- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03502928
Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
INTRODUCTION: Whiplash is an injury produced by an acceleration-deceleration mechanism that transmits energy to the cervical spine. According to the bibliography, the conservative treatment (motor control exercises and manual therapy) has shown benefits in approaching this lesion, but its efficacy is limited. Dry needling has already shown its usefulness in different musculoskeletal pathologies, however, its efficacy is unknown when it is included in conservative treatment.
OBJECTIVES: The objective of this study is to assess the effects of the incorporation of dry needling in the conventional treatment with manual therapy and motor control exercises, compared to the conventional non-invasive treatment in patients with acute or subacute whiplash.
HYPOTHESIS: The inclusion of dry needling in conventional non-invasive treatment is more effective than conventional non-invasive treatment in patients with acute or subacute whiplash.
METHODS: A randomized clinical trial will be conducted in which the subjects of study will be assigned to two groups, a control group (conventional treatment) and an experimental group (conventional treatment and dry needling).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alcalá De Henares, Spain
- Universidad de Alcala
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medical Diagnosis of Whiplash Grade I-II in the QTF
- Neck Pain
- Whiplash in Acute or Subacute Phase
Exclusion Criteria:
- Pregnancy
- Belonephobia
- Cervical Fractures-Dislocations or Neurological Deficit Secondaries to Accident
- Previous Surgery of the Cervical Spine
- Circulatory Disease, Respiratory Disease, Neurological Disease, Rheumatologic Disease and Mental Illness
- Athletes
Study Plan
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: Conventional Treatment
Motor Control + Manual Therapy
|
Neck Motor Control
Massage + Joint Mobilizations
|
|
Experimental: Experimental Treatment
Motor Control + Manual Therapy + Dry Needling
|
Neck Motor Control
Massage + Joint Mobilizations
Dry Needling in Neck Muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index. Changes from Baseline
Time Frame: 3 weeks, 6 weeks, 3 months
|
0-100% (0% = No Disability; 100% = Disability (highest level of disability)
|
3 weeks, 6 weeks, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure pain thresholds. Changes from Baseline
Time Frame: 3 weeks, 6 weeks, 3 months
|
The minimum force applied which induces pain.
Measured kg/cm2
|
3 weeks, 6 weeks, 3 months
|
|
Cervical Range of Movement. Changes from Baseline
Time Frame: 3 weeks, 6 weeks, 3 months
|
Amount of cervical movement using a goniometer
|
3 weeks, 6 weeks, 3 months
|
|
Kinesophobia. Changes from Baseline
Time Frame: 3 weeks, 6 weeks, 3 months
|
Fear of movement measured by the TAMPA scale
|
3 weeks, 6 weeks, 3 months
|
|
Cervical Motor Control. Changes from Baseline
Time Frame: 3 weeks, 6 weeks, 3 months
|
measure of cervical joint position sense using a laser
|
3 weeks, 6 weeks, 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 1489327794181094
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Whiplash Injuries
-
Linkoeping UniversityCompletedWhiplash Associated DisorderSweden
-
University Hospital, Clermont-FerrandJacques Lacarin Hospital Center; CH Issoire; CH Montluçon; CH Aurillac; CH Moulins; CH Thiers and other collaboratorsCompleted
-
University of CalgaryVivo Cura HealthRecruitingWhiplash Associated Disorder (WAD)Canada
-
Soroka University Medical CenterUnknown
-
University of IcelandLandspitali University Hospital; Reykjavik University; Empowered HealthActive, not recruiting
-
University of Southern DenmarkCompleted
-
Korean Pharmacoacupuncture InstituteUnknown
-
University Hospitals, LeicesterCompletedWhiplash Associated DisorderUnited Kingdom
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingChronic Whiplash Associated DisorderNetherlands
Clinical Trials on Motor Control
-
Riphah International UniversityCompletedPostural ControlPakistan
-
Universidad Rey Juan CarlosCompleted
-
National Yang Ming Chiao Tung UniversityActive, not recruitingShoulder Impingement SyndromeTaiwan
-
Mahidol UniversityNational Taiwan UniversityCompleted
-
KTO Karatay UniversityRecruitingChronic Neck PainTurkey (Türkiye)
-
Luleå Tekniska UniversitetUmeå University; County Council of Norrbotten, Sweden; NorrlandsklinikenCompleted
-
Research Center of Neurology, RussiaInstitute of Higher Nervous Activity and Neurophysiology of RASRecruitingDrug Resistant Epilepsy | Brain-Computer InterfacesRussian Federation
-
Universidad Autonoma de MadridCompleted
-
Universidade Estadual Paulista Júlio de Mesquita...Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.CompletedRelationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises InterventionChronic Low Back PainBrazil
-
Investigación en Hemofilia y FisioterapiaUnknownSports Physical TherapySpain