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

NCT ID: NCT01855893

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-12-31

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Auto-acupressure

Intervention Type: 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

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

Group Type: OTHER

Conventional treatment

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Gerencia de Atención Primaria, Madrid

OTHER_GOV

Sponsor Role: lead

Responsible Party

Susana Calvo Trujillo

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susana Calvo-Trujillo, MD

Role: PRINCIPAL_INVESTIGATOR

Gerencia Atención Primaria. Madrid

Locations

Gerencia de Atención Primaria

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 33280397 (View on PubMed)

Other Identifiers

12/00203

Identifier Type: -

Identifier Source: org_study_id