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Completed

NCT Number: NCT01855893

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gerencia de Atención Primaria

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auto-acupressure

Other

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

Other

Conventional treatment consist of: 7 days with paracetamol 1g /8 hours and/ or ibuprofen 400mg/ 8 hours, and tetrazepam 50 mg/ 12 hours

Primary outcomes

  1. Pain intensity

    Time frame: Ninety days

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

Secondary outcomes

  1. Perception of quality of life

    Time frame: Ninety days

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

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 17, 2013
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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