- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03095365
Dry Needling and Pain Education in the Treatment of Chronic Neck Pain
September 5, 2017 updated by: Josue Fernandez Carnero, Universidad Rey Juan Carlos
Dry Needling and Pain Neuroscience Education in Chronic Pain Patients
to compare the effects on pain, disability and psychological factors of the combination of MTrP dry needling and pain neuroscience education to MTrPs dry needing alone and control electrotherapy usual care in patients with chronic neck pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
-
San Sebastián de los Reyes, Madrid, Spain, 28702
- Hospital Universitario Infanta Sofía
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Mechanical neck pain for at least 12 weeks
- 10% or higher on the Neck Disability Index questionnaire
- 20mm or higher on the Visual Analogue Scale (VAS) of neck pain
- Presence of at least one active myofascial trigger point
Exclusion Criteria:
- Neck pain associated with whiplash injuries
- Medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis)
- Neck pain with cervical radiculopathy
- Neck pain associated with externalized cervical disc herniation
- Fibromyalgia syndrome
- Previous neck surgery
- Neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dry needling
Received Dry needling in the neck muscles.
|
Insertion of solid filament needles in the muscle
|
Active Comparator: Conventional treatment
the participants received the conventional treatment for non-specific neck pain.
|
Electrotherapy: Transcutaneous electrical nerve stimulation and microwaves
|
Experimental: Dry needling and pain neuroscience education
Received the same treatment as dry needling group and pain education.
|
Insertion of solid filament needles in the muscle
Explanation of the functioning of the central nervous system, the differences between acute pain and chronic pain and the importance of thoughts and beliefs in the processing and chronification of pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain using Visual Analogue Scale
Time Frame: 3 months
|
Visual Analogue Scale: consists of a line of 100mm which represents the "no pain" on the left side of the same and the "worst pain imaginable" on the right side
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication intake
Time Frame: 3 months
|
Medication use: number of pills
|
3 months
|
Disability using Neck Disability Index
Time Frame: 3 months
|
Neck disability index: patients ability to function in daily life activities.
|
3 months
|
Kinesiophobia using Tampa Scale of Kinesiophobia
Time Frame: 3 months
|
Tampa Scale of Kinesiophobia: participants pain-related fear of movement and (re)injury
|
3 months
|
Catastrophizing using Pain Catastrophizing Scale
Time Frame: 3 months
|
Pain Catastrophizing Scale: propensity to catastrophize about pain
|
3 months
|
Pain anxiety using Pain Anxiety Symptoms Scale
Time Frame: 3 months
|
Pain Anxiety Symptoms Scale: The anxiety behaviors associated with pain
|
3 months
|
Beck Depression Inventory-II
Time Frame: 3 months
|
Self-report measure to assess the severity of depressive symptoms
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2017
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 5, 2017
Study Registration Dates
First Submitted
March 14, 2017
First Submitted That Met QC Criteria
March 28, 2017
First Posted (Actual)
March 29, 2017
Study Record Updates
Last Update Posted (Actual)
September 8, 2017
Last Update Submitted That Met QC Criteria
September 5, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03/2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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