Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000746235
Ethics application status
Approved
Date submitted
8/03/2009
Date registered
27/08/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
In chronic tension type headache sufferers is sauna or soft tissue massage more effective than their current care in reducing headache severity and frequency.
Scientific title
In chronic tension type headache sufferers is sauna or soft tissue massage more effective than their current care in reducing headache severity and frequency
Universal Trial Number (UTN)
Trial acronym
WEST Headache trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic tension type headache 4436 0
Condition category
Condition code
Neurological 4704 4704 0 0
Studies of the normal brain and nervous system
Alternative and Complementary Medicine 239883 239883 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sauna, Three times a week for 20 minutes for eight weeks.
Intervention code [1] 241184 0
Treatment: Other
Comparator / control treatment
Soft tissue Massage. Five minutes per day, self administered in the head and neck muscles for eight weeks.
Control group
Active

Outcomes
Primary outcome [1] 240668 0
Time head pain present during day measured in hours. Diary is filled in daily.
Timepoint [1] 240668 0
Measured daily for four weeks prior to interventions and daily for two months after intervetion
Primary outcome [2] 240669 0
Pain severity measured by Visual Analogue Pain score out of 10.
Timepoint [2] 240669 0
Measured daily for four weeks prior to interventions and for two months after intervetion.
Secondary outcome [1] 257305 0
Depression as measured by the Beck Depression Inventory.
Timepoint [1] 257305 0
At four weeks prior to intervention and 8 weeks after intervention.

Eligibility
Key inclusion criteria
Chronic tension Type Headache as defined by the International headache society (IHS).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known cause of symptoms such as acute sinusitis, eyesight or ear problems,
Current diagnosis of cancer
Acute infections including viral illness
Previous spinal/brain surgery
Pregnancy
Head injury

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)
Advertisments were placed to recruit participants with chronic tension type headaches. Treatment was allocated randomly using randomisation program.Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation calculator was used.
Masking / blinding
Open (masking not 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
Recruiting
Date of first participant enrolment
Anticipated
10/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment outside Australia
Country [1] 1657 0
New Zealand
State/province [1] 1657 0

Funding & Sponsors
Funding source category [1] 4628 0
University
Name [1] 4628 0
Massey University
Country [1] 4628 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
PO Box 756, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 4172 0
None
Name [1] 4172 0
Address [1] 4172 0
Country [1] 4172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6667 0
Upper South A Ethics Committee
Ethics committee address [1] 6667 0
Ethics committee country [1] 6667 0
New Zealand
Date submitted for ethics approval [1] 6667 0
Approval date [1] 6667 0
09/09/2008
Ethics approval number [1] 6667 0

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

Contacts
Principal investigator
Name 29364 0
Address 29364 0
Country 29364 0
Phone 29364 0
Fax 29364 0
Email 29364 0
Contact person for public queries
Name 12611 0
Dr Giresh Kanji
Address 12611 0
90 Hanson St
Newtown
Wellington 6021
Country 12611 0
New Zealand
Phone 12611 0
644 9102178
Fax 12611 0
644 3895230
Email 12611 0
[email protected]
Contact person for scientific queries
Name 3539 0
Dr Giresh Kanji
Address 3539 0
90 Hanson St
Newtown
Wellington 6021
Country 3539 0
New Zealand
Phone 3539 0
6449102178
Fax 3539 0
644 3895230
Email 3539 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.