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Trial registered on ANZCTR


Registration number
ACTRN12615000364572
Ethics application status
Approved
Date submitted
18/02/2015
Date registered
22/04/2015
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Bowen Therapy in the management of chronic widespread pain
Scientific title
The effect of Bowen Therapy on pain and function in people with chronic widespread pain
Secondary ID [1] 286198 0
None
Universal Trial Number (UTN)
U1111-1167-3284
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic widespread pain 294234 0
Condition category
Condition code
Musculoskeletal 294549 294549 0 0
Other muscular and skeletal disorders
Neurological 294550 294550 0 0
Other neurological disorders
Alternative and Complementary Medicine 295005 295005 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six sessions of 45 mins of Bowen therapy over 6 weeks. Bowen therapy will be administered by a qualified Bowen therapist and involves a series of precise, gentle and painless pressure moves, called Bowen Moves, that are applied with the thumbs and fingers onto specific points of muscles, tendons and ligaments.
Intervention code [1] 291215 0
Treatment: Other
Comparator / control treatment
1) Six sessions of 45 mins of sham Bowen therapy over 6 weeks
2) Usual care for 6 weeks

Sham therapy will involve "pseudo-Bowen" moves that will involve skin touch but will not include pressure.
Usual care will require participants to continue with their normal therapy (if any) over the 6-week period.
Control group
Placebo

Outcomes
Primary outcome [1] 294331 0
Short Form McGill Pain Questionnaire II
Timepoint [1] 294331 0
1 week following the last intervention session and 6 weeks following the last intervention session.
Primary outcome [2] 294332 0
Disabilities of the Arm, Shoulder and Hand (DASH)
Timepoint [2] 294332 0
1 week following the last intervention session and 6 weeks following the last intervention session.
Primary outcome [3] 294333 0
Lower Limb Tasks Questionnaire (LLTQ)
Timepoint [3] 294333 0
1 week following the last intervention session and 6 weeks following the last intervention session.
Secondary outcome [1] 313057 0
Pressure pain threshold assessed using a manual algometer
Timepoint [1] 313057 0
1 week following the last intervention session and 6 weeks following the last intervention session.
Secondary outcome [2] 313058 0
Heat pain threshold assessed using thermode
Timepoint [2] 313058 0
1 week following the last intervention session and 6 weeks following the last intervention session.

Eligibility
Key inclusion criteria
18 - 80 years of age, stable pain for the preceding 3 months, be taking consistent analgesic medication, report a pain score > 3/10 on most days.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severe or unstable medical or psychiatric conditions, have received Bowen therapy previously, incapable of mounting and dismounting the therapy table without significant assistance, unable to provide informed consent, unhealed wounds or skin lesions, less than a month from any surgical procedure, BMI higher than 40, pregnancy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2015
Actual
7/11/2016
Date of last participant enrolment
Anticipated
Actual
3/07/2017
Date of last data collection
Anticipated
Actual
23/11/2017
Sample size
Target
45
Accrual to date
Final
31
Recruitment outside Australia
Country [1] 6672 0
New Zealand
State/province [1] 6672 0
Auckland

Funding & Sponsors
Funding source category [1] 290771 0
Charities/Societies/Foundations
Name [1] 290771 0
Bowen Association Australia
Country [1] 290771 0
Australia
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 289455 0
Individual
Name [1] 289455 0
Dr Kiho Lee, Otago Bowen Therapy
Address [1] 289455 0
Otago Bowen Therapy
35 Columba Ave
Calton Hill
Dunedin 9012
Country [1] 289455 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292402 0
Health and Disability Ethics Committee
Ethics committee address [1] 292402 0
Ethics committee country [1] 292402 0
New Zealand
Date submitted for ethics approval [1] 292402 0
02/03/2015
Approval date [1] 292402 0
22/12/2015
Ethics approval number [1] 292402 0
15/CEN/59

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

Contacts
Principal investigator
Name 55034 0
A/Prof Gwyn Lewis
Address 55034 0
Health and Rehabilitation Research Institute
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 55034 0
New Zealand
Phone 55034 0
+64 9 921 9999
Fax 55034 0
Email 55034 0
[email protected]
Contact person for public queries
Name 55035 0
Kiho Lee
Address 55035 0
Otago Bowen Therapy
35 Columba Ave, Calton Hill
Dunedin 9012
Country 55035 0
New Zealand
Phone 55035 0
+ 64 3 487 6880
Fax 55035 0
Email 55035 0
[email protected]
Contact person for scientific queries
Name 55036 0
Gwyn Lewis
Address 55036 0
Health and Rehabilitation Research Institute
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 55036 0
New Zealand
Phone 55036 0
+64 9 921 9999
Fax 55036 0
Email 55036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseShort term relief of multisite chronicpain with Bowen Therapy: A double-blind, randomized controlled trial.2020https://dx.doi.org/10.1016/j.jbmt.2020.06.025
N.B. These documents automatically identified may not have been verified by the study sponsor.