Chronic tension-type headache (CTTH) is an underestimated disabling condition that affects a large number of patients. The treatment options for both episodic tension-type headaches, but especially CTTH are few. Poor long-term effects of existing treatment for CTTH (Sarotex, SSRIs, physiotherapy) are reported. Patients with CTTH also have a high risk of developing drug overdose headache (MOH). Non-drug treatments with physiotherapy or alternative medicine also show poor long-term effects. Literature reviews show that there is surprisingly little research on CTTH. Some small clinical trials report a good effect of treatment with botulinum toxin A, but larger controlled trials are needed to confirm or deny this. The investigators will study effect of treatment with botulinum toxin A in CTTH in BACT study, and will include participants with both frequent and chronic TTH with 10 or more headache days per month. If BACT outcomes are positive, this will open a possibility for a new treatment for TTH patients.
BACT studies the efficacy of treatment with botulinum toxin with a follwthestuture injection regime in frequent and chronic tension type headache (TTH). This is be a randomized, placebo-controlled, triple blind, cross-over trial. The primary efficacy variable is the difference in monthly headache days in the active period versus the placebo period. In this study, injections will follow a slightly modified FollowTheSutures injection protocol. Study duration is 36 weeks long. The target population is male and female patients 18 to 75 years of age with TTH, with 10 or more headache days per month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
100 Allergan units Botulinum toxin A in a total of 2 ml sodium chloride (NaCl) 0,9% Braun. 5 IU of Botox per injection point (0,1ml); in total 100 IU per 20 injections points.
2ml Na Cl (sodium chloride) 0,9% Braun. 0,1ml per injection point in total 20 injections points
Namsos Sykehus
Namsos, Norway
Difference in TTH-headache days in week 5-8 of the active period versus the placebo period.
Difference in TTH- headache days in week 5-8 of the active period versus the placebo period.
Time frame: 36 weeks
50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
Time frame: 36 weeks
Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period
Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period
Time frame: 36 weeks
30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
Time frame: 36 weeks
Quality of life score on EQ-5D-5L
EQ-5D-5L at week 8 and 12 after injection
Time frame: 36 weeks
Patient Global Impression of Improvement (PGI-I)
scale 7-points - (very much better) to 7 (very much worse) 8 and 12 after injection
Time frame: 36 weeks
Average maximum pain intensity in Numeric Rating Scale (NRS from 0 to10) in week 1-4, 5-8 and 9-12
NRS scale: 0 meaning no pain and 10 meaning the worst pain imaginable)
Time frame: 36 weeks
Headache Impact Test (HIT-6)
HIT-6 at week 8 and 12 after injection
Time frame: 36 weeks
Average number of headache hours per day in week 1-4, 5-8 and 9-12.
Average number of headache hours per day in week 1-4, 5-8 and 9-12.
Time frame: 36 weeks
Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12
Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12
Time frame: 36 weeks
Acceptability
Acceptability
Time frame: 36 weeks
Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period
Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period
Time frame: 36 weeks
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