None listed
Conditions
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.
Interventions
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 p
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.
Sponsors
RMIT
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed