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Trial registered on ANZCTR


Registration number
ACTRN12608000239369
Ethics application status
Approved
Date submitted
19/02/2008
Date registered
8/05/2008
Date last updated
11/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined therapy of electroacupuncture and cognitive behavioural therapy for tension-type headache: a randomised controlled trial
Scientific title
Electroacupuncture and cognitive behavioural therapy for adults with tension-type headache compared with electroacupuncture or cognitive behavioural therapy alone on headache reduction
Secondary ID [1] 285834 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Combined therapy of EA and CBT for TTH: a randomised controlled trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tension-type Headache 2854 0
Condition category
Condition code
Alternative and Complementary Medicine 2987 2987 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention of the current study is a combined therapy of electroacupuncture (EA) and cognitive behavioural therapy (CBT). EA is one form of acupuncture. It combines needle insertion and electrical stimulation, and has been widely used in clinical practice for its safety and easy operation. CBT is a type of psychological intervention. It addresses cognitive behavioural aspects of illnesses. Acupoints located in the neck, scalp, forearms and legs will be selected. EA treatments will twice per week for four weeks followed by once per week for another two weeks. Each session will last for 30 minutes. Then subjects will have weekly 50-minute CBT consultations for another six weeks. CBT will involve a number of components including relaxation training, cognitive restructuring, attention diversion and imagery techniques. Written materials and audiotapes will also be used so that subjects can develop management skills at home in their own time.
Intervention code [1] 2583 0
Other interventions
Comparator / control treatment
Control 1: EA alone. In this EA alone group the subjects will be treated twice per week for four weeks, and then once a week for another eight weeks. Each session will last for 30 minutes. Acupoints located in the neck, scalp, forearms and legs will be selected.

Control 2: CBT alone. In the CBT alone group, the subjects will receive weekly 50-minute CBT consultation for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 3866 0
number of days with headache per four weeks (with headache diaries)
Timepoint [1] 3866 0
baseline, every 4 weeks during the 12 weeks treatment period, and for 4 weeks at the 3rd month during the follow-up period and for 4 weeks at the 6th month during the follow-up period
Primary outcome [2] 293829 0
Severity of headaches recorded using IVS.
Timepoint [2] 293829 0
baseline, the last 4 weeks of treatment period, and 4 weeks at the 3rd month during the follow-up period and for 4 weeks at the 6th month during the follow-up period
Primary outcome [3] 293830 0
Duration of headache recorded using patient daily diary
Timepoint [3] 293830 0
baseline, the last 4 weeks of treatment period, and 4 weeks at the 3rd month during the follow-up period and for 4 weeks at the 6th month during the follow-up period
Secondary outcome [1] 6508 0
number of responders (50% reduction of number of days with headache)
Timepoint [1] 6508 0
at the end of 6-week treatment, 12-week treatment and the six-month follow up period
Secondary outcome [2] 7002 0
Perceived stress score
Timepoint [2] 7002 0
at the end of 6-week treatment, 12-week treatment and the six-month follow up period
Secondary outcome [3] 7003 0
analgesics consumption for tension-type headache (TTH) per four weeks by headache diaries comparison
Timepoint [3] 7003 0
at the end of 6-week treatment, 12-week treatment and the six-month follow up period
Secondary outcome [4] 311953 0
Quality of life (SF-36)
Timepoint [4] 311953 0
at the end of 6-week treatment, 12-week treatment and the 3-month and 6-month follow-up period.
Secondary outcome [5] 311954 0
Social Support Questionnaire
Timepoint [5] 311954 0
at the end of 6-week treatment, 12-week treatment and the six-month follow up period
Secondary outcome [6] 311955 0
Acupuncture Expectancy Scale
Timepoint [6] 311955 0
baseline

Eligibility
Key inclusion criteria
1) age between 18 and 65 years at entry;
2) adept at conversational and reading English;
3) TTH that are consistent with IHS criteria (codes 2.2 and 2.3); and
4) More than one day with tension-type headahce per month.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) No exclusion based on Beck Depression Inventory (BDI) score alone. But an assessment by a psychologist will be involved if deemed necessary during the study, e.g. BDI > = 30;
2) taking analgesic on more than 15 days per month (suspected of medication-overuse headache);
3) Patients with more than 4 migraine attacks (IHS code 1.1 migraine without aura) per month or Patients with any attack (IHS code 1.2 migraine with aura) per month;
4) TTH onset after 50 years old;
5) Participants refuse to maintain existing treatments of TTH, including prophylactic medications, during the trial period;
6) Whiplash or a history of significant head injury that required hospital stay;
7) Severe unstable arrhythmia or heart failure, pregnancy or intent to get pregnant, active epilepsy, brain tumour, cancer, haemophiliac or wearing cardiac pacemakers;
8) Had eight or more sessions of acupuncture or CBT treatments for TTH in the last six months;
9) with intellectual disability; or
10) being psychotic.

