Neck PainNCT01855893
Auto-acupressure: Effectiveness for Diminishing Neck Pain of Benign Origin
A study testing Auto-acupressure and Conventional treatment in people with Neck Pain, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Auto-acupressure and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who come to consultation of Primary Care for neck pain without structural hurt or irradiation, with muscular contraction and functional and postural limitation.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Auto-acupressure for Diminishing Neck Pain of Benign Origin
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.
- Conditions
- Neck Pain
- Being tested
- Auto-acupressure, Conventional treatment
- Keywords
- Neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The pain intensity will be evaluated by means of a millimetric scale of 10 cm (Numerical Rating Scale)
Measured: Ninety days
Secondary outcomes (1)
Perception of quality of life
The perception of quality of life will be evaluated by EuroQol 5D
Measured: Ninety days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Susana Calvo Trujillo, Gerencia de Atención Primaria, Madrid
- Investigators
- Susana Calvo-Trujillo, MD, Principal investigator, Gerencia Atención Primaria. Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855893
- Sponsor's protocol ID
- 12/00203
- Status last verified
- Mar 2017
- First submitted
- 8 May 2013
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Auto-acupressure for Diminishing Neck Pain of Benign Origin
- ClinicalTrials.gov ID
- NCT01855893
- Acronym / sponsor ID
- 12/00203
- Conditions
- Neck Pain
- Keywords
- Neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auto-acupressure | Experimental | Other: Auto-acupressurePatients 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 | Other | Other: Conventional treatmentConventional treatment consist of: 7 days with paracetamol 1g /8 hours and/ or ibuprofen 400mg/ 8 hours, and tetrazepam 50 mg/ 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who come to consultation of Primary Care for neck pain without structural hurt or irradiation, with muscular contraction and functional and postural limitation.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto-acupressurePatients 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 treatmentConventional 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 |
Primary outcome
Pain intensity
Time frame: Ninety days
The pain intensity will be evaluated by means of a millimetric scale of 10 cm (Numerical Rating Scale)
1 secondary outcome
Perception of quality of life
Time frame: Ninety days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Derived from this study: PubMed 33280397Susana 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Calvo-Trujillo, MD principal investigator
Gerencia Atención Primaria. Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto-acupressure and Conventional treatment in people with Neck Pain, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Ninety days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01855893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.