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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Gerencia de Atención Primaria, Madrid
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Susana Calvo Trujillo, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier:
NCT01855893
First received: May 8, 2013
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Neck Pain
Other: Auto-acupressure
Other: Conventional treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of the Auto-acupressure for Diminishing Neck Pain of Benign Origin

Resource links provided by NLM:


Further study details as provided by Gerencia de Atención Primaria, Madrid:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: Ninety days ] [ Designated as safety issue: No ]
    The pain intensity will be evaluated by means of a millimetric scale of 10 cm (Numerical Rating Scale)


Secondary Outcome Measures:
  • Perception of quality of life [ Time Frame: Ninety days ] [ Designated as safety issue: No ]
    The perception of quality of life will be evaluated by EuroQol 5D


Estimated Enrollment: 128
Study Start Date: June 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Auto-acupressure
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.
Other: Auto-acupressure
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
Conventional treatment consist of: 7 days with paracetamol 1g /8 hours and/ or ibuprofen 400mg/ 8 hours, and tetrazepam 50 mg/ 12 hours
Other: 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855893

Contacts
Contact: Susana Calvo-Trujillo, MD 913352583 scalvo.gapm08@salud.madrid.org

Locations
Spain
Gerencia de Atención Primaria Not yet recruiting
Madrid, Spain
Principal Investigator: Susana Calvo-Trujillo         
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Instituto de Salud Carlos III
Investigators
Principal Investigator: Susana Calvo-Trujillo, MD Gerencia Atención Primaria. Madrid
  More Information

No publications provided

Responsible Party: Susana Calvo Trujillo, PhD, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT01855893     History of Changes
Other Study ID Numbers: 12/00203
Study First Received: May 8, 2013
Last Updated: May 14, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Gerencia de Atención Primaria, Madrid:
Neck pain

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014