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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25582412