Clinical trial NCT01855893: Auto-acupressure: Effectiveness for Diminishing Neck Pain of Benign Origin
Official title: Effectiveness of the Auto-acupressure for Diminishing Neck Pain of Benign Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck pain
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
First posted: 2013-05-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients who come to consultation of Primary Care for neck pain without structural hurt or irradiation, with muscular contraction and functional and postural limitation.

Exclusion Criteria:

* Injuries of skin (dermatitis, burns, sores, skin cancer) in the zone to massaging
* Structural injuries (bony fractures or injuries of muscles and tendons) in the zone to massaging
* Hemorrhage or tendency to suffer hemorrhage
* Chronic, serious diseases
* Malignant diseases and marked physical deterioration
* Psychiatric disorders
* Sensitive alterations
* Treatment with drugs of second or third level of the scale of the WHO which difficult to estimate changes for auto-acupressure
* No sign the informed consent
* Difficulty of reading comprehension or visual alterations

Primary outcomes:
measure: Pain intensity
timeFrame: Ninety days
Secondary outcomes:
measure: Perception of quality of life
timeFrame: Ninety days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia de Atención Primaria
Study officials:
affiliation: Gerencia Atención Primaria. Madrid
name: Susana Calvo-Trujillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Susana CT, Maria TML, Pilar DS, Maria MMT, Pilar MS, Valentin MG; group EDIDO-CUH. Effectiveness of self-applied acupressure for cervical pain of benign origin (EDIDO-CUH): a randomized controlled clinical trial. Acupunct Med. 2021 Oct;39(5):441-451. doi: 10.1177/0964528420961398. Epub 2020 Dec 6.