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

Effectiveness of the Auto-acupressure 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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Auto-acupressure; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Gerencia de atención primaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	The pain intensity will be evaluated by means of a millimetric scale of 10 cm (Numerical Rating Scale)	Ninety days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of quality of life	The perception of quality of life will be evaluated by EuroQol 5D	Ninety days

Collaborators and Investigators

• Sponsor: Gerencia de Atención Primaria, Madrid
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Susana Calvo-Trujillo, MD, Gerencia Atención Primaria. Madrid

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Neck pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 12/00203