Effect of dry needling in headache and neck pain of muscular origin

ISRCTN ISRCTN68233036
DOI https://doi.org/10.1186/ISRCTN68233036
Secondary identifying numbers N/A
Submission date
01/06/2012
Registration date
02/08/2012
Last edited
22/06/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Daniel Pecos-Martin
Scientific

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

Study information

Study designRandomized double-blind clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffectiveness of treatment with dry needling lower trapezius muscle in patients with head and neck pain
Study objectivesTreatment 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(s)Ethics Committee of Hospital Principe de Asturias, 10/01/2010, ref: 28/2009
Health condition(s) or problem(s) studiedHead and neck pain
InterventionPatients 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date10/01/2011
Completion date15/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants72
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment10/01/2011
Date of final enrolment15/12/2011

Locations

Countries of recruitment

  • Spain

Study participating centre

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

Sponsor information

Alcalá University (Spain)
University/education

Physiotherapy and Pain Group
Alcalá de Henares / Madrid
28806
Spain

ROR logo "ROR" https://ror.org/04pmn0e78

Funders

Funder type

University/education

Universidad de Alcalá
Government organisation / Local government
Alternative name(s)
University of Alcalá, University of Alcalá, UAH
Location
Spain

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2015 Yes No

Editorial Notes

22/06/2017: Plain English summary added.