Treatment of Chronic Refractory Headache With Acupuncture: Observational Study: OBSERVATIONAL STUDY (CRHACU) (CRHACU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03250754|
Recruitment Status : Active, not recruiting
First Posted : August 16, 2017
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment|
|Chronic Headache Disorder||Device: Electroacupuncture|
A Cochrane systematic review published in 2016 concluded that acupuncture was at least as effective as, or possibly more effective than, preventive drug treatment for migraine prophylaxis with fewer side effects compared with conventional treatments . Cochrane reviews of tension-type headache conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent, episodic, and chronic tension-type headache.
An observational, cross-sectional study, according to the STROBE guide, was conducted. The study was carried out in the Pain Service Unit of the Son Llàtzer University Hospital of Palma de Mallorca, Spain.
Between January 2010 and December 2015, data from patients with chronic refractory headache, which did not respond to conventional treatment for at least 6 months, referred to the Pain Service Unit were examined to ascertain their eligibility.
|Study Type :||Observational|
|Estimated Enrollment :||320 participants|
|Official Title:||Treatment of Chronic Refractory Headache With Acupuncture: Observational Study (CRHACU)|
|Actual Study Start Date :||March 20, 2017|
|Primary Completion Date :||July 30, 2017|
|Estimated Study Completion Date :||February 20, 2018|
Pharmacological treatment group
Treatment decision making is based on physician's choice and patient preferences. Patients were referred to the Pain Service Unit. Patients continued with a new prophylactic treatment alone
Treatment decision making is based on physician's choice and patient preferences. Patients were referred to the Pain Service Unit. Patients continued with a new prophylactic treatment and additionally, received 10 sessions of acupuncture. The treatments, which included electro-stimulation.
Needles on the extremities were stimulated by electro-stimulation device applied by a biphasic pulse generator apparatus at a frequency of pulses alternated between 2 Hz and 100 Hz and the maximum tolerable intensity.
- Number of headache attacks per month [ Time Frame: At the end of the third month of treatment ]Because the improvements observed were essentially proportional to the headache at study entry, we also calculated the percent reduction of headache days for each patient. Treatment responders were also calculated: a patient with a reduction of ≥ 50% was considered to be a treatment responder.
- Visual analogue scale (VAS) for pain [ Time Frame: at baseline, 1 month and 3-months ]a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale]). (VAS pain intensity score)
- The change of headache days after 1 month [ Time Frame: at baseline, 1 month and 3-months ]Number of headache days per month
- Assessment of satisfaction with treatment [ Time Frame: at baseline, 1 month and 3-months ]ranging from 10 (extremely Satisfied) to 0 (extremely dissatisfied)
- Sleep quality assessment [ Time Frame: at baseline, 1 month and 3-months ]ranging from 10 (good quality) to 0 (poor quality)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250754
|Son Llàtzer University Hospital|
|Palma, Balearic Islands, Spain, 07198|
|Principal Investigator:||Javier Mata, MD||Son Llatzer University Hospital|