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CompletedNCT01855893Updated Jun 9, 2017

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

An interventional study of Auto-acupressure and Conventional treatment in Neck Pain, sponsored by Gerencia de Atención Primaria, Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-09.

Sponsored by Gerencia de Atención Primaria, Madrid · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neck Pain

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Keywords

  • Neck pain
03

In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's enrollment of 160 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Gerencia de Atención Primaria, Madrid is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherAuto-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.

  • OtherConventional treatment

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

06

What researchers measure

Primary outcomes

  1. Pain intensity

    The pain intensity will be evaluated by means of a millimetric scale of 10 cm (Numerical Rating Scale)

    Time frame: Ninety days

Secondary outcomes

  1. Perception of quality of life

    The perception of quality of life will be evaluated by EuroQol 5D

    Time frame: Ninety days

07

Study locations

1 site
  • Gerencia de Atención Primaria
    Madrid, Spain
08

References and documents

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. PubMed 33280397 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01855893
Lead sponsor
Gerencia de Atención Primaria, Madrid
Collaborators
Instituto de Salud Carlos III
Responsible party
Susana Calvo Trujillo (PhD, Gerencia de Atención Primaria, Madrid) — Principal investigator
First posted
May 17, 2013
Start date
Jul 2013
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jun 9, 2017

Study contacts

Susana Calvo-Trujillo, MD
principal investigator · Gerencia Atención Primaria. Madrid

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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