Clinical Trial: Auto-acupressure: Effectiveness for Diminishing Neck Pain of Benign Origin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness of the Auto-acupressure for Diminishing Neck Pain of Benign Origin

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Gerencia de Atención Primaria, Madrid

Current Primary Outcome: Pain intensity [ Time Frame: Ninety days ]

The pain intensity will be evaluated by means of a millimetric scale of 10 cm (Numerical Rating Scale)


Original Primary Outcome: Same as current

Current Secondary Outcome: Perception of quality of life [ Time Frame: Ninety days ]

The perception of quality of life will be evaluated by EuroQol 5D


Original Secondary Outcome: Same as current

Information By: Gerencia de Atención Primaria, Madrid

Dates:
Date Received: May 8, 2013
Date Started: July 2013
Date Completion:
Last Updated: March 3, 2017
Last Verified: March 2017