Gerencia de Atención Primaria
Madrid, Spain
NCT Number: NCT01855893
The purpose of this study is to evaluate the effectiveness of the auto-acupressure (digital pressure in points of acupuncture) added to the conventional treatment.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Madrid, Spain
OBJECTIVE: To evaluate the effectiveness of the digital pressure in points of acupuncture added to the conventional treatment for diminishing the pain in patients with cervicalgia of benign origin.
MATERIAL AND METHODS: Pragmatic controlled randomized clinical trial. Patients with diagnosis of cervicalgia of benign origin will include. They will be randomly assigned to receive just conventional treatment or this plus auto-acupressure.
The professionals will once receive instruction in the Centres of Health by an experienced acupuncture professional that will supervise, in a workshop, the right application of the technique, that will consist of the application of manoeuvres of auto-acupressure by the own patient during periods of 10 minutes, once in a day during one week. The pain intensity will be evaluated by means of a millimetric scale of 10 cm (0 represents the pain absence, 10 the maximum imaginable pain, Numerical Scale Rating). The pain will be measured in the inclusion and days 1, 3, 7, 30 and 90. The sample size has been calculated to detect a minimum difference of 1.5 points (DS 2) in the scale of the pain in day 7, which implies the recruitment of, at least, 80 patients by group (if losses don't exceed 20%). Also the perception of the quality of life (euroQol-5D) and the functional capacity with the scale of Oswestry will be evaluated, at the beginning, and days 3, 7, 30 and 90. The measures in each point between the group will be compared control and intervention. The evolution of the repeated measures will compare between groups with a generalized estimating equation (GEE) model.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive instructions about how to apply auto-acupressure once in a day during one week by their health care professionals.This technique will be complementary to the conventional treatment.
Conventional treatment consist of: 7 days with paracetamol 1g /8 hours and/ or ibuprofen 400mg/ 8 hours, and tetrazepam 50 mg/ 12 hours
Time frame: Ninety days
The pain intensity will be evaluated by means of a millimetric scale of 10 cm (Numerical Rating Scale)
Time frame: Ninety days
The perception of quality of life will be evaluated by EuroQol 5D
Gerencia de Atención Primaria, Madrid
Other Gov
Effectiveness of the Auto-acupressure for Diminishing Neck Pain of Benign Origin
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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