Auto-acupressure: Effectiveness for Diminishing Neck Pain of Benign Origin
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Auto-acupressure
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Neck pain
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
Sites / Locations
- Gerencia de Atención Primaria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Auto-acupressure
Conventional treatment
Arm Description
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 consist of: 7 days with paracetamol 1g /8 hours and/ or ibuprofen 400mg/ 8 hours, and tetrazepam 50 mg/ 12 hours
Outcomes
Primary Outcome Measures
Pain intensity
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
The perception of quality of life will be evaluated by EuroQol 5D
Full Information
NCT ID
NCT01855893
First Posted
May 8, 2013
Last Updated
June 8, 2017
Sponsor
Gerencia de Atención Primaria, Madrid
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT01855893
Brief Title
Auto-acupressure: Effectiveness for Diminishing Neck Pain of Benign Origin
Official Title
Effectiveness of the Auto-acupressure for Diminishing Neck Pain of Benign Origin
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gerencia de Atención Primaria, Madrid
Collaborators
Instituto de Salud Carlos III
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auto-acupressure
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment
Arm Type
Other
Arm Description
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
Intervention Name(s)
Auto-acupressure
Intervention Description
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
Intervention Name(s)
Conventional treatment
Intervention Description
Conventional treatment consist of: 7 days with paracetamol 1g /8 hours and/ or ibuprofen 400mg/ 8 hours, and tetrazepam 50 mg/ 12 hours
Primary Outcome Measure Information:
Title
Pain intensity
Description
The pain intensity will be evaluated by means of a millimetric scale of 10 cm (Numerical Rating Scale)
Time Frame
Ninety days
Secondary Outcome Measure Information:
Title
Perception of quality of life
Description
The perception of quality of life will be evaluated by EuroQol 5D
Time Frame
Ninety days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana Calvo-Trujillo, MD
Organizational Affiliation
Gerencia Atención Primaria. Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gerencia de Atención Primaria
City
Madrid
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33280397
Citation
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.
Results Reference
derived
Learn more about this trial
Auto-acupressure: Effectiveness for Diminishing Neck Pain of Benign Origin
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