Combined therapy of electroacupuncture and cognitive behavioural therapy for tension-type headache: a randomised controlled trial

Phase 2

Completed

• Conditions: Tension-type Headache; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12608000239369
• Lead Sponsor: RMIT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of days with headache per four weeks (with headache diaries)[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];Severity of headaches recorded using IVS.[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];Duration of headache recorded using patient daily diary[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 Measures

Name	Time	Method
Acupuncture Expectancy Scale[baseline];number of responders (50% reduction of number of days with headache)[at the end of 6-week treatment, 12-week treatment and the six-month follow up period];Perceived stress score[at the end of 6-week treatment, 12-week treatment and the six-month follow up period];analgesics consumption for tension-type headache (TTH) per four weeks by headache diaries comparison[at the end of 6-week treatment, 12-week treatment and the six-month follow up period];Quality of life (SF-36)[at the end of 6-week treatment, 12-week treatment and the 3-month and 6-month follow-up period.];Social Support Questionnaire [at the end of 6-week treatment, 12-week treatment and the six-month follow up period]