- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06149442
The Importance of the Number of Incisions in the Effectiveness of Dry Needling
Effectiveness of the Dry Needling Technique According to the Number of Incisions in the Treatment of Neck Pain
The dry needling technique is a procedure increasingly used by health professionals.
Dry needling consists of the use of a filiform needle to treat musculoskeletal pain. Currently, the mechanisms by which it is an effective technique are not well understood. One of the aspects not yet evaluated is the best dose in terms of the number of times it is necessary to insert the needle into the patient to achieve the best result.
This research work aims to assess which treatment obtains the best results in the management of patients with chronic neck pain.
Study Overview
Status
Conditions
Detailed Description
With the objective of demonstrating how the dose used during the application of the dry needling technique is related to the effectiveness of the treatment, we have designed a study where three different doses of the dry needling technique for the treatment of myofascial trigger points will be compared in the upper trapezius muscle in participants with neck pain.
Randomly, the participants will be distributed to each of the treatment groups and we will measure how the effectiveness of each of the applied doses determines the result of the application of the dry needling technique in the treatment of neck pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcalá de Henares, Madrid, Spain, 28805
- Physiotherapy and Pain Institute
-
Alcalá de Henares, Madrid, Spain, 28805
- Centro Investigación Fisioterapia y Dolor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Nonspecific mechanical neck pain for more than 3 months.
- Neck pain of at least VAS 5/10.
- Reproduction of pain and symptoms subjects on palpation.
- Pain on passive stretching of the muscle.
Exclusion Criteria:
- Subjects with previous surgical intervention.
- Subjects undergoing other intervention (rehabilitation/medication).
- Positive findings that raise suspicion of cervical radiculopathy:
- Subjects diagnosed: degenerative arthropathies, inflammatory, systemic conditions (fibromyalgia).
- Cardiovascular diseases.
- Whiplash or whiplash.
- Belenophobia.
- Dizziness and vertigo.
- Pregnant.
- Thyroid disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dose of five muscle incisions
Subjects treated in this group will receive an in-out technique with a dosage of five incisions in the myofascial trigger point of the levator scapulae muscle.
|
Once we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (five incisions).
|
|
Experimental: Dose of ten muscle incisions
Subjects treated in this group will receive an in-out technique with a dosage of ten incisions in the myofascial trigger point of the levator scapulae muscle.
|
Once we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (ten incisions).
|
|
Experimental: Dose of fifteen muscle incisions
Subjects treated in this group will receive an in-out technique with a dosage of fifteen incisions in the myofascial trigger point of the levator scapulae muscle.
|
Once we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (fifteen incisions).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck pain
Time Frame: Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
|
Visual Analog Scale (VAS).
VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions.
It is a straight horizontal line of fixed length, usually 100 mm where 0 is no pain and 10 is the worst possible pain.
|
Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability (Neck disability index)
Time Frame: Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
|
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
It´s value ranges from 0 to 10 to 50 points, where 0 is the absence of disability and 50 is the highest degree of disability.
|
Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
|
|
Pain catastrophizing
Time Frame: Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
|
Pain Catastrophizing Scale (PCS).
The PCS is a 13-item instrumen that task participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time.
The PCS total scores range from 0 - 52. 0 is the best result and 52 is the worst result.
|
Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
|
|
kinesiophobia
Time Frame: Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
|
The Tampa Scale of Kinesiophobia (TSK) describe patient circumstances characterised by an "excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability to painful injury or reinjury.
The TSK is a 17 item assessment checklist.The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
|
Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
|
|
The Global Rating of Change (GRoC)
Time Frame: Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
|
It's a scale that assesses whether the patient condition has gotten worse, better, or stayed
|
Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Daniel Pecos-Martin, PhD, Alcala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIM/2022/1/008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Neck Pain
-
Hochschule OsnabruckNot yet recruitingNeck Pain | Chronic Neck Pain | Neck Disability | Neck Pain Musculoskeletal | Neck Disease
-
Istanbul University - CerrahpasaRecruitingNonspecific Neck Pain | Neck Pain MusculoskeletalTurkey (Türkiye)
-
Universitat Internacional de CatalunyaNot yet recruitingChronic Neck Pain | Non-specific Neck PainSpain
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
Benha UniversityCompletedNeck Pain | Mechanical Neck Pain | Pain Threshold | Cervical Pain, Posterior | Neck Pain Musculoskeletal | Extracorporeal Shock Wave TherapyEgypt
-
University of LahoreCompletedNeck Pain | Mechanical Neck Pain | Mobilization | Neck Pain Musculoskeletal | Proprioceptive Neuromuscular FacilitationPakistan
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Hacettepe UniversityNot yet recruitingChronic Neck PainTurkey (Türkiye)
-
Riphah International UniversityCompletedChronic Neck PainPakistan
Clinical Trials on Dose of five-incisions dry needling technique
-
Universidad San JorgeUniversity of Castilla-La ManchaCompletedParkinson DiseaseSpain
-
Universidad San JorgeCompletedStroke | SpasticitySpain
-
Abant Izzet Baysal UniversityCompletedMyofascial Pain SyndromeTurkey (Türkiye)
-
University of the Basque Country (UPV/EHU)FisioAraba Centre Physiotherapy S.C.; Toshiba Medical Systems, S.A.; Metron Medical... and other collaboratorsCompletedMyofascial Pain Syndromes | Elastography | Dry Needling, Technique for the Treatment of the Myofascial Trigger PointsSpain
-
Cardenal Herrera UniversityCompleted
-
Al-Quds UniversityCompletedPhysical Therapy | Dry Needling Technique | Mulligan MobilizationPalestinian Territory, occupied
-
University of LahoreCompletedMeralgia Paresthetica | Chronic Low-back Pain (cLBP)Pakistan
-
Riphah International UniversityCompletedTrigger PointsPakistan
-
Universitat Internacional de CatalunyaHospital Universitari de BellvitgeCompletedCarpal Tunnel SyndromeSpain
-
Ziauddin UniversityCompletedTension-Type HeadachePakistan