Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001039077
Ethics application status
Approved
Date submitted
21/12/2009
Date registered
25/11/2010
Date last updated
25/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mindfulness-based meditation for tension-type headache
Scientific title
Effects of brief mindfulness-based meditation on pain sensitivity and headache in chronic-tension-type headache sufferers.
Secondary ID [1] 253161 0
nil
Universal Trial Number (UTN)
U1111-1112-9638
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic tension-type headache 256435 0
Condition category
Condition code
Neurological 256605 256605 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness-based meditation, comprising 2 45minute session per week for 3 weeks, with additional home practice via audio CD. the meditation aims to enhance awareness and non-judgmental acceptance of bodily sensations through:
- Psychoeducation in mindfulness principles.
- Body Scan exercise
- Sitting meditation
- Breathing exercise
- Hearing exercise
- Increasing awareness and mindful acceptance of pleasant and unpleasant events
- 3 minute breathing space
- Action plan for stress management
Participants are instructed to practice exercises daily with the CD for the 3 weeks.
Intervention code [1] 255731 0
Treatment: Other
Comparator / control treatment
No treatment. The wait-list control group will be scheduled to commence the mindfulness course in the week following the second interview and diary assessments (the post treatment assessments for the treatment group).
Control group
Active

Outcomes
Primary outcome [1] 257497 0
Statistically significant reduction in headache severity compared to Control group. headache is recorded in a 2-wek diary by participants, yielding measures of intensity, duration, and days of headache. Headache severity is measured as average intensity or duration of headaches, or number of days headache.
Timepoint [1] 257497 0
6 weeks following randomization.
Secondary outcome [1] 262699 0
Statistically significant reduction in experimental acute pain sensitivity compared to Control group. pain is assessed as:
1) mean pressure pain detection threshold at finger or head (assessed by manual pressure algometer).
2) mean pain detection, intensity rating, and tolerance thresholds to cold pressor pain (assessed by immersing hand in cold water for up to 3 minutes).
3) mean muscle tenderness score (assessed by manual palpation of 7 extracephalic muscles bilaterally).
4) mean pain inhibition (assessed as the difference between pressure pain threshold at finger before and during contra-lateral painful occlusion cuff inflation).
Timepoint [1] 262699 0
6 weeks following randomization.

Eligibility
Key inclusion criteria
Satisfying International Classification of Headache Disorders II (ICHD II) criteria for chronic tension-type headache.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No psychiatric or major medical condition currently or in the last 12 months, no con-current headache or pain symptoms or diagnoses (other than Tension Type Headache (TH) and Migraine). Additionally, headache subjects will required not to be taking, or not have taken in the last 3 months, regular analgesic medication other than less than or equal to 1000mg daily of aspirin or paracetamol for no more than 15 of 30 consecutive days.

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)
Participants will be recruited via advertisements displayed in local media. Half will be allocated to treatment, half to wait-list Control. Allocation involved contacting the holder of the allocation schedule who was off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Alternately assignment to treatment or wait-list control.
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
Active, not recruiting
Date of first participant enrolment
Anticipated
10/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256206 0
University
Name [1] 256206 0
University of South Australia
Country [1] 256206 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Frome Rd, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 251547 0
None
Name [1] 251547 0
Address [1] 251547 0
Country [1] 251547 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258307 0
Uiversity of South Australia Human Research Ethics Committee
Ethics committee address [1] 258307 0
UniSA, Frome Rd, Adelaide, South Australia 5000
Ethics committee country [1] 258307 0
Australia
Date submitted for ethics approval [1] 258307 0
Approval date [1] 258307 0
18/12/2009
Ethics approval number [1] 258307 0
P367/09

Summary
Brief summary
Headache is a common condition associated with significant socio-economic impact and reduced quality of life (Schwartz, Stewart, Simon & Lipton, 1998). Cognitive Behavioural Therapy (CBT) is an effective treatment for headache, however it has several limitations, precluding it’s successful use in many headache sufferers (Fumal & Schoenen, 2008). Particularly, CBT requires considerable time for both therapist and patient, and encourages avoidance rather than coping with headache, which may increase sensitivity to headache triggers and aggravating factors (Martin, 2001). Brief mindfulness based therapy (BMBT) is an emerging behavioural intervention not subject to the above limitations of CBT. Several reports support the efficacy of BMBT in reducing pain and improving functioning in chronic pain conditions such as back pain (Morone et al 2008), fibromyalgia (Creamer et al 2000) and groups of heterogeneous chronic pain sufferers (Kabat-Zinn et al 1985; Kabat-Zinn et al 1986; Kabat-Zinn 1982). BMBT has also been shown to reduce acute pain sensitivity in healthy subjects (Creamer et al 2000, Zeiden et al 2009). This is particularly relevant to headache, in which increased pain sensitivity is a common finding, and thought to be of pathophysiological significance (Cathcart et al 2009). We recently demonstrated that headache is triggered by factor aggravating the already increased pain sensitivity in headache sufferers. Despite the potential benefits of BMBT for treating headache, the efficacy of BMBT as an intervention for headache has not been reported to date. BMBT may reduce headache by inhibiting increased pain sensitivity in headache sufferers. The present project therefore examines effects of BMBT on headache activity and pain sensitivity in frequent headache sufferers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30639 0
Address 30639 0
Country 30639 0
Phone 30639 0
Fax 30639 0
Email 30639 0
Contact person for public queries
Name 13886 0
Stuart Cathcart
Address 13886 0
School of Psychology,
University of South Australia,
St Bernards Rd, Magill
South Australia 5072
Country 13886 0
Australia
Phone 13886 0
61 8 8302 1177
Fax 13886 0
Email 13886 0
[email protected]
Contact person for scientific queries
Name 4814 0
Stuart Cathcart
Address 4814 0
School of Psychology,
University of South Australia,
St Bernards Rd, Magill
South Australia 5072
Country 4814 0
Australia
Phone 4814 0
61 8 8302 1177
Fax 4814 0
Email 4814 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
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