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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855893
• Other study ID #: 12/00203
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: June 8, 2017
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

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

Locations

Country	Name	City	State
Spain	Gerencia de Atención Primaria	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	The pain intensity will be evaluated by means of a millimetric scale of 10 cm (Numerical Rating Scale)	Ninety days
Secondary	Perception of quality of life	The perception of quality of life will be evaluated by EuroQol 5D	Ninety days