Condition category
Musculoskeletal Diseases
Date applied
01/06/2012
Date assigned
02/08/2012
Last edited
22/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to find out whether dry needling of the lower trapezius muscle reduces head and neck pain. Dry needling involves inserting a “dry” needle without medication through the skin into the muscle. The study looks at whether dry needling is more effective when performed in the most hyperalgesic (sensitive to pain) area than when it is performed in another area.

Who can participate?
Patients with head and neck pain for 3 months

What does the study involve?
Participants are randomly allocated to one of two groups. One group is treated with dry needling in the hyperalgesic zone in the lower trapezius muscle. The other group receives treatment with dry needling in a non-painful area in the same muscle. The participants’ pain and degree of disability are assessed before, immediately after, a week and one month after receiving the treatment.

What are the possible benefits and risks of participating?
Patients may benefit from the positive effects of treatment with dry needling. The study may demonstrate the importance of treatment with dry needling in the area of muscle injury associated with the patient's problem. The most important risk associated with dry needling is a certain tenderness after the puncture.

Where is the study run from?
University of Alcalá (Spain)

When is the study starting and how long is it expected to run for?
January to December 2011

Who is the main contact?
Dr Daniel Pecos-Martin

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Pecos-Martin

ORCID ID

Contact details

c/Camilo José Cela
53 Portal A-1ºC
Alcalá de Henares
28806
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of treatment with dry needling lower trapezius muscle in patients with head and neck pain

Acronym

Study hypothesis

Treatment with dry needling lower trapezius muscle improves pain and disability associated with neck pain patients. Treatment is most effective when performed in the most hyperalgesic area of this muscle and associated with the patient's pain.

Ethics approval

Ethics Committee of Hospital Principe de Asturias, 10/01/2010, ref: 28/2009

Study design

Randomized double-blind clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Head and neck pain

Intervention

Patients in the experimental group underwent a session of dry needling in the most hyperalgesic lower trapezius muscle with an acupuncture needle of 2.5 centimeters long and 0.25 millimeters thick. Technique was used as a therapeutic procedure.

Patients in the control group received the same treatment but at a distance from the point of that muscle hyperalgesic.

Both groups were followed for one month.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The differences between groups in pain sensation the patient assesed using Visual Analogue Scale (VAS). This scale was completed by patients before, week and month after surgery.
2. The problem associated with head and neck

Secondary outcome measures

1. The pain threshold to pressure measured with a pressure algometer before, immediately after, week and month after surgery. The most hyperalgesic zone in lower trapezius muscle was measured.
2. The degree of disability associated with neck pain with the questionnaire Northwick Park neck pain before and one month after the intervention.

Overall trial start date

10/01/2011

Overall trial end date

15/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult
2. Having pain in head and neck regions for three months
3. Present the lower trapezius muscle PGM3 active
4. Not having suffered any whiplash
5. Not having received invasive treatment in the last six months
6. Signing the consent form and accept the conditions of the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant exclusion criteria

1. Not accepted the conditions of the study and gave written informed consent
2. Those whose head and neck pain was shorter than three months
3. No active file PGM3 lower trapezius muscle
4. Those who had suffered some whiplash
5. Those diagnosed with migraine or tension headache
6. They had received invasive treatment in the last six months
7. They were afraid of needles
8. They were under pharmacological treatment with anticoagulants

Recruitment start date

10/01/2011

Recruitment end date

15/12/2011

Locations

Countries of recruitment

Spain

Trial participating centre

c/Camilo José Cela, 53 Portal A-1ºC
Alcalá de Henares
28806
Spain

Sponsor information

Organisation

Alcalá University (Spain)

Sponsor details

Physiotherapy and Pain Group
Alcalá de Henares / Madrid
28806
Spain

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Universidad de Alcalá

Alternative name(s)

University of Alcalá, UAH

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Spain

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25582412

Publication citations

Additional files

Editorial Notes

22/06/2017: Plain English summary added.