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)
Potential subjects will be recruited from the community and will be assessed according to the inclusion and exclusion criteria. Once completed baseline period, each eligible subject will pick up an envelop containing one number indicating the treatment allocation. The randomisation sequence will be stored in a password protected computer and a researcher who is not involved in treatment or assessment will have the access to the allocation assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random numbers will be used. The numbers will be entered into sequentially numbered, opaque sealed envelopes, one for each subject. These will be opened only when the subjects arrive for their first treatment
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 583 0
3001

Funding & Sponsors
Funding source category [1] 3106 0
University
Name [1] 3106 0
RMIT
Address [1] 3106 0
Bundoora West Campus,Plenty Road,Bundoora,VIC3083,
Victoria,Australia
Country [1] 3106 0
Australia
Funding source category [2] 290407 0
Government body
Name [2] 290407 0
National Health and Medical Research Council
Address [2] 290407 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [2] 290407 0
Australia
Primary sponsor type
University
Name
RMIT
Address
Bundoora West Campus,Plenty Road,Bundoora,VIC3083,
Victoria,Australia
Country
Australia
Secondary sponsor category [1] 2998 0
Individual
Name [1] 2998 0
Prof Ken Greenwood
Address [1] 2998 0
School of Health Sciences,
Bundoora West Campus,Plenty Road,Bundoora,VIC3083,
Victoria,Australia
Country [1] 2998 0
Australia
Secondary sponsor category [2] 2999 0
Individual
Name [2] 2999 0
Prof Charlie Xue
Address [2] 2999 0
Division of Chinese Medicine,
School of Health Sciences,
Bundoora West Campus,Plenty Road,Bundoora,VIC3083,
Victoria,Australia
Country [2] 2999 0
Australia
Secondary sponsor category [3] 3000 0
Individual
Name [3] 3000 0
Dr Zhen Zheng
Address [3] 3000 0
Division of Chinese Medicine,
School of Health Sciences,
Bundoora West Campus,Plenty Road,Bundoora,VIC3083,
Victoria,Australia
Country [3] 3000 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5083 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 5083 0
RMIT Human Research Ethics Committee, University Secretariat, RMIT, GPO Box 2476V, Melbourne, 3001
Ethics committee country [1] 5083 0
Australia
Date submitted for ethics approval [1] 5083 0
01/11/2007
Approval date [1] 5083 0
09/11/2007
Ethics approval number [1] 5083 0
21/07

Summary
Brief summary
Tension-type headache (TTH) affects up to 75% of the world population and more than 33% of Australians. There is no ideal treatment for it due to the unclear mechanism. Commonly used medications include simple pain killers and anti-depressants. They are either not effective for long-term management or not tolerated by patients due to side effects. Acupuncture has been shown to reduce the frequency and intensity of TTH within three weeks of treatment and has an excellent safety profile. Cognitive behavioural therapy (CBT) teaches patients how to cope with mental stress and correct unhelpful thoughts, belief and behaviour, and thus produces a long-term effect for TTH patients. In this current trial, we aim to assess the combined effect of electroacupuncture (EA) and CBT on TTH in short and long terms. 225 TTH patients will be recruited. After a four-week run-in period and randomisation, all subjects will have one-hour interview, and then be randomly allocated to receive either EA alone, CBT alone or EA+CBT group for a total of 12-week treatment. There will be a six-month follow-up at the end of the 12 week treatment period. Subjects will record the frequency, duration, severity and symptoms of headache and the use of headache medication during run-in, the treatment and the follow-up periods. This trial will be the first such project in the world in which acupuncture is combined with a well-received and practiced intervention in pain management for TTH, i.e., CBT. The combined therapy will be cost-effective because it will reduce the consumption of analgesics and visits to doctors, and improve effectiveness at work and quality of life as a result of reduced pain and enhanced self-management skills.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28383 0
Prof Ken Greenwood
Address 28383 0
Faculty of Computing, Health and Science
Edith Cowan University
270 Joondalup Drive
JOONDALUP WA 6027
Australia
Country 28383 0
Australia
Phone 28383 0
+61,8,6304 5979
Fax 28383 0
Email 28383 0
k.greenwood@ecu.edu.au
Contact person for public queries
Name 11540 0
Dr Dr Zhen Zheng
Address 11540 0
Level 4, Building 202, room 4.51, Plenty Road,
Bundoora West Campus, RMIT
BUNDOORA
VIC3083
Country 11540 0
Australia
Phone 11540 0
03 99257167
Fax 11540 0
03 99257178
Email 11540 0
zhen.zheng@rmit.edu.au
Contact person for scientific queries
Name 2468 0
Dr Dr Zhen Zheng
Address 2468 0
Level 4, Building 202, room 4.51, Plenty Road,
Bundoora West Campus, RMIT
BUNDOORA
VIC3083
Country 2468 0
Australia
Phone 2468 0
03 99257167
Fax 2468 0
03 99257178
Email 2468 0
zhen.zheng@rmit.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary