Chronic Tension-type Headaches Clinical Trial
Official title:
The Efficacy of Lacticum Acidum Homaccord in the Treatment of Chronic Tension-type Headaches
Chronic tension-type headaches (CTTHs) affect 30-40% of the population and account for a number of absences from, and decreased performances at, work and school as well as recreational activities. CTTHs typically occur at least 15 times a month or at least every second day, and present as an achy or tight sensation that is felt around the head . The pain may last from 30 minutes to several days and varies in intensity . Conventional treatment is palliative, consisting of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), which may produce adverse effects and analgesic rebound headaches . Lacticum acidum 30CH is a homoeopathic remedy that has been shown to have potential benefits in the treatment of CTTHs . Homaccords are the preparation of one remedy in multiple increasing potencies in a single vehicle . There has been no research done to date on Lacticum acidum Homaccord in the treatment of CTTHs.The aim of this study is to determine the efficacy of Lacticum acidum Homaccord in the treatment of chronic tension-type headaches, using the modified Headache Diary and the Headache Disability Inventory.
The study will be a four-week, double-blind, placebo-controlled study which will take place
at the Homoeopathic Health Centre at the University of Johannesburg (UJ) Doornfontein
campus. A randomized sample of 30 male and female participants between the ages of 18 and 45
years who suffer from CTTHs will be recruited. This will be done by means of purposive
sampling via advertisements placed on the UJ campuses, with relevant permission given . At
the initial consultation (day 0), prospective participants will be requested to sign the
Participant Information and Consent Form . They will then complete the Screening
Questionnaire to assess their eligibility for participating in the study. Those participants
who meet the diagnostic criteria for CTTHs, and whose symptoms match at least eight out of
the twelve Lacticum acidum headache related symptoms, will be eligible to participate. All
participants will also be requested to complete a Headache Disability Inventory.
Participants will be placed into matched pairs according to age and gender and will receive
one 30 mL bottle of their medication. On days 1-28 each participant will be requested to
complete the Headache Diary at the end of each day and to take 5 pillules of the medication
in the morning and in the evening. The first follow-up visit will occur on day 14; here
participants will complete the Headache Disability Inventory, the completed headache diaries
will be exchanged with new ones, a relevant physical examination including vital signs will
be conducted and an additional bottle of medication will be given. The final follow-up visit
will occur on day 28, where each participant will complete the Headache Disability
Inventory, and a relevant physical examination including vital signs will be recorded.
Collected data will be evaluated using frequencies, descriptive tests and cross tabulation,
the Shapiro Wilk test, the Independent samples t-test or Mann-Whitney test, and the Friedman
and Wilcoxon signed ranks tests. A possible outcome is that Lacticum acidum may have an
ameliorating effect on CTTHs and may provide a possible alternative treatment option for
this condition, opening up the field for further research.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment