 6, 12 and 26 weeks.
Secondary outcome [2] 273551 0
Quality of life specific for those with eating disorders as measured by the EDQoL.
Timepoint [2] 273551 0
Baseline, 6, 12 and 26 weeks.
Secondary outcome [3] 273552 0
Qualitative assessment of the perceptions of the intervention and the participants experience of it and its effects via an in-depth interview
Timepoint [3] 273552 0
At the end of the trial.
Secondary outcome [4] 273553 0
Analysis of acceptability of the intervention, views towards it, randomisation, likes and dislikes and expectancy and clinicians views of the intervention via self-report
Timepoint [4] 273553 0
At the end of the trial.

Eligibility
Key inclusion criteria
Participants 15 years or greater with a primary clinical diagnosis of Anorexia Nervosa with purging and/or restricting subtype. Participants must be medical stable (e.g. heart rate of >40bpm, blood pressure > 90/60mmHg, no electrolyte abnormalities and temperature > 36 degrees C. They must be receiving treatment at the Hills Private Hospital and also have the ability to provide informed written consent.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any serious co morbid medical illness other than the complications of malnutrition associated with Anorexia Nervosa, substance dependence, psychosis or bipolar disorder. Unable to attend the allocated intervention sessions or the concurrent use of acupuncture or light massage.

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)
Screening for eligibility will be undertaken over the phone by the research acupuncturist. Participants will need to be 15 years or greater with a primary diagnosis of Anorexia Nervosa, medically stable and receiving treatment at the Hills Private Hospital. If the participant is eligible and interested then an appointment will be made. Participants who consent will be randomly allocated to the study by taking the next sequentially numbered sealed opaque envelope. Randomisation will be into two study groups, acupuncture and treatment as usual or light massage and treatment as usual.
Treatment as usual is not randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by a researcher not directly involved with the trial. The randomisation sequence will be computer generated. The sequence will be concealed and held in a locked filling cabinet at the Centre for Complementary Medicine Research.
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
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264664 0
University
Name [1] 264664 0
University of Western Sydney
Country [1] 264664 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bad 1797
Penrith South NSW 1797
Country
Australia
Secondary sponsor category [1] 263802 0
None
Name [1] 263802 0
Address [1] 263802 0
Country [1] 263802 0
Other collaborator category [1] 251873 0
Hospital
Name [1] 251873 0
THe Hills Priviate Hospital
Address [1] 251873 0
499 Windsor Rd
Baulkham Hills
NSW 2153
Country [1] 251873 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266663 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 266663 0
Ethics committee country [1] 266663 0
Australia
Date submitted for ethics approval [1] 266663 0
04/02/2011
Approval date [1] 266663 0
Ethics approval number [1] 266663 0
H8934

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32344 0
Address 32344 0
Country 32344 0
Phone 32344 0
Fax 32344 0
Email 32344 0
Contact person for public queries
Name 15591 0
Sarah Fogarty
Address 15591 0
Centre for Complementary Medicine Research
LG Building 5 Cambelltown Campus
Locked Bag 1797
Penrith South DC 1797
Country 15591 0
Australia
Phone 15591 0
+61 2 46203290
Fax 15591 0
Email 15591 0
[email protected]
Contact person for scientific queries
Name 6519 0
Caroline Smith
Address 6519 0
Centre for Complementary Medicine Research
LG Building 5 Cambelltown Campus
Locked Bag 1797
Penrith South DC 1797
Country 6519 0
Australia
Phone 6519 0
+61 2 46203777
Fax 6519 0
+ 61 2 46203291
Email 6519 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
No additional documents have been identified.