NCT01855893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 9, 2017

Status Verified

March 1, 2017

Enrollment Period

3.4 years

First QC Date

May 8, 2013

Last Update Submit

June 8, 2017

Conditions

Neck Pain

Keywords

Neck pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

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

    Ninety days

Secondary Outcomes (1)

  • Perception of quality of life

    Ninety days

Study Arms (2)

Auto-acupressure

EXPERIMENTAL

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

Conventional treatment

OTHER

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

Auto-acupressureOTHER

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.

Auto-acupressure
Conventional treatmentOTHER

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

Conventional treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who come to consultation of Primary Care for neck pain without structural hurt or irradiation, with muscular contraction and functional and postural limitation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerencia de Atención Primaria

Madrid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33280397DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susana Calvo-Trujillo, MD

    Gerencia Atención Primaria. Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 17, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 9, 2017

Record last verified: 2017-03

Locations

ES(1)